(37 days)
SERRALSILK™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Not Found
This document is a 510(k) clearance letter from the FDA for surgical sutures, not a study report for an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving device performance for an AI/ML product.
Specifically, the document discusses:
- Trade/Device Name: Serralsilk™, Non-absorbable Surgical Sutures
- Regulation Number: 21 CFR 878.5030 (Natural nonabsorbable silk surgical suture)
- Regulatory Class: II
- Product Code: GAP
- Indications for Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
There is no mention of AI/ML, algorithms, performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert readers, ground truth establishment, or any other elements related to the evaluation of an AI-powered diagnostic or assistive device.
Therefore, I cannot provide the requested table or information because this document is entirely unrelated to the study of an AI/ML device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure.
APR 2 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. Scott Henderson President H & A Consultants 2584 Saddlewood Lane Palm Harbor, FL 34685
Re: K020901
Trade/Device Name: Serralsilk™, Non-absorbable Surgical Sutures Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP Dated: March 18, 2002 Received: March 20, 2002
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becared on the device is substantially equivalent (for the indications for releved above and have to totally marketed predicate devices marketed in interstate commerce use sured in also encreases) in the Medical Device Amendments, or to devices that provision in the 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nat (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 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 rr your de rice 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 r 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 comply 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.
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Page 2 - Mr. Scott Henderson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
( Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K020901
SERRALSILK™, Non-absorbable Surgical Sutures Device Name:
Indications for Use:
SERRALSILK™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
concurrence of cdrh, office of device evaluation (ode)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020901
OR
Prescription Use √
Over-The-Counter Use
SECTION III, PAGE 1
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.