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510(k) Data Aggregation
(102 days)
The FlowCardia FlowMate Injector is intended for use as a sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System.
The FlowMate Injector is a sterile saline injector intended to be used as an accessory to the CROSSER CTO Recanalization System. The CROSSER System consists of a Generator, footswitch, and disposable catheter. The FlowMate Injector is designed to infuse saline at a rate of 0.3ml/sec (18 ml/min) at a maximum back pressure of 200 PSI. The FlowMate Injector is compatible for use with a 150ml disposable sterile syringe and is operated by a footswitch. A jumper cable is supplied with the FlowMate Injector to allow connection to the CROSSER System Generator. The FlowMate Injector is programmed to first start the Injector, and then the CROSSER System Generator each time the footswitch is depressed.
The provided text describes the FlowCardia FlowMate Injector, an accessory intended for use with the FlowCardia CROSSER CTO Recanalization System as a sterile saline injector.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a comparative bench testing approach to demonstrate substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| - Infuse saline at a specified rate | - Designed to infuse saline at a rate of 0.3ml/sec (18 ml/min). |
| - Withstand maximum back pressure | - Designed to operate at a maximum back pressure of 200 PSI. |
| - Compatibility with disposable syringe | - Compatible for use with a 150ml disposable sterile syringe. |
| - Operation via footswitch | - Operated by a footswitch. |
| - Integration with CROSSER System Generator | - Jumper cable supplied for connection to the CROSSER System Generator. Programmed to first start the Injector, then the CROSSER System Generator each time the footswitch is depressed. |
| Safety Performance: | |
| - Electrical safety and electromagnetic compatibility compliance | - Electrical safety and electromagnetic compatibility tests were performed. (Implies compliance, but no specific results given). |
| - Alarm and safety function verification | - Alarm and safety function verification was performed. (Implies satisfactory performance, but no specific details). |
| Other: | |
| - Design validation | - Design validation tests were performed. (Implies compliance). |
| - Installation and set-up verification | - Installation and set-up verification tests were performed. (Implies compliance). |
| - Output volume verification | - Output volume verification tests were performed. (Implies accurate volume delivery). |
| - Life cycle testing | - Life cycle testing was performed. (Implies durability and longevity meet requirements). |
| - Substantial equivalence to predicate device | - "Based upon technological and physical comparisons the FlowCardia FlowMate Injector is substantially equivalent to the predicate device." "The predicate and FlowCardia FlowMate Injector are substantially equivalent with respect to meeting performance specifications and meeting electrical and safety standards. Both devices are intended for infusion using a 150 ml disposable syringe. In addition, both the FlowMate Injector and the predicate may be used to control other electromechanical equipment..." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "comparative bench testing" and lists several functional and safety tests. However, it does not specify the sample size used for these tests. The data provenance is described as "bench testing," indicating laboratory-based studies rather than patient data. No information on country of origin for data is provided, but since it's bench testing, it's typically conducted internally or by a contracted lab. The studies would be considered prospective in nature, as they were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are bench tests of a physical device's performance (e.g., flow rate, pressure, electrical safety) rather than studies requiring expert interpretation of medical data (like radiology images or pathology slides) to establish "ground truth." The "truth" in these tests is objective measurement against specified parameters.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Bench testing of device performance does not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. The study described is a bench performance evaluation, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The FlowMate Injector is a physical medical device, not an algorithm or AI system that would have a "standalone" algorithmic performance. The tests performed are of the device's functional and safety characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests consisted of objective engineering specifications and measurements (e.g., whether the device infused saline at 0.3ml/sec, whether it withstood 200 PSI, electrical safety standards compliance). It does not involve expert consensus, pathology, or outcomes data, as it's a non-AI, non-diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable. The FlowMate Injector is not an AI/ML device, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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