(7 days)
V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.
This document is a 510(k) summary for a medical device called the "V-Loc™ 180 Absorbable Wound Closure Device." It outlines the device's description, intended use, and its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Testing | Not applicable (no change to the device from the predicate). The device is "identical to the predicate device." |
| Biocompatibility | Materials evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of Medical Devices - Part I Evaluation and Testing. (Implicitly, the device met these criteria, as it received 510(k) clearance). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states: "Performance testing is not applicable as there has been no change to the V-Loc™ 180 absorbable wound closure device." This means there was no new performance study conducted with a test set for this 510(k) submission. The device's approval is based on its substantial equivalence to a predicate device (K082662 - V-loc™ 180 Absorbable Wound). Therefore, information on sample size, test set data provenance, and ground truth for a new test set is not provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no new performance study with a test set was conducted for this 510(k). The device's performance relies on the previous evaluation of the identical predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no new performance study with a test set was conducted for this 510(k).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The FDA clearance is based on substantial equivalence, not a comparative effectiveness study showing improvement with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical wound closure device, not an AI algorithm, so the concept of standalone performance for an algorithm is irrelevant here.
7. Type of Ground Truth Used
Not explicitly stated for this 510(k). The device's performance is established by its identity to a predicate device, which would have undergone its own testing and established its efficacy through appropriate methods (e.g., in vitro, in vivo, or clinical studies) prior to its own approval. The biocompatibility for the materials was evaluated against ISO 10993-1:2003.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a physical medical device, not an AI algorithm.
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5. 510(k) SUMMARY:
APR 2 2009
510(K) Summary of Safety and Effectiveness:
| SUBMITTER: | Surgical Devices, a global business unit of TycoHealthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473 |
|---|---|
| CONTACT PERSON: | Jennifer Brennan |
April 7, 2009
Device
Manager, Regulatory Affairs Phone: (203) 492-5346 Fax: (203) 492-5029
Synthetic Absorbable Suture
DATE PREPARED:
TRADE/PROPRIETARY NAME:
COMMON/USUAL NAME:
CLASSIFICATION NAME:
PREDICATE DEVICE(S):
DEVICE DESCRIPTION:
INTENDED USE:
TECHNOLOGICAL CHARACTERISTICS:
MATERIALS:
PERFORMANCE DATA:
The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.
V-loc™ 180 Absorbable Wound Closure Device
Polyglycolic Acid Absorbable Surgical Suture
K082662 - V-loc™ 180 Absorbable Wound
V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
V-Loc™ 180 absorbable wound closure device is identical to the predicate device.
V-Loc™ 180 absorbable wound closure device are comprised of materials which have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices - Part I Evaluation and Testing.
Performance testing is not applicable as there has been no change to the V-Loc™ 180 absorbable wound closure device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration, 9200 Corporate Boulevard Rockville MD 20850
Surgical Devices, Tyco HealthCare Group, LP % Ms. Jennifer Brennan Manger, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
APR 2 2 2009
Re: K091087
Trade/Device Name: V-loc™ Absorbable Wound Closure Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: April 7 2009 Received: April 15, 2009
Dear Ms. Brennan:
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Ms. Jennifer Brennan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
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 STATEMENT:
510(k) Number (if known):
Device Names:
V-loc™ 180 Absorbable Wound Closure Device
Indications For Use
V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate. ·
Prescription Use: X OR Over-The-Counter Use:
(Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Knare finson
(Division Sign-Off) Division of General. Restor and Neurological Devices
510(k) Nur
Раде 18
§ 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.