(118 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
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: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.
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 3-D module 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.
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Flex Focus 1202 are Track 3 transducers.
The provided text describes a 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific clinical performance acceptance criteria.
The information primarily discusses the device's technical specifications, modes of operation, intended use, indications for use, and safety aspects (thermal, mechanical, electrical, and acoustic output). It leverages existing standards and prior clearances for similar devices.
Therefore, many of the requested details regarding acceptance criteria for device performance and an accompanying study or analysis are not present in the provided text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical performance acceptance criteria for the device in terms of accuracy, sensitivity, or specificity. Instead, it relies on technical and safety compliance.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance / Compliance |
|---|---|
| Acoustic Output: | |
| Ispta ≤ 720 mW/cm² | Stated to stay below this limit |
| MI ≤ 1.9 (Track 3, non-ophthalmic) | Stated to stay below this limit |
| TI ≤ 6.0 | Maximum 6.0 |
| Clinical Measurement Accuracy: | Described and accuracies provided in User Information (details not provided in this document) |
| Safety: | |
| Thermal, mechanical, electrical safety | Tested by a recognized Certified Body |
| Acoustic Output Reporting: | Made according to FDA standards |
| Modes of Operation: | B, M, PWD, CFM, Tissue Harmonic Imaging, and combinations (including optional VFI module) |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
| Indications For Use: | Abdominal, Cardiac, Fetal, Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts, Transvaginal, Peripheral vascular, Musculoskeletal |
| Biocompatibility: | Patient contact materials are biocompatible |
| Substantial Equivalence: | Determined by FDA to be substantially equivalent to predicate devices K081154 and K100919 |
No information is provided for the following points related to a performance study:
- 2. Sample size used for the test set and the data provenance: Not applicable as no clinical performance study is detailed.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 scanner, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance as described in the prompt. For technical and safety aspects, the ground truth is often established by adherence to recognized standards and validated testing procedures.
- 8. The sample size for the training set: Not applicable as it's not a machine learning/AI device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for premarket clearance (510(k)) based on substantial equivalence, not a clinical trial report detailing performance criteria and a study to meet them. The "acceptance criteria" here largely pertain to technical specifications, safety limits, and intended/indicated uses matching those of previously cleared devices, rather than quantitative clinical efficacy metrics.
§ 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.