(131 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical applications:
Ultrasound Scanner Pro Focus 2202:
Fetal, Obstetrics, Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Transurethral. Peripheral Vascular, Musculoskeletal.
Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.
2202 supports the following scanning modes and combinations thereof:
B-mode. M-mode. CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging. Contrast harmonic imaging.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications,
The system can guide biopsy- and puncture needles.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Reference |
|---|---|---|---|
| Acoustic Output | Ispta ≤ 720 mW/cm² | The system assures acoustic output stays below pre-amendment upper limits. | N/A (General statement of compliance) |
| MI ≤ 1.9 (Track 3, non-ophthalmic) | The system assures acoustic output stays below pre-amendment upper limits. | N/A (General statement of compliance) | |
| Thermal Index (TI) ≤ 6.0 | Maximum Thermal Index values are 6.0. | N/A (General statement of compliance) | |
| Clinical Measurement Accuracy | Described and accuracies provided in User Guide. | Clinical measurements and calculations are described, and accuracies are provided with the User Guide. | User Guide (assumed to be external document) |
| Safety (Thermal, Mechanical, Electrical) | Compliance with IEC 60601-1. | The scanner 2202 has been tested by a recognized, certified body according to IEC 60601-1. | IEC 60601-1 (stated as met) |
| Acoustic Output Reporting | According to "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 2008" and "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998). | Acoustic Output Reporting is made according to the specified standards (FDA 2008 and AIUM 1998). | FDA 2008, AIUM 1998 (stated as met) |
| Intended Use & Indications for Use | Comparable to predicate devices for all listed clinical applications and modes. | Stated as "Comparable" to predicate devices (ZONARE ZS3, Philips CX50, Toshiba Aplio systems) for all indications, including the new Neonatal Cephalic application. No new indications for use, modes, features, or technologies that require clinical testing are introduced relative to the predicate devices. | Predicate Device Comparison Table (Sections 2, 7 & 8) |
Study Information
The provided document describes a 510(k) Pre-market Notification for an Ultrasound Scanner (Pro Focus 2202) and a specific transducer (N13C5 Type 8862). This submission primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new clinical studies to prove device performance against specific novel acceptance criteria.
Therefore, many of the requested study details (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable (N/A) because the core of this submission is a comparison to established devices and their existing performance and safety profiles.
Here's a breakdown of what can be gleaned:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The submission states: "This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing." This indicates that no new clinical test sets were generated or utilized to prove performance in the traditional sense of a clinical trial for a novel device. The "test set" in this context is implicitly the historical data and established clinical performance of the predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. As no new explicit clinical test set was used for this submission, there was no need for a new "ground truth" establishment by experts specifically for this device's performance claims. The substantial equivalence relies on the established ground truth and clinical acceptance of the predicate devices.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No new clinical test set requiring adjudication was performed as part of this substantial equivalence submission.
-
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:
- No. The device is a diagnostic ultrasound system. There is no mention of AI or machine learning components, nor any MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a diagnostic ultrasound system with human-in-the-loop operation. No standalone algorithm performance is reported.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For this substantial equivalence submission, the "ground truth" for the device's acceptable performance and safety is implicitly tied to the established and accepted clinical performance, safety profiles, and regulatory clearances of the predicate devices. New ground truth for a novel claim was not established as part of this submission.
-
The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no training set in that context.
-
How the ground truth for the training set was established:
- N/A. As above, not an AI/ML device.
§ 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.