Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multi-planar clinical imaging in radiology, fetal, gynecology, small organs (breast, thyroid, testes, etc.), urology, neonatal, surgery, orthopedics, abdominal, oncology (tumor volume assessment) and adult cephalic. SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.

Device Description

The BioMediCom SONOReal 3D System, cleared via K994385, K012084 and 020068, is an accessory device which adds 3D visualization capability to conventional, commercially available two dimensional imaging systems. The device does not provide diagnostic interpretation and is intended for use by or under the order of a physician. It is used to visualize features that may require closer examination in routine 2D ultrasound diagnostic imaging exams.

AI/ML Overview

The provided 510(k) summary for the BioMediCom SONOReal 3D System does not contain specific information about acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

Here's an analysis of what is available and what is missing:

Key Missing Information:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria. As such, it does not include:

A table of acceptance criteria and reported device performance.
Sample size used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
Ground truth details for test or training sets.
Training set sample size or how its ground truth was established.

Analysis of Provided Information Relevant to the Request:

A table of acceptance criteria and the reported device performance:
- N/A. The document outlines the "Intended Use" (similar functions as the predicate device), the "Device Description," and a "Comparison Chart for Substantial Equivalence" to other BioMediCom and EchoTech devices. The comparison chart focuses on functional capabilities, hardware specifications, and software features, aiming to show that the new device is substantially equivalent to previously cleared devices. It does not present specific performance metrics or acceptance criteria for those metrics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No information on a test set (or any study data) is provided. The submission relies on substantial equivalence.
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):
- N/A. No information on ground truth establishment or experts is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No information on adjudication is provided.
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:
- N/A. This device appears to be an accessory for 3D visualization and measurement, not an AI-based diagnostic tool. No MRMC study is mentioned. The device explicitly states it "does not provide any diagnostic interpretations."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. No standalone performance study information is provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No information on ground truth is provided.
The sample size for the training set:
- N/A. No information on a training set is provided.
How the ground truth for the training set was established:
- N/A. No information on a training set or its ground truth establishment is provided.

Summary:

This 510(k) summary for the BioMediCom SONOReal 3D System focuses entirely on demonstrating substantial equivalence to predicate devices (K980308, K994385, K012084, K020068) by comparing its intended use, hardware, and software features. It is for an "accessory device which adds 3D visualization capability to conventional, commercially available two dimensional imaging systems" and explicitly states it "does not provide diagnostic interpretation." Therefore, it does not include the detailed performance study information with acceptance criteria and ground truth establishment that would be expected for a device claiming diagnostic capabilities or significant algorithmic performance. The FDA's clearance is based on this substantial equivalence argument.

Summary

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KC23473

510(k) Summary SONOReal 3D System - Addition of Indications for Use BioMediCom, Ltd.

NOV 2 0 2002

510(k) Summary

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

807.92(a)(1)

Submitter Information

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

Contact Person:	Colleen Densmore
Date:	October 14, 2002
807.92(a)(2)
Trade Name:	SONOReal 3D System
Common Name:	Digital Ultrasound Image Analysis System
Classification Name(s):	System, Imaging, Pulsed Echo, Ultrasonic
Classification Number:	90IYO
807.92(a)(3)

Predicate Device(s)

EchoTech	3D FreeScan	K980308
BioMediCom	Baby Face	K994385
BioMediCom	SonoReal 3D	K012084
BioMediCom	SonoReal 3D System	K020068

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

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510(k) Summary SONOReal 3D System - Addition of Indications for Use BioMediCom, Ltd.

807.92(a)(4)

Device Description

Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multiplanar clinical imaging in radiology, fetal, gynecology, small organs (breast, thyroid, testes, etc.), urology, neonatal, surgery, orthopedics, abdominal, oncology (tumor volume assessment and adult cephalic. SONORea/™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations. The reconstruction method is unchanged from that described in the original 510(k) submissions.

807.92(a)(5)

Intended Use(s)

Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multiplanar clinical imaging in fetal, gynecological and general radiological applications such as breast, thyroid, adult cephalic, musculoskeletal, abdominal, urological, neonatal and imaging during surgical procedures (tumor volume assessment). SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.

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510(k) Summary SONOReal 3D System - Addition of Indications for Use BioMediCom, Ltd.

EchoTech3D FreeScanK980308	BioMediComSONOReal 3D SystemK020068	BioMediComSONOReal 3D SystemAddition of Indications forUse Via this Submission
Basic Function	Adds 3D imagingcapability tocommercial 2Dultrasound imagingsystems	Add 3D imagingcapability tocommercial 2Dultrasound imagingsystems	Adds 3D imaging capabilityto commercial 2Dultrasound imaging systems
Hardware	Pentium II 400 MHzFrame Grabber(VHS/S-VHS Input)Video outFoot pedal	Pentium III 833 MHzFrame Grabber(VHS/S-VHS Input)Video outHandheld controller	Pentium III 833 MHzFrame Grabber (VHS/S-VHS Input)Video outHandheld controller
Software features	Volume data acquisitionw/frame grabbing ofvideo data b/w whileusing an Electromagnetic sensor system	Volume dataacquisition w/framegrabbing of videodata b/w while usinga Gyroscopic sensorsystem	Volume data acquisitionw/frame grabbing of videodata b/w while using aGyroscopic sensor system
	Conditioning &transformation of theacquired data into aCartesian volumeSurface renderingSegmentation ofstructures from 3D data	Conditioning &transformation of theacquired data into aCartesian volumeSurface renderingSegmentation ofstructures from 3Ddata	Conditioning &transformation of theacquired data into aCartesian volumeSurface renderingSegmentation of structuresfrom 3D data
	Quantitative evaluation	NoMeasurements &calculations	NoMeasurements &calculations
Indications for Use	Cardiology/RadiologyNeurology/Gastroenterology/Urology/Surgery/Orthopedics/Oncology/Obstetrics/Gynecology	Fetal/Gynecology	Radiology/Fetal/Gynecology/Small organs (breast,Thyroid, testes, etc.)/Urology/Neonatal/Surgery/Orthopedics/Abdominal/Oncology (tumor volume

Comparison Chart for Substantial Equivalence

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DEPARTMENT OF HEALTH & HUMAN SERVICES

od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2. 0 2002

BioMediCom, Ltd. % Ms. Colleen Densmore Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K023473

Trade/Device Name: SonoReal 3D Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed imaging system Regulatory Class: II

Product Code: 90 IYO

Dated: October 14, 2002 Received: October 16, 2002

Dear Ms. Densmore:

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. Iisting 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 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 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 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:

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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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.

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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Image /page/5/Picture/1 description: The image shows the word "BIOMEDICOM" in a bold, sans-serif font. The word is enclosed in a black oval shape. The image is in black and white.

Indications for use

David k. Symm

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

Prescription Use

Image /page/5/Picture/7 description: The image shows a logo for the Standards Institution of Israel. The logo is circular and contains the letters "SI" in the center, with the text "ISO 9001" below it. The text "The Standards Institution of Israel" is written around the top of the circle, and the text "Quality Assured Firm" is written around the bottom of the circle. The logo is black and white.

BIOMEDICOM - Creative Biomedical Computing Ltd. Building 1/1 High-Tech Village, PO Box 39026, Givat-Ram, Jerusalem 91390, Israel Tel. +972-2-679-6355 • Fax +972-2-679-6358 Web: www.biomedicom.com · E-Mail: info@biomedicom.com

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.