(78 days)
No
The description focuses on a mechanical device for tissue fixation and does not mention any computational or data-driven components.
Yes
The device is described as being used for "fixation of prosthetic material to soft tissue" in surgical procedures, which is a therapeutic action.
No
The device is described as being for "fixation of prosthetic material to soft tissue" in surgical procedures, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a sterile single-use device consisting of an absorbable tack and an applicator, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "sterile single use device for the fixation of prosthetic material... onto soft tissue." This further reinforces its use in a surgical setting.
- Lack of IVD characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The description of the Syneture™ Absorbable Tack and Applicator does not involve any such testing of specimens.
Therefore, the Syneture™ Absorbable Tack and Applicator is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GDW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (for fixation of prosthetic material such as hernia mesh)
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 Syneture™ Absorbable Tack and Applicator is safe and effective and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AbsorbaTack™ and Applicator (K071061), E-Z Tac™ (K961585)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 2 8 2007
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP
150 Glover Avenue
Norwalk, CT 06856
Tel. No.: (203) 845-1000 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Daniel Campion
Associate 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 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. |
| INTENDED 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. |
| TECHNOLOGICAL
CHARACTERISTICS: | The Syneture™ Absorbable Tack and Applicator is identical
to the predicate device in terms of intended use and mode of
operation. |
| PERFORMANCE DATA: | Performance testing was conducted to verify that the
Syneture™ Absorbable Tack and Applicator is safe and
effective and performs as intended. |
1
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.
2
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
3
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 |
|---|---|
| --------------- | --------- |