(102 days)
V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
Here's a breakdown of the acceptance criteria and study information for the V-Loc™ 90 Absorbable Wound Closure Device, based on the provided text:
Acceptance Criteria and Device Performance
The provided text details performance evaluations rather than explicitly stating pre-defined "acceptance criteria" with numerical targets. However, the "Results" section indicates the device passed these evaluations by performing comparably to predicate devices or meeting specific standards.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Status / Reported Performance |
|---|---|---|
| In-vitro Performance | Needle Attachment | Meets USP/EP specification. |
| Diameter (non-barbed suture) | Maximum Overage of USP/EP specification as stated in the Instructions for Use. | |
| Tensile Strength (T=0, T=1, T=2 straight pull) | Pass | |
| Barb Holding Strength (T=0, T=1, T=2 simulated barb holding of felt medium) | Pass | |
| In-vivo Performance | Product safety and efficacy (porcine model) | No statistical differences in strength between the barbed control (Quill™ SRS MONODERM) and test devices. |
| The non-barbed control (Biosyn™) was stronger than both barbed devices at T=0 and T=3 days. | ||
| No statistical differences in strength were observed between the non-barbed control and barbed devices at T=10 and T=21 days. | ||
| Strength Loss evaluation (rat model) | Met the label claim of the Biosyn™ suture at T=2 weeks (75% of USP minimum knot pull specification). | |
| Established a strength loss specification of 90% USP minimum knot pull at T=1 week. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or animals.
- For in-vitro tests, the sample size is also not specified.
- For the porcine model, it states "Chronic 21 day study." The number of animals used is not provided.
- For the rat model, it states "degradation over 2 weeks." The number of animals used is not provided.
- Data Provenance: The studies were conducted by Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) based in North Haven, CT, USA. The studies themselves are likely proprietary data generated specifically for this 510(k) submission. Therefore, it is prospective data for the purpose of demonstrating device performance. The country of origin of the data generation is implied to be within the US or a facility controlled by the US-based company.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of external experts to establish ground truth for the test set. Performance data appears to be derived from direct physical testing (bench) and biological observation/measurement (animal models) rather than expert interpretation of images or other qualitative data requiring consensus.
4. Adjudication Method for the Test Set
- None explicitly stated. The evaluations are quantitative (e.g., tensile strength, pull force, degradation percentage) based on direct measurement, not on a subjective assessment that would typically require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a surgical suture, and its performance is evaluated through physical and biological property testing.
6. Standalone (Algorithm Only) Performance
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (suture), not an AI algorithm.
7. Type of Ground Truth Used
- The ground truth used is primarily based on:
- Direct Physical Measurements/Specifications: For in-vitro tests such as needle attachment (USP/EP specification), diameter (USP/EP), tensile strength, and barb holding strength.
- Biomechanical Measurements: For in-vivo studies, such as pull force (to assess strength) in the porcine model and knot pull strength in the rat model. This involves objective quantitative data.
- Comparison to Predicate Devices: Performance is often assessed relative to the behavior of established predicate devices (e.g., Quill™ SRS MONODERM, Biosyn™ suture).
8. Sample Size for the Training Set
- Not Applicable. The V-Loc™ 90 Absorbable Wound Closure Device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing process would be informed by general engineering principles and material science, not a data-driven training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for it. The device's characteristics are inherent to its design, materials, and manufacturing, which are validated through the performance tests described.
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K1002571
pg 1 of 2
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
MAY 1 0 2010
CONTACT PERSON:
Jennifer Brennan Manager, Regulatory Affairs Tel. No .: (203) 492-5346
DATE PREPARED: April 13, 2010
TRADE/PROPRIETARY NAME: V-Loc™ 90 Absorbable Wound Closure Device
COMMON/USUAL NAME: Synthetic Absorbable Suture
CLASSIFICATION NAME: Absorbable poly(glycolide/l-lactide) surgical suture
V-loc™ 180 Absorbable Wound Closure Device (K091087) PREDICATE DEVICE(S):
Syneture™ Biosyn™ Synthetic Absorbable Suture (K000037)
Quill™ Self-Retaining System (SRS) comprised of MONODERM™ (K072028)
DEVICE DESCRIPTION:
The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament.
The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
V-Loc™ 90 Absorbable Wound Closure Devices are indicated for soft tissue
INDICATIONS:
이러한 그래서
.
TECHNOLOGICAL CHARACTERISTICS:
MATERIALS:
PERFORMANCE DATA:
approximation where use of an absorbable suture is appropriate.
V-Loc™ 90 Absorbable Wound Closure Device is substantially equivalent to the predicate devices with regards to use in soft tissue approximation.
All components of the V-Loc™ 90 Absorbable Wound Closure Device are comprised of materials that are in compliance with ISO standard 10993-1.
Performance testing was conducted to verify that the V-Loc™ 90 Absorbable Wound Closure Device is safe and effective and performs as intended. The following is a description of tests performed and associated conclusions: 0
- In-vitro performance evaluation (bench testing)
- Needle Attachment meets USP/EP specification. 비 I
- Diameter (non-barbed suture) Maximum Overage of USP/EP specification as stated in the Instructions for Use. .
- Tensile Strength (T=0, T=1 and T=2 straight pull evaluation)- Pass
- I Barb Holding Strength (T=0, T=1, and T=2 simulated barb holding of felt medium) - Pass
- In-vivo performance evaluation
O
- Product safety and efficacy in porcine model. Chronic 21 day study 마 with biomechanical testing at T=0, T=3, T=10, and T=21 days to
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K100257: 19292
compare the pull force of the sutured incision of the control (predicate - Quill™ SRS MONODERM and Biosyn™ suture) devices and test device. Results: No statistical differences in strength between the barbed control (Quill™ SRS MONODERM) and test devices. The non-barbed control (Biosyn™) was stronger than both the barbed control and test device at time points T=0 and T=3 days. No statistical differences in strength were observed between the non-barbed control and barbed devices at T=10 and T=21 days.
- Strength Loss evaluation in the rat model. Comparison of the degradation over 2 weeks of the non-barbed control (Biosyn ™ suture) and the test device. The degradation of the V-loc™ 90 met the label claim of the Biosyn™ suture at T= 2 weeks, 75% of USP minimum knot pull specification. The additional data obtained at T=1 week was used to establish a strength loss specification of 90% USP minimum knot pull.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
MAY 1 0 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Devices, d/b/a Covidien % Ms. Jennifer Brennan Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K100257
Trade/Device Name: v-Loc™ 90 Absorbable Wound Closure Device Regulation Number: 21 CFR 878.4493
Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture
Product Code: GAM Dated: April 6, 2010 Received: April 15, 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 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
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Page 2 - Ms. Jennifer Brennan
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/ReportalProblem/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 H. Mikkelson
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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Indications For Use
510(k) Number (if known):
Device Name: V-Loc™ 90 Absorbable Wound Closure Device
Indications For Use:
V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Prescription Use × (Part 21 CFR 801 Subpart D)
ﺎ ﻣﺴ
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)
Daúd Krone for JXW
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100257
§ 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.