(28 days)
The device is intended for fixation of prosthetic material to soft tissies in various minimally invasive and open surgical procedures such as hernia repair.
The ReliaTack™ Articulating Reloadable Fixation Device is a reloadable sterile, single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an for mxaller synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. The device is offered as a stand-alone reloadable handle pre-packaged with:
- Three, single use, ReliaTack™ reloads with 10 Standard Purchase (5.1mm) absorbable . (PGLA) tacks
Or Proposed - One, single use, ReliaTack™ reload with 5 Deep Purchase (7.0mm) absorbable (PGLA) . tacks & three, single use, ReliaTack™ reloads with 8 Deep Purchase (7.0mm) absorbable (PGLA) tacks
Single use reloads can be packaged separately in the following configurations:
- one ReliaTack™ reload with 5 Standard Purchase (5.1mm) absorbable (PGLA) tacks .
- one ReliaTack™ reload with 10 Standard Purchase (5.1mm) absorbable (PGLA) tacks .
Or
Proposed - one ReliaTack™ reload with 5 Deep Purchase (7.0mm) absorbable (PGLA) tacks .
- one ReliaTack™ reload with 8 Deep Purchase (7.0mm) absorbable (PGLA) tacks .
The provided text describes a 510(k) premarket notification for the "ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks" (K151659). This device is compared to a predicate device, "ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks" (K140609). The submission aims to demonstrate substantial equivalence, not to prove clinical effectiveness or specific diagnostic performance with AI. Therefore, many of the requested categories (e.g., expert involvement, MRMC study, training set ground truth) are not applicable or cannot be extracted from this document as it pertains to a medical device for affixing materials, not an AI diagnostic tool.
Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are framed in terms of demonstrating substantial equivalence to the predicate device through various non-clinical tests. The goal is to show that the design differences (primarily tack length and reload length) do not impact safety or performance compared to the predicate.
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit: No significant adverse impact on safety/performance compared to predicate) | Reported Device Performance (Summary) |
|---|---|---|---|
| Bench Tests | Trigger Firing Force | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. |
| Joint Strength (Hyper-articulation and De-articulation) | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. | |
| Insertion/Removal Force | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. | |
| Load/Unload Force | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. | |
| Media Shear Force | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. | |
| Tack Shear Strength Loss | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. | |
| Tack Mass Loss | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. | |
| Ex Vivo Tests | Torque Required to Drive Tacks into Tissue | Conformance to technical design specifications and performance requirements. | Findings imply equivalence to predicate. |
| Usability Tests | User Interface and Functionality | Conformance to applicable medical device performance standards. | Findings imply equivalence to predicate. |
| Biocompatibility Tests | Material Safety | Conformance to ISO Standard 10993-1. | All components found to be in accordance with ISO Standard 10993-1. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a design verification activity and nonclinical testing comparison against a legally marketed predicate device (K140609). The document explicitly states: "The design differences were found to have no impact on safety or performance. This was established through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing."
Detailed Information based on provided text:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as "sample size" in terms of number of data points for a diagnostic algorithm. For the bench tests, it would refer to the number of devices or components tested. For ex vivo tests, it would refer to the number of tissue samples or test repetitions. These specific numerical sample sizes are not provided in the document.
- Data Provenance: The tests are described as bench tests using simulated tissue medium and mesh, and ex vivo tests using porcine tissue. There is no mention of country of origin, and these are prospective tests conducted for the purpose of this submission, not retrospective data analysis.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes a physical medical device (a fixation device/stapler) and its mechanical/biocompatibility performance, not an AI diagnostic device requiring expert interpretation for ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device and testing. Adjudication methods are typically used in clinical or image-based studies to establish a consensus ground truth, which is not the focus here.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This submission does not involve AI or human readers for diagnostic purposes. It is a comparison of a physical medical device to a predicate device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device; there is no algorithm in this context. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here is compliance with technical design specifications, performance requirements, applicable medical device performance standards (e.g., ISO Standard 10993-1), and the established performance characteristics of the predicate device. The performance is measured directly by mechanical and material properties, not by clinical outcomes or expert interpretation of diagnostic findings.
-
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Covidien LLC Ms. Mary Mellows Regulatory Affairs Product Manager 60 Middleton Avenue North Haven, Connecticut 06473
Re: K151659
Trade/Device Name: ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: June 18, 2015 Received: June 18, 2015
July 17, 2015
Dear Ms. Mellows:
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 (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,
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known) | K151659 |
|---|---|
| -------------------------- | --------- |
Device Name
Belia Tack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks
Indications for Use (Describe)
The device is intended for fixation of prosthetic material to soft tissies in various minimally invasive and open 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) | |
|---|---|---|
| CONTINUE ON A SEPARATE PAGE IF NEEDED | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | ||
| of this information collection, including suggestions for reducing this burden, to: | The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspect | |
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | ||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." | ||
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks June 18, 2015 Covidien -Page 36 of 116 Special 510(k)
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510(k) Summary of Safety and Effectiveness
Date Prepared:
June 18, 2015
Submitter:
Covidien 60 Middletown Avenue North Haven, CT 06473
Contact:
Mary Mellows Regulatory Affairs Product Manager Telephone: (203) 492-5284 (203) 492-5029 Fax: mary.e.mellows@medtronic.com Email:
Name of Device:
| Trade/Proprietary Name: | ReliaTack™ Articulating Reloadable Fixation Device with DeepPurchase Absorbable Tacks |
|---|---|
| Common Name: | Surgical Stapler with Implantable Staples |
| Classification Name: | Staples, Implantablea. Panel number and product code: 79 GDWb. Regulation number: 21 CFR 878.4750 |
| Predicate Device: | |
| Trade/Proprietary Name: | ReliaTack™ Articulating Reloadable Fixation Device with StandardPurchase Absorbable Tacks |
| Common Name: | Surgical Stapler with Implantable Staples |
| Classification Name: | Staples, Implantable |
| Classification Name: | Staples, Implantable |
| a. Panel number and product code: 79 GDW | |
| b. Regulation number: 21 CFR 878.4750 | |
| 510(k) Number: | K140609 |
| Manufacturer: | Covidien |
Device Description:
The ReliaTack™ Articulating Reloadable Fixation Device is a reloadable sterile, single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an for mxaller synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. The device is offered as a stand-alone reloadable handle pre-packaged with:
K140609:
-
Three, single use, ReliaTack™ reloads with 10 Standard Purchase (5.1mm) absorbable . (PGLA) tacks
Or Proposed -
One, single use, ReliaTack™ reload with 5 Deep Purchase (7.0mm) absorbable (PGLA) . tacks & three, single use, ReliaTack™ reloads with 8 Deep Purchase (7.0mm) absorbable (PGLA) tacks
Single use reloads can be packaged separately in the following configurations:
K140609:
- one ReliaTack™ reload with 5 Standard Purchase (5.1mm) absorbable (PGLA) tacks .
- one ReliaTack™ reload with 10 Standard Purchase (5.1mm) absorbable (PGLA) tacks . Or
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks June 18, 2015 Covidien Page 38 of 116 Special 510(k)
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Proposed
- one ReliaTack™ reload with 5 Deep Purchase (7.0mm) absorbable (PGLA) tacks .
- one ReliaTack™ reload with 8 Deep Purchase (7.0mm) absorbable (PGLA) tacks .
Intended Use:
The ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
Technological and Performance Characteristics:
The ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks is substantially equivalent to the predicate ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks in regard to the fixation technologies employed.
Qualitative and quantitative data were obtained and used to compare the ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks to the predicate ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks (K140609).
All aspects were found to be identical, with the exception of the following characteristics:
-
- The length of the ReliaTack™ Absorbable Tack:
- Predicate (K140609) ReliaTack™ Standard Purchase Absorbable Tacks = 5.1mm ●
- Proposed ReliaTack™ Deep Purchase Absorbable Tacks = 7.0mm .
-
- The length of the ReliaTack™ Single Use Reload
The design differences were found to have no impact on safety or performance. This was established through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing.
Tests performed to evaluate and compare technological and performance characteristics:
-
- Bench tests using simulated tissue medium and mesh were performed to evaluate the following technological and performance characteristics in order to show the equivalence of the proposed device to the predicate device (K140609):
- Trigger firing force �
- Joint strength (hyper-articulation and de-articulation) .
- . Insertion/removal force
- Load/unload force .
- . Media shear force
- Tack shear strength loss .
- . Tack mass loss
-
- Ex vivo tests using porcine tissue were performed to evaluate the following performance characteristics:
- Torque required to drive tacks into tissue ●
-
- Usability Tests
-
- Biocompatibility tests in accordance with ISO Standard 10993-1 were performed to confirm that all components of the ReliaTack™ Articulating Reloadable Fixation Device
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with Deep Purchase Absorbable Tacks are comprised of materials that are in accordance with ISO Standard 10993-1 for their intended patient contact profile.
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion:
Through the comparison of technological and performance characteristics and the results of evaluation testing, the ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks was found to be substantially equivalent to the predicate device, ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks (K140609).
§ 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.