SONOS 2000, SONOS 2500 (M2406 A)

K964309 · Hewlett-Packard Co. · IYN · Apr 22, 1997 · Radiology

Device Facts

• Record ID: K964309
• Device Name: SONOS 2000, SONOS 2500 (M2406 A)
• Applicant: Hewlett-Packard Co.
• Product Code: IYN · Radiology
• Decision Date: Apr 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

No change from existing SONOS 2500 platform reviewed during 510(k) 934041

Device Story

Sonos 2500 Ultrasound Imaging System modification; enables harmonic imaging. Input: ultrasound signals; output: harmonic echoes. Principle: Rayleigh's theory; bubble resonance in ultrasound field radiates harmonic echoes at twice incident frequency. Modification includes new transducer, circuit board updates, and software to drive/recognize transducer. Used in clinical settings by sonographers/physicians. Harmonic imaging affects receive operation only; does not increase ultrasound output relative to fundamental contrast imaging. Benefits: improved visualization of contrast agents.

Clinical Evidence

Bench testing only. No clinical data provided. Safety assessment based on physical principles of harmonic imaging and comparison to existing contrast-imaging ultrasound systems.

Technological Characteristics

Ultrasound imaging system; harmonic imaging capability. Components: new transducer, modified circuit boards, software. Sensing principle: harmonic echo detection (Rayleigh resonance). Connectivity: not specified. Sterilization: not specified.

Indications for Use

Indicated for diagnostic ultrasound imaging of patients requiring visualization of internal structures, including contrast-enhanced imaging.

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

• SONOS 2500 (K934041)
• ATL HDI 3000 (K935009)

Submission Summary (Full Text)

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K964309
APR 22 1997

# Attachment C

## 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: October 14, 1996

2) Trade Name: Sonos 2500 Ultrasound Imaging System
Common Name: Ultrasound Imaging System
Classification Pro Codes: 90 IYN & 90 IYQ

3) Identification of Predicate Device:
There are two predicate devices used for this submittal. One predicate device for this submittal is the existing SONOS 2500 system which was reviewed by FDA with K934041 and found to be SE on September 22, 1994. The second predicate device is the ATL HDI 3000 system which was reviewed by FDA with K935009 and found to be SE on October 11, 1994

4) Description of the device or modification being submitted for premarket approval.

**Functionality:** This modification allows for transmission of an ultrasound signal at one frequency and receipt of the returning echo at a different frequency.

**Scientific Concepts:** Rayleigh's theory predicts that a bubble resonating in an ultrasound field will radiate harmonic echoes at twice the frequency of the incident beam and that the harmonic echoes can be stronger than the fundamentals. Ultrasound contrast agents are made from many small bubbles. A minor system modification is made to be able to detect these harmonic echoes

**Significant Characteristics of the Modification:** New transducer, component modifications to two circuit boards and SW to recognize/drive the new transducer.

**Significant Safety Concerns:** None
FDA is reviewing the safety of contrast agents. Addition of harmonic imaging to the ultrasound systems does not increase ultrasound output relative to normal and fundamentals contrast imaging. The harmonic imaging modification only affects receive operation of the system.

5) Statement of Intended Use: No change from existing SONOS 2500 platform reviewed during 510(k) 934041

6) Predicate Device Comparison:
There are many ultrasound devices on the market that have the ability to image contrast agents and also have the ability to vary transmit and receive frequencies. This submittal uses two systems (HP Sonos 2500 and ATL HDI 3000) for predicate device comparisons.