NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES

K990952 · United States Surgical, A Division of Tyco Healthc · GAT · Apr 1, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990952
• Device Name: NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Apr 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Novafil** and Vascufil** Sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.

Device Story

Novafil and Vascufil are non-absorbable monofilament surgical sutures. Novafil is composed of polybutester (copolymer of butylene terephthalate and polytetramethylene ether glycol). Vascufil is the same polybutester material coated with Polytribolate (absorbable polymer of e-caprolactone/glycolide/poloxamer 188). These sutures are used by surgeons for tissue approximation and ligation during surgical procedures. They function as mechanical fasteners to hold tissue edges together during healing. The devices are provided sterile for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition and intended use.

Technological Characteristics

Monofilament sutures composed of polybutester (copolymer of butylene terephthalate and polytetramethylene ether glycol). Vascufil includes a coating of Polytribolate (absorbable polymer of e-caprolactone/glycolide/poloxamer 188).

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular and ophthalmic surgery. Contraindicated for microsurgery and neural tissue.

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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** NOVAFI ** AND VASCUFII **

## NOVAFIL** AND VASCUFIL** SORBABLE. MONOFILAMENT SURGICAL SUTU

## 510(k)_Summary of Safety and Effectiveness V.

- SUBMITTER:
United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856

CONTACT PERSON: Victor M. Clavelli

March 18, 1999 DATE PREPARED:

CLASSIFICATION NAME: Polyester Sutures

Polyester Sutures COMMON NAME:

PROPRIETARY NAME: Novafil** and Vascufil**

Novafil** and Vascufil** PREDICATE DEVICES:

DEVICE DESCRIPTION:

Novafil** non-absorbable monofilament surgical sutures are composed of polybutester, a copolymer of butylene terephthalate and polytetramethylene ether glycol.

Vascufil** coated non-absorbable monofilament surgical sutures are composed of polybutester, a copolymer of butylene terephthalate and polytetramethylene ether glycol. The suture is coated with POLYTRIBOLATE**, an absorbable polymer of e-caprolactone / glycolide / poloxamer 188.

INTENDED USE:

Novafil** and Vascufil** Sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol resembling an abstract human figure or a bird-like shape, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1999

Mr. Victor M. Clavelli Manager, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

K990952 Re:

> Trade Name: Novafil and Vasculfil Sterile Synthetic Nonabsorbable Sutures Regulatory Class: II Product Code: GAT Dated: March 19, 1999 Received: March 22, 1999

Dear Mr. Clavelli:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) 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 Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). 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 devices, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. The Novafil and Vascufil Surgical Sutures are indicated for use in general and soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.
- 2. These devices may not be manufactured from any material other than high molecular weight fibers composed of long chain linear polyester having recurrent aromatic rings as an integral component. 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 Novafil and Vascufil surgical sutures. Any 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 devices.

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Page 2 - Mr. Victor M. Clavelli

The sale, distribution and use of these devices is restricted to prescription use in accordance with 21 CFR 801.109.

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 devices 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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## NOVAFIL** AND VASCUFIL** NONABSORBABLE, MONOFILAMENT SURGICAL SUTURES

## III. Indications For Use:

k990952 510(k) Number (if known):

Device Name:

Novafil** and Vascufil** Sterile Synthetic Non-absorbable Sutures

Indications For Use:

Novafil** and Vascufil** sutures are indicated for use as non-absorbable sutures in general and soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use:<br>(Per 21 CFR 801.109) | X OR Over-The-Counter Use: |
|-------------------------------------------|----------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990952 |

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