SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100

K082543 · Sonocine, Inc. · IYO · Oct 14, 2008 · Radiology

Device Facts

• Record ID: K082543
• Device Name: SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
• Applicant: Sonocine, Inc.
• Product Code: IYO · Radiology
• Decision Date: Oct 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.

Device Story

SonoCiné ABU Model 100 comprises Image Acquisition Station and Image Reading Station. Acquisition station uses servo-motor guided arm to control speed/direction of previously cleared ultrasound transducers during breast scanning; interfaces with ultrasound system video output to record/store B-mode images at regular intervals. Reading station is PC-based software for after-the-fact review of stored images. Used in clinical settings by healthcare providers to assist in breast imaging. Provides standardized, automated scanning motion to improve consistency of ultrasound image acquisition compared to manual scanning; aids clinicians in identifying breast masses.

Clinical Evidence

Non-clinical testing only. System validation performed on a breast phantom containing 10 randomly positioned masses; all 10 masses were successfully identified.

Technological Characteristics

System consists of servo-motor guided arm for transducer positioning and PC-based software for image review. Interfaces with existing cleared ultrasound systems via video output. Operates in B-mode. Standalone software for image storage and review.

Indications for Use

Indicated for B-mode ultrasonic imaging of the breast as an adjunct to mammography. Not for use as a replacement for screening mammography.

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

• Orison Embrace System (K070477)
• ABUS Diagnostic Ultrasound System (K052355)

Submission Summary (Full Text)

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#### 510(K) SUMMARY 5.

# OCT 1 4 2008

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: August 10, 2008

510(k) number:

### Applicant Information: SonoCiné, Inc.

5475 Reno Corporate Drive Reno, NV 89511

### Contact Person

Robert J. Chin, Ph.D. Requlatory Consultant [phone]

### Device Information:

| Trade Name: | SonoCiné Adjunctive Breast Ultrasound System (ABU) Model |
|----------------------|----------------------------------------------------------|
| | 100 |
| Classification: | Class II |
| Classification Name: | System, imaging, pulsed echo, ultrasonic |

#### Physical Description:

SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 consisting of SonoCiné Image Acquisition Station Model 100 and SonoCiné Image Reading Station Model 100.

The SonoCiné Image Acquisition Station Model 100 is a probe guiding adjunct to ultrasound systems which have been previously cleared by FDA. The SonoCiné Image Acquisition Station Model 100 uses a servo motor guided arm to control the speed and direction of the ultrasound transducer during breast scanning examinations. In addition, the SonoCiné Image Acquisition Station Model 100 contains a computer which interfaces to the video output of ultrasound system to record and store, electronically, the ultrasound images at reqular time intervals.

The SonoCiné Image Reading Station Model 100 is a software product intended to operate on a personal computer with minimum performance configurations. The SonoCiné Image Reading Station Model 100 is a software product intended to allow after-the-fact review of the images obtained and stored by the SonoCiné Image Acquisition Station Model 100.

Intended Use: The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adiunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.

Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the following devices which were previously cleared by FDA

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The Orison Embrace System (Orison, Corp; Johnson City, TN) (K070477) and

The ABUS Diagnostic Ultrasound System (U-Systems, Inc; San Jose, CA) (K052355)

SonoCiné, Inc. claims that the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is substantially equivalent to the devices previously cleared by FDA in K070477 and K052355. SonoCiné, Inc. claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical and operational specifications compared to the predicate devices.

Test Results: DESIGN VERIFICATION TEST: The design specifications of the SonoCiné Adiunctive Breast Ultrasound System (ABU) Station Model 100 were tested and verified to confirm that the product performance fulfilled those specification requirements.

### DESIGN VALIDATION TESTS:

NON-CLINICAL TESTING: System Validation Testing was performed on a breast phantom with 10 (ten) masses randomly positioned. All 10 of the masses were successfully identified.)

The results indicate that the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is substantially equivalent to the listed predicate devices.

#### Summary:

Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 2008

SonoCinc, Inc. % Mr. Morten S. Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 E. Trimble Rd. SAN JOSE CA 35131

Re: K082543

Tradc/Device Name: SonoCiné Adjunctive Breast Ultrasound System (AUB) Model 100 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed imaging system Regulatory Class; II Product Code: IYO Dated: September 26, 2008 Received: September 29, 2008

### Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

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 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.

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## Page 2

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 (QS) 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 letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT 4.

510(k) Number (if known):

Device Name:

Indications for Use: The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE).

| (Divisi | |
|--------------------------------------------------------------|---------------|
| Divisi | |
| Radio | Abdominal and |
| 510(k | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K082543 |

5475 Reno Corporate Dr. Suite 200 Reno NV 89511 Phone [phone] Fax [phone] www.SonoCine.com

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## Diagnostic Ultrasound Indications for Use Form

## Fill out one form for each ultrasound system and each transducer.

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 (specify) | | N | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | |
| Additional Comments: Small Organ - Breast, B-Mode<br>The SonoCine Adjunctive Breast Ultrasound System is intended for B-Mode<br>ultrasonic imaging of a patient's breast. | | | | | | | | | | |

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

F-3

Jules Renen

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082543