HP SONOS 100CF ULTRASOUND IMAGING SYSTEM

K955327 · Hewlett-Packard Co. · IYN · Apr 8, 1996 · Radiology

Device Facts

• Record ID: K955327
• Device Name: HP SONOS 100CF ULTRASOUND IMAGING SYSTEM
• Applicant: Hewlett-Packard Co.
• Product Code: IYN · Radiology
• Decision Date: Apr 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.

Device Story

HP SONOS 100CF Ultrasound Imaging System modified to include endovaginal transducer and EV/Pelvic study type; system utilizes ultrasonic pulsed echo/Doppler imaging; transducer captures internal anatomical images; clinician operates system in clinical setting; output displayed on monitor for diagnostic visualization; aids healthcare provider in obstetric and gynecologic assessment; benefits patient through non-invasive diagnostic imaging.

Clinical Evidence

Bench testing only. Evidence includes acoustic output data, hazard analysis, and software validation to ensure performance specifications are met.

Technological Characteristics

System utilizes ultrasonic pulsed echo and Doppler imaging. Modification adds OEM endovaginal transducer identical to Sharplan Usight 9010. Compliance with IEC 601 and UL 544 safety standards. Software safety verified via hazard analysis and validation.

Indications for Use

Indicated for obstetrics and gynecology ultrasound imaging applications.

Regulatory Classification

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.

Predicate Devices

• HP/Philips P800 Ultrasound Imaging System (K935923)
• Sharplan Usight 9010 Laparoscopic Ultrasound System (K945796)

Submission Summary (Full Text)

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APR - 8 1996
K955327 Page 1 of 1

# Attachment D: 510(k) SUMMARY of Safety and Effectiveness

Submitted by: Rob Butler (contact person), Regulatory Approvals
Hewlett-Packard Company - Medical Products Group
3000 Minuteman Road
Andover, MA 01810
phone [phone]; fax [phone]
Summary prepared November 17, 1995.

Device Trade Name: HP 77010CF Ultrasound Imaging System
Device Common Name: HP SONOS 100CF Ultrasound Imaging System
Classification Name: FDA has classified Ultrasound Imaging Systems as Class II in 21 CFR:
- 870.2100 Cardiovascular Blood Flowmeter
- 870.2120 Extravascular Blood Flow Probe
- 870.2330 Echocardiograph
- 870.2880 Ultrasonic Transducer
- 870.2890 Vessel Occlusion Transducer
- 882.1240 Echoencephalograph
- 884.2225 Obstetric-gynecologic Ultrasonic Imager
- 884.2960 Obstetric Ultrasonic Transducer and Accessories
- 892.1550 Ultrasonic Pulsed Doppler Imaging System
- 892.1560 Ultrasonic Pulsed Echo Imaging System
- 892.1570 Diagnostic Ultrasonic Transducer

Predicate Devices: In this 510(k) submission, the legally marketed devices to which we claim equivalence are the HP/Philips P800 Ultrasound Imaging System (K935923) and the Sharplan Usight 9010 Laparoscopic Ultrasound System (K945796).

Device Description: This 510(k) submission is to add an endovaginal transducer and a new EV(EndoVaginal)/Pelvic study type to the HP SONOS 100CF Ultrasound Imaging System.

Intended Use: This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.

Technological Characteristics: This modification includes an OEM endovaginal transducer which is identical to the endovaginal transducer used with the Sharplan Usight 9010 Laparoscopic Ultrasound System. All other technological characteristics of the modification are consistent with the currently marketed (unmodified) HP SONOS 100CF Ultrasound Imaging System.

The safety of this modification is shown by compliance to medical device safety standards (such as IEC 601 and UL 544) and by the acoustic output data provided in this submission. Software safety is verified by hazard analysis and software validation to ensure performance specifications are met. This validation, safety testing, acoustic output testing, and comparison to legally marketed devices demonstrate that this modification is substantially equivalent to the legally marketed predicate devices with regards to safety, effectiveness and intended use.

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