(98 days)
Not Found
No
The 510(k) summary describes a surgical suture and does not mention any AI or ML components or functionalities. The device description focuses on the material composition and antibacterial properties.
Yes
The device is a surgical suture, which is used to approximate and/or ligate tissues, providing therapeutic benefit by aiding in wound closure and healing. Additionally, it contains an antibacterial agent to prevent infection, thereby contributing to the therapeutic outcome.
No
This device is a surgical suture used for approximation and ligation of soft tissues, not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical suture made of specific materials and coatings, not software.
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 and/or ligation." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "sterile, synthetic absorbable surgical suture." This is a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Product codes
GAM
Device Description
Coated VicryI™ Plus Antibacterial (Polyglactin 910) 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. Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The suture contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 472 µg/m. The copolymers in the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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)
The technological characteristics of the proposed device is identical to the predicate device, therefore, performance data are not necessary to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2018
Ethicon, Inc. % Ms. Donna Marshall Regulatory Affairs Manager Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K181652
Trade/Device Name: Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: August 30, 2018 Received: August 31, 2018
Dear Ms. Marshall:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181652
Device Name
Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorable Suture
Indications for Use (Describe)
Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable 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)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K181652 p. 1 of 2
Image /page/3/Picture/1 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters, with the ",INC." in smaller, red letters to the right. Below the company name is the phrase "a Johnson+Johnson company" in a cursive font.
510(k) Summary
| Submitter: | Ethicon Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151
USA |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Donna Marshall
Manager, Regulatory Affairs
Ethicon, Inc. a Johnson & Johnson company
Ph: (908) 541-3990
Fax: (908) 218-2595
e-mail: dmarsha2@its.jnj.com |
| Date Prepared: | September 26, 2018 |
|---|---|
| ---------------- | -------------------- |
| Device Trade Name: | Coated VICRYL™ Plus Antibacterial (Polyglactin 910)
Synthetic Absorbable Suture |
|----------------------|------------------------------------------------------------------------------------|
| Device Common Name: | Suture, Surgical, Absorbable |
| Class: | II |
| Classification Name: | Absorbable Poly(glycolide/L-lactide) Surgical Suture
(21 CFR 878.4493) |
| Product Code: | GAM |
| Panel: | General and Plastic Surgery Devices |
Predicate Device:
| Device Trade Name | 510(k) Number |
|---|---|
| Coated Vicryl™ Plus Antibacterial | |
| (Polyglactin 910) Absorable Suture | K132580 |
Device Description:
Coated VicryI™ Plus Antibacterial (Polyglactin 910) 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. Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The suture contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 472 µg/m. The copolymers in
4
the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).
Indications for Use:
Coated Vicry|™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Performance Data:
The technological characteristics of the proposed device is identical to the predicate device, therefore, performance data are not necessary to establish substantial equivalence.
Substantial Equivalence:
The subject device is identical to the predicate device with respect to functionality, technological characteristics and intended use. There is no material, device construction, performance specification, packaging, sterilization or manufacturing process changes to the currently marketed devices. The device differs only in the labeling (Instructions for Use) that have been revised to include the references of the latest publication of meta-analysis and guidelines for consideration of the use of triclosan-coated sutures to lower surgical site infection rates in the Actions Section. The proposed device does not raise new questions of safety or effectiveness as the predicate device and therefore substantially equivalent.
Conclusion:
Based on the intended use, fundamental scientific technology, technological characteristics and the intended use, the following subject device Coated Vicry]™ Plus Antibacterial (Polyglactin 910) Absorable Suture is considered to be substantially equivalent to the predicated device.
- Trademark IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"