(36 days)
Not Found
No
The device description and intended use are for a standard surgical suture, and there is no mention of AI, ML, or any related technologies in the provided text.
No.
The device is a surgical suture used for short-term wound support, which is a supportive function rather than a therapeutic one designed to treat or cure a disease or condition.
No
Explanation: The device is described as an absorbable, flexible multifilament suture thread for soft tissue approximation. Its function is to hold tissue together, not to diagnose a condition or disease.
No
The device description clearly states it is a physical suture thread made of a synthetic polymer, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation, including ophthalmic procedures." This describes a surgical device used in vivo (within the body) to physically join tissues.
- Device Description: The description details a "flexible multifilament suture thread" composed of a synthetic polymer. This is a physical material used for surgical closure.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, the Safil and Safil Quick sutures are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.
Product codes
GAM
Device Description
The subject device is an absorbable, flexible multifilament suture thread which is supplied sterile. It is composed of a synthetic polyglycolic acid polymer and it is indicated for soft tissue approximation where only short term wound support is required. It will be offered dyed or undyed with the FDA approved colorant D&C Violet No.2 or D&C Green No.6 in accordance with Title 21 CFR, §74.3206. The modified device is coated with an absorbable polyclyconate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K011372, K980704, K944110, K962480, K011375
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAY 2 9 2003
K031286
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
SAFIL AND SAFIL QUICK SYNTHETIC ABSORABLE SURGICAL SUTURE
April 22, 2003
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller, Manager Requlatory Affairs
800-258-1946 (phone)
610-791-6882 (fax)
georg.keller@aesculap.com (email) |
| TRADE NAME: | Safil and Safil Quick Synthetic Absorbable Surgical Suture |
| COMMON NAME: | Synthetic Absorbable Poly (Glycolide/L-lactide) Surgical Suture |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | GAM |
| CLASSIFICATION: | 878.4493, Synthetic Absorbable Poly (Glycolide/L-lactide) Surgical Suture |
| REVIEW PANEL: | General & Plastic Surgery |
INTENDED USE
Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.
DEVICE DESCRIPTION
The subject device is an absorbable, flexible multifilament suture thread which is supplied sterile. It is composed of a synthetic polyglycolic acid polymer and it is indicated for soft tissue approximation where only short term wound support is required. It will be offered dyed or undyed with the FDA approved colorant D&C Violet No.2 or D&C Green No.6 in accordance with Title 21 CFR, §74.3206. The modified device is coated with an absorbable polyclyconate.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the Safil Quick Absorbable Surgical Suture is substantially equivalent to Safil Synthetic Absorbable Surgical Suture (K011372), Safil Quick Synthetic Absorbable Surgical Suture (K980704) and the following other predicate devices:
- Vicryl Synthetic Absorbable Surgical Suture (K944110 and K962480) .
- MonoSyn Synthetic Absorbable Surgical Suture (K011375) .
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of unity or collaboration.
Public Health Service
MAY 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Georg Keller Manager Regulatory Affairs Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K031286
Trade/Device Name: Safil and Safil Quick Synthetic 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: April 22, 2003 Received: May 6, 2003
Dear Mr. Keller:
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.
2
Page 2 - Mr. Georg Keller
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. 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" (21CFR Part 807.97) you may obtain. 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,
Musiam 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
3
Page 1 of 1
(Optional Format 3-10-98)
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Safil and Safil Quick Synthetic Absorbable Surgical Sutures
Indication for Use:
Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or Over-the-Counter Use
(per 21 CFR 801.109)
Miriam C. Provost
Restorative and Neurolog
510(k) Number K031286