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The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The transducers are all multi-frequency transducers including:

• Linear Array
• Phased Linear Array
• Convex / Curved Array

The interaction with the patients is dependent upon the transducer type which may be:

• Surface Contact.
• Intra-operative,
• Laparoscopic, or
• Endocavity

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

The BK Medical ApS Ultrasound Scanner System bk2300 (K180737) did not include an AI/ML component. The provided document is a 510(k) premarket notification for an ultrasound scanner system without AI/ML functionality. Therefore, information regarding acceptance criteria and studies related to AI/ML performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable.

The performance data provided focuses on the safety and effectiveness of the ultrasound system itself, including its compliance with relevant international and FDA recognized standards for medical electrical equipment, acoustic output, usability engineering, laser safety, biocompatibility, sterilization, electrical safety, electromagnetic compatibility, and software verification and validation. These are standard tests for diagnostic ultrasound systems and do not involve AI/ML.

Here's a summary of the provided performance data relevant to a non-AI/ML device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)

2. Sample Size Used for the Test Set and Data Provenance: Not applicable as this is not an AI/ML device study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable as this is not an AI/ML device study.
4. Adjudication Method: Not applicable as this is not an AI/ML device study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: Not applicable as this is not an AI/ML device study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device study.
7. The type of ground truth used: Not applicable as this is not an AI/ML device study. The provided document does not mention the use of ground truth in the context of AI/ML performance evaluation.
8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device study.

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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 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.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

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.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

This is a 510(k) premarket notification for the BK Medical Ultrasound Scanner System bk2300, which is an ultrasound device. The information provided is typical for a 510(k) submission, focusing on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific clinical study results for novel performance claims.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to safety and performance specifications that demonstrate equivalence to predicate devices, rather than specific diagnostic accuracy metrics for AI. Since this is an ultrasound system, the performance is about its various imaging modes, clinical applications, and safety.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly describe a "test set" in the context of a clinical performance study using patient data for specific diagnostic claims for AI. For an ultrasound system, "testing" primarily refers to technical verification and validation, and acoustic output measurements.

• The section on Acoustic Output Reporting states it's "made according to the standards required by 'Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008'". These standards define measurement procedures and reporting requirements, but not a patient-based test set size.
• The document also notes that "All transducers in this submission have previous been cleared," simplifying the current submission to changes to the system rather than the transducers themselves.
• Data Provenance: Not applicable in the context of a clinical test set for AI, as this submission focuses on the safety and functional equivalence of an ultrasound system, not AI performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This FDA 510(k) submission is for a general diagnostic ultrasound system (bk2300) and its various transducers. It does not describe an AI/CADe (Computer-Aided Detection/Diagnosis) system that requires expert-established ground truth on a clinical test set. The "performance" claims are about physical parameters and safety limits, not diagnostic accuracy in interpreting images.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical test set for diagnostic performance evaluation or AI, no adjudication method would have been used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe product. MRMC studies are typically used for evaluating the effectiveness of AI/CADe systems in improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm being submitted for standalone performance evaluation. It is a diagnostic ultrasound system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance claims (e.g., acoustic output, electrical safety, biocompatibility, measurement capabilities) is established through adherence to recognized national and international standards (e.g., IEC, ISO, AIUM/NEMA standards) and technical specifications. It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy for AI.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe an AI system, therefore, there is no training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or training set, this information is not relevant to this submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical technical verification and validation study. This involves:

• Acoustic Output Measurements: The system controlling acoustic output (same as predicate Pro Focus 2202) was verified to ensure that the device's acoustic output remains below regulatory limits (Ispta ≤ 720 mW/cm² and MI ≤ 1.9, TI ≤ 6.0). This is done through standard phantom and hydrophone measurements as per AIUM/NEMA UD-2 and UD-3.
• Safety Testing: The device was tested by a recognized Certified Body to confirm compliance with a comprehensive set of safety standards, including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment specific safety), ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62359 (field characterization). These tests ensure thermal, mechanical, and electrical safety, as well as software integrity.
• Biocompatibility Testing: Patient contact materials were assessed for biocompatibility according to EN ISO 10993-1.
• Clinical Measurements and Calculations: The accuracy of clinical measurements and calculations is stated to be "described and accuracies are provided in the User Information," indicating that these were verified against established performance benchmarks, although specific metrics are not in the 510(k) summary itself.
• Technological Equivalence Comparison: The core of the 510(k) submission relies on demonstrating that the bk2300 system, including its new optional RF wireless function and the addition of Elastography (for some transducers compared to the oldest reference device, though it's present in the direct predicate), has "the same major technological characteristics" and intended use as the previously cleared predicate device (bk2300, K143298) or the reference device (ProFocus 2202, K132346). This comparison inherently "proves" that the device meets acceptance criteria by establishing its substantial equivalence to a device already deemed safe and effective by the FDA.

In essence, the "study" is a collection of engineering and regulatory compliance tests rather than a clinical trial assessing diagnostic performance.

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Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, 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.

Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: 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. An 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.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BK Medical Ultrasound Scanner System bk2300:

Based on the provided FDA 510(k) summary (K152052), there is no specific table of acceptance criteria and reported device performance defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical application (e.g., detecting a disease) as would be typical for an AI/CADe device.

Instead, this submission is for a general-purpose ultrasound scanner system. The "acceptance criteria" discussed are primarily related to engineering performance, safety, and substantial equivalence to a predicate device as required for a 510(k) clearance, rather than a clinical study evaluating diagnostic performance against specific benchmarks.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present "acceptance criteria" in the context of diagnostic performance metrics for a specific clinical task. The "performance" described is largely about meeting safety standards and functional capabilities.

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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):

• Device Name: Ultrasound Scanner System bk2300

• Regulation Number: 21 CFR 892.1550

• Regulation Name: Ultrasonic pulsed doppler imaging system

• Regulatory Class: II

• Key Features/Modes: B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging, combined mode imaging, and Elastography.

• New Modes (in this submission): Elastography, Vector Flow Imaging (VFI), Continuous Wave Doppler (CWD/CW).

• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

• 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.

• Predicate Devices:

  • B-K Medical Ultrasound Scanner Pro Focus 2202 (K043524, K100919)
  • BK Medical Ultrasound Scanner bk2300 (K140428)
  • Siemens Ultrasound Scanner System Acuson S1000 (K130619)

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.

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