AMS AMBICOR PENILE PROSTHESIS

K963328 · American Medical Systems, Inc. · FAE · Dec 4, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963328
• Device Name: AMS AMBICOR PENILE PROSTHESIS
• Applicant: American Medical Systems, Inc.
• Product Code: FAE · Gastroenterology, Urology
• Decision Date: Dec 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMS Ambicor Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in men who, after appropriate patient history, diagnostic evaluation and discussions with the urologist of other alternative treatment methods, are determined to be suitable candidates for implantation surgery.

Device Story

Inflatable penile prosthesis for treatment of chronic organic erectile dysfunction. Device consists of two cylinders implanted in corpora cavernosa and a pump implanted in scrotum. Operation: user squeezes pump bulb to transfer saline from reservoir to cylinders, creating rigidity. Deflation: user bends penis/cylinders to 55-65° angle for 6-12 seconds to release fluid back to reservoir. Used in surgical setting by urologists. Benefits patients by restoring erectile function. Includes rear tip extenders for length adjustment.

Clinical Evidence

Bench testing only. Physical, mechanical, and biocompatibility testing performed to compare Texapol and Delrin materials. No clinical data provided.

Technological Characteristics

Inflatable penile prosthesis. Materials: silicone elastomers, polyester fabric, expanded PTFE, stainless steel, nylon, and polyacetal (Texapol copolymer). Dimensions include 12 rear tip extenders (0.5 cm each). Sterilization via Steam/EtO (SAL 10^-6). Mechanical operation via fluid transfer (saline).

Indications for Use

Indicated for men with chronic, organic erectile dysfunction (impotence) who are suitable candidates for implantation surgery following diagnostic evaluation and urological consultation.

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

• AMBICOR Penile Prosthesis (K930163)

Submission Summary (Full Text)

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DEC - 4 1996
CONFIDENTIAL
Pfizer
American Medical Systems
K963328
P194

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. SUBMITTER

Name and Address: American Medical Systems
10700 Bren Road West
Minnetonka, Minnesota 55343

Phone and Fax Numbers: 612-930-4666 (phone)
612-930-6496

Contact Person: Kris Teich

Date of Summary Preparation: August 21, 1996

Establishment Registration Number: 2183959

## II. DEVICE NAME

Device Common or Usual Name: Penile Inflatable Implant

Device Trade or Proprietary Name: AMS Ambicor™ Penile Prosthesis

Classification Name: Penile Inflatable Implant (21 CFR §876.3350)

## III. PREDICATE DEVICE

Penile Inflatable Implant (21 CFR §876.3350)

## IV. DEVICE DESCRIPTION

The Ambicor Penile Prosthesis is a device intended for implantation in the body to correct erectile impotence. The device consists of two cylinders and a single pump. The cylinders are implanted in the corpora cavernosa of the penis and a pump which is implanted in the scrotum. Each time the pump bulb is squeezed, saline is pumped from the reservoir into the cylinders. This step produces the inflation that makes the penis rigid. The Ambicor Penile Prosthesis is deflated by bending the penis (and specifically, the cylinders) to a 55 - 65° angle and maintaining that position for 6-12 seconds before releasing

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The device comes with 12 rear tip extenders (RTE). Each RTE provides 0.5 cm of additional length to the device. A total of 12 RTEs are packaged with each device, potentially providing an additional 3.0 cm of length expansion per cylinder (6 RTEs/cylinder). The device consists primarily of silicone elastomers and incorporates polyester fabric, an expanded polytetrafluoroethylene (PTFE) sleeve, a polyacetal, and stainless steel components.

## V. INDICATIONS FOR USE

The AMS Ambicor Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in men who, after appropriate patient history, diagnostic evaluation and discussions with the urologist of other alternative treatment methods, are determined to be suitable candidates for implantation surgery.

## VI. COMPARISON TO PREDICATE DEVICE

For the following reasons, we maintain that the Texapol material is substantially equivalent to the Delrin material and that the change in materials poses not new questions of safety or effectiveness.

| MATERIAL/DEVICE COMPARISON | | |
| --- | --- | --- |
| FEATURE | AMBICOR Penile Prosthesis
(with Delrin components) | AMBICOR Penile Prosthesis
(with Texapol components) |
| 510(k) | K930163 | To be assigned |
| Intended Use | Erectile Dysfunction | Erectile Dysfunction |
| Material | Silicone Elastomer
Polyester Fabric
Expanded PTFE
Stainless Steel
Nylon
Delrin | Silicone Elastomer
Polyester Fabric
Expanded PTFE
Stainless Steel
Nylon
Texapol |
| Sterilization | Steam/EtO
SAL of 10^{6}
EtO Residuals within acceptable limits | Identical |
| Packaging | Foil pouch placed inside a
Tyvek/Mylar pouch | Identical |
| Anatomical Placement | Cylinders in the corporal bodies, pump
bulb in the scrotum | Identical |

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| MATERIAL/DEVICE COMPARISON | | |
| --- | --- | --- |
| FEATURE | AMBICOR Penile Prosthesis
(with Delrin components) | AMBICOR Penile Prosthesis
(with Texapol components) |
| Functional Characteristics | Inflation occurs by squeezing the pump bulb thereby pushing fluid from the reservoir to the cylinders. Deflation occurs by bending the cylinders (penis) at a 55-65° angle and holding this angle for 6-12 seconds before releasing the cylinders. Fluid transfer occurs between the outer tube and woven tubing into the reservoir via the pump bulb | Identical |
| Identity and dimensional specifications of components | Delrin is the current material for the poppet, stiffener, and snap washer used in the manufacture of Ambicor | The dimensional specifications were not changed based on the material change from Delrin to Texapol. All new material parts will be qualified prior to use. |

A. **Bench Testing**

The physical, mechanical, and biocompatibility tests used to evaluate Texapol provide data which supports our determination that Texapol is substantially equivalent to Delrin and is suitable for use in the Ambicor Penile Prosthesis.

B. **Principles of Operation**

Inflation occurs by squeezing the pump bulb thereby pushing fluid from the reservoir and pump to the cylinders. Deflation occurs by bending the cylinders (penis) at a 55-65° angle and holding this angle for 6-12 seconds before releasing the cylinders. Fluid transfer occurs between the outer tube and woven tubing into the reservoir and pump via the pump bulb

C. **Device Performance**

The Ambicor Penile Prosthesis manufactured with Texapol components is comparable with respect to intended use and

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CONFIDENTIAL p4014

technological characteristics to the Ambicor Penile Prosthesis manufactured with Delrin components.

## D. Material Comparison

Acetal resins are highly crystalline plastics based on formaldehyde polymerization technology. These resins are strong, rigid, and have good moisture, heat and solvent resistance. Both homopolymer and copolymer acetal resins can be produced.

Delrin 100 and Delrin 500 are classified as homopolymers. Homopolymers generally have higher melting points, increased hardness, higher resistance to fatigue, increased rigidity, higher tensile and flexural strength and less elongation than copolymers.

Texapol 5203 and Texapol 5209 are classified as copolymers. Copolymers have excellent balance of properties and processing characteristics including high tensile and flexural strength, fatigue resistance and hardness. They retain much of their toughness through a broad temperature range. Copolymers process easier and faster than the conventional homopolymer grades.

By comparison, both homopolymers and copolymers are suitable for use as component materials in the Ambicor Penile Prosthesis.

In summary, American Medical Systems has provided information within the 510(k) premarket notification to indicate that the Ambicor Penile Prosthesis manufactured using components made from Texapol is safe and effective for its intended use in the treatment of penile erectile dysfunction. Texapol has been shown to be comparable to Delrin in regards to the technological characteristics and intended use of the device. The data and information provided within this 510(k) premarket notification adequately supports our claim of substantial equivalence.