(63 days)
The TenderFlow™ Pediatric Venous Return Cannula is a surgically invasive device indicated for dual cannulation of the superior and inferior vena cava and single cannulation of the right atrium for venous drainage during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hourse pofuse
The design of the TenderFlow™ Pediatric Venous Return Cannula consists of a dip molded, wire reinforced, straight venous return cannula (single-stage) with thin walls, and good flow performance. A non-reinforced clamping site is provided adjacent to the flared connection site. The overall length of the cannula from end to end is 12 inches The distal portion of the spring reinforced body steps up in size both in internal diameter and outside diameter to enhance flow performance. This step-up diameter is approximately three French sizes larger than the tip section. The step occurs distal to the insertion portion of the cannula at approximately 3 to 5.5 inches from the tip. The length of the step increases with the French size.
The tip is integral to the body, not spring reinforced and is stiffened sufficiently to resist kinking and/or collapse.
The generic materials used in the TenderFlow™ Pediatric Venous Return Cannula are polyvinyl chloride and stainless steel wire which provides spring reinforcement throughout the body of the cannula. Each cannula is printed with a medical grade white ink, pigment color Marabu TPL. 970 CDT PN.
The provided text describes a medical device, the TenderFlow™ Pediatric Venous Return Cannula, and its performance evaluation for 510(k) clearance. However, it does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a detailed study description as typically understood for AI/ML device evaluations. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against predefined acceptance criteria for a new AI/ML algorithm.
Therefore, much of the requested information cannot be extracted from the provided text.
Here is what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "Performance Evaluations" comparing the new device to a predicate device and additional tests to meet "current market place performance expectations." It does not explicitly state quantitative acceptance criteria but implies that the device must be "substantially equivalent or better" than the predicate and show "no or favorable clinically significant performance differences" in additional tests.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pressure Drop Testing | Substantially equivalent or better than predicate device | "proved the modified device to be substantially equivalent or better than the predicate" |
| Hemolysis Testing | Substantially equivalent or better than predicate device | "proved better results for the modified 8 Fr. Cannula" |
| Connector Attachment | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Clamp Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Kink Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Collapse Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Tensile Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Simulated Use Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Ship Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Shelf Life Test | Conformance to "current market place performance expectations" | "showed either no or favorable clinically significant performance differences" |
| Sterility Assurance Level | 10⁻⁶ (AAMI guidelines) | Validated in accordance with AAMI guidelines to provide 10⁻⁶ SAL |
| Biocompatibility | Biocompatible for specified contact duration | Blood contacting materials found to be biocompatible |
| Material Stability | Stable over product expiry | Materials found to be stable over expiry of product |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Comparison studies of the performance of the (modified) Pediatric Venous Return Cannula and the unmodified predicate L Series Pediatric Venous Return Cannula were conducted," but details on the number of cannulas tested for each performance evaluation are not provided.
- Data Provenance: Not specified. It can be inferred that the testing was conducted by Terumo Cardiovascular Systems Corporation. The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes performance testing of a physical medical device (cannula), not an AI/ML algorithm or a diagnostic device that requires expert-established ground truth from a test set of data. The "ground truth" for these tests would be the measured physical properties or biological responses.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
This information is not applicable as the document describes performance testing of a physical medical device, not a diagnostic device involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes performance testing of a physical medical device, not an AI algorithm.
7. The type of Ground Truth Used
For physical performance tests like pressure drop, hemolysis, tensile strength, kink, collapse, etc., the "ground truth" is established by objective measurements and laboratory standards. For sterility, it's validated against AAMI guidelines. For biocompatibility, it's assessed against ISO 10993 guidelines. For material stability, it's determined by physio-chemical profiles of aged and non-aged devices.
8. The Sample Size for the Training Set
This information is not applicable as the document describes performance testing of a physical medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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).