(67 days)
Not Found
No
The device description and intended use clearly describe a physical surgical sling made of knitted polyester fabric. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is described as a sling used in transvaginal sling procedures for the treatment of urinary stress incontinence, which is a medical condition. Therefore, it is intended for a therapeutic purpose.
No
The device, IN-SLING, is described as a "sling in transvaginal sling procedures for the treatment of urinary stress incontinence." Its purpose is therapeutic (treatment), not diagnostic (identifying or characterizing a condition).
No
The device description clearly states it is a "gelatin-sealed, knitted polyester patch fabric," which is a physical material, not software.
Based on the provided information, the IN-SLING device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a sling for surgical procedures to treat urinary stress incontinence. This is a therapeutic device used in vivo (within the body), not a diagnostic device used in vitro (outside the body) to examine specimens.
- Device Description: The description confirms it's a physical patch fabric used as a sling. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVDs, such as reagents, assays, analysis of biological samples, or diagnostic results.
Therefore, the IN-SLING is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The IN-SLINGTM is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence
Product codes
OTN, PAG
Device Description
The IN-SLINGTM is a gelatin-sealed, knitted polyester patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows a date, "SEP 1 9 1997". The date is written in a simple, sans-serif font. The letters and numbers are evenly spaced and clearly legible.
510(k) Summary Influence, Inc.'s IN-SLINGTM
- For Release Upon Request Only *
Submitter's Name:
Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, California 94111
Contact Person:
Peter A. Bick, M.D. President and CEO Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, California 94111 Fax: 415-421-5622 Telephone: 415-421-5600
Date Prepared:
July 11, 1997
Trade Name:
IN-SLINGTM
Classification Name:
Mesh, Surgical, Polimeric
Classification:
The FDA has classified surgical mesh as a class II device (product code OTN, PAG ) and it is reviewed by the Plastic and Reconstructive Surgery Devices Branch.
1
Predicate Devices:
Performance Standards:
No performance standards applicable to surgical mesh have been established by the FDA.
´ Indication for Use:
The IN-SLING™ is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence
Device Description:
The IN-SLINGTM is a gelatin-sealed, knitted polyester patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
Technological Characteristics and Substantial Equivalence:
The IN-SLING™ is identical to the Vascutek Gelseal™ in terms of materials, manufacturing, processing, packaging and sterilization. The only difference between the IN-SLING and the Vascutek Gelseal™ is in the size and shape of the fabric.
The IN-SLING is substantially equivalence to Surgical Fabrics' ProteGen™ in terms of intended use and labeling. Like the ProteGen™ is used with the Vesica System as a sling in sling procedures, the IN-SLINGTM is used as a sling with Influence's transvaginal surgical systems (In-Fast and In-Tac) in sling procedures for the treatment of urinary incontinence.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Peter A. Bick, M.D. President and CEO Influence, Inc. 601 Montgomery Street, Suite 845 SAN FRANCISCO CA 94111
Re: K972651 Trade/Device Name: IN-SLINGTM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN. PAG Dated: July 14, 1997 Received: July 14, 1997
Dear Dr. Bick:
This letter corrects our substantially equivalent letter of September 19, 1997.
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
3
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 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/CDRH/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
4
Page_1 l of
K972651 510(k) Number (if known):
Device Name: ____ IN-SLING
Indications For Use:
IN-SLING is intended to be used as a sling in transvaginal sling the was as incended to be used as a sling in transvaginal so
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcoellefo
on Sign
.
Over-The-Counter Use
(Optional Format 1-2-96)
8-5
Prescription Use -(Per 21 CFR 801.109)
OR