(27 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a barbed suture, with no mention of AI or ML.
No
The V-Loc™ Nonabsorbable Wound Closure Device is a polybutester suture indicated for soft tissue approximation, which is a supportive device rather than a therapeutic one designed to treat or cure a disease.
No
The device is a wound closure device used for soft tissue approximation, not for diagnosing conditions.
No
The device description clearly describes a physical suture with barbs, made of a specific material, and supplied with needles. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a suture, which is a material used to close wounds or surgical incisions. This is a physical implant/device used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly indicates this is a surgical device used for wound closure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
V-Loc™ Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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).
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.
Syneture™ Novafil™ Synthetic Absorbable Suture (K990952), V-Loc™ 180 Absorbable Wound Closure Device (K090348)
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
§ 878.5000 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.
0
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| SUBMITTER: | Surgical Devices, a global business unit |
| of Tyco Healthcare Group LP (d/b/a Covidien) | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| NOV 10 2010 | |
| CONTACT PERSON: | Jennifer Brennan |
| Manager, Regulatory Affairs | |
| Tel. 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 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. |
| INDICATIONS: | V-Loc™ Nonabsorbable Wound Closure Devices are indicated for soft
tissue approximation. |
| TECHNOLOGICAL
CHARACTERISTICS: | V-Loc™ Nonabsorbable Wound Closure Device is substantially
equivalent to the predicate devices with regards to use in soft tissue
approximation. |
| MATERIALS: | All components of the V-Loc™ Nonabsorbable Wound Closure Device
are comprised of materials that are in compliance with ISO standard
10993-1. |
| PERFORMANCE DATA: | Performance testing was conducted to verify that the V-Loc™
Nonabsorbable Wound Closure Device is safe and effective and
performs as intended.
The following is a description of tests performed and associated
conclusions: |
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