The present CE-Certification concerns the JES Extender, a traction device for penile jengthening.

Managing Director Bent Andreasen.

Gazette A 1994 , Annex 135 Regulations concerning medical equipment,

CHAPTER 1

FIELD OF APLICATION AND DEFINITIONS

The JES Extender falls within the scope of Regulations concerning medical equipment, cf 1,2 - schedule 1C, any device produced for human aplication with a view lo anatomic changes

Gazzete A 1994 , Annex 135 Regulations concerning medical equipment

SECTION 2

MARKETING, USAGE AND REGISTRATION

Provided that the JES Extender is applied, maintained and used correctly and in accordance with the specifications of section 2 it contitutes no health hazard or safety risk for patients, users or any third parties involved.

The manual is written in Danish, of section 2,2 and in the native language of those countries where it is marketed.

EFA Production APS undertakes to provide both the manual and the packaging ( brown mahogany box, containing the constituent parts of the JES Extender) with a conspicuous, indelible and easily readable CE-certification label, of Section 3,2.

The particular design of the JES Extender precludes labeling of the device proper.

EU DIRECTIVE - SUPPLEMENT IX - CLASSIFICATION CRITERIA

Definitions in accordance with section 1.4 - Active medical devices

The JES Extender in a device for penile lengthening by means of traction.

Traction of the penis does not reply on any electrical source of energy but merely the body´s own energy on gravity.

The effect of the JES Extender does not depend on any significant transmission of energy from the medical device to the penis but penile langthening is obtained solely by constant static traction. Henca the JES Extender must be considered a non-active medical device.

The JES Extender is therefore a Class I device and an EC Declaration of Conformity will be drawn up and signed by EFA Production APS.

EU-DIRECTIVE - SUPPLEMENT VII , SUBSECTION 3 - EU DECLARATION OF CONFORMITY

GENERAL DESCRIPTION OF THE DEVICE

The JES Extender utilízes the principle of traction for tissue espansion.

The device consists of a basal, anatomically shaped plastic ring and a distal plastic-silicone nupport, connected by two adjustable metal bars. The basal plastic ring is fastened around the root of the penis and the plastic- silicone nupoort is attached at the head of the penis.

Modifiable traction of the penis is transmitted via the two adjustable metal bars connecting the basal ring and the distal support. (Please refer to illustrations and descriptions in the JES Extender manual).

 

DESIGN DRAWINGS

For further information pleause refer to the JES Extender manual, Supplement 1 .

The design drawings will constitute Supplement 2 of the total material submitted for CE certification.

RISK ANALYSIS

The following hazards have been taken into consideration :

a) The basal ring : to obtain a diametre which will not constitute a risk at erection by blocking afferent and deferent vassels. An inner diameter of 42 mm. Is also considered optimal by a study reporting on a device for traction of the urethra to correct scarring caused by previous mutilating cystoscopy (Early examinations of the badder were) carried out by the introduction of thick tubes for possible visualization of the wall and the contants of the bladder and subsequent disruption of bladder stones via the tubes.

Lesions of the urethral wall caused by the tube led to scarring and contarctions (Ref. 1)

In two patients with exceptionally large peníses, both when jimp and during erection, the basal ring, provided whit a specially designed recess for the urethra, proved to allow of unhampered erection.

Ref, 1 : Emerson CH. Vorrichtung zum Strecken der Harnröhre.

Kaiserliches Patentamt, Patentschrift nr. 166168 Klasse 30d, 29 märz 1904.

b) The distal plastic-silicone support; To design a support, which nigth be fastened nera the penile head without compromising the blood supply and thus damage the tissue through jack of oxygen. The illustrations of the JES Extender manual show that between the two holes in the.bowl-shaped support, through which the tubes are passed, is an uncovared triangular area that permits unimpeded blood supply.

c) The two adjustable connecting bars; To achieve a functioning of the basal ríng via the two connective bars which might facilitate attainment of the desired angle of the penis during arection without inadvertantly blocking deferent vassels with the basal ring.

d) The employment of exclusively non-reactive POM (Hostaform). The connective metal bars are made of Nitin coaled brass. Nitin is an intermetallic alloy of nickel and Lin, derived by electrolytic precipitation.

Despite the fact that clinical trials have proven that nickel allergics do not react to the coating, which contains 35 per cent of nickel, such patients are recommended to use silver- or gold coated devices.

TESTINGS - CLINICAL DATA

No proper unbiazcd, randomized, double-blind trials have been carried out, but treatment whit the JES Extender has been perfomed at the scandinavian Clinic of Surgery.

No actual study reports have been drawn up, but as the device has been used for treatment individual data have been recorded.

Initially the device was tested on 22 patients, consisting of three diferent categories :

a) 10 patients who had not undergone surgical penile lengthening 3 months prior to,
b) 10 patients who had undergone surgical penile lengthening 3 months prior to treatment with the device and
c) Two patients who started treatment with the device 2 weeks after surgery.

Clinical data appear from Clinical testing on page.

EU DIRECTIVE - SUPPLEMENT VII, SUBSECTTION 4 - EU DECLARATION OF CONFORMITY

As of now there have been no reports concerning malfunctioning on deterioration of the JES Extender, neither have any injuries been reported.

This product is the first of its kind and no technical or medical considerations related to the various features of the device have led the producer to withdraw any similar device from the market.

EU DIRECTIVE - SUPPLEMENT X - CLINICAL EVALUATION

1. General provisions

1.1. Provided that it is used for its proper purposes the device is guarantead to comply with the requiraments concerning characteristics and performance stipulated in Supplement I, subsections 1 and 3

On the condition that the device is used correctly and in accordance with the provided manual the design and the process of manufacture safeguard against any deterioration of the patient´sclinical condition and any hazard to either his or any third party´s health or safety.

All decisions concerning the design have been reached after carefully weighing risk factors against possible advantages and strict safety and health precautionary measures.

Testing of the device has not revealed any injuries, nor any short-term or long-term adverse effects.

The device possesses the yielding capacity stated by the manufaturer and after three months of at least 12 hours correct daily usage all 22 patients had obtained a measurable lengthening of the penis.

1.1.1. A survey of relevant scientific literature, describing the purpose and the mechanism of similar devices.

(Parts of the following are intented for later publication and will be submitted to a Medical Journal. The text is structured a a medical report).

INTRODUCTION

No proper unbiazed, randomized double-blind study has been performed.

The JES Extender es a medical device, categorized a a Class I device

Over a 2- year period, from January 1st to January 1st 1996 more than 400 patients have undergone surgical penile lengthening and thickening at the Scandinavian Clinic of Plastic Surgery. Also, on the basis of African reports on penile lengthening achieved by attaching weights, such as stones, to the penis, and on the fact that traction has led to expansion of lip tissue in Plate-lipped Negroes and ear tissue in Masai Warriors and womwn, experiments involving penile traction have been performed at the clinic during the same period.

Initially two patients had lead weights, in the shape of Acartridge belts@, weighing from 600 to 1.000 gram, attached to the penis.

Whenever possible the weights were worn for more then six hours a day and after a period of 4-6 months the patients had obtained an average lengthening of approximately 0.5 cm per month.

Following the same principle patients in the USA have had 2-pound weights suspended from their penises attached to silicone tubes fastened around the corona glandis. This device was marketed under the name of the PLD or the PLD Hangman. A similar device, marketed under the name of the PUD or the PUD Tugger, consisted of a steel eylinder, which was fastened around the glans (also used for circumcision) and to which various weights were attached. A German patient, who was treated at the clinic, informed the staff of the clinic that he had ordered a PLD Hangman, as he wanted to attempt traction treatment after undergoing penile surgery.

The American manufacturer delivered a traction device with weights, weighing a total of 3 kilo.

In 1940 Lmerson, the German Physician, began studies on the lengthening of urethral contractions, caused by the formation of scar tissue following mutilating cystoscopies (Ref.1).

In 1912 The German manufacturer Lother patented a similar device in Norway (Ref. 3. ). Only references published by the respective patent agencies are currently available (Ref. 1 and 3).

In contrast to the previously mentioned devices which apply traction by means of weights fastened around the glans the two latter devices operate on the shaft of the penis.

Ref. 1 Emarson CH. Vorrichtuny zym Strecken der Harnröhre.

Kaiserliches Patentamt, Patenschrift nr 166168 Klasse 30 d, 29 märz 1904.

Ref. 3 Lother M. Apparat til strekning af urinror. Norsk Patent nr. 23227, 13. August 1912.

2. Clinical Testing

2.1. Purpose

To obtain penile lengthening without previous surgical lengthening and to further improve the results achieved by surgery a device was required which was painless and more effective than earlier designs and which, when used correctly, would not damage the tissue.

To serve this purpose a new traction device was designed, whose vector was shifted from its earlier position immediately below the glans to a proximal position so that the force of traction was exerted on the shaft of the penis. New features were the anatomically correct basic plastic ring provided with a recess for the urethra, which was to be positioned around the root of the penis and the optimal distal part for the fastening of the glans by means of a silicone tube, passed through two holes in a bowl-shaped plastic support. Another novelty was the construction of two dynamic metal bars, whose purpose was to apply traction to the penis. The bars werrw fitted with 2 small manual screws for infinitely variable adjustment and the force was regulated by means of built in cylinders with springs, which were actuated by pistons attached to the two screws. )Please refer to the construction diagrams).

The two dynamic metal bars were hinged to the basal ring permitted the penis to assume any angular position, yet another innovation.

2.2. Ethical considerations

Subsequent testing was performed in accordance with the Helsinki Declaration, adopted in 1964 at the 18th session of the World Medical Assembly in Helsinki, Finland, last revised in 1989 at the 41th session of the Assembly in Hongkong.

2.3. Methods

Prototypes of the JES Extender Traction device were tested over a 12-month period at the Scandinavian Clinic of Surgery on 22 male patints ranging from 23 to 45 years of age. A traction force of 1.000 gram was applied to the penis daily for at least 12 hours.

The patients were not randomized but divided consecutively into three different groups:

a) 10 patients who had not undergone surgical penile lengthening

b) 10 patients who had undergone surgical penile lengthening three months prior to the application of the traction device

c) Two patients who had undergone surgical penile lengthening two weeks prior to the application of the traction device.

Data are based on self-reported measurements. Previous studies indicate that patients who have paid for their treatment are not likely to over-estimate the results but expect to get their money´s worth.

Furthermore, the patients were sceptical at the outset and such patients tend to complain of insufficient effect rather than overestimate the results (Ref. 2) (This paragraph is intented for inclusion in the Discussion of a future publication)

RESULTS

All patients from no. 1 up to and including no. 11 were treated without previous operation, patients no. 12 up to and including 20 were treated with traction three months after surgical lengthening and numbers 21 and 22 were treated with traction two weeks after surgical lengthening.

The 10 patients who were treated with traction without previous surgical lengthening achieved an average lengthening of the penis at erection of 2.8 cm (range 1.5 - 5.0cm) after using the device for at least 12 hours a day over a period of 16.4 weeks (range 8 - 24 weeks).

Those patients who had undergone surgical penile lengthening three months prior to application of the device achieved an average lengthening of 4.5 cm (range 3.0 - 5.5 cm) after using the JES Extender for an average period of 16.0 weeks (range 16 - 16 weeks)

However, if the JES Extender is applied only two weeks after surgery an average lengthening of 9.5 cm (range 8.0 - 11 cm) is achieved after using the device for averagely 20 weeks ( range 16 - 24 weeks ). During the period of testing 4 patients had minor epidermal abrasions at the site of the corona, but no other injuries were reported. The abrasions occurred during fastening of the device and were caused by the somewhat rugged exterior of the prototype. When used correctly the ultimate design does not cause abrasions or epidermolysis.

Owing to pain in the head of the penis two patiensts who had previously undergone surgical penile lengthening started out gently by using the device for only 30 - 45 minutes per day and then gradually increased the timespan to two hours per day over a period of two weeks. After two months they were able to use the device for approximately 12 hours on end.

The remaining patients started out by using the device for a minimun of two successive hours and then after 1 - 2 weeks gradually increased the timespan to approximately 12 hours on end.