(30 days)
The device is intended for fixation of prosthetic material to soft tissue 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 absorbable 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 prepackaged with three 10 standard purchase tack single use reloads. The reloads and handle that are packaged together are designed to be used together.
The ReliaTack ™ Articulating Reloadable Fixation Device can accommodate
10 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks
5 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical "acceptance criteria" for each performance test. Instead, it describes "performance evaluations... to show ReliaTack™... is substantially equivalent to the predicate device and perform as intended." The reported device performance is implicitly that it meets the standard of substantial equivalence for these tests as compared to the predicate.
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Trigger Firing Force | Substantially equivalent to the predicate device (AbsorbaTack™ Absorbable Fixation Device K123109) in terms of trigger firing force. | The ReliaTack™ device was shown to be substantially equivalent to the predicate device with regard to Trigger firing force. |
| Shaft Side Load | Substantially equivalent to the predicate device (AbsorbaTack™ Absorbable Fixation Device K123109) in terms of shaft side load. | The ReliaTack™ device was shown to be substantially equivalent to the predicate device with regard to shaft side load. |
| Media Shear Force | Substantially equivalent to the predicate device (AbsorbaTack™ Absorbable Fixation Device K123109) in terms of media shear force. | The ReliaTack™ device was shown to be substantially equivalent to the predicate device with regard to media shear force. |
| Safety Lock-Out Test | Demonstrates effective safety lock-out mechanism. | Test performed, and results indicated substantial equivalence. (Specific performance details not provided, but implies successful function) |
| Tissue trauma (in vivo, patient) | Demonstrates acceptable levels of tissue trauma for the patient during use. | Test performed, and results indicated substantial equivalence. (Specific performance details not provided, but implies acceptable levels) |
| Tissue trauma (in vivo, user) | Demonstrates acceptable levels of tissue trauma for the user during operation. | Test performed, and results indicated substantial equivalence. (Specific performance details not provided, but implies acceptable levels) |
| Biocompatibility | All components of ReliaTack™ are comprised of materials which are in accordance with ISO Standard 10993-1. | All components of ReliaTack™ are comprised of materials which are in accordance with ISO Standard 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual performance test (e.g., number of devices tested for trigger firing force, number of in-vivo experiments). It generally refers to "performance evaluations."
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, however, the tests listed (in vitro and in vivo) are typically prospective by nature for a pre-market evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The study is focused on bench and in-vivo animal testing (implied by "in vivo" and lack of human clinical trials mentioned), not on human interpretation or diagnosis, which would typically involve expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials. This submission focuses on engineering performance and biocompatibility.
5. 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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in medical imaging or diagnostic contexts. The ReliaTack™ device is a surgical fixation device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The ReliaTack™ is a mechanical surgical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering measurements, physical properties, and biological responses (for biocompatibility and in-vivo tissue trauma). For equivalence claims, the ground truth is often established by adherence to recognized standards (e.g., ISO 10993-1 for biocompatibility) and direct comparison to the performance characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set
Not Applicable. As this is a mechanical medical device and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. There is no training set for this device.
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510(k) Summary
K140609 Page 1 of 3
This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
Submitter Information
| Name: | Covidien Ilc |
|---|---|
| Address: | 60 Middletown Avenue |
| North Haven, CT 06473 | |
| Establishment Registration: | 1219930 |
| Name of contact person: | Clare Santulli |
| Regulatory Affairs Manager | |
| Covidien | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 USA | |
| Phone: (203) 492-7635 | |
| Date prepared: | March 7, 2014 |
| Trade or proprietary name: | ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks |
| Common or usual name: | Surgical Stapler with Implantable Staple |
| Classification name: | Staple, Implantable |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | GDW |
| Legally marketed devices to which equivalence is claimed: | AbsorbaTack™ Absorbale Fixation Device (K123109) |
Reason for 510(k) submission:
To obtain market clearance for the ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase
.
.
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:
Absorbable Tacks
| 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 absorbable 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 prepackaged with three 10 standard purchase tack single use reloads. The reloads and handle that are packaged together are designed to be used together.The ReliaTack ™ Articulating Reloadable Fixation Device can accommodate 10 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks 5 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks |
|---|---|
| Intended use of the device: | The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair. |
| Summary comparing the technological characteristics of the subject and predicate devices: | The ReliaTack ™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks is substantially equivalent to the predicate devices with regard to Trigger firing force, media shear force and shaft side load. |
| Materials: | All components of ReliaTack ™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks are comprised of materials which are in accordance with ISO Standard 10993-1. |
| Performance Data: | Bench performance evaluations were completed to show ReliaTack ™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks is substantially equivalent to the predicate device and perform as intended.The tests performed to show substantial equivalence of the ReliaTack ™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks to the predicate device are as follows: |
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- . in vitro
- Trigger Firing Force o
- Shaft Side Load o
- Media Shear Force ்
- Safety Lock-Out Test o
- in vivo .
- Tissue trauma (patient) o
- Tissue trauma (user) o
- Biocompatibility .
Conclusion:
The results of the tests performed demonstrate that the subject device, ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines above three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2014
Covidien LLC Ms. Clare Santulli Regulatory Affairs Manager 60 Middletown Avenue North Haven, Connecticut 06473
Re: K140609
Trade/Device Name: ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: March 7, 2014 Received: March 10, 2014
Dear Ms. Santulli:
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
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Page 2 - Ms. Clare Santulli
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting 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 SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140609
Device Name
ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks
Indications for Use (Describe)
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Peter L. Hudson -S 2014.04.08 15:44:55 -04'00'
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§ 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.