(70 days)
Not Found
No
The summary describes a physical surgical sling and instrument, with no mention of software, data processing, or AI/ML terms.
Yes
The device is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence, which is a therapeutic purpose.
No
The device is described as a system for the surgical placement of a pubourethral sling to treat stress urinary incontinence. Its intended use is therapeutic (treatment), not diagnostic (identifying or characterizing a condition).
No
The device description explicitly states it consists of a sling and a surgical instrument, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Smart Sling System is a surgical implant (a sling made of mesh) and a surgical instrument used within the body for a surgical procedure to treat stress urinary incontinence. It does not analyze specimens taken from the body.
Therefore, the Smart Sling System falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
The AMS Smart Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pubourethral
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 and a literature review.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Caldera "T" Sling (K050516), MonarcTM Subfascial Hammock (K023516), SparcTM Sling System (K011251)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
ડ. 510(k) Summary Statement
FEB 2 2 2007
| Submitter: | American Medical Systems (AMS)
10070 Bren Road West
Minnetonka, MN 55343
Phone: 952.933.6139
FAX: 952.930.5785 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brad Onstad |
| Device Common Name: | Sub-Urethral Sling System; Surgical Mesh |
| Device Trade Name: | AMS Smart Sling System |
| Device Classification Name: | Surgical Mesh, polymeric (OTN) |
| Predicate Devices: | Caldera "T" Sling (K050516),
MonarcTM Subfascial Hammock (K023516),
SparcTM Sling System (K011251) |
Device Description
The AMS Smart Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.
Indications for Use
The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Comparison to Predicate Devices
The AMS Smart Sling System provides physicians an alternative surgical approach to implant sub-urethral slings to treat female stress urinary incontinence. The AMS Smart Sling System material, design and characteristics are substantially equivalent to those exhibited by T-Sling, Monarc, Sparc and other surgical meshes cleared for commercial distribution. The materials, design and characteristics of the AMS Smart Sling Surgical Needle Instrument (also called "Needle Passer") used for sling placement are substantially equivalent to those embodied in the Caldera "T" Sling, Monarc Subfascial Hammock Needle Passer and Sparc Sling needles as well as other surgical instruments cleared for commercial distribution.
Supporting Information
Substantial equivalency was supported by previously cleared and new bench and biocompatibility testing, cadaver studies and a literature review.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized depiction of an eagle or bird-like figure with three swooping lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Brad Onstad Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K063713 Trade/Device Name: AMS Smart Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: December 14, 2006 Received: December 14, 2006
Dear Mr. Onstad:
This letter corrects our substantially equivalent letter of February 22, 2007.
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 (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 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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: AMS Smart Sling System
Indications For Use: The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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)
Mark A. Milliken
(Division Sign-Off) Division of General, Testorative, and Neurological De . . ces
510(k) Number
111 化663717