(40 days)
The IntraClude Intra-Aortic Occlusion Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
The IntraClude Intra-Aortic Occlusion Device is a 9 Fr (3mm), triple-lumen, 100-cm-long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation during cardiopulmonary bypass (CPB). The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The shaft is provided with an extended strain relief, which tapers from 10.5 Fr to the remaining 9 Fr catheter, and is designed to prevent kinking and to avoid compressing the shaft when the hemostasis valve of an arterial cannula introducer sheath is firmly closed around the catheter body.
The large central lumen of the IntraClude catheter serves three functions: accommodating the guidewire, delivering cardiopledia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring. The hub has two flexible extension tubes with an integrated luer connection to provide access for accessories. The shaft is provided with markers to indicate the insertion depth. A Clamp-Lock™ device, provided on the extended strain relief portion, allows the IntraClude catheter to be locked in position to prevent balloon migration during aortic occlusion. The devices are provided sterile and non-pyrogenic; they are intended for single use only.
The provided 510(k) summary describes the Edwards Lifesciences® IntraClude™ Intra-Aortic Occlusion Catheter and its functional and safety testing to support substantial equivalence. However, it does not describe a study that involves an AI/ML device, nor does it provide details sufficient to answer many of the specific questions about AI/ML device acceptance criteria or studies (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies).
The document is for a traditional medical device (a catheter) and focuses on engineering and biocompatibility testing. Therefore, I will extract information related to the device's functional and safety testing as acceptance criteria and their performance, but many parts of your request are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours. | All data met pre-determined acceptance criteria. |
| Mechanical Integrity | Tensile testing (bond strength of catheter, lumens, connected accessories). | All data met pre-determined acceptance criteria. |
| Fluid Dynamics | Flow and Venting Rates (cardioplegia flow, aortic root venting rates). | All data met pre-determined acceptance criteria. |
| Durability | Catheter Bending (functionality after manipulation). | All data met pre-determined acceptance criteria. |
| Pressure Resistance | Dynamic Pressure (integrity after exposure to dynamic water flow and manipulation). | All data met pre-determined acceptance criteria. |
| Balloon Performance | Balloon testing (inflation times, diameter, shape, insertion/retraction force, burst pressures). | All data met pre-determined acceptance criteria. |
| Clinical Validation | Design Validation | Validated through animal and cadaver studies. |
| Overall Safety & Efficacy | All necessary verification steps | Met pre-determined acceptance criteria to confirm safety and efficacy. |
Regarding the specific questions tailored for AI/ML devices:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this device. This device is a physical catheter, not an AI/ML software. The "test set" would refer to the samples used in the functional and safety tests (e.g., number of catheters tested for tensile strength, balloon inflation, etc.). These numbers are not provided in the summary.
- The design validation states "animal and cadaver studies," but no sample sizes or provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for this device. As a physical catheter, there is no "ground truth" in the AI/ML sense established by experts for a test set. Ground truth for a physical device is typically based on engineering specifications, physical measurements, and observational outcomes in animal/cadaver studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this device. This pertains to expert review of output for AI/ML systems.
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 for this device. An MRMC study is for evaluating diagnostic performance of readers, often with AI assistance. This device is a therapeutic and monitoring catheter, not a diagnostic imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for this device. This pertains to standalone AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional and safety tests, the "ground truth" would be the pre-defined engineering specifications, performance benchmarks, and industry standards (e.g., ISO 10993 for biocompatibility).
- For the design validation ("animal and cadaver studies"), the "ground truth" would be observed physiological responses, successful occlusion, cardioplegia delivery, pressure monitoring accuracy, and anatomical compatibility in these models.
8. The sample size for the training set
- Not applicable for this device. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable for this device. There is no "training set" for this non-AI/ML device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).