ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

K123109 · Covidien · GDW · Oct 23, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K123109
• Device Name: ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
• Applicant: Covidien
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Oct 23, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AbsorbaTack™ Absorbable Fixation Devices are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures such as hernia repair.

Device Story

AbsorbaTack™ is a sterile, single-use fixation device for attaching prosthetic material (e.g., hernia mesh) to soft tissue. The device consists of an applicator and absorbable tacks made of a synthetic polyester copolymer (lactic and glycolic acid). It is used by surgeons in minimally invasive or open surgical procedures. The device features a shaft with an internal flex cable and spring mechanism to ensure tack deployment even when the shaft is bent. The surgeon manually operates the applicator to deploy tacks into the tissue. The device is intended to secure mesh, facilitating tissue repair. The design modifications in this version improve shaft flexibility and reinforcement without changing the fundamental principle of operation or intended use.

Clinical Evidence

Bench testing only. No clinical data provided. Performance specifications were verified to remain unchanged following design modifications.

Technological Characteristics

Absorbable synthetic polyester copolymer (lactic and glycolic acid) dyed with D&C violet #2. Mechanical fixation device. Features a modified shaft with an internal flex cable, shortened stiffener, and extended spring. Materials evaluated per ISO 10993-1:2003. Sterile, single-use.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue in minimally invasive and open surgical procedures, including hernia repair.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• AbsorbaTack™ Absorbable Fixation Device (K090470)

Submission Summary (Full Text)

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AbsorbaTack™ Absorbable Fixation Device

## OCT 2 3 2012 Submitter Information: Name: Surgical Solutions, a global business unit of Covidien Address: 60 Middletown Avenue North Haven, CT 06473 Name of contact person: Renee Borgesano Manager, Regulatory Affairs Covidien Phone: [phone] Fax: [phone] 1219930 Establishment Registration: Date prepared: September 27, 2012 Name of device: Trade or proprietary name: AbsorbaTack™ Absorbable Fixation Device Common or usual name: Absorbable Tack and Applicator Classification name: Implantable Staple Device Classification: Pursuant to 21 CFR 878.4750, this product is a Class II device. Classification panel: General and Plastic Surgery (79) Regulation: 21 CFR 878.4750 Product Code: GDW Reason for 510(k) submission: To obtain premarket clearance for the change in the design of the AbsorbaTack™ Absorbable Fixation Device with no changes in the indications or intended use of the device. Predicate Device(s): AbsorbaTack™ Absorbable Fixation Device (K090470) Device description: AbsorbaTack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C violet #2. The device is offered with 5, 10, 15, 20, or 30 tacks. Intended use of the device: AbsorbaTack™ Absorbable Fixation Devices 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: AbsorbaTack™ Absorbable Fixation device is similar to the predicate device except for the revised shaft design. The design modifications include adding a flex cable in the inner drive tube of the shaft to allow for continuous rotation if the outer tube is bent to ensure tack deployment, shortening an existing stiffener to reinforce the interface between the outer shaft tube and the body

## 510(k) Summary of Safety and Effectiveness

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AbsorbaTack™ Absorbable Fixation Device

halves, and extending the spring up the entire length of the outer shaft tube that is outside of the body halves.

Material characteristics: Devices are comprised of materials which have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices – Part 1, Evaluation and Testing and is identical to the predicate device. No new materials are introduced in the proposed device.

Performance data: There has been no change to the performance specifications of the AbsorbaTack™ Absorbable Fixation Device. The modified design does not change the performance of the device for its intended use.

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 23 2012

Covidien % Ms. Renee Borgesano Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K123109

Trade/Device Name: ABSORBATACK™ Absorbable Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 03, 2012 Received: October 04, 2012

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 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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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

cerely yours,

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): K123109

ABSORBATACK™ Absorbable Fixation Device Device Name:

Indications For Use:

The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 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 K123109
: