(36 days)
Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.
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.
The provided document is a 510(k) summary for the Safil and Safil Quick Synthetic Absorbable Surgical Suture. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a detailed clinical study in the way AI/ML devices often do.
Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML context. Instead, it focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices.
Here's why the requested information cannot be extracted from this document:
- Type of Device: The device is a surgical suture, a physical medical device. The concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "standalone performance" are typically applied to AI/ML software or diagnostic devices that generate a result based on data analysis.
- Regulatory Pathway: A 510(k) submission primarily relies on demonstrating "substantial equivalence" to existing legally marketed devices. This usually involves:
- Comparing technological characteristics (materials, design, intended use).
- Bench testing to ensure physical properties (e.g., tensile strength, absorption profile) are comparable.
- Sometimes, biocompatibility testing.
It generally does not involve clinical studies with the kind of structured "acceptance criteria" and "ground truth" assessment seen for AI/ML algorithms.
- Absence of Data: The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This reinforces that there aren't formal, quantitative acceptance criteria for clinical performance that the manufacturer needs to meet and prove through a study for this specific device type and regulatory pathway.
- Focus on Predicate Devices: The "Performance Data" section simply states that no performance standards exist, and the "Substantial Equivalence" section lists predicate devices. This implies that the 'proof' of safety and effectiveness comes from its similarity to devices already on the market, rather than a novel study demonstrating adherence to new performance metrics.
In summary, the provided text describes a medical device (surgical suture) pursuing a 510(k) clearance based on substantial equivalence, which does not involve the detailed performance study and acceptance criteria typically associated with AI/ML devices.
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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 ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Georg Keller, Manager Requlatory Affairs800-258-1946 (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) .
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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.
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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
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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
§ 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.