(67 days)
IN-SLING is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence
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.
The provided document is a 510(k) summary for the IN-SLINGTM device. It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the IN-SLING device itself. Therefore, many of the requested elements (acceptance criteria, specific study details, sample sizes, expert qualifications, etc.) are not present in this type of submission.
Here's a breakdown of what can be extracted from the document regarding "acceptance criteria" and "study":
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the way typically seen for a new device's efficacy or safety study. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" is implicitly tied to the performance of the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes the device and claims substantial equivalence, but it does not detail a study with a test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as no such ground truth establishment is described for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no test set requiring adjudication is described.
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 MRMC study is not mentioned. The device is a surgical mesh, not an AI or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as no performance study requiring ground truth is described.
8. The sample size for the training set
This information is not provided. Since this is a physical medical device (surgical mesh), not an AI algorithm, the concept of a "training set" in this context is not relevant.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
Summary based on the provided document:
The 510(k) submission for the IN-SLINGTM establishes substantial equivalence topredicate devices, specifically Surgical Fabrics' ProteGen™ and Vascutek's Gelseal™.
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Predicate Devices:
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Basis for Substantial Equivalence:
- To Vascutek Gelseal™: The IN-SLING™ is stated to be "identical to the Vascutek Gelseal™ in terms of materials, manufacturing, processing, packaging and sterilization." The only difference is in the size and shape of the fabric.
- To Surgical Fabrics' ProteGen™: The IN-SLING™ is substantially equivalent in terms of "intended use and labeling." Both are used as slings in sling procedures for the treatment of urinary incontinence.
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Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criteria are that the IN-SLING™ performs as safely and effectively as its predicate devices. This is established by demonstrating identical materials, manufacturing, and processing to one predicate, and identical intended use and labeling to another. No new performance studies for the IN-SLING™ itself are detailed in this summary; rather, its performance is considered equivalent to devices already on the market and deemed safe and effective by the FDA.
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Study Proving Acceptance: The document does not describe a standalone performance study for the IN-SLING™. The "proof" is the detailed comparison of its characteristics and intended use to the legally marketed predicate devices, as presented in the 510(k) submission.
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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.
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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.
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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
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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 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
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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
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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on Sign
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Over-The-Counter Use
(Optional Format 1-2-96)
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Prescription Use -(Per 21 CFR 801.109)
OR
§ 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.