SERRALSILK

K020901 · Serral, S.A. DE C.V. · GAP · Apr 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020901
• Device Name: SERRALSILK
• Applicant: Serral, S.A. DE C.V.
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Serralsilk™ is a non-absorbable surgical suture used for soft tissue approximation and ligation. It is intended for use by surgeons in clinical settings, including cardiovascular, ophthalmic, and neurological procedures. The device functions as a mechanical fastener to hold tissue edges together or ligate vessels during surgery. It is provided as a sterile, ready-to-use surgical instrument.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural nonabsorbable silk surgical suture. Class II device. Product code GAP. Regulation 21 CFR 878.5030.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures.

Regulatory Classification

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 species Bombyx mori (B. mori ) of the family Bombycidae. 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.

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 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 [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

( 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