(132 days)
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
The provided text is a 510(k) summary for the FloPatch FP120 device, focusing on modifications related to reprocessing of "Single-Use Only" devices. It refers to a previous 510(k) submission (K222242) for the original device. This document primarily details performance data for the reprocessing capabilities of the device, rather than the initial clinical performance or diagnostic accuracy of the device itself.
Therefore, much of the requested information regarding acceptance criteria for device performance and the study proving it (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, type of ground truth) is not directly available in the provided document. The document focuses on demonstrating that reprocessing does not degrade the device's technical characteristics, assuming its original performance was already established in K222242.
However, I can extract the information related to the acceptance criteria and the study for the reprocessing modifications.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (for reprocessing modifications):
The acceptance criteria for the reprocessing modifications were that repeated reprocessing does not adversely affect specific device characteristics. The reported performance confirms that these criteria were met.
| Test | Brief Description | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Simulated Use Cycles | Verified that the device can be reprocessed up to six cycles (consisting of soiling, cleaning and disinfection). | Device functions correctly after up to six reprocessing cycles. | Pass |
| Manual Cleaning | Validate a manual cleaning process during the reprocessing of the FloPatch FP120. | Manual cleaning process is validated and effective. | Pass |
| Low Level Disinfection | Validate a low level disinfection process during the reprocessing of the FloPatch FP120. | Low level disinfection process is validated and effective. | Pass |
| Acoustic Output | Verified that repeated reprocessing does not adversely affect the acoustic output of the transducer. | Acoustic output unaffected by reprocessing. | Pass |
| Transducer Performance | Verified that repeated reprocessing does not adversely affect transducer performance characteristics: • Velocity Accuracy • Flow Velocity and Depth | Transducer performance characteristics (Velocity Accuracy, Flow Velocity & Depth) unaffected by reprocessing. | Pass |
| Physical Integrity | Verified that repeated reprocessing does not adversely affect the physical integrity of the FloPatch FP120. | Physical integrity unaffected by reprocessing. | Pass |
| Cumulative Runtime | Verified that repeated reprocessing does not adversely affect the battery runtime. | Battery runtime unaffected by reprocessing. | Pass |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in this document. The description only mentions "repeated reprocessing" and "up to six cycles," implying a limited number of devices were tested for these engineering/validation tests.
- Data Provenance: Not specified. These are likely internal validation studies conducted by Flosonics Medical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for these engineering/reprocessing validation tests. Ground truth would be based on objective measurements and established standards for cleaning, disinfection, and device performance specifications.
4. Adjudication method for the test set:
- Not applicable. The tests described are objective engineering and validation tests, not subjective expert reviews.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done, as this submission is for reprocessing modifications, not the initial clinical efficacy of the device's diagnostic capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this refers to the effects of reprocessing on the physical device and its components, not the performance of an algorithm. The device "outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time." The performance of this application and its underlying algorithm would have been assessed in the K222242 submission, not in this document.
7. The type of ground truth used:
- For these reprocessing tests, the "ground truth" would be the pre-reprocessing performance specifications of the device and established engineering/biomedical standards for cleaning, disinfection, acoustic output, and physical integrity.
8. The sample size for the training set:
- Not applicable. These are validation tests for reprocessing, not machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).