(110 days)
This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.
The cannulae consist of either a Polyvinyl Chloride (PVC) body or a silicone wirewound kink-resistant body with auto-inflate cuff. The cannula is used for direct cannulation within the coronary sinus to deliver cardioplegia solution during cardiopulmonary bypass surgery. The back of the cannula body terminates in a locking female luer. These cannulae utilize a guidewire or solid stylet to facilitate trans-atrial introduction. The cannulae are nonpyrogenic. single use, and sterile.
The provided text describes a 510(k) summary for the DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff. This is a medical device submission, and the content primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance criteria through detailed studies involving human subjects or complex AI algorithms.
Therefore, many of the requested categories in your prompt, particularly those related to AI performance, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies, are not applicable to this type of device submission as described in the provided text. This submission focuses on engineering and functional testing for a physical medical device.
However, I can extract the relevant information concerning acceptance criteria and the engineering/functional study that proves the device meets those criteria from the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Verification Testing: |
- Pass kink test
- Pass simulated use test
- Pass bond joint tensile test
- Pass leak testing of all bonded connections
- Pass introducer twist test
- Pass introducer tensile test | Summary of Design Verification Testing:
The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option. Samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing. |
| Performance Testing: - Acceptable retention within the coronary sinus (retention force testing) | Summary of Performance Testing:
The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style. Samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document repeatedly states "All samples" passed the verification and performance testing but does not specify the numerical sample size used for each test.
- Data Provenance: Not specified. This is a submission to the US FDA, so the testing was likely conducted in the US, but the document does not explicitly state the country. The data is prospective as it was performed specifically for this submission.
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. This is a physical medical device. The "ground truth" for these engineering and functional tests is defined by the objective performance standards of the tests themselves (e.g., a certain force before failure, absence of leaks, successful simulation). Expert opinion in the manner of medical image interpretation is not relevant for these types of tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, this is not a study requiring expert adjudication of results. The tests are objective and pass/fail is determined by predefined engineering specifications.
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 a physical medical device (cannula), not an AI-powered diagnostic or assistive technology. No human reader studies or MRMC studies were performed or are relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. There is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is the engineering and functional specifications for the device's performance (e.g., pre-defined force limits for tensile tests, quantifiable leak rates, ability to withstand kinking). These are objective criteria established during the device design and manufacturing process.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set for this type of device.
§ 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).