(271 days)
(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA018S, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place.
(Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate.
(Models FEMII010A, FEMII014A, FEMII014A, FEMII008AT, FEMII010AT, FEMII012AT, FEMII014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass.
Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.
The ERMI Pediatric Arterial Cannulae are used to access the aorta or femoral artery during cardiopulmonary bypass.
Here's an analysis of the provided 510(k) summary, specifically addressing the requested information about acceptance criteria and the study that proves the device meets those criteria:
Device: Edwards Lifesciences Research Medical Inc. Pediatric Arterial Cannulae
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional testing | Successfully undergone |
| Biocompatibility testing | Successfully undergone |
| Dimensions (smaller diameter & length than predicate) | Confirmed. This is the only difference noted between the subject and predicate devices. |
2. Sample size used for the test set and the data provenance
The 510(k) summary does not provide details on the sample size used for functional or biocompatibility testing, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states the tests were "successfully undergone."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. The summary focuses on engineering and biocompatibility testing, which generally do not involve clinical experts in establishing ground truth in the same way as, for example, diagnostic imaging devices.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary. Given the nature of functional and biocompatibility testing, a traditional adjudication method for establishing ground truth from multiple expert readings is typically not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or is relevant for this medical device. This device is a physical medical instrument (cannula) used during cardiopulmonary bypass, not an AI or diagnostic imaging tool. Therefore, there is no human-in-the-loop AI assistance aspect to evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or is relevant for this medical device. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The ground truth used for this device would be based on engineering specifications and established regulatory standards for functional performance and biocompatibility of medical devices.
- Functional Testing: Ground truth would be defined by the pre-established performance specifications (e.g., flow rates, resistance, integrity under pressure, connection security).
- Biocompatibility Testing: Ground truth would be defined by the biological response observed in accordance with ISO 10993 standards and relevant regulatory guidelines.
8. The sample size for the training set
This information is not provided and not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are validated through engineering principles and quality systems, not machine learning training.
9. How the ground truth for the training set was established
This information is not provided and not applicable. As explained above, there is no training set for this type of device. The "ground truth" for its design and manufacturing is established through adherence to quality management systems (e.g., ISO 13485, 21 CFR Part 820) and compliance with industry standards for materials and performance.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).