(15 days)
The Jostra Flowprobe FP-32E is indicated for use as a flow measuring device to be used as an electromagnetic blood flow transducer as a direct product replacement for the BioMedicus flowprobe DP-38 in extracorporeal circuits for up to 6 hours.
The Jostra Flowprobe FP-32E is a single, sterile device for single use only and not to be re-sterilized by the user. The flowprobe is made from polycarbonate and is available in a 3/8" size.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Jostra Flowprobe FP-32E:
Device Name: Jostra Flowprobe FP-32E
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it indicates that "performance testing was performed to demonstrate substantial equivalency to the predicate device."
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Functional testing | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful functional testing. |
| Flow measurement accuracy | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful flow measurement accuracy. |
| Pressure testing | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful pressure testing. |
| Electrical safety | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful electrical safety testing. |
| Biocompatibility | Passed | "Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device." Additionally, "in-vitro testing was performed to determine the effects on cellular components," which supports biocompatibility. |
| Equivalence to Predicate Device (Medtronic-BioMedicus DP-38 Bio-Probe) | Achieved | The overall conclusion is that the device is "substantially equivalent ... in intended use, principles of operation, materials, design, and performance" to the predicate device. The only noted difference is the material (polycarbonate vs. acrylic), which is stated not to affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only states that "Performance testing included" various types of tests.
- Data Provenance: Not specified, but the submission is from Jostra AG, Germany, so the testing was likely conducted in Germany or by a third-party testing facility. The study is non-clinical (bench testing), not involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This was a non-clinical, bench testing study. Ground truth was established through engineering and performance measurements against established standards or the predicate device's performance.
4. Adjudication Method for the Test Set:
Not applicable. This was a non-clinical, bench testing study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not applicable or done. The study was non-clinical (bench testing) and did not involve human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical flow probe, not an AI algorithm. Its performance is inherent to its design and function, not dependent on human interpretation or AI.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical testing was based on:
- Engineering specifications and design requirements.
- The established performance characteristics of the predicate device (Medtronic-BioMedicus DP-38 Bio-Probe).
- Industry standards for functional, pressure, electrical safety, and biocompatibility testing for medical devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical flow probe and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).