SERRALESTER

K020902 · Serral, S.A. DE C.V. · GAT · May 20, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020902
• Device Name: SERRALESTER
• Applicant: Serral, S.A. DE C.V.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: May 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SERRALESTER™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

SERRALESTER™ is a non-absorbable surgical suture composed of poly(ethylene terephthalate). Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device functions as a mechanical fastener to hold tissue edges together or ligate vessels during surgical intervention. Provided sterile for clinical use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Poly(ethylene terephthalate). Type: Nonabsorbable surgical suture. Classification: Class II, 21 CFR 878.5000. Product Code: GAT.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. No specific patient population or contraindications provided.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

| | <i>Miriam C. Provost</i> <div>(Division Sign-Off)</div> <div>Division of General, Restorative</div> <div>and Neurological Devices</div> |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K020902 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use | |
|------------------|-----------------------------------------|----|----------------------|--|
|------------------|-----------------------------------------|----|----------------------|--|