(218 days)
The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.
The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent. Cuff length and texture differences do not affect flow characteristics.
This document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device: the "DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula."
It does not contain any information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria in the way typically expected for a detailed regulatory submission demonstrating new device efficacy or safety.
Instead, this document is a submission to demonstrate substantial equivalence to predicate devices. It explicitly states:
- "The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula."
- "The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent."
- "The materials used for the cuffs and cannula body are silicone which is same as that for DLP and SARNS 3M marketed RCSP devices. Materials have been tested to be biocompatibility acceptable."
- "No difference in Safety and Efficacy. Since materials, indications and technology are the same, no new issues of Safety and Efficacy of the device are introduced."
- "The differences are minor and nonsignificant differences."
Therefore, based on the provided text, I cannot complete the requested table or answer most of the questions because the document's purpose is not to present a new study with specific performance metrics and acceptance criteria. It argues for equivalence based on existing knowledge of predicate devices.
Here's how I would answer based only on the provided text, highlighting the absence of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Implied: Equivalence to predicate devices in Safety and Efficacy | "No difference in Safety and Efficacy." "Differences are minor and nonsignificant differences." |
| Materials Biocompatibility | "Materials have been tested to be biocompatibility acceptable." |
| Function: Perfusion of cardioplegia solutions retrograde through the coronary sinus | "The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus." (Implies it performs this function, but no test results are provided.) |
| Flow Characteristics | "Cuff length and texture differences do not affect flow characteristics." (Implies acceptable flow, but no data provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. No clinical or performance test data on a "test set" is presented in this summary.
- Data provenance: Not specified. The document relies on the established safety and efficacy of predicate devices, not new data from this specific device.
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. No ground truth for a test set was established as no new performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 document is for a physical medical device (cannula), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This document is for a physical medical device (cannula), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new ground truth was generated as no new performance study is described. The basis for safety and efficacy is "sameness" to existing devices.
8. The sample size for the training set
- Not applicable. This document is for a physical medical device (cannula), not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This document is for a physical medical device (cannula), not a machine learning model.
§ 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).