SERRALNYL

K020146 · Serral, S.A. DE C.V. · GAR · Apr 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020146
• Device Name: SERRALNYL
• Applicant: Serral, S.A. DE C.V.
• Product Code: GAR · General, Plastic Surgery
• Decision Date: Apr 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Serralnyl™ is a non-absorbable polyamide surgical suture used for soft tissue approximation and ligation. Device is utilized by surgeons in clinical settings including general, cardiovascular, ophthalmic, and neurological procedures. Suture provides mechanical wound closure; facilitates healing by holding tissue edges together. Device is sterile, single-use, and manually applied by clinicians.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-absorbable polyamide surgical suture. Class II device (Product Code: GAR).

Indications for Use

Indicated for general soft tissue approximation and/or ligation in general, cardiovascular, ophthalmic, and neurological procedures. No specific age or gender restrictions provided.

Regulatory Classification

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.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 5 2002

Serral, S.A. de C.V. c/o Mr. Scott Henderson President H & A Consultants 2584 Saddlewood Lane Palm Harbor, Florida 34685

Re: K020146

Trade Name: Serralny1™ Non-absorbable Surgical Sutures Regulation Number: 878.5020 Regulation Name: Non-absorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: January 22, 2002 Received: January 28, 2002

Dear Mr. Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave review for rear form have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to may 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, the chartence 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, (Act, that do not require appears to the general controls provisions of the Act. The general uncrolor, mainer and the Act include requirements for annual registration, listing of devices, oon one hereins or actice, 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 If your device 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 or any I 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) I ms letter will anow you to begin mains of substantial equivalence of your device to a legally premarket notification. THC PDF intellig of basification 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 If you desire specific acrise for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Far 067.10 to mix 12.0 million ally, for questions on the promotion and advertising of Compliance at [phone] Fride of Compliance at [phone]. Also, please note the your do roo, pread of the reference to premarket notification" (21CFR Part 807.97). regulation chittied, Thisordians on your responsibilities under the Act may be obtained from the Outcr general information on your terpational 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,

Muriam 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

(020146 510(k) Number (if known):

SERRALNYL™, Non-absorbable Surgical Sutures Device Name:

Indications for Use:

SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or SENNALNTL - Surures are indicated 10, about almic 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 K020146

Prescription Use

OR

Over-The-Counter Use _

SECTION III, PAGE 1