V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE by SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE

The V-Loc™ 180 absorbable wound closure device (Size 4-0) 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.

AI/ML Overview

The provided text is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This type of submission is for medical devices and typically does not involve studies with human readers, AI assistance, or complex ground truth establishment as seen in diagnostic imaging AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing (in vitro and in vivo), material characterization, and compliance with standards.

Therefore, many of the requested fields (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that "Performance testing (in vitro and in vivo) was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device (Size 4-0) is safe and effective and performs as intended." However, it does not explicitly list specific numerical acceptance criteria or the detailed reported device performance in a table format. For 510(k) submissions, the “acceptance criteria” are generally met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device, and the performance testing supports this claim of equivalence.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Acceptance Criteria (Inferred from Substantial Equivalence and Performance Testing)	Reported Device Performance
Material Composition Equivalence: Device materials are comparable to predicate devices and conform to biocompatibility standards.	V-Loc™ 180 is comprised of materials evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of Medical Devices - Part I Evaluation and Testing. (Implied to meet the standard).
Technological Characteristics Equivalence: Device is identical in key technological characteristics to the predicate device.	V-Loc™ 180 Absorbable Wound Closure device (Size 4-0) is identical to the predicate device (implied this equivalence was demonstrated).
Safety and Effectiveness: Performance testing (in vitro and in vivo) confirms the device is safe and effective for its intended use.	Performance testing (in vitro and in vivo) was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device (Size 4-0) is safe and effective and performs as intended (implied that the results met the safety and effectiveness criteria).
Intended Use: Device is suitable for soft tissue approximation where an absorbable suture is appropriate.	Indicated for soft tissue approximation where use of an absorbable suture is appropriate. (Implied that performance supports this indication).

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document mentions "Performance testing (in vitro and in vivo)" but does not specify sample sizes for these tests, nor does it provide details on data provenance (country, retrospective/prospective). For this type of device, "in vivo" testing typically refers to animal studies rather than human clinical trials for a 510(k).
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 medical device (suture) submission, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 device is an absorbable suture, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a suture device, "ground truth" would be established through physical and mechanical characterization (e.g., tensile strength, degradation rates) and biological response studies (e.g., biocompatibility) rather than expert consensus on images or pathology. The document indicates that materials were evaluated per ISO 10993-1, which provides standards for biological evaluation.
The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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5. 510(k) SUMMARY:

K093408
page 1 of 1

510(K) Summary of Safety and Effectiveness:

. .

イ・

SUBMITTER:

CONTACT PERSON:

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473

Nishith Desai Associate Manager, Regulatory Affairs Phone: (203) 492-6339 Fax: (203) 492-5029

NOV 12 2009

DATE PREPARED:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDIČATE DEVIČE(S):

DEVICE DESCRIPTION:

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

MATERIALS:

PERFORMANCE DATA:

August 24, 2009

V-Loc™ 180 Absorbable Wound Closure Device

Synthetic Absorbable Suture

Polyglycolic Acid Absorbable Surgical Suture

V-Loc™ 180 Absorbable Wound closure Device. K091807
Syneture™ Maxon™ Synthetic Absorbable Suture, K990951
Quill™ Self-Retaining (SRS) comprised of PDO (Polydioxoanone), K080985

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 (Size 4-0) is identical to the predicate device.

V-Loc™ 180 absorbable wound closure device (Size 4-0) is 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 (in vitro and in vivo) was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device (Size 4-0) is safe and effective and performs as intended.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Surgical Devices Tyco Healthcare Group LP (d/b/a Covidien) % Mr. Nishith Desai Associate Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

MOV 12 2003

Re: K093408

Trade/Device Name: V-Loc™ 180 Absorbable Wound Closure Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: October 30, 2009 Received: November 2, 2009

Dear Mr. Desai:

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. Iisting 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 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

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Page 2 - Mr. Nishith Desai

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

for Nohan

Mark N. Mallekson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT:

510(k) Number (if known): K093408

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:
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)

David Krane for WXW

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K093406

Regulation Number and Section

§ 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.