The Sofia™ (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

Device Description

The Sofia™ (ATUS) device consists of three (3) major components 1) an exam table which houses the examination pyramid, motor drive assembly, fluidics evacuation and storage system, and the power supply assembly 2) an ultrasound probe which is embedded into the exam pyramid on one end and connected to the ultrasound system on the other end, 3) an ultrasound system that acquires and stores the ultrasound data from the patient's breast exam.

AI/ML Overview

The provided text describes the 510(k) summary for the Sofia™ (ATUS) Imaging Device (K080555). However, it does not contain information about specific acceptance criteria or a study proving the device meets them, in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to legally marketed devices.

Here's a breakdown of what is available in the document related to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are mentioned for the Sofia™ (ATUS) device itself.
The document primarily states that the device is substantially equivalent to predicate devices.
The "Summary of Studies" section refers to non-clinical design verification and validation tests, including mechanical performance and simulated use tests.
Performance information: "The results of the Sofia™ (ATUS) systems performance evaluations demonstrate that the Sofia™ (ATUS) device design is well suited for its intended use." This is a general statement, not a quantified performance metric.
Electrical Safety Testing: The document lists several IEC, UL, and CAN/CSA standards that the device will be tested against by an independent laboratory prior to commercial distribution. These are safety and electromagnetic compatibility standards, not clinical performance metrics. The specific results of these tests are not reported in this 510(k) summary, only the commitment to perform them.

2. Sample Size for the Test Set and Data Provenance:

No information is provided regarding a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are non-clinical (mechanical, simulated use, electrical safety).

3. Number of Experts and Qualifications for Ground Truth:

No information is provided about experts used to establish ground truth for a test set. The clinical claim is based on substantial equivalence to predicate devices, not de novo clinical performance validation against a ground truth.
An "expert in the field of acoustic sonography" provided an opinion and performed acoustic output testing, which relates to safety and operational characteristics, not clinical diagnostic accuracy.

4. Adjudication Method:

No adjudication method is mentioned as there is no described clinical test set or ground truth establishment process in the context of diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The submission does not describe any human reader studies, with or without AI assistance. The device itself is an imaging system, and at the time of this filing (2008), the term "AI" as applied to medical device assistance was not prevalent in such summaries.

6. Standalone (Algorithm Only) Performance:

No standalone (algorithm only) performance is described. The device is an ultrasound imaging system; its output is images for interpretation by a human radiologist. There's no indication of an embedded algorithm for automated diagnostic interpretation independent of a human.

7. Type of Ground Truth Used:

No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned because no clinical performance study against a ground truth is described in this 510(k) summary. The "ground truth" for this 510(k) is primarily the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set:

No information about a training set sample size is provided. This device is an imaging system, not a machine learning algorithm that requires a training set in the typical sense for diagnostic output.

9. How Ground Truth for the Training Set was Established:

Not applicable, as no training set for a diagnostic algorithm is described.

In summary, the K080555 document for the Sofia™ (ATUS) Imaging Device is a 510(k) submission primarily establishing substantial equivalence to existing ultrasound systems. It focuses on the device's design, intended use, and non-clinical safety/performance validations, rather than detailing a clinical study with specific acceptance criteria, ground truth, or statistical performance metrics.

Summary

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K080555

JUN - 3, 2008

Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

1. Contact Person

Mark L. Stribling President & CEO iVu Imaging Corporation www.ivuimaging.com 4121 Grace Ln, Grapevine, TX 76051-6586 Tel: 817-545-9766 Fax: 817-354-0062 Email: mstribling@ivuimaging.com

2. General Information

Name:	iVu Imaging Corporation
Trade Name:	Sofia™ (ATUS) Imaging Device
Classification Name:	Transducer, Ultrasonic, Diagnostic
Classification:	This device is classified by the Reproductive, Abdominaland Radiological Devices into Class II, (21 CFR 892.1560Ultrasonic pulsed echo imaging system and 892.1570Diagnostic ultrasonic transducer)

3. Device Description

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The Sofia™ (ATUS) device, as well as, the two predicate devices (Trade Name: FFBU Diagnostic Ultrasound System manufactured by U-Systems, Inc (K032640), Trade Name: ABUS Diagnostic Ultrasound System manufactured by U-Systems, Inc (K052355) utilize standard B-Mode grayscale ultrasound to achieve their intended use. Both the Sofia™ (ATUS) device and the U-Systems FFBU and ABUS systems use automated linear ultrasound transducers to evaluate breast tissue. The Sofia™ (ATUS) device, as well as, the U-Systems FFBU and ABUS systems all use automated linear transducers to acquire serial 2D grayscale images of the entire breast. These 2D images can then be reviewed by a radiologist to determine if any abnormal anatomical features are present in the patient's breast. The Sofia™ (ATUS) system utilizes the same mode of operations, general operating principals, as well as, general and specific indications for use as the predicate devices described above.

4. Intended Use

5. Substantial Equivalence Comparison

The iVu Sofia™ (ATUS) device is substantially equivalent to the following devices with respect to intended use, design, materials and construction:

The FFBU Diagnostic Ultrasound System manufactured by U-. Systems, Inc (K032640)
. The ABUS Diagnostic Ultrasound System manufactured by U-Systems, Inc (K052355).

Section 4 of this 510K shows much more detail relative to specific similarities and differences between the Sofia™ (ATUS) system and the predicate devices; also a table is provided for clarity. The Sofia™ (ATUS) device and the predicate devices are substantially equivalent in their intended uses and / or device design. In addition to the similar intended use, all of the predicate devices utilize B-Mode Grayscale Ultrasound to achieve their intended use. Both the Sofia™ (ATUS) and the predicate devices use automated linear ultrasound transducers to image breast tissue. Both the Sofia™ (ATUS) device and the predicate devices use commercially available FDA 510K approved ultrasound systems to acquire ultrasound images.

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The Sofia™ (ATUS) system uses the GE LOGIQ e (K050126). The U-Systems ABUS and FFBU systems use the Siemens Antares DUS (K023720). Refer to Attachment I for a copy of the GE Medical Systems 510K (K050126).

A brief discussion of the similarities and differences between the Sofia™ (ATUS) device and its predicate devices is provided below.

Similarities

Similar to the Sofia™ (ATUS), the U-Systems FFBU system uses an automated . linear transducer to acquire serial 2D images of the patient's breast. The FFBU system uses a commercially available FDA 510K approved ultrasound system to acquire and process B-Mode grayscale images of a patient's breast.
Similar to the Sofia™ (ATUS), the U-Systems ABUS system uses an automated . linear transducer to acquire serial 2D images of the entire patient's breast. The ABUS system uses a commercially available FDA 510K approved ultrasound system to acquire and process B-Mode grayscale images of a patient's breast.

Differences

. The Sofia™ (ATUS) system uses an FDA 510K approved linear transducer manufactured by GE Medical Systems. The U-Systems ABUS device uses a custom automated linear transducer. The transducers listed above are all broad band transducers with frequency ranges between 7MHZ and 11MHZ.
t The Sofia™ (ATUS) system positions the patient in a prone position lying on its examination table with the breast in a pendulous position within the pyramid shaped dome. The U-Systems ABUS and FFBU devices position the patient in a supine position and use the transducer housing of its devise to compress the breast tissue between the transducer face and the thoracic wall.
. iVu's pendulous position of the breast in a fluid environment eliminates the need for breast compression. No new issues of safety or efficacy are created.

6. Summary of Studies

The function and performance of the Sofia™ (ATUS) system have been evaluated through non-clinical design verification and validation tests. Testing included mechanical performance evaluations and simulated use tests. The results of the Sofia™ (ATUS) systems performance evaluations demonstrate that the Sofia™ (ATUS) device design is well suited for its intended use.

iVu Imaging completed mechanical performance evaluations to verify that the Sofia™ (ATUS) system meets predetermined specifications, conforms to product performance requirements, and supports the compatibility of internal components. Test results, as documented in Section 7, support that the Sofia™ (ATUS) system meets the predetermined specifications and performance requirements for its intended use.

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Additional testing of The Sofia™ (ATUS) device will be performed by an independent testing laboratory (Intertek Testing Services NA, Inc) and must demonstrate conformance with the IEC 60601 series of electrical and electromagnetic safety standards before commercial distribution begins. In Section 7 of this document, under "ELECTRICAL SAFETY TESTING" is a signed certification by the President of iVu attesting to the fact that such testing will occur prior to commercialization. The following specific standards will be tested.

DocumentNumber	Description
IEC 60601-1	IEC 60601-1 Issue 1988/12/01 Ed:2 Medical Electrical EquipmentPart 1: General Requirements for Safety; (Amd. 1-1991)(CENELEC EN 60601-1: 1990) (Amd. 2-1995) (Corrigendum-1995)
UL 60601-1	UL 60601-1 UL Standard for Safety Medical Electrical Equipment,Part 1: General Requirements for Safety Issued: 4/25/2003 Ed: 1
CAN/CSA-C22.2 No.601.1-M90	CAN/CSA-C22.2 No. 601.1-M90 Canadian Electrical Code, Part I.Rev. 1999
IEC 60601-1-2	IEC 60601-1-2 Issued: 2001/09/30 Ed:2 Medical ElectricalEquipment Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Req. andTests

In Section 7, Bench testing included testing performed in-house, as well as, an opinion from an expert in the field of acoustic sonography who also performed and documented acoustical output testing. In-house testing, the opinion, and acoustic testing demonstrate the safety and effectiveness of the Sofia (ATUS) system.

7. Conclusion (statement of equivalence)

The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the Sofia™ (ATUS) Device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes on its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2008

iVu Imaging Corportaion % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OF 44087

Rc: K080555

Trade/Device Name: Sofia™ Automated Tomographic Ultrasound (ATUS) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: ITX and IYO Dated: May 16, 2008 Received: May 19, 2008

Dear Mr. Lehtonen:

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 Sofia™ Automated Tomographic Ultrasound (ATUS), as described in your premarket notification:

Transducer Model Number

12L-RS

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.

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

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Page 2 - Mr. Lehtonen

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 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

Sincerely yours,

Vogue McHanz

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

Enclosure(s)

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Indications for Use Statement

Page 1 of 1

510(k) Number: K080255

Sofia™ Automated Tomographic Ultrasound (ATUS) Device Name:

Indications for use:

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aomi M Whang
(Division Sign-Off)

D sion of Reproductive, Abdominal a F -diological Devices ! (U(k) Number

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Diagnostic Ultrasound Indications for Use Form

510(K) Number: K080555

Device Name: Sofia ™ Automated Tomographic Ultrasound (ATUS) device Ultrasound probe - GE 12L-RS

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)
IntraoperativeNeurological
Pediatric
Small Organ (Breast)		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
MusculoskeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=New indication: P=Previously Cleared by FDA; E= Added Under Appendix E

Additional Comments: The iVu Imaging Sofia™ Automated Tomographic Ultrasound (ATUS) device is intended for ultrasonic breast examinations.

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

lone In Whay

(Division Sign-Off) Division of Reproductive, Abdominal ar Radiological Dev 510(k) Number

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.