(214 days)
Not Found
No
The device description and performance studies focus on mechanical properties and animal testing, with no mention of AI or ML.
No
The device is used for fixation of surgical mesh to tissues for tissue reinforcement, which is a structural or mechanical function, not a therapeutic one.
No
The device is described as a system for fixation of surgical mesh to tissues, used to attach or reinforce tissues by fastening them. Its intended use and description focus on mechanical fixation, not on diagnosing any conditions or diseases.
No
The device description explicitly lists physical components such as a stainless steel Fixation Device, Surgical Mesh, and a stainless steel Extraction Device. The performance studies also focus on the mechanical properties and biological interactions of these physical components.
Based on the provided information, the EndoFast Reliant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures." This describes a surgical procedure performed on the body, not a test performed outside the body on samples.
- Device Description: The components (fixation device, surgical mesh, extraction device) are all designed for physical manipulation and attachment of tissues within the body.
- Performance Studies: The performance studies focus on the mechanical properties of the device and mesh (insertion force, pullout strength, fatigue, etc.) and animal studies evaluating safety and effectiveness in vivo. These are typical tests for surgical devices, not IVDs which would involve analytical performance on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The EndoFast Reliant System does not perform this function.
N/A
Intended Use / Indications for Use
The EndoFast Reliant System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.
Product codes
FTL
Device Description
The EndoFast Reliant System is a sterile, single use system consisting of the following components: stainless steel Fixation Device preloaded with the Spider Fastener. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener. Surgical Mesh; Polypropylene monofilament Mesh. A stainless steel Extraction Device; provided for easy removal of the Spider Fastener when needed under direct vision. Endogun’s EndoFast Reliant System is used to attach or reinforce tissues by fastening them with Spider Fasteners. These Fasteners will attach a suitably designed mesh onto the tissue to ensure fixation between two tissues. The devices are preloaded for single use. The EndoFast Reliant System is supplied sterilized and ready for use upon removal from its packaging. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Fixation Device and Fastener were tested for Insertion force, Fatigue testing, Dynamic grip strength, Retraction in response to different tension forces, Rigidity tests, Cyclic loading, Fatigue testing for durability and integrity of the Fastener, Anterior Fixation, Pullout strength, Reliability tests, Fastener spread, Ergonomics and Sterility. The Extraction Device was tested for its reliability. The mesh was tested according to the FDA "Guidance for the Preparation of Premarket Notification Application for a Surgical Mesh". The following performance tests were performed on the mesh: Anterior Fixation, Sterility, Thickness, Weave characteristics, Pore size, Mesh density, Tensile strength, Pullout strength, Burst strength, Tear resistance, Fatigue and Flexibility. Results of this testing indicate that the EndoFast Reliant System is substantially equivalent to the predicate devices.
A series of animals were implanted with the EndoFast device in order to evaluate the safety and effectiveness of using the EndoFast Reliant as a tissue reinforcing system. Altogether five different experiments were conducted using 4 sheep (2 before sacrifice) and a pig as an animal model. Two of the sheep studies included two months of followup. Following animal sacrifice, the pathological effects on tissues were assessed by histological examination. The animal study established the safety and efficacy of using the EndoFast Reliant as a tissue reinforcing system. Specially, this study demonstrated that the EndoFast Reliant device is safe for its intended use, it is easy to introduce, the insertion procedure is simple, fast and the anchoring is effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
K060329 1/3
510(K) SUMMARY PREPARED AUGUST 13, 2006 EndoFast Reliant System
SEP 1 1 2006
- Applicant's Name: Endogun Medical Systems 12 Haplada St. South Industrial Park Kiryat Shmona 11013 ISRAEL Tel (972)4-681-8801 Fax (972)4-681-8806
- Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
- Product Name: EndoFast Reliant
- Common Name: Minimal invasive fastening device with surgical polymeric Mesh
- Classification: KOG and GCI (Endoscope and accessories), FTL (Mesh, Surgical Polymeric) 21 CFR 876.1500, 21 CFR 878.3300 Class: II
- Device Description: The EndoFast Reliant System is a sterile, single use system consisting of the following components:
stainless steel Fixation . A Device preloaded with the Spider Fastener. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.
- . Surgical Mesh; Polypropylene monofilament Mesh
- · A stainless steel Extraction Device; provided for easy removal of the Spider Fastener when needed under direct vision.
Endogun's EndoFast Reliant System is used to attach or reinforce tissues by fastening them with Spider Fasteners. These Fasteners
1
| | will attach a suitably designed mesh onto the tissue to ensure
fixation between two tissues. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The devices are preloaded for single use. |
| | The EndoFast Reliant System is supplied sterilized and ready for
use upon removal from its packaging. |
| | The Fixation Device is provided with a
safety pin that prevents inadvertent
deployment of the Spider Fastener. |
| Intended Use: | The EndoFast Reliant System is indicated for fixation of
surgical mesh to tissues for tissue reinforcement during
minimally invasive procedures |
| Predicate Device: | The predicate device for the Fixation Device is: A & A Tacker
Endoscopic Stapler (K003949). |
| | The predicate device for the surgical Mesh is AMS Large Pore
Polypropylene Mesh (K033636). |
Performance Data
The Fixation Device and Fastener were tested for Insertion force, Fatigue testing, Dynamic grip strength, Retraction in response to different tension forces, Rigidity tests, Cyclic loading, Fatigue testing for durability and integrity of the Fastener, Anterior Fixation, Pullout strength, Reliability tests, Fastener spread, Ergonomics and Sterility. The Extraction Device was tested for its reliability.
The mesh was tested according to the FDA "Guidance for the Preparation of Premarket Notification Application for a Surgical Mesh". The following performance tests were performed on the mesh: Anterior Fixation, Sterility, Thickness, Weave characteristics, Pore size, Mesh density, Tensile strength, Pullout strength, Burst strength, Tear resistance, Fatigue and Flexibility.
Results of this testing indicate that the EndoFast Reliant System is substantially equivalent to the predicate devices.
Performance Testing - animal
A series of animals were implanted with the EndoFast device in order to evaluate the safety and effectiveness of using the EndoFast Reliant as a tissue reinforcing system. Altogether five different experiments were conducted using 4 sheep (2 before sacrifice) and a pig as an animal model. Two of the sheep studies included two months of followup. Following animal sacrifice, the pathological effects on tissues were assessed by histological examination.
The animal study established the safety and efficacy of using the EndoFast Reliant as a tissue reinforcing system. Specially, this study demonstrated that the EndoFast Reliant device is safe for its intended use, it is easy to introduce, the insertion procedure is simple, fast and the anchoring is effective.
2
Comparison with Predicate Devices:
The EndoFast System provides an approximation of soft tissues and fixation of surgical mesh to tissues similar to the cleared A & A Tacker Endoscopic Stapler (K003949) except for some differences in the insertion technique and the structure. The EndoFast's Mesh is substantially equivalent to AMS Large Pore Polypropylene Mesh (K033636). The performance and differences were tested for safety and efficacy.
Ko60329 3/3
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol. The text is in all caps and appears to be in a simple, sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2006
Endogun Medical Systems % Yoram Levy 31 Haavoda Street Binyamina, Israel 30500
Re: K060329
Trade/Device Name: EndoFast Reliant System Regulation Number: 21CFR §878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: September 11, 2006 Received: September 11, 2006
Dear Mr. Levy:
This letter corrects our substantially equivalent letter of September 11, 2006. 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 (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.
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); 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.
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Page 2 - Yoram Levy
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Friem
Mark N. Melkerson Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
14060329
Device Name:
EndoFast Reliant
- The EndoFast Reliant System is indicated for fixation of Indications for . surgical mesh to tissues for tissue reinforcement during Use: minimally invasive procedures
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Use Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number
Pbh
(Dirig
ivision Sign-Off) Division of General, Restorative and Neurological Devices
Number Kdo 0329