(195 days)
No
The 510(k) summary describes a physical wound closure device (suture) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
This device is a suture used for wound closure and tissue approximation, which are functions of surgical repair rather than therapeutic treatment.
No
The device is a wound closure device (suture) used for soft tissue approximation. It does not diagnose any condition or disease.
No
The device description clearly states it is a physical suture made from a copolymer, with barbs and supplied in pre-cut lengths affixed to needles. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for soft tissue approximation," which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture prepared from a copolymer of glycolic acid and trimethylene carbonate" with "unidirectional barbs." This describes a physical medical device used for closing wounds.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVDs are devices used to perform tests on samples taken from the human body to detect diseases, conditions, or infections. This device is a surgical tool used for physical repair of tissue.
N/A
Intended Use / Indications for Use
V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.
Product codes
GAM
Device Description
The V-Loc™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). 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)
Performance testing was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device is safe and effective and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Syneture™ Maxon™ Synthetic Absorbable Suture (K990951), Quill TM Synthetic Absorbable Barbed Suture (K042075)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K062662 Page 1 of 1
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 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Renee Borgesano
Manager, Regulatory Affairs
Tel. No.: (203) 492-6060 |
| DATE PREPARED: | September 11, 2008 |
| TRADE/PROPRIETARY NAME: | V-Loc TM 180 Absorbable Wound Closure Device |
| COMMON/USUAL NAME: | Synthetic Absorbable Suture |
| CLASSIFICATION NAME: | Polyglycolic Acid Absorbable Surgical Suture |
| PREDICATE DEVICE(S): | Syneture TM Maxon TM Synthetic Absorbable Suture (K990951) |
| | Quill TM Synthetic Absorbable Barbed Suture (K042075) |
| DEVICE DESCRIPTION: | The V-Loc TM 180 Absorbable Wound Closure Device is a suture
prepared from a copolymer of glycolic acid and trimethylene carbonate.
Each device has unidirectional barbs along the axis of the monofilament. |
| | The V-Loc TM 180 Absorbable Wound Closure Device will be offered dyed
with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP
(EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied
in pre-cut lengths affixed to various needle types. |
| INDICATIONS: | V-Loc TM 180 Absorbable Wound Closure Device is indicated for soft
tissue approximation where use of an absorbable suture is appropriate. |
| TECHNOLOGICAL
CHARACTERISTICS: | V-Loc TM 180 Absorbable 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 TM 180 Absorbable 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 TM 180
Absorbable Wound Closure Device is safe and effective and performs as
intended. |
.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features 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 eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
MAR 2 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Ms. Renee Borgesano Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K082662
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: II Product Code: GAM Dated: February 26, 2009 Received: March 4, 2009
Dear Ms. Borgesano:
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 Fed-ral 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,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
2
Page 2 -- Ms. Renee Borgesano
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
L.A., m. D.A.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: V-Loc™ 180 Absorbable Wound Closure Device
Indications For Use:
V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.
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)
Daniel Krone for MXM 3/26/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082662