(60 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Applications:
- Fetal (Sometimes called Obstetrics) .
- Abdominal ●
- Intra-operative ●
- Intra-operative (Neuro) (sometimes called Neuro Surgical) ●
- Pediatrics .
- Small Organ (Sometimes called Small Parts) .
- . Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
- Adult Cephalic (Cephalic is sometimes called trans-cranial) ●
- Trans-rectal
- . Trans-vaqinal
- . Trans-urethral
- Musculo-skeletal (Conventional)
- Musculo-skeletal (Superficial)
- Cardiac Adult
- Peripheral Vessel (Sometimes called Peripheral Vascular) .
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 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.
This document is an FDA 510(k) premarket notification for the BK Medical Ultrasound Scanner System bk2300, dated January 16, 2015. It primarily details the device's indications for use, its substantial equivalence to predicate devices, and summaries of non-clinical tests. The document does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically concerning clinical performance metrics. It focuses on safety and technological equivalence.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a summary of the available information:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. The document discusses regulatory compliance, safety standards, and intended uses, but does not specify performance acceptance criteria or report specific performance metrics from clinical studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The document exclusively mentions "non-clinical tests" and does not refer to clinical studies or test sets.
3. 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)
- Not applicable. No clinical test set or ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication method is mentioned.
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. The device is an ultrasound scanner system, not an AI assistance tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth is mentioned. The document primarily relies on non-clinical testing for safety and technical characteristics.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this document does not describe an AI/ML device relying on trained models.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is mentioned.
General Information from the Document (Relevant to Device and Regulatory Approval):
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Device Name: Ultrasound Scanner System bk2300
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Regulation Number: 21 CFR 892.1550
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Regulation Name: Ultrasonic pulsed doppler imaging system
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Regulatory Class: II
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Key Features/Modes: B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging, combined mode imaging, and Elastography.
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New Modes (in this submission): Elastography, Vector Flow Imaging (VFI), Continuous Wave Doppler (CWD/CW).
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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
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Clinical Applications (Indications for Use): Fetal, Abdominal, Intra-operative (Neuro), Pediatrics, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional & Superficial), Cardiac Adult, Peripheral Vessel.
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Predicate Devices:
Non-Clinical Test Summaries (Relied upon for Substantial Equivalence):
- Acoustic Output: Evaluated according to AIUM/NEMA UD-2 and UD-3 standards, and FDA guidance "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008". Output stays below pre-amendments upper limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0).
- Thermal, mechanical, and electrical safety: Tested by a recognized Certified Body and complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37.
- Biocompatibility: Complies with EN ISO 10993-1.
- Software Lifecycle: Complies with IEC 62304.
- Specific Transducers mentioned with new indications:
- System bk2300 (general): Elastography, Vector Flow Imaging (VFI).
- Transducer 9018: New indication for Elastography (N24) for Trans-rectal and Trans-vaginal applications.
- Transducer 9051: New indication for Elastography (N24) and Vector Flow Imaging (N23) for Pediatric, Small Organ, Musculo-skeletal (Conventional), Musculo-skel. (Superficial), and Peripheral vessel applications.
- Transducer 9062: New indication for Elastography (N24) for Intra-operative, Intra-operative (Neuro), Pediatric, and Neonatal Cephalic applications.
- Transducer 9077: New indication for Continuous Wave Doppler (CWD) for Abdominal, Adult Cephalic, and Cardiac Adult applications. Also, CWD has been added as a "new mode" for these applications ("N" in the CWD column).
The document's purpose is to demonstrate substantial equivalence to existing legally marketed devices, primarily focusing on safety and technological characteristics rather than providing new clinical performance data against specific acceptance criteria.
§ 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.