Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.

Device Description

Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, and Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, and Segmentation of structures from 3D data.

AI/ML Overview

The provided text is a 510(k) Summary for the SONOReal 3D System, which is a digital ultrasound image analysis system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria.

Based on the provided document, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or provide quantitative performance metrics for the SONOReal 3D System in a study. The summary primarily focuses on comparing the new device (BioMediCom SONOReal 3D System) with a predicate device (EchoTech 3D FreeScan) to establish "substantial equivalence" based on function, hardware, software features, and indications for use.

The relevant comparison table provided is:

	EchoTech (Predicate Device)	BioMediCom (SONOReal 3D System)
Trade Name	3D FreeScan	SONOReal 3D System
510(k) Number	K980308	K994385 (listed as predicate's number in the table, but K012084 is for SONOReal in this submission)
Basic Function	Adds 3D imaging capability to commercial 2D ultrasound imaging systems	Adds 3D imaging capability to commercial 2D ultrasound imaging systems
Hardware	Pentium II 400 MHz, Frame Grabber (VHS/S-VHS Input), Video out, Foot pedal	Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, Handheld controller
Software features	Volume data acquisition w/frame grabbing of video data b/w while using an Electro magnetic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3D data, Quantitative evaluation, Measurements & calculations	Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3D data, No Quantitative evaluation, No Measurements & calculations
Indications for Use	Gynecology/OB, radiology, neurology, gastroenterology, urology, surgery, orthopedics, and oncology	Fetal/Gynecology

Assessment: The "reported device performance" is essentially the feature set and intended use, which is deemed substantially equivalent to the predicate except for the lack of quantitative measurements and a narrower range of indications for use. There are no numerical performance metrics (e.g., accuracy, precision) provided in this document.

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

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The focus is on comparison to a predicate device's specifications and functionality.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention any experts being used to establish ground truth for a test set. This type of information would typically be found in a clinical performance study, which is not detailed here.

4. Adjudication Method

The document does not describe any adjudication method. This is consistent with the absence of a detailed performance study involving expert assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document does not describe an MRMC comparative effectiveness study. It's a 510(k) submission focused on substantial equivalence rather than comparative effectiveness. Therefore, there's no mention of effect size for human readers with or without AI assistance.

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

The document does not describe a standalone performance study for the algorithm. The device, as described, is a system intended to be used "by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D clinical imaging." It does not provide "quantitative measurement capabilities or diagnostic interpretations" for standalone assessment.

7. The Type of Ground Truth Used

The document does not specify any type of ground truth used for performance evaluation. Given the nature of a 510(k) submission demonstrating substantial equivalence, the "ground truth" for approval is primarily the existence and specifications of a legally marketed predicate device.

8. The Sample Size for the Training Set

The document does not mention any training set size. As a system that does not provide diagnostic interpretations or quantitative measurements, it's unlikely to have been developed using machine learning in the way typically requiring a "training set" for an AI algorithm. Its functions (volume data acquisition, conditioning, surface rendering, segmentation) are described as direct processing tasks.

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

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary of Device Purpose and Approval Context:

The SONOReal 3D System is cleared as substantially equivalent to the EchoTech 3D FreeScan. Its purpose is to add 3D imaging capabilities to existing 2D ultrasound systems for fetal and gynecological applications. Crucially, the document states: "The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations." This clarification indicates that the device's role is visualization, not automated diagnosis or measurement, which explains the absence of detailed performance studies against specific clinical acceptance criteria in this submission. The FDA's clearance is based on its similarity in function and safety to a predicate device.

Summary

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SEP 2 6 2001

K 012084/
Page 1 of 3

510(k) Summary SONOReal 3D System BioMediCom, Ltd.

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21 CFR (807.92(a).

807.92(a)(1)

Submitter Information

Colleen Hittle, Official Correspondent 7992 Castleway Drive Indianapolis, IN 46250 (317) 849-1916 Phone: (317) 577-9070 Facsimile:

Contact Person: Colleen Hittle

May 25, 2001 Date:

807.92(a)(2)

Trade Name:

Common Name:

SONOReal 3D System

901YO

3D FreeScan

Digital Ultrasound Image Analysis System

System, Imaging, Pulsed Echo, Ultrasonic

Classification Name(s):

Classification Number:

807.92(a)(3)

Predicate Device(s)

EchoTech

K980308

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

SK23

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K0/2084
Page 2 of 3

510(k) Summary SONOReal 3D System BioMediCom, Ltd.

807.92(a)(5)

Intended Use(s)

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K01208
Perz3of

510(k) Summary SONÓReal 3D System BioMediCom, Ltd.

	EchoTech	BioMediCom
	3D FreeScan	SONOReal 3D System
	K980308	K994385
		Addition of GynecologyIndication for Use
Basic Function	Adds 3D imaging capabilityto commercial 2Dultrasound imaging systems	Adds 3D imaging capabilityto commercial 2Dultrasound imaging systems
Hardware	Pentium II 400 MHz	Pentium III 833 MHz
	Frame Grabber (VHS/S-VHS Input)	Frame Grabber (VHS/S-VHS Input)
	Video out	Video out
	Foot pedal	Handheld controller
Software features	Volume data acquisitionw/frame grabbing of videodata b/w while using anElectro magnetic sensorsystem	Volume data acquisitionw/frame grabbing of videodata b/w while using aGyroscopic sensor system
	Conditioning &transformation of theacquired data into aCartesian volume	Conditioning &transformation of theacquired data into aCartesian volume
	Surface rendering	Surface rendering
	Segmentation of structuresfrom 3D data	Segmentation of structuresfrom 3D data
	Quantitative evaluation	No
	Measurements &calculations	No
Indications for Use	Gynecology/OB, radiology,neurology,gastroenterology, urology,surgery, orthopedics, andoncology	Fetal/ Gynecology

Comparison Chart for Substantial Equivalence

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized lines or strokes, possibly representing people or services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2001

BioMediCom, Ltd. % Ms. Colleen Hittle The Anson Group Official Correspondent 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K012084

Trade/Device Name: SONOReal 3D System Digital Ultrasound Image Analysis Syst Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: June 21, 2001 Received: July 3, 2001

Dear Ms. Hittle:

Jear Ms. Hittle:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your section Fro(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interscripts for the stated in the enclosure) to regary manated produced Device Americal Device Ameradments, or to commerce prior to May 20, 1970, the chaounters with the provisions of the Federal Food. Drug, devices that have been recassince in accessars val of a premarket approval application (PMA). and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, deletere, market the do roos see neguirements for annual registration, listing of general controls provisions of the free 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 additional controls. Existing major regulations affecting your device can be It may be subject to additional controliations, 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 that I DI has made a actoring administered by other Federal agencies. You must or any I edelar statutes and rogulatents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 OF IC Ford 007), accems (20) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalerice and finis nemits your device to notification. The FDA finding of substantial equivalence or 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
r and the may of the start of the following numbers, hased on the regulatio If you desire specific advice for your device on our laboring regulation (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and acrease of your armined, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note the regulation on Office of Compliance at (301) 394-4039. Also, produce noter. Other general information on by reference to premarket notification" (2) Cr Cr F an Cool. 7 ) " Sision of Small Maufacturers,
your responsibilities under the Act may be obtained from the Division of Smal your responsibilities under the Act may oe bolled nom and BRND) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-fire examping bron International and Coulsumer Assistance avoid decided dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon 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

Applicant: BioMediCom, Ltd.

510(k) Number (if known):

Device Name: SonoReal 3D

Indications For Use:

Intended to be used by or under the direction of a physician and in conjunction with standard intended to be used by or under the direction on a in fetal and gynecological applications. The unfrasound system does not currently provide any quantitative measurement capabilities or SONOReal™ system does not carrently provided to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over The Counter

(Per 21 CFR, 801.109)

(Optional Format 1-2-96)

Nancy C. Brogdon
(Division
ision of Abdominal.
radi

3 (Ok) Nun

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.