(60 days)
Not Found
No
The device description and intended use focus on a physical implant and surgical instrument, with no mention of AI/ML capabilities or data processing.
Yes
The device is indicated for the "treatment of male stress urinary incontinence (SUI)," which is a medical condition, making it a therapeutic device.
No
Explanation: The device is a surgical sling system used for treatment, not for diagnosing a condition. It is an implantable medical device.
No
The device description explicitly states it consists of a sling (polymeric mesh) and a surgical instrument (Needle Passer), which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical implant to treat male stress urinary incontinence. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical sling and surgical instrument used for implantation. It does not involve testing samples of human origin (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro testing, such as reagents, calibrators, controls, or analysis of biological samples.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant for the treatment of male stress urinary incontinence (SUI).
Product codes
FTL
Device Description
The AMS Male Transobturator Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement using a transobturator approach. The slings are made from polymeric mesh and have resorbable sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Substantial equivalency was supported by previously cleared and new bench and biocompatibility testing, cadaver studies, clinical data and a literature review.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982155, K023516, K011251, K040537, K040623
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the text "K053371" on the top line and "Page 1 of 1" on the second line. The text is written in a handwritten style. The image appears to be a page number from a document.
510(k) Summary Statement న్.
| Submitter: | American Medical Systems (AMS)
10070 Bren Road West
Minnetonka, MN 55343
Phone: 952.933.4666
FAX: 952.930.6496 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Frank B. Freedman, Ph.D. |
| Device Common Name: | Sub-Urethral Sling System; Surgical Mesh |
| Device Trade Name: | AMS Male Transobturator Sling System |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Devices: | Short Shaft Straight-In Bone Fixation System (trade
name "InVance) (K982155)
Monarc Subfascial Hammock (K023516),
Sparc Sling System (K011251),
Apogee (K040537),
Perigee (K040623) and other devices |
Device Description
The AMS Male Transobturator Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement using a transobturator approach. The slings are made from polymeric mesh and have resorbable sutures.
Indications for Use
The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant for the treatment of male stress urinary incontinence (SUI).
Comparison to Predicate Devices
The AMS Male Transobturator Sling System provides physicians an alternative surgical approach to implant sub-urethral slings to treat male stress urinary incontinence. The AMS Male Transobturator Sling material, design and characteristics are substantially equivalent to those exhibited by Monarc, Sparc, Apogee, Perigee and other surgical meshes cleared for commercial distribution. The materials, design and characteristics of the AMS Male Transobturator Surgical Needle Instrument (also called "Needle" and *Needle Passer'') used for sling placement are substantially equivalent to those embodied in the Monarc Subfascial Hammock Needle Passer and other surgical instruments cleared for commercial distribution.
Supporting Information
Substantial equivalency was supported by previously cleared and new bench and biocompatibility testing, cadaver studies, clinical data and a literature review.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
2006 FEB 3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Frank B. Freedman, Ph.D. Senior Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343
Re: K053371
Trade/Device Name: AMS Male TO Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 5, 2006 Received: January 6, 2006
Dear Dr. Freedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. or re-s) Fe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the 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 r ou may, dierels 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.
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 or any v 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.
2
Page 2 - Dr. Freedman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial «quivalence 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Loubac Buelup
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Ko53371
Device Name: AMS Male TO Sling System
Indications For Use: The AMS Male Transobturator Sling System is indicated for a suburethral sling implant to treat male stress urinary incontinence.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
()ver-The-Counter Use (21 CFR 801 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
bare Bucklin
(Division Sign Division of General. Restorative, and Neurological Devices
510(k) Number K05337