(196 days)
Coated VICRYL Plus Antibacterial Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
The Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. It is coated with a mixture composed of equal parts of Polyglactin 370 (65%PLA/35%PGA, a copolymer of glycolide and L-lactide) and calcium stearate. A small amount of an antibacterial agent, Irgacare MP** (triclosan), has been added to the suture coating. Irgacare** MP is the tradename given by CIBA Specialty Chemicals Corp. for their high purity material that meets U.S.P. specifications for triclosan. Coated VICR YL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a multifilament suture and is available dyed and undyed. It meets U.S.P. requirements, except for diameter, as described in the U.S.P. Monograph for synthetic absorbable surgical suture. The dyed version of the device is available with an approved color additive (D&C Violet No.2). The product is available in U.S.P. sizes 5-0 through 2 in a variety of lengths, with or without needles, and on LIGAPAK* dispensing reels.
The subject device is identical to the predicate device (K032420) in all aspects, including design, materials, sterilization and packaging. The only difference between the proposed and the predicate devices lies in the some labeling statements.
The provided document describes a 510(k) summary for a surgical suture, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance (like effect size of AI assistance, MRMC studies, training set size, etc.) are not applicable and cannot be found in the provided text.
The document focuses on demonstrating substantial equivalence of a new version of a surgical suture (Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture) to a previously cleared predicate device (K032420). The argument for acceptance is based on the new device being "identical to the predicate device... in all aspects, including design, materials, sterilization and packaging" with only minor labeling differences.
Here's the information that can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria here are based on substantial equivalence to the predicate device. The performance data is deemed "not necessary" because of this identical nature.
| Acceptance Criterion (Based on Predicate Device Equivalence) | Reported Device Performance (Proposed Device) |
|---|---|
| 510(k) Number: K032420 | K132580 (New device identifier) |
| Product Code: GAM | Same |
| Regulation: 21 CFR § 878.4493 | Same |
| Absorbable: Yes | Yes |
| Characteristics: Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture | Same |
| Intended use: Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular, and neurological tissues. Should not be used where extended approximation of tissue under stress is required. Should not be used in patients with known allergic reactions to Irgacare MP**. | Same (with labeling modifications) |
| How supplied: Sterile, Multifilament strand (braided), Available in a variety of lengths, with or without needles, and on LIGAPAK* dispensing reels. The devices are available in one, two or three dozen boxes. | Same |
| Color: Undyed or Dyed Suture Strands | Same |
| Material Composition: Composed of a copolymer made from 90% glycolide and 10% L-lactide. Coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and Calcium Stearate. | Same |
| Breaking Strength Retention profile: Approximate percent breaking strength remaining (%BSR) 14 Days -75%, 21 Days -50%, 28 Days -25%. | Same |
| Absorption profile: Absorption is essentially complete between 56 and 70 days. | Same |
| USP requirements: Meets USP Monograph -except for diameter. | Same |
| Sterilization: Sterilized by Ethylene Oxide | Same |
| Packaging: Foil packaging | Same |
| Antibacterial agent: The suture contains Irgacare MP** (triclosan), a broad-spectrum antibacterial agent, at no more than 472ug/m. | Same |
| Labeling Comparison: Modifications in ACTION section regarding meta-analyses of clinical trials referencing benefits of triclosan-coated sutures. | Modified labeling (see original document for full text) |
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 substantial equivalence submission for a physical medical device (suture), not an AI/ML device requiring a test set for performance evaluation in the typical sense. Performance data for the device was not deemed necessary due to its identical nature to the predicate. The labeling modifications refer to pre-existing meta-analyses of randomized clinical trials, but details on sample size or provenance of those studies are not provided in this 510(k) summary.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the suture itself, "ground truth" is established by adherence to physical specifications, material composition, and performance characteristics (like breaking strength and absorption profile) that match the predicate device and meet USP requirements. For the labeling changes related to antibacterial efficacy and reduction of surgical site infections, the ground truth is derived from previous "zone of inhibition studies" and "animal studies," and referenced "prospectively planned meta-analyses of randomized clinical trials."
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below.
| Device Common Name: | Absorbable Poly (glycolide/L-lactide) Surgical Suture | |
|---|---|---|
| Device Proprietary Name: | Coated VICRYL* Plus Antibacterial (Polyglactin 910)Synthetic Absorbable Suture | |
| Submitter: | Ethicon, Inc.Route 22 WestP.O. Box 151Somerville, NJ 08876 | |
| Contact: | Peter CecchiniFellow, Regulatory Affairs908-218-2457pcecchin@its.jnj.com | |
| Date Prepared: | February 27, 2014 | |
| Classification Regulation: | Suture, Surgical, Absorbable Poly (glycolide/L-lactide)Surgical Suture; 21 CFR §878.4493 | |
| Panel: | General and Plastic Surgery Devices | |
| Product Code: | GAM | |
| Predicate Device: | Coated VICRYL* Plus Antibacterial (Polyglactin 910)Synthetic Absorbable Suture (K032420) |
Indications for Use:
Coated VICRYL Plus Antibacterial Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Device Description:
The Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. It is coated with a mixture composed of equal parts of Polyglactin 370 (65%PLA/35%PGA, a copolymer of glycolide and L-lactide) and calcium stearate. A small amount of an antibacterial agent, Irgacare MP** (triclosan), has been added to the suture coating. Irgacare** MP is the tradename given by CIBA Specialty Chemicals Corp. for their high purity material that meets U.S.P. specifications for triclosan. Coated VICR YL*
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Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a multifilament suture and is available dyed and undyed. It meets U.S.P. requirements, except for diameter, as described in the U.S.P. Monograph for synthetic absorbable surgical suture. The dyed version of the device is available with an approved color additive (D&C Violet No.2). The product is available in U.S.P. sizes 5-0 through 2 in a variety of lengths, with or without needles, and on LIGAPAK* dispensing reels.
The subject device is identical to the predicate device (K032420) in all aspects, including design, materials, sterilization and packaging. The only difference between the proposed and the predicate devices lies in the some labeling statements.
Performance Data:
The technological characteristics of the proposed device are identical to the predicate device, therefore, performance data are not necessary to establish substantial equivalence.
Substantial Equivalence:
The purpose of this 510(k) submission is to obtain a modified indication for use and modified labeling for the Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture. A comparison of the proposed and predicate device is provided below.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K132580 | K032420 |
| Product Code | GAM | GAM |
| Regulation | 21 CFR § 878.4493 | 21 CFR § 878.4493 |
| Absorbable | Yes | Yes |
| Characteristics | Same | Coated VICRYL* Plus Antibacterial (Polyglactin910) Synthetic Absorbable Suture |
| Intended use | Same | Indicated for use in general soft tissueapproximation and/or ligation, except forophthalmic, cardiovascular, and neurologicaltissues. Should not be used where extendedapproximation of tissue under stress isrequired. Should not be used in patients withknown allergic reactions to Irgacare MP**. |
| How supplied | Same | Sterile, Multifilament strand (braided)Available in a variety of lengths, with or withoutneedles, and on LIGAPAK* dispensing reels.The devices are available in one, two orthree dozen boxes. |
| Color | Same | Undyed or Dyed Suture Strands |
| Proposed Device | Predicate Device | |
| Material | Same | Composed of a copolymer made from 90% |
| Composition | glycolide and 10% L-lactide. Coated with a mixture | |
| composed of equal parts of a copolymer of glycolide | ||
| and lactide (Polyglactin 370) and Calcium Stearate. | ||
| Breaking Strength | Same | Approximate percent breaking strength remaining |
| Retention profile | (%BSR) 14 Days -75% 21 Days sizes -50% 28 Dayssizes -25% | |
| Absorption profile | Same | Absorption is essentially complete between 56 and70 days. |
| USP requirements | Same | Meets USP Monograph -except for diameter |
| Sterilization | Same | Sterilized by Ethylene Oxide |
| Packaging | Same | Foil packaging |
| Antibacterial agent | Same | The suture contains Irgacare MP |
| ** (triclosan), a broad-spectrum | ||
| antibacterial agent, at no more | ||
| :: | than 472ug/m. | |
| Labeling | In ACTIONS section: | In ACTIONS section: |
| Using zone of inhibition studies, Coated VICR YL | Using zone of inhibition studies, Coated VICRYL | |
| Plus Antibacterial Suture has been shown to inhibit | Plus Antibacterial Suture has been shown to inhibit | |
| colonization of the has been shown to inhibitcolonization of the suture by Staphylococcus aurens | colonization of the has been shown to inhibitcolonization of the suture by Staphylococcus | |
| Staphylococcus epidermidis, Methicillin Resistant S. | aureus , Staphylococcus epidermidis, Methicillin | |
| aureus . Methicillin Resistant S. epidermidis and | Resistant S. aureus . Methicillin Resistant S. | |
| Escherichia coli which are microorganisms known to | epidermidis and Escherichia coli which are | |
| contribute to surgical site infections. Animal studies | microorganisms known to contribute to surgical site | |
| have demonstrated that VICRYL Plus Antibacterial | infections. Animal studies have demonstrated that | |
| suture inhibits bacterial colonization of suture after | VICR YL Plus Antibacterial suture inhibits bacterial | |
| direct in vivo challenge with bacteria. Prospectively | colonization of suture after direct in vivo challenge | |
| planned meta-analyses of randomized clinical trials | with bacteria. | |
| were performed on the use of suture containing | ||
| triclosan to lower surgical site infection rates. | ||
| Examples of such meta-analyses are referenced | ||
| below 1. 2. | ||
| Wang, Z.X., Jiang, C.P., Cao, Y., Ding, | ||
| Y.T., Systematic review and meta-analysis oftriclosan-coated sutures for prevention ofsurgical site infections., Br. J. Surgery, 2013. | ||
| 2Edminston, C.E., Doud, F.C., Leaper, D. Is therean evidence based argument for embracing anantimierobial (triclosan) - coated suture technologyto reduce the risk for surgical site infections? : Ameta-analysis. Surgery; 2013; 154; 89-100. |
Substantial Equivalence Comparison Table
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus in its talons.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Ethicon Incorporated Mr. Peter Cecchini Fellow, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K132580
Trade/Device Name: Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/1-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: February 10, 2014 Received: February 11, 2014
Dear Mr. Cecchini:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Mr. Peter Cecchini
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
. Indications for Use
510(k) Number (if known) K132580
Device Name
i
Coated VICR YL * Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture
Indications for Use (Describe)
Coated VICRYL Plus Antibacterial Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
avid Krause
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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.