(28 days)
D970012
No
The device description and performance studies focus on mechanical properties and materials, with no mention of AI or ML.
Yes
The device is intended for the "treatment of chronic, organic, erectile dysfunction" which aligns with the definition of a therapeutic device.
No
The device is an implantable penile prosthesis designed to treat erectile dysfunction by providing penile rigidity. It is a therapeutic device, not one that gathers information about a patient's condition for diagnosis.
No
The device description clearly outlines a physical, implantable medical device consisting of cylinders, cables, springs, and silicone, with no mention of software as a component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of chronic, organic, erectile dysfunction (impotence) through surgical implantation. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant designed to provide penile rigidity. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro analysis, such as reagents, assays, or sample preparation.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
FAE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile / corpus cavernosum
Indicated Patient Age Range
men
Intended User / Care Setting
implantation surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AMS Spectra™ Concealable Penile Prosthesis (K082006), AMS DURA II® Penile Prosthesis (K953640)
Reference Device(s)
D970012
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
7.3 510(k) Summary Statement (21CFR 807.92)
| Submitter | American Medical Systems Inc. (AMS)
10700 Bren Road West
Minnetonka, MN 55343 | |
|--------------------|-----------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Stephanie George
Phone (952)-930-6389
Fax (952)-930-5785 | APR - 9 2009 |
| | Paul Bulger
Phone (952) 930-6543
Fax (952) 930-5785 | |
| 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
(K082006)
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
1
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.
2
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,
3
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) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.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 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 (800) 638-2041 or (240) 276-3150 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