(78 days)
Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Modified Coated VICRYL* Plus Antibacterial (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* Plus suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate and a small amount of an antimicrobial agent, Irgacare MP (triclosan).
The provided text describes a 510(k) summary for a "Modified Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-driven device.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or extractable from this type of regulatory submission for a surgical suture.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material Composition: Copolymer of 90% glycolide and 10% L-lactide with Polyglactin 370 and calcium stearate coating, and triclosan. | "Modified Coated VICRYL* Plus Antibacterial (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* Plus suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate and a small amount of an antimicrobial agent, Irgacare MP (triclosan)." |
| Intended Use: General soft tissue approximation and/or ligation, excluding ophthalmic, cardiovascular, and neurological tissues. | "Modified Coated VICRYL* Plus Antibacterial suture is intended for use in general soft tissue approximation and/or ligation, except for use in ophthalmic, cardiovascular and neurological tissues." |
| Indications for Use: General soft tissue approximation and/or ligation, excluding ophthalmic, cardiovascular, and neurological tissues. | "Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues." |
| Technological Characteristics: Sterile, braided synthetic absorbable suture conforming to USP Monograph for absorbable surgical sutures (except for diameter), containing antibacterial agent Irgacare MP. | "The modified device has similar technological characteristics as the predicate devices. Like the currently marketed Coated VICRYL* Plus suture device, it is a sterile, braided synthetic absorbable suture that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Like the currently marketed Coated VICRYL Plus Antibacterial suture, the modified device , contains Irgacare** MP, an antibacterial agent." |
| Performance: Conformance to USP Monograph for absorbable surgical sutures; in-vivo/in-vitro performance as intended and claimed. | "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to "Non-clinical laboratory testing" and "in-vivo/in-vitro testing" but does not detail sample sizes, study design (retrospective/prospective), or data provenance (e.g., country of origin for clinical or animal studies).
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)
This is not applicable to a submission for a surgical suture of this type. The "ground truth" for a suture would relate to its physical and biological performance, not an expert-based interpretation as in a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies primarily to diagnostic studies involving human readers or interpretation.
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 not an AI-driven device, nor is it a diagnostic device where reader performance is the primary metric.
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), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" would be established through:
- USP Monograph adherence: Objective chemical and physical properties (e.g., tensile strength, knot security, degradation profile).
- In-vivo/in-vitro testing: Performance metrics demonstrating expected biological response (e.g., absorption rate, tissue reactivity, antimicrobial efficacy) and physical integrity in relevant environments. This is a form of direct observation and measurement rather than expert consensus on interpretation.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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K032420
OCT 22 2003
100 million in the states :
. 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
SECTION 8
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary ofSafety and Effectiveness | |
|---|---|
| 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 VICRYL* PlusAntibacterial (Polyglactin 910) SuturePREDICATE DEVICES NAME: Coated VICRYL* PlusAntibacterial (Polyglactin 910) Suture. | |
| Device Description | Modified Coated VICRYL* Plus Antibacterial (Polyglactin 910)suture is a synthetic absorbable sterile surgical suture composed ofa copolymer made from 90% glycolide and 10% L-lactide.Modified Coated VICRYL* Plus suture is coated with a mixturecomposed of equal parts of a copolymer of glycolide and lactide(Polyglactin 370) and calcium stearate and a small amount of anantimicrobial agent, Irgacare MP (triclosan). |
| Intended Use | Modified Coated VICRYL* Plus Antibacterial suture is intendedfor use in general soft tissue approximation and/or ligation, exceptfor use in ophthalmic, cardiovascular and neurological tissues. |
| Indications Statement | Modified Coated VICRYL* Plus Antibacterial suture is indicatedfor use in general soft tissue approximation and/or ligation, exceptfor ophthalmic, cardiovascular and neurological tissues. |
| TechnologicalCharacteristics | The modified device has similar technological characteristics as thepredicate devices. Like the currently marketed Coated VICRYL*Plus suture device, it is a sterile, braided synthetic absorbablesuture that conforms to the USP Monograph for absorbablesurgical sutures, except for diameter. Like the currently marketedCoated VICRYL Plus Antibacterial suture, the modified device ,contains Irgacare** MP, an antibacterial agent. |
| Performance Data | Non-clinical laboratory testing was performed demonstrating thatthe device conformed to the USP Monograph for absorbablesurgical sutures. Additionally, in-vivo/in-vitro testing wasprovided showing that the device performed as intended and asclaimed. |
| 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 LibrojoSenior Project Manager, Regulatory AffairsETHICON ProductsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151 |
| Date | August 1, 2003 |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures, represented by flowing lines, suggesting unity and collaboration. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Mr. Rey Librojo Regulatory Affairs Ethicon. Inc. Route 22 West Somerville. New Jersey 08876
Re: K032420
Trade/Device Name: Modified Coated VICR YL* Plus Antibacterial (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: August 1. 2003 Received: August 7, 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 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. 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,
Sincerely yours,
Mark A Milkerson
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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
Modified Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture
Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
(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
(Optional Format 1-2-9G)
Mark N Millner
Ision Sign-Of ision of Genera "estorative Verrological Levices
(k) Number K032420
- 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.