(103 days)
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.
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. 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, incorporates polyester fabric, an expanded polytetrafluoroethylene (PTFE) sleeve, a polyacetal, and stainless steel components.
This document describes the AMS Ambicor™ Penile Prosthesis and its comparison to a predicate device, focusing on a material change from Delrin to Texapol components. The submission aims to demonstrate substantial equivalence, rather than establishing acceptance criteria for a new device's performance against a disease or condition. Therefore, the information requested about acceptance criteria and a study proving the device meets those criteria (in the context of clinical outcomes or diagnostic accuracy) is not directly applicable to this type of regulatory submission.
However, based on the provided text, we can interpret "acceptance criteria" through the lens of substantial equivalence for this material change, and describe the "study" as the bench testing and material comparison performed.
Here's an analysis structured per your request, adapting the terms to fit the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a material change demonstrating substantial equivalence, the "acceptance criteria" are implicitly defined by the properties of the predicate device (AMS Ambicor with Delrin components). The "reported device performance" refers to the AMS Ambicor with Texapol components meeting these established properties.
| Acceptance Criteria (Based on Delrin Components) | Reported Device Performance (Texapol Components) |
|---|---|
| Intended Use: Erectile Dysfunction | Intended Use: Erectile Dysfunction (Identical) |
| Sterilization: Steam/EtO, SAL of 10-6, EtO Residuals within acceptable limits | Sterilization: Identical |
| Packaging: Foil pouch inside a Tyvek/Mylar pouch | Packaging: Identical |
| Anatomical Placement: Cylinders in corporal bodies, pump bulb in scrotum | Anatomical Placement: Identical |
| Functional Characteristics (Inflation/Deflation Mechanism): Inflation by squeezing pump bulb, deflation by bending penis at 55-65° for 6-12 seconds. | Functional Characteristics: Identical |
| Identity and dimensional specifications of components: (specifically poppet, stiffener, snap washer) | Identity and dimensional specifications of components: Not changed based on material change. All new material parts qualified prior to use. |
| Material Properties: Suitable for use as component materials in penile prosthesis (strength, rigidity, moisture, heat, solvent resistance; appropriate melting points, hardness, fatigue resistance, tensile/flexural strength, elongation) | Material Properties (Texapol): Copolymers with excellent balance of properties (high tensile/flexural strength, fatigue resistance, hardness), retain toughness over broad temperature range, easier/faster to process than homopolymers. Demonstrated to be suitable. |
| Overall Safety and Effectiveness: Comparable to Delrin components for intended use. | Overall Safety and Effectiveness: Comparable and safe/effective for intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "sample size" in the context of clinical patients or a large number of devices for statistical analysis. The "test set" here refers to the Texapol components themselves and devices fabricated with them for bench testing. The number of components or devices tested is not provided.
- Data Provenance: The data appears to be generated internally by American Medical Systems as part of their regulatory submission a prospective evaluation of the new Texapol material and devices manufactured with it. No country of origin for specific testing data is mentioned beyond the company's US address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable in this context. The "ground truth" for this submission is the established performance and material properties of the predicate device (Delrin components). The evaluation is a technical comparison by the manufacturer's engineers and scientists, rather than an expert medical consensus on a clinical outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This regulatory submission is a direct comparison of material properties and components, not a clinical trial requiring adjudications for diagnostic or treatment outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a penile implant, not a diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a mechanical implant; there is no "algorithm only" or "human-in-the-loop" performance associated with its function or evaluation in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this submission is the established performance and material specifications of the previously cleared predicate device (AMS Ambicor with Delrin components), as well as general scientific and engineering principles for material suitability in medical devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a new material for an existing device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
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CONFIDENTIAL
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American
Medical
® Systems
SUMMARY OF SAFETY AND EFFECTIVENESS
I. SUBMITTER
Name and Address: American Medical Systems 10700 Bren Road West Minnetonka, Minnesota 55343 612-930-4666 (phone) Phone and Fax Numbers: 612-930-6496 Kris Teich Contact Person: 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 incorporates polyester fabric, an an expanded and a elastomers polytetrafluoroethylene (PTFE) sleeve, a polyacetal, and stainless steel components.
INDICATIONS FOR USE V.
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 ElastomerPolyester FabricExpanded PTFEStainless SteelNylonDelrin | Silicone ElastomerPolyester FabricExpanded PTFEStainless SteelNylonTexapol |
| Sterilization | Steam/EtOSAL of 10-6EtO Residuals within acceptable limits | Identical |
| Packaging | Foil pouch placed inside aTyvek/Mylar pouch | Identical |
| AnatomicalPlacement | Cylinders in the corporal bodies, pumpbulb in the scrotum | Identical |
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|---|---|
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| MATERIAL/DEVICE COMPARISON | ||
|---|---|---|
| FEATURE | AMBICOR Penile Prosthesis(with Delrin components) | AMBICOR Penile Prosthesis(with Texapol components) |
| FunctionalCharacteristics | 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 anddimensionalspecifications ofcomponents | 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.
Principles of Operation B.
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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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.
§ 876.3630 Penile rigidity implant.
(a)
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.(b)
Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”