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 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.

AI/ML Overview

The iMESH Tacker is a device for fixing prosthetic material to soft tissue, primarily in hernia repair. The acceptance criteria and the study proving it meets these criteria are based on its substantial equivalence to predicate devices, namely the Covidien Protack (K090470) and Absorbatack (K071061).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Comparison to Predicate: Absorbatack K071061)	Reported Device Performance (iMESH Tacker)
Indications for Use: Identical for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.	Met (Identical)
Technology: Similar technology including in-line handle, tip, and pre-loaded tacks.	Met (Similar)
Material: Identical to predicate device (Absorbatack).	Met (Identical)
Environment of Use: Identical (Hospitals, sub-acute care institutions, and surgery centers).	Met (Identical)
Performance Specifications - Fixation Force (Degradation and Consistency): Similar to predicate (Absorbatack).	On Implantation: 17.07 N (iMESH Tacker) vs. 16.46 N (Absorbatack) - Similar
	After 14 Days: 18.82 N (iMESH Tacker) vs. 8.35 N (Absorbatack) - Improved performance for iMESH Tacker, still deemed similar/acceptable.
	Mid-section average: 17.06 N (iMESH Tacker) vs. 11.50 N (Absorbatack) - Similar/Acceptable
	Upper and lower sections average: 17.08 N (iMESH Tacker) vs. 22.113 N (Absorbatack) - Similar/Acceptable

Note on Differences: The only stated differences are the iMESH Tacker's helical, bio-absorbable tack (Protack also has a helical tack, Absorbatack has screw) and its articulating tip to facilitate tack placement (the predicates have non-articulating tips). These differences were not considered to preclude substantial equivalence as the performance data demonstrated similarity or improvement where applicable.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a separate "test set" in the context of an AI/ML device. The performance data is presented as a comparison of the iMESH Tacker's fixation force with that of a predicate device (Absorbatack, K071061).

Sample Size: The exact sample size (number of tacks, trials, etc.) for the fixation force testing is not explicitly stated. The data provided (e.g., "On implantation 17.07 N") represents the results of the tests, not the number of samples used to achieve those results.
Data Provenance: The document implies the testing was conducted by EasyLap Ltd., the manufacturer based in Kfar Truman, Israel. The data would be considered prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable to this 510(k) submission. The device is a mechanical surgical instrument, not an AI/ML diagnostic or prognostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is derived from physical and mechanical testing (e.g., fixation force measurements) against a specified standard or comparison to a predicate device's established performance.

4. Adjudication Method for the Test Set

This information is not applicable. Since the "ground truth" is based on physical performance measurements, there is no need for human adjudication of results in the way there would be for an image-based diagnostic AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The iMESH Tacker is a surgical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement are not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The iMESH Tacker is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the iMESH Tacker's performance validation is based on objective physical and mechanical performance data, specifically:

Fixation Force measurements: Quantifying the force required for a tack to remain in place on implantation and after a set period (14 days).
Comparison to Predicate Device Performance: The primary "ground truth" or benchmark is the established mechanical performance of a legally marketed predicate device (Covidien Absorbatack). The claim of substantial equivalence hinges on demonstrating that the iMESH Tacker's performance characteristics align with or are superior to the predicate, within acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. The iMESH Tacker is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in this context.

Summary

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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) SummaryPage 1 of 215-Mar-11	JUN - 8
EasyLap Ltd.30 Ha'Ella St.Kfar Truman, 73150Israel	Tel - 011-972-528565644Fax - 011-972-776201003
Official Contact:	Einat Duvdevany - CEO
Proprietary or Trade Name:	iMESH Tacker
Common/Usual Name:	Implantable staple
Classification Name/Code:	GDW - Implantable stapleCFR 878.4750
Device:	iMESH Tacker
Predicate Devices:	K090470 - Covidien - ProtackK071061 - Sorbx (Covidien) - Absorbatack
	iMESH Tacker	CovidienAbsorbatackK071061	CovidienProtackK090470
Product Classification	GDW	GDW	GDW
CFR	874.4750	874.4750	874.4750
Indications for Use	For fixation ofprosthetic material tosoft tissue in variousminimally invasive andopen general surgicalprocedures, such ashernia repair	For fixation ofprosthetic material tosoft tissue in variousminimally invasive andopen general surgicalprocedures, such ashernia repair	For use in affixingprosthetic material orapproximately tissue.May be used bothendoscopically and inopen procedures
Environments of Use	Hospitals, sub-acutecare institutions, andsurgery centers.	Hospitals, sub-acutecare institutions, andsurgery centers.	Hospitals, sub-acutecare institutions, andsurgery centers.
Patient Population	Individualsundergoingprocedures whereprosthetic mesh isbeing used.	Individualsundergoingprocedures whereprosthetic mesh isbeing used.	Individualsundergoingprocedures whereprosthetic mesh isbeing used.
Delivery DeviceDesign	Handles with triggers	Handles with triggers	Handles with triggers
Tip design	Articulating tip	Non-articulating tip	Non-articulating tip
Tacks pre-loaded intip	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,disposable	Yes	Yes	Yes
Performance Testing
Fixation Force	On implantation17.07 NAfter 14 days18.82 N	On implantation16.46 NAfter 14 days8.35 N	Not tested
Fixation ForceMid-section average,upper and lowersections average	17.0617.08	11.5022.113	Not tested

Device Description:

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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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 (800) 638-2041 or (301) 796-7100 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)

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

Regulation Number and Section

§ 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.