(84 days)
No
The description focuses on a mechanical device for mesh fixation and does not mention any AI/ML components or functions.
No
The device is described as being used for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue during surgical procedures. Its function is to secure material, not directly treat a disease or condition in a therapeutic manner.
No
Explanation: The device is a surgical tacker used for fixation of prosthetic material, not for diagnosing conditions. Its function is to facilitate a surgical procedure, not to identify or analyze a disease or medical condition.
No
The device description clearly describes a physical, sterile, single-use device with an applicator and absorbable tacks, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- iMESH Tacker Function: The iMESH Tacker is a surgical device used to physically attach prosthetic material (like hernia mesh) to soft tissue within the body during a surgical procedure. It does not analyze or test any biological samples.
The description clearly outlines its use as a surgical tool for fixation, not for diagnostic testing of biological specimens.
N/A
Intended Use / 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.
Product codes
GDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (for fixation of prosthetic material)
Indicated Patient Age Range
Individuals undergoing procedures where prosthetic mesh is being used.
Intended User / Care Setting
Hospitals, sub-acute care institutions, and surgery centers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance Testing:
Fixation Force:
On implantation: 17.07 N
After 14 days: 18.82 N
Mid-section average, upper and lower sections average: 17.06, 17.08
Degradation and consistency of fixation force were tested and found to be similar to predicate - K071061 - Absorbatack.
Key Metrics
Not Found
Predicate Device(s)
K090470 - Covidien - Protack, K071061 - Sorbx (Covidien) - Absorbatack
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K110728
pase 193
Premarket Notification 510(k) Section 5 - 510(k) Summary
ﺮ ﻣ
iMESH Tacker
2011
| | 510(k) Summary
Page 1 of 2
15-Mar-11 | JUN - 8 | |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| EasyLap Ltd.
30 Ha'Ella St.
Kfar Truman, 73150
Israel | Tel - 011-972-528565644
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
CFR 878.4750 | | |
| Device: | iMESH Tacker | | |
| Predicate Devices: | K090470 - Covidien - Protack
K071061 - Sorbx (Covidien) - Absorbatack | | |
| | iMESH Tacker | Covidien
Absorbatack
K071061 | Covidien
Protack
K090470 |
| Product Classification | GDW | GDW | GDW |
| CFR | 874.4750 | 874.4750 | 874.4750 |
| Indications for Use | For fixation of
prosthetic material to
soft tissue in various
minimally invasive and
open general surgical
procedures, such as
hernia repair | For fixation of
prosthetic material to
soft tissue in various
minimally invasive and
open general surgical
procedures, such as
hernia repair | For use in affixing
prosthetic material or
approximately tissue.
May be used both
endoscopically and in
open procedures |
| Environments of Use | Hospitals, sub-acute
care institutions, and
surgery centers. | Hospitals, sub-acute
care institutions, and
surgery centers. | Hospitals, sub-acute
care institutions, and
surgery centers. |
| Patient Population | Individuals
undergoing
procedures where
prosthetic mesh is
being used. | Individuals
undergoing
procedures where
prosthetic mesh is
being used. | Individuals
undergoing
procedures where
prosthetic mesh is
being used. |
| Delivery Device
Design | Handles with triggers | Handles with triggers | Handles with triggers |
| Tip design | Articulating tip | Non-articulating tip | Non-articulating tip |
| Tacks pre-loaded in
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,
disposable | Yes | Yes | Yes |
| Performance Testing | | | |
| Fixation Force | On implantation
17.07 N
After 14 days
18.82 N | On implantation
16.46 N
After 14 days
8.35 N | Not tested |
| Fixation Force
Mid-section average,
upper and lower
sections average | 17.06
17.08 | 11.50
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.
1
K110728
Page 293
iMESH Tacker
Premarket Notification 510(k) Section 5 – 510(k) Summary
ﺔ
510(k) Summary Page 2 of 3 1 5-Mar-1 l
Comparison to Predicates
2
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.
3
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
4
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
5
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