(78 days)
The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The Syneture™ Absorbable Tack and Applicator are sterile single use devices for the fixation of prosthetic material, such as hernia mesh, onto soft tissue. The Absorbable Tack is formed from synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is offered with a range of 5 to 20 tacks.
The provided text describes a 510(k) summary for the Syneture™ Absorbable Tack and Applicator. This is a medical device, not an AI/ML algorithm or software as a medical device (SaMD). Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this type of submission.
510(k) submissions for devices like the Syneture™ Absorbable Tack and Applicator typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics against specific acceptance criteria for diagnostic or algorithmic accuracy.
- Acceptance Criteria & Device Performance: The document states "Performance testing was conducted to verify that the Syneture™ Absorbable Tack and Applicator is safe and effective and performs as intended." However, it does not provide a table of specific acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility standards) or the quantitative results of these tests. This information would typically be detailed in the full 510(k) submission, but is summarized here. The summary explicitly states that the device "is identical to the predicate device in terms of intended use and mode of operation," which is the primary form of 'performance' justification in a 510(k) for substantial equivalence.
Given the nature of the device and the provided document, the requested details for AI/ML evaluation metrics are not present.
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SEP 2 8 2007
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP150 Glover AvenueNorwalk, CT 06856Tel. No.: (203) 845-1000 |
|---|---|
| CONTACT PERSON: | Daniel CampionAssociate II, Regulatory Affairs |
| DATE PREPARED: | July 10, 2007 |
| TRADE/PROPRIETARY NAME: | Syneture™ Absorbable Tack and Applicator |
| COMMON/USUAL NAME: | Absorbable Tack and Applicator |
| CLASSIFICATION NAME: | Implantable Staple |
| PREDICATE DEVICE(S): | AbsorbaTack™ and Applicator (K071061)E-Z Tac™ (K961585) |
| DEVICE DESCRIPTION: | The Syneture™ Absorbable Tack and Applicator are sterilesingle use devices for the fixation of prosthetic material, suchas hernia mesh, onto soft tissue. The Absorbable Tack isformed from synthetic polyester derived from a lactic acid andglycolic acid copolymer. The Applicator is offered with a rangeof 5 to 20 tacks. |
| INTENDED USE: | The Syneture™ Absorbable Tack and Applicator are intendedfor fixation of prosthetic material to soft tissue in variousminimally invasive and open general surgical procedures, suchas hernia repair. |
| TECHNOLOGICALCHARACTERISTICS: | The Syneture™ Absorbable Tack and Applicator is identicalto the predicate device in terms of intended use and mode ofoperation. |
| PERFORMANCE DATA: | Performance testing was conducted to verify that theSyneture™ Absorbable Tack and Applicator is safe andeffective and performs as intended. |
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Public Health Service
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United States Surgical, a Division of Tyco Healthcare Group, LP % Mr. Daniel Campion Regulatory Affairs Associate II 150 Glover Avenue Norwalk, Connecticut 06856
SEP 2 8 2007
Re: K071920
Trade/Device Name: Syneture™ Absorbable Tack and Applicator Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: September 18, 2007 Received: September 19, 2007
Dear Mr. Campion:
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.
If your device is classified (see above) into etther 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 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.
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Page 2 - Mr. Campion
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
for
Mark N. Melkerson
Director Division of General, Restorative and Neurological 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: Syneture™ Absorbable Tack and Applicator
Indications For Use:
The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
| Prescription Use(Part 21 CFR 801 Subpart D) | X | 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 General, Restorative, and Neurological Devices
| 510(k) Number | L071926 |
|---|---|
| --------------- | --------- |
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.