(103 days)
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No
The device description and performance studies focus on mechanical and material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence), which is a medical condition, making it a therapeutic device.
No
Explanation: The device is described as a penile prosthesis intended for the treatment of erectile dysfunction by implantation, and its description focuses on its mechanical function (inflation/deflation) rather than on identifying, detecting, or monitoring a disease or condition.
No
The device description clearly outlines physical components intended for implantation (cylinders, pump, reservoir, rear tip extenders) made of various materials, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description: The description clearly states that the AMS Ambicor Penile Prosthesis is a device intended for implantation in the body to correct erectile impotence. It involves physical components (cylinders, pump) that are surgically placed within the patient.
- Intended Use: The intended use is the treatment of chronic, organic, male erectile dysfunction through implantation surgery. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a surgically implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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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.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Cylinders in the corporal bodies, pump bulb in the scrotum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Device Performance: The Ambicor Penile Prosthesis manufactured with Texapol components is comparable with respect to intended use and technological characteristics to the Ambicor Penile Prosthesis manufactured with Delrin components.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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CONFIDENTIAL
Image /page/0/Picture/2 description: The image shows two lines of text. The first line reads "K963328", and the second line reads "piny". The text appears to be handwritten in black ink on a white background. The handwriting is somewhat messy and uneven.
Image /page/0/Picture/3 description: The image contains two logos. The first logo is for Pfizer, and it features the company's name in a stylized font inside of an oval shape. The second logo is for American Medical Systems, and it features a stylized "A" with the company's name to the right.
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 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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| f | 1 |
|---|---|
| ---------------------------- | --- |
| 7
4
| 1 | - |
|---|---|
| ------------- | --- |
| 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.
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.