(46 days)
The TriAngle Sling is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
The TriAngle Sling is a knitted patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
This document does not include information about acceptance criteria or a study proving that a device meets such criteria.
The provided text is a 510(k) summary for the TriAngle Sling, which is a medical device for treating urinary stress incontinence. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria in the manner you've requested.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria & Reported Device Performance: The document states, "Performance testing and information in the application demonstrated that TriAngle sling is biocompatible and provides equivalent performance to the In-Sling." It does not list specific quantitative acceptance criteria (e.g., tensile strength, pore size, elasticity ranges) nor does it provide the measured performance values for the TriAngle Sling against those criteria. It relies on a general statement of equivalence to the predicate.
- Study Design Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present because a 510(k) summary for a Class II device like this typically does not require a comprehensive clinical trial or an in-depth performance study with human readers/experts. The demonstration of substantial equivalence often relies on material characterization, mechanical testing, biocompatibility testing, and comparison of technological characteristics to a legally marketed predicate device.
- Training Set Information: Similarly, there is no mention of a training set, as the evaluation type described doesn't involve machine learning algorithms that require training data.
In summary, the provided K980482 document for the TriAngle Sling is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study with the specific performance criteria and study methodology you've inquired about.
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510(k) Summary Influence, Inc.'s TriAngle Sling 510(k) Number 19044
MAR 2 7 1998
Submitter's Name:
Peter A. Bick, M.D., President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: 415-546-7700/Fax: 415-546-7744
Trade Name:
TriAngle Sling
Classification Name:
Mesh, Surgical, Polymeric (, OTN.)
Predicate Device:
Influence In-Sling (K972651)
Indication for Use:
The TriAngle Sling is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
Device Description:
The TriAngle Sling is a knitted patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
Technological Characteristics and Performance:
The TriAngle Sling is very similar to the Influence In-Sling. Performance testing and information in the application demonstrated that TriAngle sling is biocompatible and provides equivalent performance to the In-Sling.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Mark D. Kramer Consultant to Influence, Incorporated 11812 Quince Mill Drive NORTH POTOMAC MD 20878
SEP 2 8 2012
Re: K980482 Trade/Device Name: TriAngle Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: February 9, 1998 Received: February 9, 1998
Dear Mr. Kramer:
This letter corrects our substantially equivalent letter of March 27, 1998.
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Weeks
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:
TriAngle Sling
Indications for Use:
The TriAngle Sling is indicated to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of General and Restorative Devices
510(k) Number 1980482
Prescription Use
(Per 21 CFR 801.109) OR Over the Counter Use __
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§ 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.