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

Device Description

The Sonalis System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists of two parts: the system console and the transducer. The console contains the user interface, a display, system electronics and optional peripherals (printers). The removable transducers are connected to the system using standard technology. The Sonalis system uses standard transducer technology and supports linear and curved linear arrays. The Sonalis system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

AI/ML Overview

The provided text is a 510(k) Summary for the KOH-3189 Sonalis Ultrasound System. The document focuses on establishing substantial equivalence to a predicate device (Sonada ultrasound system) rather than detailing specific acceptance criteria and a study to prove meeting those criteria.

Here's an analysis of the information, addressing your points where possible, and noting where information is explicitly not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy. The basis for clearance is substantial equivalence to a predicate device. The "performance" claimed is that the device "operates identically to the predicate device" in its fundamental mechanism of action and intended use.

The closest to acceptance criteria are references to meeting various standards:

UL 2601-1 Safety Requirements for Medical Equipment
CSA C22.2 No 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA UD 2 Standard for Real-Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment.
AIUM/NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment.
IEC 1157 Declaration of Acoustic Power.
IEC60601-1-2
IEC60601-2-37

And a statement that "Both systems [Sonalis and predicate] have acoustic output levels below the applicable FDA limits." However, specific numerical limits or measured performance against these limits are not provided in this summary.

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

Not applicable. This submission is for a general-purpose diagnostic ultrasound system, not an AI or image analysis device that would typically involve a "test set" of patient data for performance evaluation in the way you're asking. The evaluation is based on technical specifications and comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable, as no test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a traditional ultrasound imaging system, not an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed.

6. If a Standalone Study Was Done

No. The submission is based on substantial equivalence, meaning its performance is compared to an existing, cleared device, not typically a standalone performance study as would be done for a novel technology or AI. The FDA letter does mention a postclearance special report requested to contain "complete information, including acoustic output measurements based on production line devices," but this is a post-market requirement for validation, not a pre-market standalone performance study for clinical efficacy.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate device, and the demonstration that the new device is functionally equivalent and meets the same standards. There isn't a clinical "ground truth" derived from patient outcomes or pathology related to the diagnostic performance of the device itself described in this document.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

Summary of Device Acceptance Rationale (based on the provided text):

The Sonalis Ultrasound System was accepted based on substantial equivalence to a previously cleared predicate device, the Sonada ultrasound system (K993092). The key arguments for substantial equivalence presented are:

Intended Use: Both systems are intended for diagnostic ultrasound imaging of the human body, specifically mentioning trans-rectal imaging and prostate/rectal wall studies for the Sonalis system (with additional specific transducers listed for Small Organ and Peripheral Vascular imaging).
Technological Characteristics: Both operate identically, using piezoelectric material in transducers to transmit and receive sound waves, converting them into 2D images.
Safety & Effectiveness:
- Similar technologies for imaging and signal processing.
- Acoustic output levels are below applicable FDA limits for both.
- Manufactured from materials evaluated and found safe.
- Designed to meet various international and national safety and performance standards (UL, CSA, AIUM/NEMA, IEC).

The FDA's clearance letter confirms this substantial equivalence determination, with a specific condition for a post-market special report on acoustic output measurements from production units.

Summary

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KOH-3189

510(k) Summary of Safety and Effectiveness

FEB - 9 2005

This summary of safety and effectiveness is provided as part pf the Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions To 21CFR.Part 807, Subpart E, Section 807.92 Content and Format of a 510 (k) Summary.

Submitted By: 1)

3G Ultrasound Corporation 200 Williams Drive Ramsey, NJ 07446

Contact Person: Raul Gutierrez

Phone:(201) 280-4419 Fax: (201) 825-1165

Date Prepared: September 03, 2004

Proprietary Name: 2) Sonalis Ultrasound System
CommonIUsual Name: Diagnostic Ultrasound with Accessories

Classification Name: 21 CFR892.1560

892.1560 Product Code 90-IYO Ultrasonic Pulsed Echo Imaging System Product Code 90-ITX Diagnostic Ultrasound Transducer# 892.1570

Substantially Equivalent Devices 3)

3G Ultrasound Corporation believes that the Sonalis Platform System and transducers are substantially equivalent to the currently marketed Sonada ultrasound System and transducers cleared in K993092.

Device Description 4)

The Sonalis System is a general purpose ,mobile ,software controlled ,diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

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The device consists of two parts: the system console and the transducer. The console contains the user interface, a display, system electronics and optional peripherals ( printers).

The removable transducers are connected to the system using standard technology. The Sonalis system uses standard transducer technology and supports linear and curved linear arrays.

The Sonalis system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

The Sonalis Platform system has been designed to meet the following standards:

UL 2601-1 Safety Requirements for Medical Equipment .
CSA C22.2 No 601-1, Safety Requirements for Medical Equipment .
AIUM/NEMA UD 2 Standard for Real-Time Display of Thermal and Mechanical Output . Indices on Diagnostic Ultrasound Equipment.
AIUM/NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Output . Indices on Diagnostic Ultrasound Equipment.
IEC 1157 Declaration of Acoustic Power .
1EC60601-1-2 .
. 1EC60601-2-37

4) Intend Use

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

Typical examinations using the Sonalis Platform system

Prostate and rectal wall studies. .

5} Technical Characteristic

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.

6) Conclusion

The Sonalis Platform ultrasound system and transducers are substantially equivalent in safety and effectiveness to the Sonada system and transducers.

Both systems are intended for diagnostic ultrasound imaging. .

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Both Systems are essentially the same technologies for imaging and signal processing.
- · Both systems have acoustic output levels below the applicable FDA limits.
- Both systems are manufactured of materials with matcrials that have been evaluated and found to be safe for its application.

End of 510(k) Summary

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy line.

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3G Ultrasound, Inc. % Paul Schneider, Ph.D. Official Correspondent Schneider Associates, Inc. 12672 Coral Lakes Drive BOYNTON BEACH FL 33437

Re: K043189

Trade Name: SONALIS 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: January 27, 2005 Received: January 28, 2005

Dear Dr. Schneider:

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 SONALIS Ultrasound System, as described in your premarket notification:

Transducer Model Number

SONO 2001 SONO 2002

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

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Page 2 - Dr. Schneider

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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I coloral statutes and regaranents, 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 (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I 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 In Appendix O, (chelood) of the Samostic Ultrasound Systems and Transducers." If the special Seeking Marketing Clearantee of Blaghesable 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 squivalence of your device to a legally marketed notification. THE I D. I 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 (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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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Page 3 – Dr. Schneider

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Lyman

for
N
B

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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Appendix F

Diagnostic Ultrasound Indications for Use Form

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify) *		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:

Mode of Operation

Additional Comments:

SONALIS ULTRASOUND SYSTEM_

*_Thyroid, Testes, Breast

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

David A. Layman

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

Prescription Use (Per 21 CFR 801.109)

Section 3-3 F-3

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Appendix F

Diagnostic Ultrasound Indications for Use Form

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatnc
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N
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 EMode of Operation

Additional Comments:

SONO 2001 Transducer

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

David A. Bergman

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) ്പെടുന്ന of Reproductive, Abdominal tinlegical Devices

Devices
K043189

Section 3-2 F-3

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Appendix F

Diagnostic Ultrasound Indications for Use Form

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	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		N
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments:

SONO 2002 Transducer Thyroid, Testes, Breast

Mode of Operation

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

David A. Heymann

Prescription Use (Per 21 CFR 801.109)

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

Section 3-3 F-3

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.