(87 days)
Caprosyn* synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological surgery, or microsurgery.
Absorbable poly(glycolide/L-lactide) surgical suture
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The documents are a brief summary of safety and effectiveness for a surgical suture and an FDA clearance letter for the same device. Therefore, I cannot provide the requested information.
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SUMMARY OF SAFETY AND EFFECTIVENESS IX.
United States Surgical. SUBMITTER: a division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, CT 06856 Robert Zott CONTACT PERSON: August 21, 2003 DATE PREPARED: CLASSIFICATION NAME: Absorbable poly(glycolide/L-lactide) surgical suture Surgical Suture COMMON NAME: PROPRIETARY NAME: Caprosyn* Absorbable Surgical Suture PREDICATE DEVICES: K013671: L-25 Absorbable Suture The device is indicated for use in general soft INDICATIONS: tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological surgery, or microsurgery. MATERIALS: Glycolide, Caprolactone, Tri-Methylene
A + 11 = A + 11 = A
Carbonate, and Lactide polymers.
NOV 17 2003
· Caprosyn is a trademark of United States Surgical, a division of Tyco Healthcare Group, LP
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes above a wavy line.
NOV 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Zott Regulatory Affairs Program Manager United States Surgical Tyco Healthcare 150 Glover Avenue Norwalk, Connecticut 06856
Re: K032586
Trade/Device Name: Caprosyn Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: October 22, 2003 Received: October 27, 2003
Dear Mr. Zott:
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. Drue. and Cosmetic Act (Act) that do not require approval of a premarket approval application (I^M A). 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. Insting 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 - Mr. Robert Zott
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam 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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III. INDICATIONS FOR USE
510(k) Number (if known): K032586
Device Name: Caprosyn* Absorbable Surgical Suture
Indications For Use:
Caprosyn* synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological surgery, or microsurgery.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use:(Per 21 CFR 801.109) | OR Over-The-Counter Use: |
|---|---|
| ------------------------------------------- | -------------------------- |
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032586
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
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.(b)
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.