SUTRASILK SILK SUTURE

K994177 · Visionary Medical Supplies, Inc. · GAP · Feb 8, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994177
• Device Name: SUTRASILK SILK SUTURE
• Applicant: Visionary Medical Supplies, Inc.
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Feb 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

SutraSilk is a nonabsorbable, sterile, surgical suture composed of braided or twisted fibroin protein filaments derived from Bombyx mori silk. Sutures may be uncoated or coated with silicone, paraffin wax, or natural gum (virgin silk) and are supplied with attached needles. Used by surgeons in clinical settings for soft tissue approximation and ligation. The device provides mechanical wound closure, facilitating tissue healing. It is a manual surgical instrument; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Testing conducted according to United States Pharmacopeia (USP) methods for diameter, tensile strength, and suture-needle attachment. Results confirmed compliance with USP standards.

Technological Characteristics

Material: Fibroin protein from Bombyx mori. Construction: Braided or twisted multifilamentous fibers. Coatings: Silicone, paraffin wax, or natural gum. Standards: Meets USP specifications for diameter and tensile strength. Sterilization: Not specified. No software or electronic components.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring surgical sutures, including cardiovascular, ophthalmic, and neurological procedures. Prescription use only.

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.

Predicate Devices

• Ethicon silk nonabsorbable sutures

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a sequence of characters in a bold, handwritten style. The characters appear to be 'K994177', with some stylistic variations in the way the numbers are formed. The overall impression is that of a quickly written or stylized code or identifier.

SutraTec, Inc. 8726 53td Place, East Bradenton, Florida 34202

## 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

The assigned 510(k) number is: ___

## Applicant:

SutraTec, Inc. 8726 53rd Place, East Bradenton, Florida 34202 Mr. Joseph B. Gross, CEO Tel: [phone]

## Contact:

Jonathan Green Attorney-at-Law Corporate Secretary, SutraTec 4740 Connecticut Avenue, N.W. Suite 708 Washington D.C. 20008 Tel: [phone]

## Date of 510(k) summary preparation: December 8, 1999

## Trade name: SutraSilk

Common name: Suture, nonabsorbable, silk

## Predicate devices:

SutraSilk nonabsorbable silk sutures manufactured by SutraTec are equivalent to Ethicon silk nonabsorbable sutures.

## Device description:

SutraSilk silk suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.

This non-absorbable suture is composed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specifications.

The suture may be uncoated or have a silicone coating, a paraffin wax coating, or a natural gum coating (Virgin silk). The sutures come with needles attached.

{1}------------------------------------------------

### Intended use:

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

### Performance tests to demonstrate substantial equivalency:

To establish the technical equivalency of SutraTec nonabsorbable braided silk surgical sutures with the predicate devices, tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted for diameter, tensile strength and suture-needle attachment.

The test results shows that SutraTec devices tested meet USP standards and are technically equivalent to the predicate devices tested.

Jonathan Green

onathan Green, Corporate Secretary, SutraTec

Dec. 9, 1999
Date

. A

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Public Health Service

8 2000 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SutraTec, Inc. c/o Mr. Jonathan Green 4740 Connecticut Avenue, N.W., Suite 708 Washington, D.C. 20008

Re: K994177 Trade Name: SutraSilk Regulatory Class: II Product Code: GAP Dated: December 9, 1999 Received: December 10, 1999

Dear Mr. Green:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Tuesday, October 26, 1993 (Vol. 58, No. 205, Pages 57557 and 57558). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at [phone] or [phone]. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. The SutraSilk is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
- 2. This device may not be manufactured from any material other than multifilamentous fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the SutraSilk. Anv deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

{3}------------------------------------------------

### Page 2 - Mr. Jonathan Green

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597, or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely vours.

NexAP P Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

# 499 4177

# Indications for use

SutraSilk nonabsorbable silk sutures are indicated for use in general soft tissue Sutraonit nonaboorbable ont batalog use in cardiovascular, ophthalmic and neurological procedures.

ARO for JZO

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K994177 |

**Prescription Use** YES
(Per 21 CFR 801.109)