(189 days)
The VESSEL EVERTER System is indicated for use with the Microvascular Anastomotic COUPLER and FLOW COUPLER Device in the anastomosis of only arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The VESSEL EVERTER System is indicated for use with COUPLER and FLOW COUPLER System sizes from 2.0 to 4.0 mm.
Two accessory devices comprise the Vessel Everter System: Vessel Everter and Sizing Guide. The Vessel Everter system is an accessory device to the GEM FLOWCOUPLER System, a pair of implantable rings that are used for end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.
The Vessel Everter System are two non-implantable, sterile, single use hand-held devices that facilitate sizing and use of the GEM FLOWCOUPLER System. The Vessel Everter is comprised of a handle with two soft silicone end effectors (tips), one on each end. The instrument handle features two separate silicone end effectors, each of a different size, intended to be used at the surgeon's discretion. The Vessel Everter end effector is designed with a narrowing tip to allow for engagement with multiple sizes of vessels, corresponding with a coupler size of 2.0-4.0 mm rings. The Vessel Everter is used to press vessel tissue onto the GEM FLOWCOUPLER rings. To accomplish this, the surgeon presses the Vessel Everter into the tissue, flaring the tissue onto and over the Coupler locking pins.
The Sizing Guide is a hard, plastic handle featuring holes on either end through which the vessel's outer diameter may be measured. The holes' diameters are intended to match the inner diameters of the various GEM FLOWCOUPLER rings. The holes correlate to vessel diameters of 2.0 mm to 4.0 mm in 0.5 mm increments. The surgeon may use the sizing guide to guide the selection of which coupler they will use for each particular anastomosis. The Sizing Guide is used by placing the vessel on the sizing guide and comparing the vessel diameter to the holes in the Sizing Guide.
The Vessel Everter and Sizing Guide are sterilized by ethylene oxide and are provided sterile for-single-patient use. The Vessel Everter and Sizing Guide are not implantable and are disposed of after single use.
The parent device, GEM FLOWCOUPLER System, remains unchanged and is not addressed in this submission.
The provided text describes a 510(k) premarket notification for the GEM FlowCoupler System accessories (Vessel Everter and Sizing Guide). It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. Instead, it details performance testing for a medical device's physical and biological properties.
Therefore, many of the requested fields cannot be filled as they pertain to AI/ML device validation studies. However, I can extract the available information regarding the device's performance testing for the physical accessories.
Here's a breakdown based on the provided text, acknowledging the limitations for AI/ML specific information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Silicone tip retention - tensile force | Subject devices met acceptance criteria |
| Retention Barb - Cantilever Loading | Subject devices met acceptance criteria |
| Coupler Engagement and Disengagement Force | Subject devices met acceptance criteria |
| Intimal Integrity (porcine vessels) | Subject devices met acceptance criteria |
| Biocompatibility: Cytotoxicity (L929 MEM Elution) | Not cytotoxic per ISO10993-5 (PASS) |
| Biocompatibility: Sensitization (Kligman Maximization test) | Non-sensitizer per ISO10993-10 (PASS) |
| Biocompatibility: Irritation (intracutaneous injection in rabbit) | Negative per ISO10993-10 (PASS) |
| Biocompatibility: Toxicity (systemic injection in mouse) | Negative for toxicity per ISO10993-11 (PASS) |
| Biocompatibility: Rabbit blood hemolysis test | Non-hemolytic per ASTM F756 (PASS) |
2. Sample size used for the test set and the data provenance
The text mentions "porcine vessels" for the Intimal Integrity Verification Testing but does not specify the sample size. It does not mention any human data or specific provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are physical and biological evaluations of the device's materials and mechanical properties, not an AI/ML diagnosis where expert ground truth is established.
4. Adjudication method for the test set
Not applicable. This concept is relevant for AI/ML performance evaluation against a human-adjudicated ground truth.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests outlined typically refers to established standards and measurement techniques for mechanical properties (e.g., force measurements), material characteristics (e.g., cytotoxicity assays), and biological responses (e.g., hemolysis tests). For the intimal integrity test, the "ground truth" would be the observed integrity of the porcine vessel intima after device use.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.