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510(k) Data Aggregation
(100 days)
The TandemHeart Venous Cannula Set is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator and dilator are intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support.
The TandemHeart Venous Cannula Set consists of three components, as shown in Figure 1: a 21 Fr. Venous Cannula. 14 Fr. Obturator, and an optional 14/21 Fr. Two-stage Dilator, that accepts a 0.035 in. guidewire. The device is intended to cannulate vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device. The cannulae are available in two configurations: 1. 21 Fr. x 62 cm. with options for tip curvature of 0° and 50° 2. 21 Fr. x 72 cm. with tip curvature of 50°. The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wirereinforced for visualization under fluoroscopy. Insertion depth markings are incorporated in the cannula body from 10 to 62 or 72 cm, depending on the length option, measured from the distal tip. The cannula includes a suture wing to provide a means for securing the cannula to the patient. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or the removal process. The 14 Fr. Obturator is provided to facilitate placement of the venous cannula, within the target vessel, and is designed with a tapered distal tip. The Obturator proximal end contains a luer hub to aid in the removal of the obturator. The Obturator body is constructed of a radiopaque material for visualization under fluoroscopy: The Obturator includes a hemostasis cap that provides the interface between the cannula proximal connector and obturator body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/obturator assembly into the target vessel. The 14/21 Fr. Dilator is provided to aid introduction of the obturator/cannula assembly at the insertion site.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TandemHeart Venous Cannula Set:
The provided text describes a 510(k) summary for the TandemHeart Venous Cannula Set. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria in the same way a novel device might. Therefore, the "acceptance criteria" here refer to the performance criteria used to validate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance (TandemHeart Venous Cannula) |
|---|---|
| Flow vs. Pressure Drop (HQ) | "This testing verified that despite the longer length of the TandemHeart Venous Cannula and distal tip taper relative to the Bio-Medicus Femoral Venous Cannula, it was able to sustain flows comparable to the predicate." (Implies meeting or exceeding the flow performance of the predicate at comparable pressure drops.) |
| System Capacity | "in-vitro system capacity testing" was conducted. (No specific quantitative result is provided, but it's implied that it contributed to the conclusion of substantial equivalence for flow characteristics.) |
| Flexibility | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies meeting the requirements established for these similar cleared devices.) |
| Strength | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies meeting the requirements established for these similar cleared devices.) |
| Biocompatibility | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies meeting the requirements established for these similar cleared devices. This would typically involve ISO 10993 testing or equivalence to predicate's biocompatibility.) |
| In-vitro Hemolysis | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies meeting the requirements established for these similar cleared devices. This would typically involve a quantitative measure of hemoglobin release and comparison to acceptable limits.) |
| Leak Testing | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies meeting the requirements established for these similar cleared devices.) |
| Sterilization | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies validation of sterilization methods, likely to a Sterility Assurance Level (SAL) of 10^-6, in line with established standards and the predicate's requirements.) |
| Shelf Life | "addressed by comparison with reference devices, specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72 that were cleared under K052570 and K082425, respectively." (Implies a validated shelf life, demonstrating the device maintains its sterility and functional properties over a defined period, in line with the predicate or reference devices.) |
| Overall Design Input Requirements | "Based on the performance test results and data from these two other devices, the TandemHeart Venous Cannula Set was found to meet established design input requirements and thus to be substantially equivalent to the predicate Medtronic Bio-Medicus Femoral Venous Cannula and Introducer." (The ultimate acceptance criterion for a 510(k) is meeting design input requirements and demonstrating substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or subjects. The studies were described as "non-clinical performance testing" and "in-vitro system capacity testing and flow vs. pressure drop (HQ)." For the other aspects (Flexibility, Strength, Biocompatibility, In-vitro Hemolysis, Leak testing, Sterilization, and Shelf Life), the text states they were "addressed by comparison with reference devices," implying that specific testing on the current device might not have been performed in a new study but rather leveraged existing data or demonstrated equivalence to devices already proven to meet these criteria.
- Data Provenance: The studies for flow characteristics were "in-vitro" (laboratory-based). For other characteristics, it relies on "comparison with reference devices," specifically the CardiacAssist Transseptal Cannula Set-EF and EF-72, which were previously cleared by the FDA (K052570 and K082425). This suggests leveraging existing regulatory data from other devices by the applicant, rather than explicitly new "retrospective" or "prospective" clinical data for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies described are non-clinical, in-vitro performance tests and comparisons to reference devices. There is no mention of human expert-based ground truth establishment for a diagnostic output.
4. Adjudication Method for the Test Set
This section is not applicable. There was no expert adjudication process described, as the studies are entirely non-clinical performance evaluations against engineering specifications or comparative data.
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
This section is not applicable. The device is a medical cannulation set, not an AI-powered diagnostic tool, and therefore no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a medical cannulation set, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
- For Flow vs. Pressure Drop and System Capacity: The ground truth would be engineering specifications and performance data of the predicate device. The goal was to prove the new device performed "comparable to the predicate."
- For Flexibility, Strength, Biocompatibility, In-vitro Hemolysis, Leak testing, Sterilization, and Shelf Life: The ground truth was based on the established performance data and regulatory compliance of previously cleared reference devices (CardiacAssist Transseptal Cannula Set-EF and EF-72) and likely relevant international and national consensus standards for medical devices (though not explicitly named).
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI/ML model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
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