(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intraoperative (specify): N1 (16MHz Probe)
Intraoperative Neurological: N (16MHz Probe)
Adult Cephalic: N (1MHz TCD Probe); P (2MHz TCD Probe, 2MHz TCD Monitoring Probe)
Peripheral Vascular: p3 (Doppler-Box System); P (4MHz Pencil Probe, 8MHz Pencil); N (4MHz Monitoring)
The Doppler-Box only contains the Doppler hardware, everything else (e.g. QL software, database) is located on a standard PC that is connected to the Doppler-Box. The probes are connected to the Doppler-Box. All sonograms are saved on the PC and can be evaluated, printed and archived. The QL software was especially designed for the Doppler-Box. At the same time, the QL software features an M-Mode. All gates are displayed in one window thus orientation is a lot easier. The Doppler-Box can be used together with the appropriate probes for the entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological tests can be performed).
This FDA 510(k) summary for the Doppler-Box system is for substantial equivalence to predicate devices, not for a de novo marketing authorization. Therefore, it does not typically include clinical performance studies with acceptance criteria in the same way a novel device might. The "study" here is more focused on demonstrating that the device meets safety and performance standards equivalent to existing legally marketed devices, primarily through technical specifications and comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating equivalence to predicate devices (Spencer Technologies TCD 100M and DWL Elektronische Systeme GmbH Multi-Dop® X) and compliance with the IEC 61157 performance standard (for acoustic output). The reported performance is primarily in terms of acoustic output parameters.
| Acceptance Criteria Category | Specific Criteria (Reference/Standard) | Reported Device Performance (Doppler-Box) |
|---|---|---|
| Substantial Equivalence | Demonstration that the Doppler-Box has the same intended use and similar technological characteristics to the predicate devices (Spencer Technologies TCD 100M, K002533; DWL Elektronische Systeme GmbH Multi-Dop® X, K931801). Any differences do not raise new questions of safety or effectiveness. | The Doppler-Box is described as "similar to currently distributed pulsed Doppler ultrasound systems." It contains Doppler hardware, and the software runs on a standard PC. It allows for measurements of blood flow velocities in arteries and display of signals in an FFT. Its intended uses (e.g., Adult Cephalic, Peripheral Vascular, Intraoperative Neurological with various probes) align with standard clinical applications for TCD devices, with some new indications identified (N) as part of the submission, but these are still within the scope of ultrasonic pulsed Doppler imaging. The submission explicitly states: "The Doppler-Box is substantially equivalent to predicate devices described herein." |
| Acoustic Output Safety | Maximum acoustic output level under the FDA recommended limit as defined by IEC 61157. | "Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time." The following acoustic output parameters were measured for various probes: |
- 1MHz TCD Probe: ISpTA.3=484 mW/cm², ISpPA.3=4.84 W/cm², Power=206 mW, MI=0.376, TIC=3.22, PD=20.0 µs, PRF=5000 Hz
- 2MHz TCD Monitoring Probe: ISpTA.3=524.5 mW/cm², ISpPA.3=17.48 W/cm², Power=111.2 mW, MI=0.465, TIC=1.99, PD=20.0 µs, PRF=1500 Hz
- 2MHz TCD Probe: ISpTA.3=490 mW/cm², ISpPA.3=18.55 W/cm², Power=123.7 mW, MI=0.469, TIC=1.93, PD=13.0 µs, PRF=2000 Hz
- 4MHz Pencil Probe: ISpTA.3=319.9 mW/cm², ISpPA.3=4.00 W/cm², Power=17.17 mW, MI=0.167, PD=20.0 µs, PRF=4000 Hz
- 4MHz Monitoring Probe: ISpTA.3=635.7 mW/cm², ISpPA.3=15.89 W/cm², Power=42.6 mW, MI=0.318, PD=20.0 µs, PRF=2000 Hz
- 8MHz Pencil Probe: ISpTA.3=434.7 mW/cm², ISpPA.3=16.72 W/cm², Power=18.1 mW, MI=0.199, PD=13.0 µs, PRF=2000 Hz
- 16MHz Intraoperative Probe: ISpTA.3=64.0 mW/cm², ISpPA.3=0.64 W/cm², Power=0.722 mW, MI=0.032, PD=5.0 µs, PRF=12000 Hz |
| Biocompatibility | Probes coming into contact with patients must be made of biocompatible materials. | Materials of probes coming into contact with patient are: Lexan® ®, POM, Epoxy Resin (all USP-Class VI). |
| Software Functionality | Software collects and processes "rough" data, sends it to a PC, and allows for displaying, processing, and managing data, including displaying velocity spectrum, calculating envelopes, and performing functional tests. | "The Doppler-Box contains the hardware and software which collects and processes "rough" data and sends it via network connection to a Windows® based PC. The main application software is a software running on the PC, it is presenting data, probing and calculating, and managing data [...] The main user screen shows a v-spectrum. All gates may be seen calculated. Envelopes can be recorded and functional test can be performed." The QL software includes "M-Mode" and allows for simultaneous use of probes. |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission primarily focused on demonstrating substantial equivalence through technical specifications and comparison to predicate devices, and adherence to performance standards (IEC 61157).
- Test Set Sample Size: The document does not describe a clinical "test set" with a specific number of patients or samples in the way a clinical trial would. The "tests" mentioned are for acoustic output measurements and material biocompatibility. These are typically laboratory-based tests on the device itself and its components, not an evaluation using patient data.
- Data Provenance: Not applicable in the context of a clinical test set from patients. The data presented (acoustic output) would be derived from laboratory measurements of the Doppler-Box system and its probes. The manufacturer, Compumedics Germany GmbH, is based in Germany, implying the development and initial testing likely occurred there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of submission relies on technical standards compliance and comparison to previously cleared devices, not on expert-adjudicated clinical ground truth from a test set of patient data.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
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
Not applicable. This device is an ultrasound Doppler system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Doppler-Box is a hardware and software system that provides data for human interpretation (e.g., clinicians reading velocity spectra). It is not an algorithm performing a standalone diagnostic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. The "ground truth" for this submission revolves around:
- Technical Specifications: Demonstrating that the device's technical characteristics (e.g., acoustic output) meet regulatory limits and are similar to predicate devices.
- Biocompatibility Standards: Evidence that materials are USP-Class VI.
- Functional Equivalence: The software performs functions analogous to those found in predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning system that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See point 8.)
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.