The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.

Device Description

The SONALIS® is a real time, two-dimensional, diagnostic system that produces high quality images. The system currently supports imaging applications for trans-aectorl ultrasound imaging. The system consists of:

. system console,
. keyboard.
. ultrasound probe,
. ultrasound probe connector,
. power cord,
high resolution LCD monitor to display the image,
System Operating Manual ●
B&W graphic printer .

AI/ML Overview

The provided text is a 510(k) summary for the SONALIS® Ultrasound System from Best NOMOS, dated November 24, 2009, with an FDA acceptance date of February 19, 2010.

Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" table with performance metrics (e.g., sensitivity, specificity, accuracy) is present in the provided document. The submission is a 510(k) for a medical device that operates identically to a predicate device. Therefore, the primary acceptance criterion is substantial equivalence to the predicate device (Sonalis Ultrasound System, K043189).

The "reported device performance" in this context is the assertion that the device functions identically to the predicate device and is compliant with relevant safety standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device (Sonalis Ultrasound System, K043189) in:	The SONALIS® Ultrasound System is the same device as the predicate except for updated components that do not affect safety and efficacy. The SONALIS® Ultrasound System is the same device with respect to: - Intended Use - Design - Technological Characteristics
Compliance with Safety Standards	Compliant to: - UL60601-1 (2003), 1st Edition Medical Electrical Equipment, Part 1, General Requirements for Safety - IEC 60601-1 (1988), 2nd Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95) - IEC 60601-2 (2001), 2nd Edition Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility - IEC 60601-2-37 (2001), 1st Edition Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment +A1(2004)
Biocompatibility	Tested in accordance with the testing requirements of the ISO 10993 Recognized Standards and found to be safe for its intended use.
No new questions concerning safety or effectiveness compared to the predicate device	Stated directly in the Conclusion: "The Sonalis Ultrasound System introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device."
Intended Use: Diagnostic ultrasound imaging of the human body, specifically trans-rectal imaging (Prostate and Rectal wall studies).	The intended use matches the predicate device and is explicitly stated: "The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific "test set" for performance evaluation, nor does it mention any clinical studies involving patient data. This is characteristic of a 510(k) submission for a device demonstrating substantial equivalence, especially when the changes from the predicate are minor and do not affect performance. The proof of meeting acceptance criteria is based on the claim of identical operation and compliance with standards, not new clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No information is provided regarding experts to establish ground truth because no specific clinical test set requiring expert interpretation is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described, as no clinical test set is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done, as this is a diagnostic ultrasound system, not an AI-based interpretation device. It is a hardware device for imaging.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The SONALIS® is a diagnostic ultrasound imaging system, not an algorithm, and it explicitly requires human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No ground truth is described because no clinical performance study involving patient data was conducted or reported in this 510(k) summary. The "ground" for approval is the technical equivalence to a previously cleared device and compliance with safety standards.

8. The sample size for the training set

No training set is mentioned. This device is an imaging system, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Kloozoy

510(k) Summary 807.92(c)

FEB 1 9 2010

SPONSOR Company Name:

Company Address

ﺎ ﮨﮯ

Best NOMOS

One Best Drive Pittsburg, PA 15202

Telephone:

(800) 70-NOMOS

Contact Person:

Andrew Chi Palko

Summary Preparation Date: November 24, 2009

DEVICE NAME

Trade Name: Common/Usual Name: Classification Name:

Regulation Number: Product Code: Device Class:

PREDICATE DEVICE

Legally Marketed Equivalent Device Company 3G Ultrasound Inc. Sonalis Ultrasound System

807.92(a)(2)

807.92(a)(1)

Sonalis® Ultrasound System Diagnostic Ultrasound System Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer 892.1560, 892.1570 IYO, ITX Class II

510(k) # K043189

Product

DEVICE DESCRIPTION

. system console,
. keyboard.
. ultrasound probe,
. ultrasound probe connector,
. power cord,
high resolution LCD monitor to display the image, �
System Operating Manual ●
B&W graphic printer .

2023-24

807.92(a)(3)

807.92(a)(4)

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DEVICE INTENDED USE

807.92(a)(5)

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

This device operates identically to the predicate device in that the piezoelectrical material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D images.

NONCLINICAL AND CLINICAL TEST

807.92(b)

SAFETY and EFFECTIVENESS

.. - - - ---------------------------------------------------------------------------------------------------------------------------------------------------------------------

The SONALIS® is compliant to the safety standards.

UL60601-1 (2003), 181 Edition Medical Electrical Equipment, Part 1, General Requirements for Safety

IEC 60601-1 (1988), 2nd Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95)

IEC 60601-2 (2001), 2nd Edition Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility IEC 60601-2-37 (2001), 1st Edition Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment +A1(2004)

BIOCOMPATIBILITY

SONALIS® was tested in accordance with the testing requirements of the ISO 10993 Recognized Standards and found to be safe for its intended use.

CONCLUSION

807.92(b)(3)

The SONALIS® Ultrasound System is the same device as the predicate except for updated components that do not affect safety and efficacy. The SONALIS@ Ultressound System is the same device

Intended Use
. Design
Technological Characteristics 0

The Sonalis Ultrasound System introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device.

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Image /page/2/Picture/0 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 coiled around it, topped with three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Best NOMOS % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

FEB 1 9 2010

Re: K100204

Trade/Device Name: SONALIS Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 15, 2010 Received: January 22, 2010

Dear Mr. Devine:

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 iddions 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 In Include in Including of 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish frither 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 manon coss not incan 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 Parts 801 and 809); medical device reporting freporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K100204

Device Name: SONALIS

Indications for Use:

The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging.

Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number_

Page 1 of 1

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TRACK 1

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	Amplitude	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic .
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N= new indication: P= previously cleared by FDA; E= added under Appendix E

. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Additional Comments: Sonalis TRT TRIVIEW -467 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K100204

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.