(174 days)
Not Found
Not Found
No
The summary describes a standard absorbable surgical suture and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an absorbable surgical suture used for general soft tissue approximation and ligation, which are surgical procedures, not therapeutic treatments.
No
This device is an absorbable surgical suture used for approximation and ligation of soft tissues, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is an "absorbable surgical suture," which is a physical, hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is a surgical suture. It is used in the body to approximate and ligate soft tissue during surgery.
The description clearly indicates it's a physical device used during a medical procedure, not a test performed on a sample from a patient.
N/A
Intended Use / Indications for Use
Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
PREMARKET NOTIFICATION
SUBMISSION - 510 (k)్లు వైద్యశాల నిర్మించిన దూర
Owner Operator # 9044488
: : : : : , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
ASSUFIL™ 510(k)K021767
NOV 1 9 2002
510 (k) SUMMARY
| Applicant | : Assut Europe Spa
Zona Industriale - Magliano dei Marsi (AQ)
67062 - Italy |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | : MMC International, LLC
Mr. Lucio Improta
131 Highwood Drive - S. Glastonbury, CT 06073
Tel. (860) 633-8807 - fax. (860) 657-8913
e-mail : mmcintern@aol.com |
| Submission Date | : May 20, 2001 |
| Trade Name | : Assufil TM |
| Common Name | : absorbable surgical suture |
| Classification Name | : 878-4490 - Suture - absorbable - coated-braided
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