(98 days)
The TenderFlow™ Pediatric Arterial Cannula is a surgically invasive device intended for short term use and indicated for cannulation and perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
The design of the TenderFlow™ Pediatric Arterial Cannula consists of a dip molded, wire reinforced cannula (single-stage) with thin walls and good flow performance. A non-reinforced clamping site is provided adjacent to the connector. The overall length of the cannula from end to end is approximately 9 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 stepup diameter is approximately four to five French sizes larger than the tip section. The step occurs distal to the insertion portion of the cannula at approximately 1 to 2 inches from the tip. The length of the step increases with the French size. The tip is integral to the body, is not spring reinforced and is stiffened sufficiently to resist kinking and/or collapse. The pediatric arterial cannula has a ¼" barbed connector in either a vented (with luer cap) or non-vented design. The pediatric arterial cannula also includes an optional introducer with a vent cap. This introducer can be used to stiffen the cannula during insertion and reduce blood loss.
Below is an analysis of the provided text regarding the TenderFlow™ Pediatric Arterial Cannula, focusing on acceptance criteria and the supporting study.
Note: The provided text is a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving absolute safety and effectiveness through extensive de novo studies often seen in drug development or novel medical technologies. Therefore, many of the typical acceptance criteria and study components associated with proving efficacy from scratch will not be explicitly detailed or even present in this document. The focus is on demonstrating that the new device performs similarly enough to the predicate device and does not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria in a 510(k) are typically tied to demonstrating that the modified device performs comparably to the predicate device. The document explicitly states that the performance evaluations were conducted to show substantial equivalence. Specific quantitative acceptance criteria are not provided in this summary, but the type of performance assessed and the general outcome are described.
| Acceptance Criterion (Implicitly for Substantial Equivalence) | Reported Device Performance | Comments |
|---|---|---|
| Pressure Drop vs. Flow Rate (demonstrate comparable hemodynamic performance) | Performed comparably to the predicate device (Terumo L Series Arterial Cannula). | "Comparison studies of the performance... were conducted for pressure drop versus flow rate with water testing... showed either no or favorable clinically significant performance differences." |
| Hemolysis Testing (demonstrate comparable blood trauma) | Performed comparably to or better than the predicate device. | "The hemolysis testing compared the unmodified 10 Fr. to the modified 6 Fr. device... The 6 Fr. performed equal to or better than the 10 Fr. unmodified device." |
| Connector Attachment (demonstrate structural integrity) | Test conducted on the modified device only; assumed to meet internal specifications for integrity. | "All other tests listed below were conducted on the modified device only because these speak to device integrity." Results showed "no or favorable clinically significant performance differences." |
| Clamping Test (demonstrate structural integrity) | Test conducted on the modified device only; assumed to meet internal specifications for integrity. | (Same as above) |
| Kink Test (demonstrate resistance to kinking) | Test conducted on the modified device only; assumed to meet internal specifications for integrity. | (Same as above, also: "The tip is stiffened sufficiently to resist kinking.") |
| Leak Test (demonstrate fluid containment) | Test conducted on the modified device only; assumed to meet internal specifications for integrity. | (Same as above) |
| Air Venting and Priming (demonstrate proper functionality) | Test conducted on the modified device only; assumed to meet internal specifications for functionality. | (Same as above) |
| Tensile Test (demonstrate material strength/robustness) | Test conducted on the modified device only; assumed to meet internal specifications for strength. | (Same as above) |
| Simulated Use Test (demonstrate functionality under simulated conditions) | Test conducted on the modified device only; assumed to meet internal specifications for simulated use. | (Same as above) |
| Ship Test (demonstrate integrity after shipping) | Test conducted on the modified device only; assumed to meet internal specifications for shipping robustness. | (Same as above) |
| Shelf Life Test (demonstrate long-term stability) | Test conducted on the modified device only; assumed to meet internal specifications for shelf life. | (Same as above; "material characterization studies... demonstrate stability of the materials, and found the materials to be stable over the expiry of the product.") |
| Biocompatibility (demonstrate biological safety) | Materials found to be biocompatible. | "The blood contacting materials were found to be biocompatible." Conducted per ISO 10993. |
| Sterilization (demonstrate effective sterilization) | Conditions validated to provide SAL of 10-6. | "Sterilization conditions have been validated in accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10-6." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of devices or experimental runs) used for each test (pressure drop, hemolysis, etc.). It mentions performing "comparison studies" and "all other tests" but does not quantify the sample sizes.
- Sample Size for Test Set: Not explicitly stated for any of the performance tests.
- Data Provenance: The studies appear to be retrospective in the sense that they are laboratory-based engineering and bench testing, performed on manufactured devices. They are not clinical studies on human subjects. The country of origin of the data is implied to be within the company's testing facilities (Terumo Cardiovascular Systems Corporation in Ann Arbor, Michigan, USA), but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to the type of device and study presented. For a mechanical device like a cannula, "ground truth" is established by direct measurement against engineering specifications and validated test methods, not by expert consensus on observational data. Performance criteria (e.g., pressure drop, hemolysis rate) are objectively measured.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication (e.g., 2+1, 3+1) is a method for resolving discrepancies in expert opinion for qualitative assessments (e.g., image interpretation). The tests described are objective, quantitative measurements in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret data (e.g., medical images) and the AI's impact on reader performance is being evaluated. The TenderFlow™ Pediatric Arterial Cannula is a physical surgical device, not an AI-driven diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Objective measurement against engineering specifications: For tests like connector attachment, clamp test, kink test, leak test, tensile test, ship test, and shelf life test. These likely have predefined pass/fail criteria.
- Comparative measurements against a predicate device: For pressure drop and hemolysis, the "ground truth" for acceptance is "substantially equivalent or better" performance compared to the legally marketed predicate device.
- Compliance with recognized standards: For biocompatibility (ISO 10993) and sterilization (AAMI guidelines), the ground truth is adherence to these established benchmarks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. There is no concept of a "training set" as there would be for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 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).