AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

K090663 · American Medical Systems, Inc. · FAE · Apr 9, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090663
• Device Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Applicant: American Medical Systems, Inc.
• Product Code: FAE · Gastroenterology, Urology
• Decision Date: Apr 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

Device Story

The AMS Spectra™ is a sterile, single-use, implantable penile prosthesis designed to treat chronic organic erectile dysfunction. The device consists of a pair of malleable cylinders surgically implanted into the corpora cavernosa. Each cylinder features articulating polymer and metal segments held together by a central cable and spring assembly, encased in a silicone outer surface. The device provides rigidity for intercourse and can be positioned for concealment. Rear tip extenders (RTEs) allow for length adjustment to match patient anatomy. The device is operated by the patient through manual manipulation to transition between concealed and erect states. It provides a mechanical solution to restore penile rigidity, benefiting patients by enabling sexual function.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through nonclinical mechanical performance testing, including evaluations of cycle life, springback angle, column strength, bend force, and packaging integrity.

Technological Characteristics

Implantable penile prosthesis; malleable articulating polymer and metal segments; silicone outer surface; cable and spring tensioning mechanism; available in 9.5-, 12-, and 14-mm diameters and 12-, 16-, and 20-cm lengths; adjustable via rear tip extenders (RTEs).

Indications for Use

Indicated for men with chronic, organic erectile dysfunction who are suitable candidates for implantation surgery.

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

• AMS Spectra™ Concealable Penile Prosthesis (K082006)
• AMS DURA II® Penile Prosthesis (K953640)

Reference Devices

• AMS 700™ CXR (D970012)
• AMS 700™ CX/LGX (D970012)

Submission Summary (Full Text)

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#### 7.3 510(k) Summary Statement (21CFR 807.92)

| Submitter | American Medical Systems Inc. (AMS)<br>10700 Bren Road West<br>Minnetonka, MN 55343 | |
|--------------------|-----------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Stephanie George<br>Phone [phone]<br>Fax [phone] | APR - 9 2009 |
| | Paul Bulger<br>Phone [phone]<br>Fax [phone] | |
| Preparation Date | March 10, 2009 | |
| Device Common Name | Penile Prosthesis | |
| Device Trade Name | AMS Spectra™ Concealable Penile Prosthesis | |
| CFR Number | 21 CFR Part 876.3630 | |
| Regulatory Class | Class II (special controls) | |
| Product Codes | 78 FAE (penile prosthesis) | |
| Predicate Devices | AMS Spectra™ Concealable Penile Prosthesis<br>(K082006)<br>AMS DURA II® Penile Prosthesis (K953640) | |

### Indications for Use

The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

## Device Description

The AMS Spectra™ Concealable Penile Prosthesis consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. Each device consists of two cylinders and may include rear tip extenders (RTEs) for additional length. All components consist of implantable, biocompatible materials.

The cylinder consists of a malleable section of articulating polymer and metal segments. A cable extends through the center of the articulating segments. The

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proximal and distal ends of the cable are each connected to a spring that is encased in a metal housing. The entire outside surface of the cylinder is made of silicone.

The articulating segments, held together by the cable and spring assemblies, provide sufficient friction and rigidity. This allows the patient to position the device for concealment or for intercourse.

Spectra cylinders are available in 9.5-, 12-, and 14-mm diameters. Each cylinder diameter is available in three lengths: 12-, 16-, and 20-cm.

The total cylinder length can be adjusted by adding rear tip extenders (RTEs) to the proximal cylinder end. A range of RTE lengths is included to accommodate the patient's total intracorporal length.

Rear tip extenders may be attached to the Spectra™ cylinders in 0.5-cm increments, and may extend the cylinder lengths from 0.5- to 7.5-cm, with the exception of 7-cm. The RTEs are the same as those used with the inflatable AMS 700™ CXR and CX/LGX models (D970012). These RTE components' functional performance has been demonstrated in use with the 700™ IPP products.

### Substantial Equivalence

The AMS Spectra™ Concealable Penile Prosthesis was subjected to mechanical performance tests to evaluate its function. These tests included evaluations of cycle life, springback angle, column strength (rigidity), bend force, and packaging. For each test, acceptance criteria were established prior to testing. The outcome of each test was that the acceptance criteria were met by the Spectra™ product, demonstrating substantial equivalence to the predicate products.

Because the intended use and technological characteristics of the predicate Spectra™ and DURA II® devices were maintained in the subject AMS Spectra™, a clinical study was not conducted for the subject Spectra™ device.

The nonclinical performance tests demonstrated that the Spectra™ device is as safe, as effective, and performs as well as or better than the predicate Spectra™ and DURA II® penile prostheses.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stephanie George Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

APR - 9 2009

Re: K090663 Trade/Device Name: AMS Spectra" Concealable Penile Prosthesis Regulation Number: 21 CFR 876.3630 Regulation Name: Penile rigidity implant Regulatory Class: II Product Code: FAE Dated: March 10, 2009 Received: March 12, 2009

Dear Ms. George:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris · Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 7.2 Statement of Indications for Use

# Indications for Use

# 1090663

510(k) Number (if known): Unknown

Device Names: AMS Spectra™ Concealable Penile Prosthesis

Indications For Use:

AMS Spectra™ Concealable Penile Prosthesis

The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Signature

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number