(141 days)
Not Found
No
The document describes a mechanical tacker for mesh fixation and does not mention any AI or ML components or functionalities.
No
The device is used for the fixation of prosthetic material, such as hernia mesh, to soft tissue. It helps to secure rather than treat a medical condition.
No
Explanation: The device is used for fixation of prosthetic material to soft tissue, such as in hernia repair, which is a therapeutic rather than diagnostic function. It does not gather information about a patient's condition or diagnose a disease.
No
The device description clearly outlines physical components including a handle, shaft, articulating tip, and bio-absorbable tacks, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair." This describes a surgical device used in vivo (within the body) during a procedure.
- Device Description: The description details a surgical tacker and absorbable tacks used to physically attach mesh to tissue. This is a mechanical device for surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on samples to gain diagnostic information. This device is used in vivo for surgical fixation.
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 (comma separated list FDA assigned to the subject device)
GDW
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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. |
| Tel Aviv | |
| Israel | |
| Phone: | +972-52-6717051 |
| Fax: | +972-3-5037673 |
| E-mail: | Einat.Duvdevany@thdlap.com |
Contact person:
| Name: | Tali Hazan |
|---|---|
| Address: | Ramot-Naftali, 13830 |
| Israel | |
| Phone: | +972-50-5292304 |
| Fax: | +972-72-2448981 |
| E-mail: | tali.hazan@talmed.co.il |
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
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
- Predicate Device (K110728) - | Modified iMESH Tacker
- New Device - |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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. | 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. |
| Single use | Yes | Yes |
| Supplied sterile | Yes | Yes |
| Materials | Same or Similar | Same or Similar |
| Environment of use | 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. |
| | Delivery Device
Design | Handle with triggers |
| Tip design | Articulating tip | Articulating tip |
| Tacks pre-loaded in
tip | Yes | Yes |
| Tip material | Stainless steel | Stainless steel |
| Number of tacks pre-
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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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.