(269 days)
The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.
The Bunegin-Albin Air Aspiration Set is comprised of an air aspiration catheter, wire guide, entry access needle, dilator, syringe, stopcock, and scalpel. The air aspiration catheter is manufactured from radiopaque extruded polyethylene tubing and is designed with a pre-molded winged fitting. The catheter is 5.8 French in size with an endhole diameter of 0.035 inches. The wire guide is manufactured from stainless steel coils, a safety wire, and a mandril wire. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. The set also includes a 12 cc syringe, a low pressure three way stopcock, and a scalpel. The Bunegin-Albin Air Aspiration Set is sterilized by ethylene oxide and intended for one-time use.
This documentation outlines the acceptance criteria and the results of various studies conducted for the Bunegin-Albin Air Aspiration Set to demonstrate its performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance (Zero Time) | ||
| Catheter Shaft Tensile | Peak load of catheter shaft section ≥ 15 N (BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Sideport Tensile | Peak load of catheter sideport section ≥ 15 N (BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Hub-to-Shaft Tensile | Peak load of catheter hub-to-shaft section ≥ 15 N (BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Air Aspiration | No air shall enter the hub (Annex D of BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Liquid Leakage | No part of the catheter shall leak liquid (Annex C of BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Kink Length | Catheter shall not kink (Annex B of BS EN 13868) | Acceptance criterion met. |
| Wire Guide Corrosion | No evidence of corrosion that could affect functional performance (Annex B of BS EN ISO 11070) | Acceptance criterion met. |
| Wire Guide Flex | No signs of defects or damage, including flaking or material loss (Annex G of BS EN ISO 11070) | Acceptance criterion met. |
| Wire Guide Fracture | Wire guide shall not fracture when wound around an approximate former (Annex F of BS EN ISO 11070) | Acceptance criterion met. |
| Wire Guide Tensile | Peak load to failure ≥ 10 N (Annex H of BS EN ISO 11070) | Acceptance criterion met. |
| Wire Guide Rotations to Failure | Characterized for the wire guide. | The number of rotations to failure was characterized. (Specific values not provided in this document but implied to be sufficient for meeting overall acceptance related to design input requirements.) |
| Wire Guide Tip Deflection | Characterized for the wire guide. | The tip deflection side loads were characterized. (Specific values not provided in this document but implied to be sufficient for meeting overall acceptance related to design input requirements.) |
| Dilator Shaft Tensile | Peak load of dilator shaft section ≥ 15 N (BS EN ISO 11070) | Acceptance criterion met. |
| Dilator Hub-to-Shaft Tensile | Peak load of dilator hub-to-shaft section ≥ 15 N (BS EN ISO 11070) | Acceptance criterion met. |
| Dimensional, Compatibility, Surface Analysis | All measurements and dimensional requirements within listed tolerances. Set components compatible. External surface of effective length free of extraneous matter. | Acceptance criterion met. |
| Particulate Testing | Meet USP 788 thresholds for small volume injections. | Acceptance criterion met. |
| Resistance to Overriding Testing | Testing conducted in accordance with ISO 594-2. | Acceptance criterion met. |
| Separation Force Testing | Testing conducted in accordance with ISO 594-2. | Acceptance criterion met. |
| Unscrewing Torque Testing | Testing conducted in accordance with ISO 594-2. | Acceptance criterion met. |
| Performance (3-Year Accelerated Aging) | ||
| Catheter Shaft Tensile | Peak load of catheter shaft section ≥ 15 N (BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Sideport Tensile | Peak load of catheter sideport section ≥ 15 N (BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Hub-to-Shaft Tensile | Peak load of catheter hub-to-shaft section ≥ 15 N (BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Air Aspiration | No air shall enter the hub (Annex D of BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Liquid Leakage | No part of the catheter shall leak liquid (Annex C of BS EN ISO 10555-1) | Acceptance criterion met. |
| Catheter Kink Length | Catheter shall not kink (based on a 20 mm kink radius) (Annex B of BS EN 13868) | Acceptance criterion met. |
| Dilator Shaft Tensile | Peak load of dilator shaft section ≥ 15 N (BS EN ISO 11070) | Acceptance criterion met. |
| Dilator Hub-to-Shaft Tensile | Peak load of dilator hub-to-shaft section ≥ 15 N (BS EN ISO 11070) | Acceptance criterion met. |
| Animal Testing | ||
| Acute performance of aspiration catheter in animal model | Catheter shall receive a grading of "adequate" or "good" in each of the performance parameters, and it shall be able to remove air from the target sites. | Acceptance criterion met. |
| Biocompatibility | ||
| Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, In Vivo Thrombogenicity) | Testing performed per ISO 10993-1 and FDA guidance to ensure biocompatibility. | Acceptance criterion met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for each physical and chemical test (e.g., Catheter Shaft Tensile, Wire Guide Corrosion). Instead, the document refers to compliance with international standards (e.g., BS EN ISO 10555-1, BS EN ISO 11070, ISO 594-2, BS EN 13868, USP 788) which would implicitly define sample sizes for such tests.
For the Animal Testing, a specific sample size is not stated, but the testing evaluated the "acute performance" in an animal model. The provenance would be experimental ("prospective" if considered in the context of device development) rather than clinical human data. The country of origin for the animal study is not specified in the provided text.
The data for all engineering performance and biocompatibility tests is based on prospective testing conducted specifically for this device submission to demonstrate compliance with standards and design input requirements. The country of origin of this testing data is not explicitly stated, but it is for a device manufactured by Cook Incorporated, presumably in the US or one of their international facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the engineering performance tests (tensile strength, kink resistance, leakage, etc.) and particulate testing, "ground truth" is established by adherence to quantitative specifications defined by international standards (e.g., ≥ 15 N, no air entry, no liquid leak, USP 788 thresholds). Therefore, these do not rely on human expert consensus in the same way clinical image interpretation might. The "experts" in this context would be the technicians and engineers performing and verifying the tests against the defined standards.
For Animal Testing, the grading of "adequate" or "good" for performance parameters and ability to remove air would imply evaluation by experts, likely veterinary surgeons or researchers with expertise in animal models and medical device performance. The number and specific qualifications of these experts are not provided.
For Biocompatibility testing, "ground truth" is established by the results of standardized tests per ISO 10993-1 and FDA guidance. Experts would be toxicologists and other scientific professionals interpreting these results, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
For the physical, chemical, and mechanical performance tests, the adjudication method is direct comparison of measured values against predefined numerical or qualitative acceptance criteria outlined in international standards. There is no mention of a human consensus or specific adjudication for these quantitative evaluations beyond meeting the standard.
For the Animal Testing, the "grading of 'adequate' or 'good'" suggests an assessment, but the specific adjudication method (e.g., single expert, 2+1 consensus) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a physical medical instrument (an air aspiration set), not an AI or imaging diagnostic device that would typically involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable as this is a physical medical device. The "performance" studies are standalone in the sense that they evaluate the device's physical properties and functionality without human intervention being part of the device's performance mechanism, but rather as the operators and evaluators of the device.
7. Type of Ground Truth Used
The ground truth for the various tests is established through a combination of:
- International Standards and Specifications: For most physical, mechanical, and chemical tests (tensile strength, kink length, leakage, particulate counts, etc.), the ground truth is defined by the acceptance criteria set forth in specific ISO and BS EN standards (e.g., BS EN ISO 10555-1, BS EN ISO 11070, ISO 594-2, BS EN 13868, USP 788 thresholds).
- Empirical Observation/Expert Assessment: For animal testing, the ground truth is based on the observed "adequate" or "good" performance and the ability to remove air from target sites, likely evaluated by trained personnel.
- Biocompatibility Standards: For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1 and FDA guidance, demonstrated through specific laboratory test results.
8. Sample Size for the Training Set
Not applicable in the context of device performance testing for substantial equivalence. There is no mention of a "training set" as this device does not involve machine learning or AI algorithms requiring data for training. The studies described are for verification and validation of the manufactured product.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).