VIRILIS PENILE PROSTHESIS

K983015 · Specialty Surgical Products, Inc. · FTQ · Feb 5, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983015
• Device Name: VIRILIS PENILE PROSTHESIS
• Applicant: Specialty Surgical Products, Inc.
• Product Code: FTQ · Gastroenterology, Urology
• Decision Date: Feb 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

Device Story

The Virilis Penile Prosthesis is a surgically implanted device designed for the treatment of erectile dysfunction. It is placed into the corpora cavernosa of the penis to provide the rigidity necessary for vaginal penetration. The device is intended for use by surgeons in a clinical or hospital setting. By restoring penile rigidity, the prosthesis aims to enable sexual function for patients suffering from erectile dysfunction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Penile prosthesis for implantation into the corpora cavernosa. Class III device (21 CFR 876.3630).

Indications for Use

Indicated for patients diagnosed with erectile dysfunction requiring penile implantation to achieve rigidity for vaginal penetration.

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.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 5 1999

T. Jan Varner President & C.E.O. Specialty Surgical Products, Inc. 302 North First Street P.O. Box 218 Hamilton, Montana 59840

Dear Mr. Varner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

~~~

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Re: K983015 Virilis Penile Prosthesis Dated: November 30, 1998 Received: December 2, 1998 Regulatory Class: III 21 CFR 876.3630/Procode: 78 FTO

Image /page/0/Picture/15 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

FEB 5 1999

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## APPENDIX V

510(k) Number (if known): __K983015___

Device Name: Virilis Penile Prostheses _______________________________________________________________________________________________________________________________________

Indications For Use:

The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------------------------|
| | |
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K983015 |

Prescription Use __________ OR __________ Over-The-Counter Use __________

(Per 21 CFR 801.109) (Optional __________)

(Optional Format 1-2-96)