PHILIPS SONO DIAGNOST 800 by HEWLETT-PACKARD CO.

This document does not contain the information required to populate the provided template regarding acceptance criteria and a study proving device performance.

The document is a 510(k) summary for a software modification to an ultrasound imaging system (SD 800 SonoDiagnost). It describes a change that automates the determination of flow angles in Doppler and CVI imaging.

Here's why the requested information is not present:

Acceptance Criteria and Reported Device Performance: The document describes a functionality (automatic determination of flow angles) but does not provide specific performance metrics (e.g., accuracy, precision, speed improvement) or acceptance criteria for those metrics.
Sample Size, Ground Truth, Expert Qualifications, Adjudication, MRMC, Standalone Performance, Training Set Information: This document is a high-level summary for regulatory submission, focusing on device description, intended use, and comparison to a predicate device. It does not detail specific validation studies, clinical trials, or the methodologies used to establish ground truth or train algorithms. It mentions an "algorithm that is described in detail in Appendix C of the 510(k) report," but Appendix C is not provided here.

In essence, this document is a regulatory overview of a software change, not a detailed study report.

Summary

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MAR 1 9 1997

K963706

Attachment C

SD 800 SW Modification

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

1. Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date Summary was prepared: August 26,1996
1. Trade Name: SD 800 SonoDiagnost Ultrasound Imaging System Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ

3) Identification of Predicate Device:

The predicate device for this submittal is existing SD 800 human interface controls which were reviewed by FDA on the SD 800 system that was submitted as part of K935923.

1. Description of the device or modification being submitted for premarket approval.
  Functionality: This SW modification allows for automatic determination of the flow angles used in Doppler and CVI imaging.

Scientific Concepts: The automatic flow angle is determined using an algorithm that is described in detail in Appendix C of the 510(k) report.

Significant Characteristics of the Modification: Since the flow angle will be set automatically use of this SW modification will reduce the time a sonographer needs to set the angle. The sonographer still has the ability to overide the automatic placement if they do not like the automatic angle positioning.

1. Statement of Intended Use: No change from existing SD 800 platform reviewed during 510(k) 935923.
1. Predicate Device Comparison: The SD 800 already has the ability to manually position the flow angle cursor in the image. The new SW allows this position to automatically be determined by the system. Both sets of SW allow for final manual adjustment of the position.

Regulation Number and Section

§ 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.