RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS

K140609 · Covidien · GDW · Apr 9, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140609
• Device Name: RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
• Applicant: Covidien
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Apr 9, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

ReliaTack™ Articulating Reloadable Fixation Device is a sterile, single-use surgical instrument for attaching prosthetic mesh to soft tissue. Device features an articulating, reloadable handle prepackaged with absorbable synthetic polyester copolymer tacks (lactic and glycolic acid, dyed with D&C Violet No. 2). Used by surgeons in minimally invasive or open surgical settings (e.g., hernia repair). Surgeon manually operates the device to deploy tacks into tissue to secure mesh. Device performance relies on mechanical trigger firing, shaft articulation, and tack retention. Benefits include secure fixation of prosthetic material during surgical procedures.

Clinical Evidence

Bench testing only. Evaluations included trigger firing force, shaft side load, media shear force, safety lock-out, and biocompatibility per ISO 10993-1. No clinical data provided.

Technological Characteristics

Materials: Absorbable synthetic polyester copolymer (lactic/glycolic acid) per ISO 10993-1. Form factor: Articulating, reloadable handle with 5.1mm absorbable tacks. Energy source: Manual. Sterilization: Not specified.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue in minimally invasive and open surgical procedures, including hernia repair. No specific age or gender restrictions provided.

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 (K123109)

Submission Summary (Full Text)

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## 510(k) Summary

K140609 Page 1 of 3

This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.

Submitter Information

| Name: | Covidien Ilc |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Address: | 60 Middletown Avenue |
| | North Haven, CT 06473 |
| Establishment Registration: | 1219930 |
| Name of contact person: | Clare Santulli |
| | Regulatory Affairs Manager |
| | Covidien |
| | 60 Middletown Avenue |
| | North Haven, CT 06473 USA |
| | Phone: [phone] |
| Date prepared: | March 7, 2014 |
| Trade or proprietary name: | ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks |
| Common or usual name: | Surgical Stapler with Implantable Staple |
| Classification name: | Staple, Implantable |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | GDW |
| Legally marketed devices to which equivalence is claimed: | AbsorbaTack™ Absorbale Fixation Device (K123109) |

Reason for 510(k) submission:

To obtain market clearance for the ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase

.

.

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:

Absorbable Tacks

| Device description: | The ReliaTack ^™ Articulating Reloadable Fixation Device is a reloadable sterile, single use device for fixation of prosthetic material, such as 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 No. 2. The device is offered as a stand-alone reloadable handle prepackaged with three 10 standard purchase tack single use reloads. The reloads and handle that are packaged together are designed to be used together.<br>The ReliaTack ^™ Articulating Reloadable Fixation Device can accommodate <ul><li>10 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks </li><li>5 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks </li></ul> |
|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use of the device: | The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair. |
| Summary comparing the technological characteristics of the subject and predicate devices: | The ReliaTack ^™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks is substantially equivalent to the predicate devices with regard to Trigger firing force, media shear force and shaft side load. |
| Materials: | All components of ReliaTack ^™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks are comprised of materials which are in accordance with ISO Standard 10993-1. |
| Performance Data: | Bench performance evaluations were completed to show ReliaTack ^™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks is substantially equivalent to the predicate device and perform as intended.<br>The tests performed to show substantial equivalence of the ReliaTack ^™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks to the predicate device are as follows: |

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- . in vitro
- Trigger Firing Force o
- Shaft Side Load o
- Media Shear Force ்
- Safety Lock-Out Test o
- in vivo .
- Tissue trauma (patient) o
- Tissue trauma (user) o
- Biocompatibility .

Conclusion:

The results of the tests performed demonstrate that the subject device, ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines above three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 9, 2014

Covidien LLC Ms. Clare Santulli Regulatory Affairs Manager 60 Middletown Avenue North Haven, Connecticut 06473

Re: K140609

Trade/Device Name: ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: March 7, 2014 Received: March 10, 2014

Dear Ms. Santulli:

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

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Page 2 - Ms. Clare Santulli

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140609

Device Name

ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Peter L. Hudson -S 2014.04.08 15:44:55 -04'00'

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