K Number

Device Name

SONOS 5500 ULTRASOUND IMAGING SYSTEM

Manufacturer

HEWLETT-PACKARD CO.

Date Cleared

1998-05-22

(88 days)

Product Code

IYO ITX IYN

Regulation Number

892.1560

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. Clinical Applications: Opthalmic, Fetal, Abdominal, Adult Cephalic, Cardiac Adult. Mode of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B+M, B+M+Color (CVI), B+PW), Harmonic Imaging of tissue, Harmonic Imaging of contrast agents.

Device Description

Functionality: No change. Design cleared with K964309 has the ability to perform harmonic imaging of tissue. Scientific Concepts: Use of harmonic imaging reduces clutter in the image. Clutter exists in images of difficult to image patients. It therefore follows that reducing clutter if it exists will improve 2D/ B-mode image quality. Significant Characteristics of the Modification: This submittal is being done solely for the purpose of allowing FDA to review claims of effectiveness. Significant Safety Concerns: None. Harmonic Imaging of tissue is being done today with several systems already the market.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K964309, K973767, K961459

Reference Devices

K964309

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary focuses on harmonic imaging technology and does not mention AI or ML.

Therapeutic

No
The device is described as "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis, not treatment.

Diagnostic

Yes
The device's "Intended Use / Indications for Use" explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

The device description explicitly refers to "Diagnostic ultrasound imaging" and "Mode of Operation" which are inherently tied to hardware components (ultrasound transducers, processing units, etc.). The submission is a modification to an existing ultrasound system (K964309), not a standalone software application.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The provided description clearly states the device is an ultrasound imaging system. It uses sound waves to create images of internal structures of the human body and analyze fluid flow.
Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This involves direct interaction with the patient's body, not testing samples taken from the body.
Clinical Applications: The listed clinical applications (Ophthalmic, Fetal, Abdominal, Adult Cephalic, Cardiac Adult) are all areas where ultrasound imaging is used directly on the patient.

The device is a diagnostic imaging device, specifically an ultrasound system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.
Ophthalmic, Fetal, Abdominal, Adult Cephalic, Cardiac Adult.
Harmonic Imaging of tissue is a new indication (N) with this submittal Harmonic Imaging of contrast agents was added under appendix E based on K964309.

Product codes

90 IYN, 90 IYO, 90 ITX

Device Description

Functionality: No change. Design cleared with K964309 has the ability to perform harmonic imaging of tissue.
Scientific Concepts: Use of harmonic imaging reduces clutter in the image. Clutter exists in images of difficult to image patients. It therefore follows that reducing clutter if it exists will improve 2D/ B-mode image quality.
Significant Characteristics of the Modification: This submittal is being done solely for the purpose of allowing FDA to review claims of effectiveness.
Significant Safety Concerns: None. Harmonic Imaging of tissue is being done today with several systems already the market. They are manufactured and marketed by : HP, ATL, Acuson.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging

Anatomical Site

Ophthalmic, Fetal, Abdominal, Adult Cephalic, Cardiac Adult.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K964309, K973767, K961459

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

KA80687 MAY 22 1998

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: 978-659-2404 Date Summary was prepared: February 19, 1998
1. Trade Name: Sonos 5500 Ultrasound Imaging System Common Name: Ultrasound Imaging System Classification Pro Codes: 90 IYN / 90 IYO / 90 ITX

3) Identification of Predicate Device:

Predicate Device	SE Decision Date	510(k) Number
HP: Sonos 2500 Ultrasound System w/ Harmonic Imaging	4/22/97	K964309
Acuson: Sequoia Harmonic Imaging w/ contrast	12/23/97	K973767
ATL: High Definition Imaging (HDI) System	3/26/97	K961459

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

Functionality: No change. Design cleared with K964309 has the ability to perform harmonic imaging of tissue.

Scientific Concepts: Use of harmonic imaging reduces clutter in the image. Clutter exists in images of difficult to image patients. It therefore follows that reducing clutter if it exists will improve 2D/ B-mode image quality.

Significant Characteristics of the Modification: This submittal is being done solely for the purpose of allowing FDA to review claims of effectiveness.

Significant Safety Concerns: None. Harmonic Imaging of tissue is being done today with several systems already the market. They are manufactured and marketed by : HP, ATL, Acuson.

Statement of Intended Use: No change from existing platforms.

6) Predicate Device Comparison:

Diagnostic ultrasound imaging systems by their nature are designed to image tissue. There are also an increasing number of systems that have been designed to image contrast agents with harmonic imaging Comparisons made between HI of contrast agents and HI of tissue show that the existing HI design for contrast can also do HI of tissue.

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 1998

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

Re: K980687 Harmonic Tissue Imaging Option for the HP Sonos 5500 Ultrasound Imaging System February 20, 1998 Dated: Received: February 23, 1998 Regulatory class: TT 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 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, Druq 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 following transducers intended for use with the Harmonic Tissue Imaging Option for the HP Sonos 5500 Ultrasound System, as described in your premarket notification:

Transducer Model Number

Model HP 21330A Phased Array

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. ನ್ನ 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.

Page 2 - Paul Schrader

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.

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97) . be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 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 Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Elhrist A. Seymore
T. Lillian Yin, Ph.D.

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

Diagnostic Ultrasound Indications for Use Form Fill out one form for each ultrasound system or transducer Pg_1_of Pg_1_

510(k) # (if known) : K980687 Device Name: Phased Array Transducer (21330A)

Indications for Use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.

	Mode of Operation
Clinical Applications	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Opthalmic	N/A	E	N/A	E	N/A	E	E	E	E	N/A
Fetal	N/A	E	E	E	E	E	E	E	E	N/A
Abdominal	N/A	E	E	E	E	E	E	E	E	N/A
Intra-Operative
(Specify)	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	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	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	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	E	E	E	E	E	E	E	E	N/A
Cardiac Adult	N/A	E	E	E	E	E	E	E	E	N
Cardiac Pediatric	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	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	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Laproscopic	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

NA= Not applicable for this mode

P=Previously Cleared by FDA E= added under Appendix E

N=New Indication

...

Combined modes are : B+M, B+M+Color (CVI), B+PW.

Other: Harmonic Imaging of tissue is a new indication (N) with this submittal Harmonic Imaging of contrast agents was added under appendix E based on K964309 .

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

Concurrence of CDRH, Ofice of Device Evaluation (ODE)

David A. Segeen
(Division Sign-Off)

Division of Reproductive, Abdominal, E and Radiological D

510(k) Number K980687