(97 days)
The AMS Spectra™ Concealable Penile Prosthesis is a sterile, nonpyrogenic, 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.
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 segments. A cable extends through the center of the articulating segments. The 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.
The AMS Spectra™ Concealable Penile Prosthesis did not include a clinical study. The device's acceptance criteria and performance were established through non-clinical performance tests, comparing it to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cycle Life | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Springback Angle | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Column Strength (Rigidity) | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Bend Force | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Bond Strength | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Packaging | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Sterilization | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Biocompatibility | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Cadaveric Evaluation | Not explicitly stated, but implied to be satisfactory. | Undertaken with physicians, implying satisfactory performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. The tests were performed on the "Spectra™ product," which refers to the device itself.
Data Provenance: The data is from non-clinical performance tests conducted by American Medical Systems Inc. (AMS). These are laboratory tests and a cadaveric evaluation, not data from human subjects. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the cadaveric evaluation, "physicians" were involved. The specific number and qualifications (e.g., Urologist, years of experience) are not provided in the document. For the other non-clinical tests (cycle life, strength, etc.), ground truth was established by engineering specifications and industry standards relevant to the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This was not a human observer study requiring an adjudication method. The non-clinical tests involved objective measurements against a predetermined, internal acceptance criterion.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The device is a physical implant, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the AMS Spectra™ Concealable Penile Prosthesis is a physical medical device, not an algorithm or AI. It does not perform a diagnostic or interpretive function that would require "standalone" performance evaluation in that context. The "standalone" performance here would refer to the device's functional integrity as an implant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical performance tests was based on pre-established acceptance criteria derived from engineering specifications and the performance characteristics of the predicate devices. For the cadaveric evaluation, the ground truth was likely based on physician feedback and assessment of the device's functionality and implantability.
8. The Sample Size for the Training Set
There is no training set in the context of this device. This device is a physical implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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| Submitter | American Medical Systems Inc. (AMS)10700 Bren Road WestMinnetonka, MN 55343 | OCT 20 2008 |
|---|---|---|
| Contact Person | Stephanie GeorgePhone (952)-930-6389Fax (952)-930-5785 | |
| Preparation Date | July 14, 2008 | |
| 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 | DURA II® Penile Prosthesis (K953640)AMS 600MTM Malleable Penile Prosthesis (K912935)AMS 650TM Malleable Penile Prosthesis (K951716) |
7.3 510(k) Summary Statement (21CFR 807.92)
Indications for Use
The AMS Spectra™ Concealable Penile Prosthesis is a sterile, nonpyrogenic, 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 segments. A cable extends through the center of the articulating segments. The 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.
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AMS Spectra™ Concealable Penile Prosthesis Special 510(k)
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 performance tests to evaluate its function. These tests included evaluations of cycle life, springback angle, column strength (rigidity), bend force, bond strength, packaging, sterilization, biocompatibility, and cadaveric evaluation with physicians. 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 the fundamental scientific technology of the predicate DURA II® and AMS 600M™ and 650TM Malleables were maintained with the AMS Spectra™, a clinical study was not conducted for SpectraTM.
The nonclinical performance tests demonstrated that the Spectra™ device is as safe, as effective + and performs as well as or better than the legally marketed DURA II® and AMS 600MTM and 650TM Malleable 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 2008
Ms. Stephanie George Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
K082006 Re:
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: October 14, 2008 Received: October 15, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the 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) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jozue M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AMS Spectra™ Concealable Penile Prosthesis Special 510(k)
7.2 Statement of Indications for Use
Indications for Use
510(k) Number (if known):
K082006 Unknown
Device Names:
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 NEEDED)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number J
CONFIDENTIAL
§ 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.”