AU5 ULTRASOUND IMAGING SYSTEM

K980468 · Biosound Esaote, Inc. · IYN · Aug 26, 1998 · Radiology

Device Facts

• Record ID: K980468
• Device Name: AU5 ULTRASOUND IMAGING SYSTEM
• Applicant: Biosound Esaote, Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

The AU5 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

Device Story

AU5 is an ultrasound imaging system used by physicians for diagnostic imaging in cardiac, abdominal, peripheral vessel, and fetal applications. It processes ultrasonic signals from various transducer types (annular array, mechanical sector, linear, convex, phased array) to produce real-time 2D, M-mode, PW Doppler, CW Doppler, CFM Doppler, and Power Doppler images. The system features multifrequency probes, biopsy attachments, and an optional ECG interface. It includes a DICOM storage module (DSM) for data management and a centronics output for computer interfacing. The device is operated by clinicians in a clinical setting to visualize internal structures, aiding in diagnostic decision-making and patient management.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological comparison and bench testing of acoustic output measurements.

Technological Characteristics

Ultrasound imaging system utilizing annular array, mechanical sector, linear, convex, and phased array transducers. Supports 2D, M-mode, PW/CW/CFM/Power Doppler imaging. Frequencies range from 2.25 MHz to 15 MHz. Features include multifrequency probes, biopsy attachments, 14-inch monitor, and DICOM storage module. Connectivity via centronics output. Optional ECG interface.

Indications for Use

Indicated for diagnostic ultrasound imaging in cardiac, abdominal, peripheral vessel, and fetal applications for patients requiring such examinations.

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

• AU4 Esaote (K944485)

Submission Summary (Full Text)

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## AUG 26 1998

K98 0468

Safety and Effectiveness Summary AUS Biosound Esaote

# Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

## Submitter Information

Colleen Hittle, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 [phone] Phone: [phone] Facsimile:

Colleen Hittle Contact Person:

January 27, 1998 Date: June 1, 1998 Revised:

807.92(a)(2)

AUS Trade Name:

Ultrasound Imaging System Common Name:

System, Imaging, Pulsed Doppler, Ultrasonic Classification Name(s):

Classification Number: 90IYN; 90IYO

807.92(a)(3)

## Predicate Device(s)

K94485 AU4 Esaote

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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Safety and Effectiveness Summary AUS Biosound Esaote

#### 807.92(a)(5)

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## Intended Use(s)

The AU5 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

...

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### Safety and Effectiveness Summary AUS Biosound Esaote

## Comparison Chart for Substantial Equivalence

| General Characteristics | Esaote | Esaote |
|----------------------------|-----------------------|-----------------------|
| | AU5 | AU4 (K#944485) |
| | | |
| Transducer Type | Annular Array | Annular Array |
| | Mechanical Sector | Mechanical Sector |
| | Linear | Linear |
| | Convex | Convex |
| | Phased Array | Phased Array |
| 2D Freq MHz | 2.5/15 | 2.5/15 |
| PW Freq MHz | 2.25/10 | 2.25/10 |
| CW Freq MHz | 2.25/5.0 | 2.25/5.0 |
| Imaging Modes | Real-time/2D | Real-time/2D |
| | M Mode | M Mode |
| | PW Doppler | PW Doppler |
| | CW Doppler | CW Doppler |
| | CFM Doppler | CFM Doppler |
| | Power Doppler | Power Doppler |
| Probes MHz | | |
| Annular array | 2.5, 3.5, 7.5, 10, 13 | 2.5, 3.5, 7.5, 10, 13 |
| Mechanical Sector | 13 | 13 |
| Linear | 3.5 - 7.5 | 3.5 - 7.5 |
| Convex | 3.5 - 5.0 | 3.5 - 5.0 |
| Multifrequency probes | Yes | Yes |
| Special probes | IVT transvaginal | IVT transvaginal |
| | TRT transrectal | TRT transrectal |
| Biopsy attachments | Linear Array | Linear Array |
| | Convex | Convex |
| Monitor size (inches) | 14 | 12 |
| Programmabillity | 6 presets | 6 presets |
| Pulsed/CW Doppler | Yes | Yes |
| HIPRF | No | No |
| 2D Updating | Yes | Yes |
| CW steerable | Yes | Yes |
| Audio stereo | Yes | Yes |
| Color doppler upgrade | Yes | Yes |
| ECG | Option | Option |
| Computer interface | centronics output | centronics output |
| DSM (Dicom storage module) | Yes | No |
| External size - width | 540 mm | 540 mm |

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

AUG 26 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Colleen Hittle Official Correspondent Biosound Esaote 8000 Castleway Drive Indianapolis, IN 46350

K980468 Re: AU5 Ultrasound Imaging System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Dated: July 27, 1998 Received: July 28, 1998

Dear Ms. Hittle:

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 legally marketed predicate 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the AU5 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

CA11, CA13, CA711A, IOE13A, IVT12, LA12, LA13A, LA14, TRT12, LP13A, P10A, P12A, PT10A, PA11A, SMA50, SMA32

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. ਜੋ 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.

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#### Page 2 - Colleen Hittle

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G,
(enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. Tt should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your The FDA finding of substantial equivalence of your premarket notification. 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 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Colleen Hittle

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Simind W. de yomm
Lillian Xin, 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

Enclosures

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