IMESH TACKER

K110728 · Easylap , Ltd. · GDW · Jun 8, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110728
• Device Name: IMESH TACKER
• Applicant: Easylap , Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Device Story

iMESH Tacker is a sterile, single-use, disposable surgical instrument used for fixing prosthetic mesh to soft tissue during hernia repair or other general surgical procedures. The device consists of a handle with a trigger mechanism and an articulating tip pre-loaded with 30 helical, bio-absorbable tacks made of a lactic acid and glycolic acid copolymer (PLA/PGA). The articulating tip design facilitates tack placement in both open and minimally invasive surgical environments. Operated by surgeons in hospitals, surgery centers, or sub-acute care institutions, the device allows for precise fixation of mesh. The bio-absorbable nature of the tacks provides secure fixation that maintains strength over time, benefiting the patient by reducing the need for permanent foreign materials while ensuring mesh stability.

Clinical Evidence

Bench testing only. Performance testing compared fixation force at implantation and after 14 days. Results showed iMESH Tacker maintained 17.07 N at implantation and 18.82 N after 14 days, compared to the predicate (Absorbatack) which showed 16.46 N at implantation and 8.35 N after 14 days. No clinical data provided.

Technological Characteristics

Single-use, sterile, disposable applicator. Features an articulating stainless steel tip and handle with trigger mechanism. Pre-loaded with 30 helical, bio-absorbable tacks (PLA/PGA copolymer). Mechanical actuation. No software or electronic components.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue in minimally invasive and open general surgical procedures (e.g., hernia repair) in individuals undergoing procedures requiring prosthetic mesh.

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

• Covidien Protack (K090470)
• Covidien Absorbatack (K071061)

Submission Summary (Full Text)

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K110728
pase 193

Premarket Notification 510(k) Section 5 - 510(k) Summary

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iMESH Tacker

2011

| | 510(k) Summary<br>Page 1 of 2<br>15-Mar-11 | JUN - 8 | |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| EasyLap Ltd.<br>30 Ha'Ella St.<br>Kfar Truman, 73150<br>Israel | Tel - 011-972-528565644<br>Fax - 011-972-776201003 | | |
| Official Contact: | Einat Duvdevany - CEO | | |
| Proprietary or Trade Name: | iMESH Tacker | | |
| Common/Usual Name: | Implantable staple | | |
| Classification Name/Code: | GDW - Implantable staple<br>CFR 878.4750 | | |
| Device: | iMESH Tacker | | |
| Predicate Devices: | K090470 - Covidien - Protack<br>K071061 - Sorbx (Covidien) - Absorbatack | | |
| | iMESH Tacker | Covidien<br>Absorbatack<br>K071061 | Covidien<br>Protack<br>K090470 |
| Product Classification | GDW | GDW | GDW |
| CFR | 874.4750 | 874.4750 | 874.4750 |
| Indications for Use | For fixation of<br>prosthetic material to<br>soft tissue in various<br>minimally invasive and<br>open general surgical<br>procedures, such as<br>hernia repair | For fixation of<br>prosthetic material to<br>soft tissue in various<br>minimally invasive and<br>open general surgical<br>procedures, such as<br>hernia repair | For use in affixing<br>prosthetic material or<br>approximately tissue.<br>May be used both<br>endoscopically and in<br>open procedures |
| Environments of Use | Hospitals, sub-acute<br>care institutions, and<br>surgery centers. | Hospitals, sub-acute<br>care institutions, and<br>surgery centers. | Hospitals, sub-acute<br>care institutions, and<br>surgery centers. |
| Patient Population | Individuals<br>undergoing<br>procedures where<br>prosthetic mesh is<br>being used. | Individuals<br>undergoing<br>procedures where<br>prosthetic mesh is<br>being used. | Individuals<br>undergoing<br>procedures where<br>prosthetic mesh is<br>being used. |
| Delivery Device<br>Design | Handles with triggers | Handles with triggers | Handles with triggers |
| Tip design | Articulating tip | Non-articulating tip | Non-articulating tip |
| Tacks pre-loaded in<br>tip | Yes | Yes | Yes |
| Material of tip | Stainless steel | Stainless steel | Stainless steel |
| # of Tack pre-loaded | 30 | 10 and 20 | 30 |
| Tack Design | Helical | Screw | Helical |
| Tack shape | Bio-Absorbable | Bio-Absorbable | Non-bio-Absorbable |
| Tack Length | 6.3 mm | 5 mm | 3.8 mm |
| Material of Tack | PLA/PGA | PLA/PGA | Titanium |
| Packaging | Sterile | Sterile | Sterile |
| Single patient use,<br>disposable | Yes | Yes | Yes |
| Performance Testing | | | |
| Fixation Force | On implantation<br>17.07 N<br>After 14 days<br>18.82 N | On implantation<br>16.46 N<br>After 14 days<br>8.35 N | Not tested |
| Fixation Force<br>Mid-section average,<br>upper and lower<br>sections average | 17.06<br><br>17.08 | 11.50<br><br>22.113 | Not tested |

#### Device Description:

The iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is pre-loaded with 30 tacks.

### Indications for Use:

The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

#### Patient population:

Individuals undergoing procedures where prosthetic mesh is being used.

#### Environment of Use:

Hospitals, sub-acute care institutions, and surgery centers.

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iMESH Tacker

## Premarket Notification 510(k) Section 5 – 510(k) Summary

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## 510(k) Summary Page 2 of 3 1 5-Mar-1 l

# Comparison to Predicates

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K110728
Page 3 of 3

iMESH Tacker

Premarket Notification 510(k) Section 5 - 510(k) Summary

## 510(k) Summary Page 3 of 3 15-Mar-11

#### Summary of substantial equivalence:

We have demonstrated that the iMESH Tacker is equivalent to the predicates in design and performance characteristics:

The iMESH Tacker is viewed as substantially equivalent to the predicate devices because:

### Indications -

ﺃﻟ

- Identical indications for use indicated for fixation of prosthetic material to soft tissue in . various minimally invasive and open general surgical procedures, such as hernia repair to predicate - K071061 - Absorbatack
### Technology -

- Similar technology which incorporates, an in-line handle, a tip and pre-loaded tacks -. K071061 - Absorbatack
- Similar tack design helical K090470 Protack .

### Materials -

- . Identical materials to predicate - K071061 - Absorbatack
### Environment of Use -

- Identical to predicate K071061 Absorbatack .
## Performance specifications -

- . Degradation and consistency of fixation force were tested and found to be similar to predicate - K071061 - Absorbatack
#### Differences -

The only difference between the proposed iMESH Tacker and the predicates is:

- . Helical, bio-absorbable tack and
- . Deployment device, the iMESGH Tacker, has an articulating tip to help facilitate tack placement.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

EasyLap Ltd. % PreMedic, Inc. Mr. Paul Dryden 24301 Woodsage Drive Bonita Springs, Florida 34134

JUN - 8 2011

Re: K110728

Trade/Device Name: iMESH Tacker Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 29, 2011 Received: June 1, 2011

Dear Mr. Dryden:

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. Isting 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 - Mr. Paul Dryden

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.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.

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 Statement

Page 1 of 1

510(k) Number:

KIIO728 (To be assigned)

Device Name:

iMESH Tacker

Indications for Use:

The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

Daniel Kramer/MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110728