SONOS 5500 IMAGING SYSTEM

K971116 · Hewlett-Packard Co. · ITX · Jan 12, 1998 · Radiology

Device Facts

• Record ID: K971116
• Device Name: SONOS 5500 IMAGING SYSTEM
• Applicant: Hewlett-Packard Co.
• Product Code: ITX · Radiology
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic Ultrasound Imaging of the human body in the applications detailed below.

Device Story

The 21380A is an intraoperative phased array ultrasound transducer designed for use with the Sonos 5500 Imaging System. It functions as an acoustic imaging probe, capturing ultrasound signals from internal body structures during surgical procedures. The transducer transforms reflected acoustic waves into electrical signals, which the Sonos 5500 system processes to generate real-time diagnostic images. Operated by clinicians in surgical or clinical settings, the device provides visual feedback to assist in intraoperative decision-making and anatomical assessment. The primary modification from the predicate device involves the use of new patient contact materials. The device benefits patients by enabling high-resolution, real-time visualization of cardiovascular and peripheral structures during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Phased array ultrasound transducer. Materials of construction include new patient contact materials. Operates as an accessory to the Sonos 5500 Imaging System. Connectivity is via proprietary transducer interface. Sterilization method not specified.

Indications for Use

Indicated for diagnostic ultrasound imaging in intra-operative cardiovascular, pediatric, adult cardiac, pediatric cardiac, and peripheral vessel applications. Modes include B, M, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, and combined modes (B+M, B+M+CVI, B+PW).

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Intra-Operative transducer (21275A) (K944048)

Submission Summary (Full Text)

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K 97116

JAN 12 1998

# Attachment C
## Intraoperative Imaging Transducer

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: March 3,1997

2) Trade Name of Platform: Sonos 5500 Imaging System (upgrade to Sonos 2500 system)
Model Number of Transducer: 21380A
Common Name: Ultrasound Imaging System
Classification Pro Codes: 90 IYN & 90 IYQ ←
> Should be 90IYN & 90IYQ
> 90ITX also Applies
> and 3/31/97

3) Identification of Predicate Device:
The predicate device for this submittal is the existing Intra-Operative transducer (21275A) which was reviewed by FDA on the 77030A system that was submitted as part of K944048.

4) Description of the device or modification being submitted for premarket approval.
Functionality: The new transducer has equivalent functionality to the existing transducer now being used.
Scientific Concepts: same as existing intra-operative transducer
Significant Characteristics of the Modification: The new intra-operative transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA.

5) Statement of Intended Use: No change from existing intra-operative transducers reviewed during 510(k) K944048.

6) Predicate Device Comparison: There are no significant differences in safety and efficacy between the 21275A and 21380A transducers. A detailed comparison of the transducers can be found in the 510(k) report.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JAN 12 1998

Paul Schrader
Regulatory Affairs
Hewlett Packard Company
Medical Products Group
3000 Minuteman Road
Andover, MA 01810

Re: K971116
Intra-Operative Imaging Transducer 21380A
Dated: October 7, 1997
Received: October 14, 1997
Regulatory Class: II
21 CFR 892.1570/Procode 90 ITX

Dear Mr. Schrader:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the 21380A transducer intended for use with the SONOS 5500 System.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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Page 2 - Paul Schrader

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph.D. at [phone].

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Ultrasound Device Indications Statement

Fill out one form for each ultrasound system or transducer

Pg_1_of Pg_1_

510(k) # (if known): K971116

Device Name: Phased Array Transducer (21380A)

Indications for Use: Diagnostic Ultrasound Imaging of the human body in the applications detailed below.

| Clinical Applications | Mode of Operation | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Opthalmic | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Fetal | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Abdominal | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Intra-Operative: Cardiovascular | N/A | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A |
| Intra-Operative Neurological | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Pediatric | N/A | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A |
| Small Organ (Specify) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Neonatal Cephalic | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Adult Cephalic | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Cardiac Adult | N/A | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A |
| Cardiac Pediatric | N/A | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A |
| Trans-esophageal | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Trans-rectal | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Trans-vaginal | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Intra-Luminal | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Trans-urethral | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Peripheral Vessel | N/A | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A |
| Laproscopic | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |

Other Indications or Modes: Combined modes are: B+M, B+M+CVI, B+PW.

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number 971116

Prescription Use (Per 21 CRR 801.109)