(56 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transcranial (=Adult cephalic), Transrectal, Small organs, Transvaginal, Musculoskeletal.
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.
This 510(k) premarket notification describes the B-K Medical Ultrasound Scanner ProFocus 2202. The submission primarily focuses on establishing substantial equivalence to a predicate device (Siemens Acuson CV70 Cardiovascular system K032111) based on intended use, technological characteristics, and safety standards, rather than providing a detailed clinical study with specific acceptance criteria and performance metrics for the ProFocus 2202 itself.
Based on the provided text, a direct table of acceptance criteria and reported device performance for specific clinical measurements is not explicitly available as it would be for a typical diagnostic algorithm study. The document states: "Clinical measurements and calculations are described and accuracies are provided with the User Guide." However, the User Guide is not included in this extract.
The key acceptance criteria from the submission are primarily related to safety and acoustic output, and the comparison to the predicate device.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria and performance below are primarily related to safety, acoustic output, and equivalence to the predicate device, as the document does not present a clinical study with performance metrics (e.g., sensitivity, specificity) for new clinical claims.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (ProFocus 2202) | Study/Evidence |
|---|---|---|---|
| Acoustic Output | Ispta ≤ 720 mW/cm² | Ispta ≤ 720 mW/cm² | Measured and calculated according to "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998) and FDA guidance (CDRH, September 30, 1997). The system asserts it will always stay below these limits. |
| MI ≤ 1.9 (Track 3, non ophthalmic) | MI ≤ 1.9 (Track 3, non ophthalmic) | Measured and calculated according to "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998) and FDA guidance (CDRH, September 30, 1997). The system asserts it will always stay below these limits. | |
| TI ≤ 6.0 | TI ≤ 6.0 | Measured and calculated according to "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998) and FDA guidance (CDRH, September 30, 1997). | |
| Safety Standards | Compliance with IEC 60601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 60601-2-37, EN/ISO 10993-1. | The scanner 2202 has been tested by a recognized, certified body according to IEC 60601-1. The comparison table explicitly states compliance with all listed standards for the ProFocus 2202. | Testing by a recognized, certified body. Comparison to predicate device which also complies with relevant standards. |
| Biocompatibility | Patient contact materials comply with ISO10993-1. | All transducers used together with 2202 comply with ISO10993-1. | Adherence to ISO10993-1. |
| Intended Use | Similar intended uses to predicate device (K032111), particularly for Transcranial (Adult cephalic). | The device "has similar intended uses." Specifically, "Transcranial (Adult cephalic), is the same." | Comparison table against predicate device showing similar clinical applications and modes of operation. |
| Technological Characteristics | Similar major technological characteristics to predicate device. | Device supports B-mode, M-mode, CWD-mode, PWD mode, CFM, THI, CHI, 3D, and various mode combinations, matching or exceeding predicate capabilities. | Comparison table against predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the context of performance evaluation for a diagnostic algorithm (e.g., images for accuracy assessment). The testing described is primarily for safety, acoustic output, and physical device characteristics. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This type of information would be relevant for studies evaluating diagnostic accuracy, which is not described in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set for diagnostic performance is described, no 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. This is a submission for an ultrasound imaging system, not an AI-powered diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an ultrasound imaging system, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For the safety and acoustic output measurements, the "ground truth" is derived from established engineering and physics standards (e.g., AIUM 1998, IEC 60601-1). For the claim of "Clinical measurement accuracy," the document states "accuracies are provided with the User Guide," implying that the ground truth for these measurements would be based on comparison to known physical standards or established medical practices, but the details are not in this document.
For establishing substantial equivalence regarding intended use and technological characteristics, the "ground truth" is the characteristics and performance of the legally marketed predicate device (Siemens Acuson CV70 Cardiovascular system K032111).
8. The Sample Size for the Training Set
Not applicable. The device is an ultrasound imaging system, not an AI/ML model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.