MENTOR GENESIS PENILE PROSTHESIS

K040959 · Mentor Corp. · FAE · Oct 29, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040959
• Device Name: MENTOR GENESIS PENILE PROSTHESIS
• Applicant: Mentor Corp.
• Product Code: FAE · Gastroenterology, Urology
• Decision Date: Oct 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

Device Story

Flexible silicone elastomer penile prosthesis; implanted in pairs into corpora cavernosa; features silver wire coil and core for structural support; allows manual positioning for intercourse and concealment. Hydrophilic coating applied to external surfaces. Used by physicians in surgical setting for management of erectile dysfunction. Provides mechanical rigidity to facilitate intercourse.

Clinical Evidence

Bench testing only. Testing included package integrity, water uptake, lubricity, coating coverage, retention angle, column strength, device length, cyclic fatigue, and tail cap separation force. Biocompatibility testing (ISO 10993-5) included cytotoxicity, systemic toxicity, intracutaneous reactivity, sensitization, mouse lymphoma, and AMES test. All specifications met.

Technological Characteristics

Silicone elastomer construction; silver wire coil and core for rigidity; hydrophilic coating on external surfaces. Dimensions include trimmable proximal section. Non-powered, mechanical implant. Sterilization method not specified.

Indications for Use

Indicated for management of impotence in patients with conditions including epispadias, pelvic fracture, spinal cord injury/disease, prostatectomy, abdominal-perineal resection, multiple sclerosis, diabetes mellitus, alcoholism, arteriosclerosis, hypertensive vascular disease, priapism, Peyronie's disease, or psychogenic impotence.

Regulatory Classification

Identification

A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

Special Controls

The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”

Predicate Devices

• Acu-Form Penile Prosthesis (K900371)

Reference Devices

• Titan Inflatable Penile Prosthesis (P000006/S1)

Submission Summary (Full Text)

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## OCT 2 9 2004

This 510(k) summary of safety and effectiveness information is being summitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: K040959

| Contact Person: | Donna A. Crawford<br>Director, Corporate Regulatory Affairs<br>Mentor Corporation<br>201 Mentor Drive<br>Santa Barbara, CA 93111 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
| | Telephone: [phone]<br>FAX: [phone] |
| Date Prepared: | April 7, 2004 |

#### Device Name and Classification

| Proprietary Name: | Mentor GenesisTM Penile Prosthesis |
|----------------------|------------------------------------|
| Common Name: | Penile Prosthesis |
| Classification Name: | Penile Rigidity Implant |
| Class: | Class II |
| Product Code: | 78FAE |
| CFR #: | 21 CFR §876.3630 |

#### Device Description

The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis.

All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.

#### Substantial Equivalence Claim

The Mentor Genesis Penile Prosthesis is essentially identical in design and function to Mentor's Acu-Form Penile Prosthesis (510(k) K900371) with the exception that it has been modified to incorporate a hydrophilic coating. This coating was previously submitted and approved by FDA for Mentor's Titan Inflatable Penile Prosthesis under PMA P000006/S1.

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#### Indications for Use

The Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

#### Summary of Testing

Physical and Mechanical testing conducted on the Genesis Penile Prosthesis included Package Integrity, Water Uptake, Lubricity, Coating Coverage, Retention Angle, Column Strength, Device Length, Cyclic Fatigue and Tail Cap Separation Force. The Genesis device met all test specifications.

Biocompatibility testing performed on the Genesis Penile prosthesis included Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Sensitization (30-Day and 12-Week), Mouse Lymphoma, and Bacterial Reverse Mutation (AMES). These tests were conducted in accordance with ISO10993-5. The Genesis Penile Prosthesis met all specifications and passed all testing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 9 2004

Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

Re: K040959

Trade/Device Name: Mentor Genesis " Penile Prosthesis Regulation Number: 21 CFR §876.3630 Regulation Name: Penile rigidity implant Regulatory Class: II Product Code: 78 FAE Dated: October 8, 2004 Received: October 12, 2004

Dear Ms. Crawford:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Mentor Genesis™ Penile Prosthesis

Indications for Use:

The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming Fire Memor Genebes, including epispadias; pelvic fracture; spinal cord injury or disease; nom a varroy; cystectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; prosuteolorir), arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

or

Over the Counter Use

(Per CFR 801.109)

(Optimal Format 1-2-96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number _

000009