(10 days)
Not Found
No
The summary describes suture reloads and suturing devices, focusing on mechanical performance and material properties. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is described as suture reloads for endoscopic suturing devices, intended for soft tissue approximation. While these are used in surgical procedures, their primary function is to physically bring tissues together, not to treat or cure a disease or condition in a therapeutic sense. They are tools for physical repair.
No
The device description indicates it is "Absorbable and non-absorbable synthetic suture reloads for endoscopic suturing devices," intended for "soft tissue approximation." It is a surgical tool for placing stitches, not a device used to identify, detect, or monitor a medical condition or disease.
No
The device description clearly states it is "Absorbable and non-absorbable synthetic suture reloads for endoscopic suturing devices," indicating a physical, hardware component (sutures and reloads). The performance studies also describe bench top and in vivo tests related to physical properties like tensile strength and tissue passage.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "placement of running stitches in soft tissue" and "soft tissue approximation" during endoscopic surgery. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description is "Absorbable and non-absorbable synthetic suture reloads for endoscopic suturing devices." This describes a surgical tool/material, not a diagnostic test.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for tissue repair.
N/A
Intended Use / Indications for Use
V-Loc™ 180 Absorbable Reload:
The V-Loc™ 180 absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ 180 absorbable reloads are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
V-Loc™ PBT Non-Absorbable Reload:
The V-Loc™ PBT non-absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ PBT non-absorbable reloads are indicated for soft tissue approximation.
Product codes
GAM, GAT, OCW
Device Description
Absorbable and non-absorbable synthetic suture reloads for endoscopic suturing devices
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 has been performed in support of the intended use of these devices. This testing verifies that the V-Loc™ 180 Absorbable Reload and the V-Loc™ PBT Non-Absorbable Reload are substantially equivalent to the predicate devices. The following performance standards were used:
- USP Monograph for Sutures (33, NF 28, 2010) Physical Test Diameter
- USP Monograph for Sutures (33, NF 28, 2010) Physical Test Needle Attachment
The subject devices were evaluated in the following bench top and in vivo tests:
- Needle Attachment
- Insertion / Removal Forces through Port Cannula
- Tensile Strength
- Barbed Suture Holding Strength
- Tissue Passage
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091087, K082662, K103052, K934738, K090419, K955747
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.
0
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| SUBMITTER: | Covidien llc (formerly registered as Tyco Healthcare, LP) |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Tel. No .: (203) 492-5000 | |
| CONTACT PERSON: | Robert Zott |
| Program Director, Regulatory Affairs | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 USA | |
| Phone: (203) 492-5493 | |
| Fax: (203) 492-6602 | |
| DATE PREPARED: | May 17, 2011 |
| TRADE/PROPRIETARY NAME: | V-Loc™ 180 Absorbable Reload |
| V-Loc™ PBT Non-Absorbable Reload | |
| Endo Stitch™ Endoscopic Suturing Device | |
| SILS™ Stitch Endoscopic Suturing Device | |
| COMMON/USUAL NAME: | Synthetic Absorbable and Nonabsorbable Sutures |
| Endoscopic Suturing Devices | |
| CLASSIFICATION NAME: | V-Loc™ 180 Absorbable Reload: |
| Absorbable poly(glycolide/l-lactide) surgical suture | |
| 21 CFR 878.4493 | |
| V-Loc™ PBT Non-Absorbable Reload: | |
| Nonabsorbable poly(ethylene terephthalate) surgical suture | |
| 21 CFR 878.5000 | |
| Endo Stitch™ Endoscopic Suturing Device | |
| Endoscopic Tissue Approximation Device | |
| 21 CFR 876.1500 | |
| SILS™ Stitch Endoscopic Suturing Device | |
| Endoscopic Tissue Approximation Device | |
| 21 CFR 876.1500 | |
| PREDICATE DEVICE(S): | V-Loc™ 180 Absorbable Wound Closure Device, |
| Covidien (K091087 and K082662) | |
| V-Loc™ Non-Absorbable Wound Closure Device (PBT), | |
| Covidien (K103052) | |
| Endo Stitch™ Endoscopic Suturing Device, Covidien | |
| (K934738) | |
| SILS™ Stitch, Covidien (K090419) |
Addendum to Special 510(k) Premarket Notification for V-Loc™ 180 and V-Loc™ PBT Reloads - 06/01/2011
™ Trademark Page 1 of 26
.
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| USSC Non-absorbable Sutures, Covidien (K955747) | |
|---|---|
| DEVICE DESCRIPTION: | Absorbable and non-absorbable synthetic suture reloads for endoscopic suturing devices |
| INTENDED USE: | V-Loc™ 180 Absorbable Reload: |
| The V-Loc™ 180 absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ 180 absorbable reloads are indicated for soft tissue approximation where use of an absorbable suture is appropriate. |
V-Loc™ PBT Non-Absorbable Reload:
The V-Loc™ PBT non-absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ PBT non-absorbable reloads are indicated for soft tissue approximation. |
| TECHNOLOGICAL CHARACTERISTICS: | The implantable portions of the V-Loc™ Reloads are identical to the predicate V-Loc™ Wound Closure Devices in terms of indications, labeling, materials, performance, and technology. The only differences are the manner in which they are attached to their respective needles and the lengths in which they are supplied. The modifications include the addition of a braided leader and ferrule in order to connect the V-Loc™ suture to a needle specifically designed to be captured and passed between the jaws of an endoscopic suturing device. The needles and materials used for the leader and ferrule have been previously-cleared in the cited predicate devices. The Endo Stitch™ and SILS Stitch™ Endoscopic Suturing Devices have not been changed. |
| MATERIALS: | All component materials of the V-Loc™ 180 Absorbable Reload and the V-Loc™ PBT Non-Absorbable Reload have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices, according to their intended use. These materials have also been previously cleared in predicate devices for the identical intended use. |
| PERFORMANCE DATA: | Performance testing has been performed in support of the intended use of these devices. This testing verifies that the V-Loc™ 180 Absorbable Reload and the V-Loc™ PBT Non-Absorbable Reload are substantially equivalent to the predicate devices. The following performance standards were used: |
2
- · USP Monograph for Sutures (33, NF 28, 2010) Physical Test Diameter
- · USP Monograph for Sutures (33, NF 28, 2010) Physical Test Needle Attachment
The subject devices were evaluated in the following bench top and in vivo tests:
- Needle Attachment
- · Insertion / Removal Forces through Port Cannula
- · Tensile Strength
- · Barbed Suture Holding Strength
- · Tissue Passage
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
JUN - 3 2011
Re: K111442
Trade/Device Name: V-Loc™ 180 Absorbable Reload, V-Loc™ PBT Non-Absorbable Reload Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM, GAT, OCW Dated: May 17, 2011 Received: May 24, 2011
Dear Mr. Zott:
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. Ilsting 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
4
Page 2 - Mr. Robert Zott
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 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.him 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 vours.
fn Dothan,
Oct.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known).
V-Loc™ 180 Absorbable Reload Device Name:
Indications for Use:
The V-Loc™ 180 absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ 180 absorbable reloads are indicated for soft tissue approximation 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111442
6
Covidien IIc (formerly registered as Tyco Healthcare, LP)
Indications for Use
510(k) Number (if known):
Device Name: V-Loc™ PBT Non-Absorbable Reload
Indications for Use:
The V-Loc™ PBT non-absorbable reloads are intended for use with the Endo Stitch™ suturing device and SILS™ Stitch suturing device. The Endo Stitch™ suturing device and SILS™ Stitch suturing device, when used with the reloads, have application in endoscopic surgery for the placement of running stitches in soft tissue. The V-Loc™ PBT non-absorbable reloads are indicated for soft tissue approximation.
Prescription Use X (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 Kuneber Mxm
rgical, Orthopedic, and Restorative Devices
510(k) Number K111442