iMESH Tacker

K153202 · Thd Lap · GDW · Mar 24, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153202
• Device Name: iMESH Tacker
• Applicant: Thd Lap
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Mar 24, 2016
• Decision: SESE
• Submission Type: Special
• 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 manual surgical instrument for fixing prosthetic material (e.g., hernia mesh) to soft tissue. Device consists of an in-line handle, a shaft with an articulating tip, and pre-loaded bio-absorbable helical tacks. Operated by surgeons in hospitals, sub-acute care institutions, and surgery centers. Surgeon manually triggers the applicator to deploy tacks into tissue to secure mesh. Violet-colored tacks are made of synthetic PLA/PGA copolymer. Device facilitates mesh fixation during hernia repair, providing mechanical stability for the prosthetic material.

Clinical Evidence

Bench testing only. Performed strength, functional, mechanical, in-vivo degradation, use simulation, endotoxin, and real-time aging shelf-life testing. All tests met acceptance criteria.

Technological Characteristics

Manual surgical applicator with articulating tip; stainless steel tip; pre-loaded with 30 helical tacks. Tack material: synthetic PLA/PGA copolymer. Single-use, sterile. 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 such procedures.

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

• iMESH Tacker (K110728)

Submission Summary (Full Text)

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

March 24, 2016

THD LAP Ms. Einat Duvdevany General Manager 1 Nirim St. Tel Aviv. Israel

Re: K153202

Trade/Device Name: iMESH Tacker Regulation Number: 21 CFR 878.4750 Regulation Name: Implant staple Regulatory Class: Class II Product Code: GDW Dated: February 23, 2016 Received: February 25, 2016

Dear Ms. Duvdevany:

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/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 Industry and Consumer Education 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

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

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# Indications for Use

510(k) Number (if known) K153202

Device Name iMESH Tacker

Indications for Use (Describe)

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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for THD. The logo features the letters "THD" in a bold, dark blue font. Above the letters is a curved, yellow shape that resembles a swoosh. There is also a small yellow line extending from the bottom right of the letter "D".

## Special 510(K) Summary

## THD Lap Ltd's modified iMESH Tacker (IMT)

## Date Prepared: 20 October, 2015

## 510(k) owner name:

| Company name: | THD Lap Ltd |
|---------------|-------------------------------------|
| Address: | 1st Nirim St.<br>Tel Aviv<br>Israel |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

## Contact person:

| Name: | Tali Hazan |
|----------|--------------------------------|
| Address: | Ramot-Naftali, 13830<br>Israel |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

## Device Name:

Common or usual name: Implantable Staple Proprietary/Trade name: iMESH Tacker

Classification name iMESH Tacker has been classified as Class II device under the following classification name:

| Name | Product<br>Code | 21 CFR Ref. | Panel |
|----------------------|-----------------|-------------|---------------------------|
| Staples, implantable | GDW | 878.4750 | General & Plastic Surgery |

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Image /page/4/Picture/1 description: The image shows the logo for THD. The letters "THD" are in dark blue, with a yellow swoosh above the letters. There is also a small yellow swoosh to the right of the letter "D". The logo is simple and modern.

## Predicate Device:

The modified iMESH Tacker is substantially equivalent to the originally legally marketed iMESH Tacker which was cleared under 510(k) number K110728.

## Device description:

Like the original iMESH Tacker, the modified 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 (PLA/PGA). The modified device's implantable Tack is violet colored. The Applicator is pre-loaded with up to 30 Tacks.

The iMESH Tacker is comprised of 3 parts:

- An in-line handle,
- A shaft with an articulating tip
- The bio-absorbable Tacks

The modified iMESH Tacker is identical to the original iMESH Tacker with the exception of a change in the color of the tacks to violet, several minor internal changes and slight changes to packaging and certain components. We believe that none of these changes affect the substantial equivalency determination of the device with its predicate device.

## 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.

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Image /page/5/Picture/1 description: The image shows the logo for THD. The logo consists of the letters "THD" in a bold, dark blue font. Above the letters is a curved, yellow shape that resembles a swoosh. There is also a small yellow line extending from the bottom right of the letter "D".

## Technological characteristics and Substantial Equivalence:

The modified IMT is substantially equivalent with the original IMT cleared under K110728 as identified above under 'predicate device' section.

Both new and predicate device have the same indications for use, same shape, design and characteristics. All changes that differs the new device from the original device (predicate) were fully addressed and evaluated.

| Feature | iMESH Tacker<br>- Predicate Device (K110728) - | Modified iMESH Tacker<br>- New Device - |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | The iMESH Tacker is indicated<br>for fixation of prosthetic material<br>to soft tissue in various minimally<br>invasive and open general surgical<br>procedures, such as hernia repair. | The iMESH Tacker is indicated<br>for fixation of prosthetic material<br>to soft tissue in various minimally<br>invasive and open general surgical<br>procedures, such as hernia repair. |
| Single use | Yes | Yes |
| Supplied sterile | Yes | Yes |
| Materials | Same or Similar | Same or Similar |
| Environment of use | Hospitals, sub-acute care<br>institutions and surgery centers | Hospitals, sub-acute care<br>institutions and surgery centers |
| Patient population | Individuals undergoing procedures<br>where prosthetic mesh is being<br>used. | Individuals undergoing procedures<br>where prosthetic mesh is being<br>used. |
| | Delivery Device<br>Design | Handle with triggers |
| Tip design | Articulating tip | Articulating tip |
| Tacks pre-loaded in<br>tip | Yes | Yes |
| Tip material | Stainless steel | Stainless steel |
| Number of tacks pre-<br>loaded | 30 | 30 |
| Tack shape | Helical | Helical |
| Biocompaibility | Yes | Yes |
| Technology | Manual | Manual |
| Mode of operation | Tack insertion using the Tacker | Tack insertion using the Tacker |
| Tack material | PLA/PGA | PLA/PGA |
| Tack color | Non-colored (Transparent/Natural) | Violet |
| Performances | Same (equivalent) | Same (equivalent) |

The substantial equivalence table is following presented:

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Image /page/6/Picture/1 description: The image shows the logo for THD. The logo consists of the letters "THD" in a bold, dark blue font. Above the letters is a curved, yellow shape that resembles a swoosh. There is also a smaller yellow shape below the letters.

## Non-clinical performance data:

The following non-clinical tests were performed:

- Strength Testing ●
- . Functional Testing
- In-vivo Degradation Tests .
- Mechanical testing .
- Use simulation test .
- Endotoxin testing .
- Shelf life using real-time aging .

The device passed all tests and successfully met all acceptance criteria.

## Conclusions:

The evaluation of the THD Lap Ltd's Modified iMESH Tacker Device non-clinical tests, demonstrate that the device is as safe and as effective as the predicate device and that all performance tests' acceptance criteria were met. Therefore, we believe it is substantially equivalent to the iMESH Tacker legally marketed devices previously cleared.