(17 days)
Indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL Rapide suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Modified Coated VICRYL* Rapide (Polyglactin 910) suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. Modified Coated VICRYL* Rapide suture is first coated (inner coating) with a copolymer of 90/10% w/w caprolactone / glycolide and subsequently coated with a mixture composed of equal parts of Polyglactin 370 (copolymer of glycolide and L-lactide) and vegetable-based calcium stearate.
The provided document is a 510(k) premarket notification for a *"Modified Coated VICRYL Rapide (Polyglactin 910) Suture"**. This document describes a medical device (a surgical suture), not a diagnostic algorithm or AI/ML-driven device. Therefore, the questions related to the performance of a device that requires a "test set," "training set," "ground truth," "experts," or "multi-reader multi-case studies" are not applicable to this type of device.
The document discusses substantial equivalence to a predicate device and provides information on the device's description, intended use, indications, and technological characteristics. The section on "Performance Data" is brief, stating only: "Results of verification testing indicates that the product meets the established performance requirements."
Without specific details of the "verification testing" or "established performance requirements," it is impossible to populate a table of acceptance criteria or describe the study in the detail requested for an AI/ML device. For a surgical suture, performance criteria would typically relate to:
- Tensile Strength (initial and retained over time): How strong the suture is and how quickly it loses strength as it absorbs.
- Knot Security: How well knots hold.
- Absorption Profile: The rate at which the suture material is absorbed by the body.
- Biocompatibility: The body's reaction to the material.
- Sterility: Ensuring the suture is free of viable microorganisms.
- Coating Characteristics: Adhesion, slipperiness, and integrity of the coating.
Given the information provided, here's what can be extracted and a clear statement regarding the inapplicability of the AI/ML-specific questions:
Device Name: Modified Coated VICRYL* Rapide (Polyglactin 910) Suture
Device Type: Synthetic absorbable sterile surgical suture
Predicate Device: Coated VICRYL* Rapide (Polyglactin 910) Suture
Intended Use: Indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred for a Suture Device) | Reported Device Performance |
|---|---|
| Meets established performance requirements (e.g., tensile strength, absorption profile, knot security, biocompatibility, sterility, coating properties). | "Results of verification testing indicates that the product meets the established performance requirements." |
- Note: The document only provides a high-level statement and does not detail the specific performance requirements (acceptance criteria) or the precise results of the "verification testing." For a suture, these would typically be defined metrics related to material properties, strength, and absorption.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical medical device (suture), not an AI/ML algorithm that uses distinct test sets of data. Performance is evaluated through physical and biological testing that doesn't involve "test sets" in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical medical device (suture). The concept of "ground truth" established by experts for a test set is not relevant to its evaluation. Performance is assessed through standardized laboratory and in-vivo testing by technical personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical medical device (suture). Adjudication methods for test sets are not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (suture). MRMC studies are used for evaluating diagnostic software or AI tools, not physical devices. No human "readers" are involved in the performance evaluation of a suture in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (suture). It is not an algorithm, and the concept of "standalone performance" in an AI/ML context does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. This is a physical medical device (suture). Performance is based on objective measurements from laboratory and in-vivo studies (e.g., tensile strength measurements, absorption profiles from animal studies, biocompatibility testing), not a "ground truth" derived from expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set
- Not Applicable. This is a physical medical device (suture), not an AI/ML algorithm. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device (suture), not an AI/ML algorithm. There is no concept of a "training set" or "ground truth" for it.
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K033746 P9
page 1/2
DEC 1 8 2003
| Statement | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and510(k) Statements..." (21 CFR 807) and can be used to provide asubstantial equivalence summary to anyone requesting it from theAgency. |
|---|---|
| MODIFIED DEVICE NAME: Modified Coated VICRYL* Rapide(Polyglactin 910) Suture | |
| PREDICATE DEVICE NAME: Coated VICRYL* Rapide(Polyglactin 910) Suture. | |
| Device Description | Modified Coated VICRYL* Rapide (Polyglactin 910) suture is asynthetic absorbable sterile surgical suture composed of acopolymer made from 90% glycolide and 10% L-lactide. ModifiedCoated VICRYL* Rapide suture is first coated (inner coating) witha copolymer of 90/10% w/w caprolactone / glycolide andsubsequently coated with a mixture composed of equal parts ofPolyglactin 370 (copolymer of glycolide and L-lactide) andvegetable-based calcium stearate. |
| Intended Use | Indicated only for use in superficial soft tissue approximation ofthe skin and mucosa, where only short term wound support (7-10days) is required. Coated VICRYL Rapide suture is not intendedfor use in ligation, ophthalmic, cardiovascular or neurologicalprocedures. |
| Indications Statement | Indicated only for use in superficial soft tissue approximation ofthe skin and mucosa, where only short term wound support (7-10days) is required. Coated VICRYL Rapide suture is not intendedfor use in ligation, ophthalmic, cardiovascular or neurologicalprocedures. |
| TechnologicalCharacteristics | |
| The modified device has similar technological characteristics as thepredicate devices. Like the currently marketed VICRYL* Rapidesuture device, it is a sterile, braided synthetic absorbable suturewhich is also coated. | |
| Performance Data | Results of verification testing indicates that the product meets theestablished performance requirements. |
| Conclusions | |
| Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that themodified device is substantially equivalent to the Predicate Devicesunder the Federal Food, Drug, and Cosmetic Act. | |
| Contact | Rey Librojo |
| Senior Project Manager, Regulatory Affairs | |
| ETHICON Products | |
| ETHICON, Inc. | |
| Rt. #22, WestSomerville, NJ 08876-0151 | |
| Date | November 25, 2003 |
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K033746 page 21
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Mr. Rey Librojo Senior Project Manager Ethicon. Inc. Route 22 West Somerville, New Jersey 08876-0151
Re: K033746
K033740
Trade/Device Name: Modified Coated VICRYL* Rapide (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: November 24, 2003 Received: December 1, 2003
Dear Mr. Librojo:
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 sct 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. Rey Librojo
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
a 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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510(k) Number (if known):
Device Name:
Indications for Use:
Modified Coated VICRYL* Rapide (Polyglactin 910) Synthetic Absorbahle Suture
INDICATIONS FOR USE
(033-
Modified Coated VICRYL* Rapide synthetic absorbable suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL Rapide suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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8033746
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
. ...
30(k) Number_
- Trademark
Page iii
§ 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.