(30 days)
Not Found
No
The summary describes a mechanical fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench and in vivo tests of mechanical properties and biocompatibility, not algorithmic performance.
No
The device is described as a fixation device used to attach prosthetic material to soft tissue during surgery, primarily for procedures like hernia repair. Its function is structural fixation rather than treating a disease or medical condition directly.
No
The device is described as a fixation device for prosthetic material during surgical procedures, not as a tool for diagnosis or detection of medical conditions.
No
The device description clearly outlines a physical, reloadable fixation device with absorbable tacks made of synthetic material. It describes hardware components like a handle and reloads, and the performance studies focus on mechanical and biological properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair." This describes a surgical device used directly on a patient's tissue during a procedure.
- Device Description: The description details a mechanical device that deploys tacks made of an absorbable material. This is consistent with a surgical fixation device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to perform tests on samples to aid in diagnosis, monitoring, or screening.
Therefore, the ReliaTack ™ Articulating Reloadable Fixation Device is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
Product codes
GDW
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
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
Not Found
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
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:
- in vitro
- Trigger Firing Force
- Shaft Side Load
- Media Shear Force
- Safety Lock-Out Test
- in vivo
- Tissue trauma (patient)
- Tissue trauma (user)
- Biocompatibility
Key Metrics
Not Found
Predicate Device(s)
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
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
.
.
1
:
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: |
2
- . 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.
3
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
4
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
5
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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