FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM

K032640 · U-Systems, Inc. · IYO · Sep 11, 2003 · Radiology

Device Facts

• Record ID: K032640
• Device Name: FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: U-Systems, Inc.
• Product Code: IYO · Radiology
• Decision Date: Sep 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.

Device Story

FFBU Diagnostic Ultrasound System performs B-mode ultrasonic imaging of breast tissue; functions as adjunct to mammography. System utilizes automatic scanning linear array transducer to acquire ultrasound data. Hardware and software modifications upgrade system to Track 3 status. Operated by clinical personnel in diagnostic settings. Output provides visual ultrasound images for clinician review to assist in breast examination and diagnostic decision-making. Benefits include supplemental diagnostic information for breast assessment.

Clinical Evidence

Bench testing only. Performance verified according to the FFBU System Test Plan.

Technological Characteristics

Diagnostic ultrasound system; B-mode imaging; automatic scanning linear array transducer (L9-5 XW MHz). Track 3 system classification. Hardware and software components.

Indications for Use

Indicated for diagnostic B-mode ultrasonic imaging of the breast as an adjunct to mammography. Intended for use with an automatic scanning linear array transducer.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• USI-2000 Horizon (K022517)

Submission Summary (Full Text)

{0}------------------------------------------------

K032640

# SEP 1 1 2003

CONFIDENTIAL U-Systems Inc.510(k) Notification Device Modification

### 2.3 510(k) Summary

# 510(k) Summary for Traditional 510(k) U-Systems Ultrasound System U-Systems Inc.

Prepared August 15, 2003

| Product Name: | FFBU Diagnostic Ultrasound System | | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Manufacturer: | U-Systems Inc.<br>110 Rose Orchard Way<br>San Jose, CA 95134<br>Telephone [phone]<br>Fax [phone] | | | | | | | | |
| Generic Name | Diagnostic Ultrasound System | | | | | | | | |
| Classification Name: | Ultrasound Imaging System and Transducers (Class II);<br>Classification codes: | | | | | | | | |
| | IYO 892.1560 System, Imaging Pulsed Echo, Ultrasonic<br>ITX 892.1570 Transducer, Ultrasonic, Diagnostic | | | | | | | | |
| Contact Person: | Sheila W. Pickering Ph.D.<br>2081 Longden Circle<br>Los Altos, California 94024<br>Telephone/Fax [phone]<br>e-mail: [e-mail] | | | | | | | | |

#### A. Legally Marketed Predicate Device

The FFBU System modification is substantially equivalent to the original USI-2000 Horizon device cleared in 510(k) (K022517). The intended use and the technological characteristics of the modification are the same as the predicate device.

#### B. Device Description

The FFBU Diagnostic Ultrasound system represents hardware and software changes to the predicate device and changes it to a Track 3 system.

#### C. Intended Use

The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.

#### D. Substantial Equivalence

The FFBU System is substantially equivalent to the USI-2000 Horizon System. with regard to intended use and technological characteristics.

#### E. Performance Data

The FFBU System performance has been verified according to the FFBU System Test Plan. The FFBU Test Plan and the summary of test results to date are included in this submission.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

SEP 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

U-Systems, Inc. % Mr. Heinz-Joerg Steneberg Responsible Third Party Official TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K032640

Trade Name: U-Systems FFBU Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: August 25, 2003 >> Received: August 27, 2003

Dear Mr. Steneberg:

We have reviewed your Section 510(k) premarket 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 U-Systems FFBU Diagnostic Ultrasound System, as described in your premarket notification:

### Transducer Model Number

### L9-5 XW MHz

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device

{2}------------------------------------------------

can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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. It 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 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, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

{3}------------------------------------------------

Page 3 – Mr. Steneberg

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

, i

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

CONFIDENTIAL. U-Systema Inc..510(k) Nulification Device Mndification

## 3.2. Diagnostic Ultrasvund Indications for Use Forms ( No New Indications for Use Previously Cleared Indications for Use) Diagnostic Ultrasound Indications for Use

510(k) Number(s):

Device Nume:

U-Systems FFBU Diagnostic Ultrasound System

| Intended Use: | | | | | | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | |
|------------------------------------------|---|-------------------|---|-----|-----|------------------|------------------------------------------------------------------------------------|------------------------------|------------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laproscopic | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |

U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.

N = new indication

I' = previously cleared by I'I)A

(P) HASIL DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

016

Nancy C. Brogdon

(Division Sign-C Division of Reproductive, and Radiological Devices 510(k) Number

*Prescription Use* √

{5}------------------------------------------------

# CONFIDENTIAL
U-Systems Inc.510(k) Notification Device Modification

#### Diagnostic Ultrasound Indications for Use

S10(k) Number:

Device Name:

L 9-S XW MHz Transduccr

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>Mode of Operation | | | | | | | | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |

1J-Systems L. 9-5 X W MI-12 Transducer is intended for diagnostic breast examinations.

- N = now indication P = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE (IN ANOTHER PAGE IF NEBIDBO) Concurrence of CDRH, Office of Device Evaluation (ODE)

017

Nancy C Brogdon

*Prescription Use* ✓

ାମ:

(Division Sign (Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _