(128 days)
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be:
- For the measurement of cerebral artery blood velocities to determine the presence of hemo-dynamically significant deviations from normal values;
- To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and internal carotid artery via the eye. The robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.
While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninyasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger.
Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The system is intended for use during: - Diagnostic exams;
- Surgical interventions.
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.
EMS-9D PRO and EMS-9D EXP are Transcranial Doppler (TCD) ultrasound system, which is developed based on the EMS-9D, it inherits all the EMS-9D's hardware and mechanical structure design. EMS-9D PRO and EMS-9D EXP are not only a Transcranial Doppler ultrasound system which used non-invasive technique to obtain the information of blood flow velocities throughout the body, but also a blood pressure monitor. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain, and continuously measuring blood pressure.
TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow.
The EMS-9D PRO and EMS-9D EXP integrate main unit, TCD probes, Nano Core module, upper arm blood pressure module and analog output module (EMS-9D EXP only), dedicated software, remote control, headframe, upper arm cuff, finger cuff and optional probes.
EMS-9D EXP/EMS-9D PRO should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
The provided text describes a Transcranial Doppler Ultrasound System (EMS-9D EXP/PRO) and references several non-clinical tests to assert its substantial equivalence to predicate devices, particularly regarding its Transcranial Doppler Ultrasound part, Nano Core part (Finger Arterial Blood Pressure), and Upper Arm Cuff Measurement part.
However, the document is a 510(k) Summary for regulatory submission, not a detailed clinical study report. It focuses on demonstrating equivalence to previously cleared devices rather than presenting novel clinical efficacy data with defined acceptance criteria and study results in the typical sense of a diagnostic performance study.
Therefore, many of the requested details about acceptance criteria, specific study design (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for new clinical performance evaluation are not explicitly present or applicable in this regulatory summary. The document primarily relies on engineering performance specifications and comparison to predicate device specifications.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly substantial equivalence to the predicate devices and adherence to relevant safety and performance standards. The "reported device performance" refers to the specifications of the proposed device, which are shown to be equivalent to the predicate.
| Characteristic | Acceptance Criteria (Predicate Device K173801) | Reported Device Performance (Proposed Device) | Comparison |
|---|---|---|---|
| Transcranial Doppler Ultrasound Part | |||
| Product Code | IYN, ITX, OQQ | IYN, ITX, OQQ | No difference |
| Regulation No. | 21 CFR 892.1550, 21 CFR 892.1570 | 21 CFR 892.1550, 21 CFR 892.1570 | No difference |
| Class | II | II | No difference |
| Intended Use | As described for K173801 (long text) | As described for proposed device (long text) | No difference |
| Configuration | EMS-9D: Main Unit + Transducer | EMS-9D EXP/PRO: Main Unit + Transducer + NIBP Module | Yes, added NIBP module (see Analysis 1) |
| Input Power | 80VA | 120VA | Yes, higher (see Analysis 2) |
| 1.6MHz PW Probe | |||
| Depth | not less than 150 mm | not less than 150 mm | No difference |
| Speed range | 10cm/s~300cm/s | 10cm/s~300cm/s | No difference |
| Maximum Error | ±15% | ±15% | No difference |
| 2MHz PW Probe | |||
| Depth | not less than 150 mm | not less than 150 mm | No difference |
| Speed range | 10cm/s~300cm/s | 10cm/s~300cm/s | No difference |
| Maximum Error | ±15% | ±15% | No difference |
| 4MHz CW Probe | |||
| Depth | not less than 85 mm | not less than 85 mm | No difference |
| Speed range | 10cm/s~300cm/s | 10cm/s~300cm/s | No difference |
| Maximum Error | ±15% | ±15% | No difference |
| 8MHz CW Probe | |||
| Depth | not less than 35 mm | not less than 35 mm | No difference |
| Speed range | 10cm/s~200cm/s | 10cm/s~200cm/s | No difference |
| Maximum Error | ±15% | ±15% | No difference |
| 16MHz PW Probe | |||
| Depth | not less than 8 mm | not less than 8 mm | No difference |
| Speed range | 10cm/s~120cm/s | 10cm/s~120cm/s | No difference |
| Maximum Error | ±15% | ±15% | No difference |
| Nano Core Module (Finger Arterial Blood Pressure) | |||
| Product Code | DXQ (K173916 Finapres NOVA) | DXQ | No difference |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | No difference |
| Classification | Class II | Class II | No difference |
| Upper Arm Cuff Measurement Part | |||
| Regulation No. | 21CRF 870.1120 (K182433) | 21CRF 870.1120 | No difference |
| Classification | Class II | Class II | No difference |
| Product Code | DXQ | DXQ | No difference |
| Intended Use | Reusable blood pressure cuff for NIBP systems | Reusable blood pressure cuff for NIBP systems | No difference |
| Patient Populations | Adult | Adult | No difference |
| Circumference | 25-35cm | 25-35cm | No difference |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | No difference |
| Sterility | Non-sterile | Non-sterile | No difference |
| Max. Leakage |
§ 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.