SERRALGUT

K020597 · Serral, S.A. DE C.V. · GAL · Aug 14, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020597
• Device Name: SERRALGUT
• Applicant: Serral, S.A. DE C.V.
• Product Code: GAL · General, Plastic Surgery
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or SERVALOOT - surares are thalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Story

SERRALGUT™ is an absorbable surgical suture used for soft tissue approximation and ophthalmic procedures. It is intended for use by surgeons in clinical settings. The device functions as a mechanical fastener to hold tissue edges together during the healing process. It is not indicated for cardiovascular or neurological applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbable surgical suture, plain and chromic. Class II device (Product Code: GAL).

Indications for Use

Indicated for general soft tissue approximation and ophthalmic procedures. Contraindicated for cardiovascular and neurological procedures.

Regulatory Classification

Identification

An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

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 Department of Health & Human Services USA. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines above them, creating a sense of movement and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 4 2002

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

Re: K020597

Trade/Device Name: SERRALGut™ Suture Regulation Number: 878.4830 Regulation Name: Suture, absorbable, natural, plain and chromic Regulatory Class: Class II Product Code: GAL Dated: July 5, 2002 Received: July 9, 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 (OS) 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" (21 CFR 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,

Stept Rwdw
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): K020597

SERRALGUT™, Absorbable Surgical Sutures, Plain and Chromic Device Name:

Indications for Use:

SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or SERVALOOT - surares are thalmic procedures, but not for use in cardiovascular and neurological procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| | <img alt="signature" src="signature.png"/> |
|--|--------------------------------------------|
| | (Division Sign-Off) |

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K020597 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
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| <img alt="prescription use" src="prescription_use.png"/> | | |

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