(27 days)
V-Loc™ Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.
The V-Loc™ Nonabsorbable Wound Closure Device is a polybutester suture prepared from a copolymer of butylene terephthalate and polytetramethlyene ether glycol. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ Nonabsorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with [Phthalocyaninato(2-)] copper (21 CFR 74.3045) at a level not exceeding 0.5% by weight of the suture in sizes USP (EP) 3-0 (Metric 3), 2-0 (Metric 3.5), 0 (Metric 4) and 1 (Metric 4.5). They will be supplied in pre-cut lengths affixed to various needle types.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:
Device: V-Loc™ Nonabsorbable Wound Closure Device
K Number: K103052
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Needle Attachment meets USP/EP specification | Meets USP/EP specification. |
| Diameter (non-barbed suture) Maximum Overage | Meets USP/EP specification as stated in the Instructions for Use. |
| Tensile Strength (T=0 straight pull evaluation) | Pass |
| Barb Holding Strength (T=0 simulated barb holding of felt medium) | Pass |
| Product safety and efficacy in porcine model (burst pressure) | No statistical differences in burst pressure between the barbed control (V-Loc™ 180 Absorbable) and test device (V-Loc™ Nonabsorbable). |
Note: The document explicitly states "No statistical differences" in burst pressure, indicating that the new device performed equivalently to the predicate device in this critical in-vivo measure, which serves as the acceptance criterion for efficacy and safety in this context.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing (In-vitro): Not explicitly stated numbers for each test (needle attachment, diameter, tensile strength, barb holding strength). The document states these tests were conducted, implying sufficient samples were used to demonstrate compliance.
- Sample Size for In-vivo Performance Evaluation (Porcine Model): Not explicitly stated, but the study was a "Chronic 21 day study."
- Data Provenance: The bench tests are laboratory-based. The in-vivo study was conducted using a porcine model, which is an animal model. The country of origin of the data is not specified, but the submission is to the U.S. FDA by an American company (Covidien). The studies appear to be prospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a medical suture, and the "ground truth" for its performance is established through objective physical measurements (tensile strength, diameter, etc.) and direct biological/biomechanical outcomes (burst pressure in a porcine model), not through expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the assessment criteria are objective physical and biomechanical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images. The V-Loc™ device is a surgical suture, and its assessment focuses on physical and biological performance rather than human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a sense, the entire evaluation is "standalone" because the device performance is measured directly (e.g., tensile strength, burst pressure) without human interpretation being part of the primary outcome measure. There is no algorithm, as this is a physical medical device.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth is based on established USP/EP specifications for medical sutures and direct physical measurement outcomes (pass/fail for tensile strength, barb holding strength).
- In-vivo Study: The ground truth is based on direct biomechanical outcomes (burst pressure measurements) in a porcine model, comparing the test device to a predicate device. This is a form of direct performance measurement in a biological system.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
{0}------------------------------------------------
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| SUBMITTER: | Surgical Devices, a global business unitof Tyco Healthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473 |
| NOV 10 2010 | |
| CONTACT PERSON: | Jennifer BrennanManager, Regulatory AffairsTel. No.: (203) 492-5346 |
| DATE PREPARED: | September 30, 2010 |
| TRADE/PROPRIETARY NAME: | V-Loc™ Nonabsorbable Wound Closure Device |
| COMMON/USUAL NAME: | Synthetic Nonabsorbable Suture |
| CLASSIFICATION NAME: | Nonabsorbable poly(ethylene terephthalate) surgical suture |
| PREDICATE DEVICE(S): | Syneture™ Novafil™ Synthetic Absorbable Suture (K990952)V-Loc™ 180 Absorbable Wound Closure Device (K090348) |
| DEVICE DESCRIPTION: | The V-Loc™ Nonabsorbable Wound Closure Device is a polybutestersuture prepared from a copolymer of butylene terephthalate andpolytetramethlyene ether glycol. Each device has unidirectional barbsalong the axis of the monofilament.The V-Loc™ Nonabsorbable Wound Closure Device will be offeredboth Undyed (clear) and Dyed with [Phthalocyaninato(2-)] copper (21CFR 74.3045) at a level not exceeding 0.5% by weight of the suture insizes USP (EP) 3-0 (Metric 3), 2-0 (Metric 3.5), 0 (Metric 4) and 1(Metric 4.5). They will be supplied in pre-cut lengths affixed to variousneedle types. |
| INDICATIONS: | V-Loc™ Nonabsorbable Wound Closure Devices are indicated for softtissue approximation. |
| TECHNOLOGICALCHARACTERISTICS: | V-Loc™ Nonabsorbable Wound Closure Device is substantiallyequivalent to the predicate devices with regards to use in soft tissueapproximation. |
| MATERIALS: | All components of the V-Loc™ Nonabsorbable Wound Closure Deviceare comprised of materials that are in compliance with ISO standard10993-1. |
| PERFORMANCE DATA: | Performance testing was conducted to verify that the V-Loc™Nonabsorbable Wound Closure Device is safe and effective andperforms as intended.The following is a description of tests performed and associatedconclusions: |
{1}------------------------------------------------
COVIDIEN™ V-LOC™ NONABSORBABLE WOUND CLOSURE DEVICE
Page 2/2
In-vitro performance evaluation (bench testing) .
- Needle Attachment meets USP/EP specification. .
- Diameter (non-barbed suture) Maximum Overage of ■ USP/EP specification as stated in the Instructions for Use.
- l Tensile Strength (T=0 straight pull evaluation)- Pass
- . Barb Holding Strength (T=0 simulated barb holding of felt medium) - Pass
- · In-vivo performance evaluation
Product safety and efficacy in porcine model ●
Chronic 21 day study with biomechanical testing at T=3, T=7, and T=21 days to compare the burst pressure of the sutured incision of the control (predicate V-Loc™ 180 Absorbable Wound Closure Device) and the test (V-Loc™ ).
Results: No statistical differences in burst pressure between the barbed control (V-Loc™ 180) and test device (V-Loc™ Nonabsorbable).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Covidien LLC % Ms. Jennifer Brennan Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
NOV 1 0 2010
Re: K103052
Trade/Device Name: V-Loc " Nonabsorbable Wound Closure Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: October 12, 2010 Received: October 14, 2010
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 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
{3}------------------------------------------------
Page 2 - Ms. Jennifer Brennan
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications For Use
510(k) Number (if known): __ 长 ١٥3052
NOV 1 0 2010
Device Name: V-Loc™ Nonabsorbable Wound Closure Device
Indications For Use:
V-Loc™ Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krane for MCM
(Division Sign Off)
(Division Sign-6 Division of Surgi al Orthopedic, and Restorative L. . vices
510(k) Number K103052
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.