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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes Design Validation Tests as the primary method to demonstrate the device meets its performance requirements. The specific acceptance criteria and reported performance are as follows:

Acceptance Criteria	Reported Device Performance
Identification of masses on a breast phantom	All 10 masses successfully identified on a breast phantom.

Note: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) that were met through a clinical study involving human patients. The validation test focused on the ability to identify masses in a phantom.

Study Details

Based on the provided text, the primary "study" proving the device meets acceptance criteria is a non-clinical phantom study.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 1 breast phantom with 10 masses.
- Data Provenance: Not applicable as it was a non-clinical phantom study. There is no mention of country of origin or whether it was retrospective or prospective data from human subjects.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for the test set (phantom) would have been the known locations and presence of the 10 masses designed into the phantom. No human experts were required to establish this.
Adjudication Method for the Test Set:
- Not applicable. As the ground truth was inherent in the phantom design, no adjudication among experts was needed. The testing simply verified if the device could identify the pre-defined masses.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on intended use, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, supported by non-clinical phantom testing. There is no mention of comparing human reader performance with and without AI assistance.
If a Standalone (algorithm only without human-in-the-loop performance) study was done:
- Yes, a standalone (algorithm/device only) test was performed on the phantom. The "System Validation Testing" was performed on the device itself to identify the masses within the phantom, without explicit mention of a human-in-the-loop for this specific test.
The Type of Ground Truth Used:
- Known physical properties/design of the phantom. For the system validation test, the ground truth was the 10 randomly positioned masses within the breast phantom.
The Sample Size for the Training Set:
- Not applicable. The document does not describe the use of an algorithm that would require a "training set" in the context of machine learning or AI. This device appears to be an imaging system that uses servo motors to guide an ultrasound transducer and software for image review, rather than an AI-driven diagnostic tool.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set is described.

Summary

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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 (650) 593-5225

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.

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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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, and a symbol in the center. The text around the border is not clearly legible, but it appears to be in all capital letters. The central symbol consists of three curved lines that resemble stylized bird wings or flowing lines. The logo is black and white.

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 (800) 638-2041 or (240) 276-3150 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 (775) 851-7474 Fax (775) 256-1845 www.SonoCine.com

Page 9

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Small Organ - Breast, B-ModeThe SonoCine Adjunctive Breast Ultrasound System is intended for B-Modeultrasonic 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

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.