VISORB SWIFT

K023710 · Cp Medical · GAM · Jan 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023710
• Device Name: VISORB SWIFT
• Applicant: Cp Medical
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General soft tissue approximation; including use in Ophthalmic surgery, but not for use in Cardiovascular and Neurological tissue approximation.

Device Story

VISORB Swift™ is a synthetic absorbable surgical suture composed of polyglycolic acid. It is used by surgeons for general soft tissue approximation, including ophthalmic procedures. The device functions as a mechanical fastener to hold tissue edges together during the healing process, after which it is absorbed by the body. It is provided as a sterile, ready-to-use surgical instrument.

Clinical Evidence

Bench testing only; performance meets or exceeds USP 25 standards.

Technological Characteristics

Synthetic absorbable suture material (polyglycolic acid). Meets USP 25 performance requirements. Sterile.

Indications for Use

Indicated for general soft tissue approximation, including ophthalmic surgery. Contraindicated for cardiovascular and neurological tissue approximation.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.

Predicate Devices

• Ethicon (unspecified)
• B/BRAUN (unspecified)

Submission Summary (Full Text)

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JAN 1 7 2003

KO23710

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

| Device Name: | |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | VISORB Swift™ |
| Common Names: | Absorbable suture, synthetic absorbable suture, PGA suture |
| Classification Names: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Establishment Name, Contact & Registration Number: | |
| Name: | C.P. Medical, Inc. |
| | 836 N.E. 24th. Ave |
| | Portland, Oregon 97232 |
| | Tele: [phone] |
| | Fax: [phone] |
| Contact: | Mary Ann Greenawalt (VP Legal & Regulatory) |
| | or |
| | Sue Ridge (Technical Writer - Regulatory) |
| Classification: | |
| Device Class: | Class 11 |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | 79GAM |
| Intended Use: | VISORB Swift™ Absorbable Surgical Sutures are indicated for use in general soft tissue approximations, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue approximation. |
| Equivalent Predicated Device: | |
| | VISORB Swift™ synthetic absorbable suture is substantially equivalent to the predicate devices marketed by Ethicon and B/BRAUN. The comparison data demonstrates that equivalency can be drawn with respect to the design, material composition, performance and intended use. |
| Performance Standard: | |

VISORB Swift™ meets or exceeds the performance requirements set forth by USP 25.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

CP Medical Mary Ann Greenawalt Legal and Regulatory Affairs 836 N.E. 24" Avenue Portland, Oregon 97232

Re: K023710

Trade/Device Name: VISORB Swift™ Regulation Number: 878.4840 Regulation Name: Synthetic, absorbable suture, polyglycolic acid Regulatory Class: Class II Product Code: GAM Dated: November 1, 2002 Received: November 4, 2002

Dear Ms. Greenawalt:

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 (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 – Ms. Mary Ann Greenawalt

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), 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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Page 1 of 1 .

510(k) Number: K02-3710

Device Name(s): VISORB Swift™

## Intended Use(s) of the Device:

General soft tissue approximation; including use in Ophthalmic surgery, but not for use in Cardiovascular and Neurological tissue approximation.

Miriam C. Provost

ivision Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K023710

Please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-decoration: line-through;"></div> |
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Over-The-Counter Use _______

(per 21 CFR 801.109)

Or

(Optional format 1-2-96)