K021767 · Assut Europe S.P.A. · GAM · Nov 19, 2002 · General, Plastic Surgery
Device Facts
Record ID
K021767
Device Name
ASSUFIL
Applicant
Assut Europe S.P.A.
Product Code
GAM · General, Plastic Surgery
Decision Date
Nov 19, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4493
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
Device Story
Assufil is an absorbable surgical suture used for general soft tissue approximation and ligation. It is a multifilament, coated, braided suture designed to hold tissue edges together during the healing process before being absorbed by the body. The device is intended for use by surgeons and healthcare professionals in clinical or surgical settings. By providing temporary mechanical support to tissues, it facilitates wound closure and healing. The suture is provided sterile and is intended for single use.
Clinical Evidence
No clinical data provided; substantial equivalence is based on device characteristics and intended use.
Technological Characteristics
Absorbable poly(glycolide/L-lactide) surgical suture. Coated, braided multifilament construction. Class II device. Sterilized for single use.
Indications for Use
Indicated for general soft tissue approximation and ligation in patients requiring an absorbable suture.
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.
Submission Summary (Full Text)
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**PREMARKET NOTIFICATION**
SUBMISSION - 510 (k)్లు వైద్యశాల నిర్మించిన దూర
Owner Operator # 9044488
: : : : : , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
ASSUFIL™ 510(k)K021767
# NOV 1 9 2002
510 (k) SUMMARY
K021767
| Applicant | : Assut Europe Spa<br>Zona Industriale - Magliano dei Marsi (AQ)<br>67062 - Italy |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | : MMC International, LLC<br>Mr. Lucio Improta<br>131 Highwood Drive - S. Glastonbury, CT 06073<br>Tel. (860) 633-8807 - fax. (860) 657-8913<br>e-mail : mmcintern@aol.com |
| Submission Date | : May 20, 2001 |
| Trade Name | : Assufil <sup>TM</sup> |
| Common Name | : absorbable surgical suture |
| Classification Name | : 878-4490 - Suture - absorbable - coated-braided<br>multifilament |
Indication for use : Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
{1}------------------------------------------------
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around a stylized symbol. The symbol consists of three curved lines that resemble a person or people.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### NOV 1 9 2002
Assut Europe S.P.A. c/o MMC International, LLC Lucio Improta 10147 Umberland Place Boca Raton, Florida 33428
Re: K021767
Trade/Device Name: Assufil Regulation Number: 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: August 22, 2002 Received: August 22, 2002
Dear Mr. Improta:
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 reguirements for annual registration. Iisting 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.
{2}------------------------------------------------
Page 2 -- Mr. Lucio Improta
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muramic Purent
far 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
{3}------------------------------------------------
| PREMARKET NOTIFICATION |
|------------------------|
| SUBMISSION - 510 (k) |
Data: 05-20-2001 Pag. 8 di 27
Owner Operator # 9044488
ASSUFIL™ 510(k)K021767
510 (k) # 021767
DEVICE NAME
Assufil™ - absorbable suture
### INDICATION FOR USE
Assufil™ It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Muriane C. Provost
(Division Sign-Oft) Division of General, Restorative and Neurological Devices
510(k) Number_KC2176
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