(61 days)
SERRALESTER™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
SERRALESTER™ Surgical Suture
The provided text is a 510(k) clearance letter from the FDA for a surgical suture. It declares the device, SERRALESTER™ Surgical Suture, substantially equivalent to legally marketed predicate devices.
This type of document does not typically contain detailed information about acceptance criteria or specific studies proving a device meets these criteria in the way that a clinical trial report or a performance study summary would.
Therefore, based only on the provided text, I cannot extract the requested information. The document is an administrative clearance, not a scientific study report.
Here's why each of your requested points cannot be addressed by the provided text:
- A table of acceptance criteria and the reported device performance: This document states the device is "substantially equivalent" to predicate devices, but it does not define specific performance acceptance criteria for the new device nor report its performance against such criteria.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. Such studies are more common for diagnostic imaging AI than for surgical sutures.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable to a surgical suture.
- The type of ground truth used: Not applicable/mentioned. For sutures, "ground truth" might refer to material properties or in vivo performance, but specific metrics are not in this document.
- The sample size for the training set: Not applicable/mentioned. This refers to AI algorithms, not a physical medical device like a suture.
- How the ground truth for the training set was established: Not applicable/mentioned.
In summary, the provided FDA 510(k) letter confirms regulatory clearance but does not detail the technical studies, acceptance criteria, or performance data that would have been submitted to the FDA as part of the clearance process.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 2002
SERRAL, S.A. de C.V. c/o Mr. Scott Henderson President H & A Consultants 2584 Saddlewood Lane Palm Harbor, Florida 34685
Re: K020902
SERRALESTER™ Surgical Suture Regulation Number: 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT 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 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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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
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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INDICATIONS FOR USE
K020902 510(k) Number (if known):
SERRALESTER™, Non-absorbable Surgical Sutures Device Name:
Indications for Use:
SERRALESTER™ 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)
| Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| 510(k) Number | K020902 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | ----------------------------------------- | ---- | ---------------------- | -- |
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.