(131 days)
S&T Microsurgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
S&T Microsurgical Suture
I am sorry, but the provided text from the FDA 510(k) approval letter (K031531) for the "S&T Microsurgical Suture" does not contain information regarding acceptance criteria or studies proving the device meets those criteria in the way you've described.
This document is a letter of substantial equivalence, which means the FDA has determined that the "S&T Microsurgical Suture" is as safe and effective as a legally marketed predicate device. The information typically requested in your prompt (e.g., specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, details of AI assistance, effect sizes, training set details) is not part of this type of FDA communication.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, often through comparison of technological characteristics, indications for use, and a summary of performance data (which might include bench testing, animal studies, or limited human clinical data, but usually not in the detailed format you're asking for). It does not typically involve the rigorous establishment of acceptance criteria and the publication of detailed study results as one might find for a novel device or a PMA.
Therefore, I cannot extract the requested information from the provided text.
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Public Health Service
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
S & T AG c/o Mr. Bernard Teitz President Micrins Surgical, Inc. 28438 Ballard Drive Lake Forest, Illinois 60045
Re: K031531
Trade/Device Name: S&T Microsurgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: April 7, 2003 Received: July 31, 2003
Dear Mr. Teitz:
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 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 may be subject 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 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. Bernard Teitz
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for 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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Micrins Surgical. Inc
Page 1 of 1
K031531 510 (k) NUMBER (IF KNOWN): not known
S&T MICROSURGICAL SUTURE DEVICE NAME:
INDICATIONS FOR USE:
S&T Microsurgical Suture is 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 NEEDED.)
CONCURANCE of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter-Use (Optional Format 1-2-96)
Miriam C. Provoost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031531
28-138 Ballard Drive - Lake Forest. IL 600-15
Telephone 847 549 1410 - Fax 847 549 151
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(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.