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510(k) Data Aggregation
(200 days)
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling.
- . Plastic Handle; connects to the Fixation Device.
- . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.
The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.
The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling.
- Plastic Handle; connects to the Fixation Device. .
The fasteners are introduced through a 5mm trocar in laparoscopic procedures.
This document primarily details the substantial equivalence of the "EndoFast Reliant™ SCP" and "EndoFast Reliant™ LAP" devices to predicate devices. It describes various performance and non-clinical tests conducted, but it does not provide specific acceptance criteria or detailed study results in a format that would allow for the direct extraction of "reported device performance" to compare against acceptance criteria for an AI/software device.
The document focuses on the physical and functional characteristics of a surgical mesh fixation system, not on an AI or software device. Therefore, many of the requested categories for AI/software studies are not applicable or cannot be extracted from this text.
However, I can extract the information related to the performance testing that was conducted for this medical device, which is a physical surgical tool.
Acceptance Criteria and Study for EndoFast Reliant™ SCP and LAP (Surgical Devices)
This submission describes the performance testing of the EndoFast Reliant™ SCP and EndoFast Reliant™ LAP, which are physical surgical devices for mesh fixation. The document emphasizes substantial equivalence to predicate devices based on a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted but does not explicitly state quantitative acceptance criteria or detailed numerical performance results in a table format for direct comparison. Instead, it broadly states that tests were performed to "demonstrate appropriate functionality," "validate endurance," "verify deployment reliability and pullout force," and "assure adequate performances." The overall conclusion is substantial equivalence, implying that the device met internal criteria derived from the predicate.
| Acceptance Criteria Category (Derived) | Stated Purpose of Test | Reported Device Performance (Summary from Text) |
|---|---|---|
| Functional Characteristics | To demonstrate appropriate functionality characteristics after sterilization, vibration, drop test, and shelf life study. | Performed; implies appropriate functionality demonstrated. |
| Fastener Support Endurance to Cyclic Loads | To validate the endurance of the SCP Spider Fastener in supporting the cyclic load on the surgical mesh. | Performed; implies endurance was validated. |
| Fastener Deployment Reliability & Pull-Out Force | To verify deployment reliability and pullout force required for fastener failure. To verify no influence of surgical mesh/artificial tissue on fastener deployment. | Performed; implies reliability and adequate pull-out force verified, and no negative influence on deployment. |
| Fixation Device and Handle Reliability & Force | To verify reliability of the Fixation Device and Handle in deploying fasteners without fault and to test deployment force. | Performed; implies reliability and force during deployment verified. |
| Comparative Pull-Out Tests | To assess the new products' equivalency with predicate devices. | Performed; implies equivalency with predicate devices was demonstrated. |
| Gamma Sterilization Validation | To assure products' SAL 10⁻⁶ using 25 kGy. | Performed; implies SAL 10⁻⁶ achieved. |
| EtO Sterilization Validation | To assure products' SAL 10⁻⁶ using overkill approach. | Performed; implies SAL 10⁻⁶ achieved. |
| Shelf Life Tests | To assure adequate performances during shelf life using accelerated aging. | Performed; implies adequate performances during shelf life demonstrated. |
| Biocompatibility | Evaluated with accordance to ISO 10993-1 and FDA Blue Book Memorandum, G95-1. | Performed; implies compliance with biocompatibility standards. |
| MR Compatibility | To assure safe use of the device at MRI environment. | Performed; implies safe use at MRI environment is assured. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "two cadaver studies were performed" but does not specify the sample size (number of cadavers or fasteners tested) for these studies or any other non-clinical tests.
The data provenance is from non-clinical tests and cadaver studies, implying laboratory and controlled anatomical specimen testing rather than human clinical data. The studies were conducted by the applicant, Israel Biomedical Innovations Ltd.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or not provided as the tests are non-clinical, mechanical, and sterilization validations, not involving human expert assessment for "ground truth" in the context of diagnostic interpretation.
4. Adjudication Method
This information is not applicable or not provided as the tests are non-clinical and do not involve human diagnostic interpretation.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is a physical surgical tool, not an AI or imaging diagnostic aid for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This is not applicable as the device is a physical surgical tool, not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical tests:
- Engineering specifications and standards: For functional characteristics, endurance, reliability, pull-out force (e.g., meeting predefined force thresholds, successful deployment rates).
- Biological safety standards: For sterilization (SAL 10⁻⁶) and biocompatibility (ISO 10993-1, G95-1).
- Comparative data: For pull-out tests, implicitly comparing against the performance of predicate devices.
- Anatomical relevance: For cadaver studies, simulating surgical use.
8. Sample Size for the Training Set
This is not applicable as this document describes a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a physical medical device, not an AI or machine learning model.
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