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 fetal and gynecological applications. 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

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, Segmentation of structures from 3D data, and Measurement and calculations Via this submission.

AI/ML Overview

The provided 510(k) summary for the BioMediCom SONOReal 3D System focuses on the addition of a measurement function to an already existing 3D ultrasound system. The document does not contain a detailed study with acceptance criteria and reported device performance metrics in the way a typical clinical trial or performance study would.

Instead, the submission appears to be a substantial equivalency claim, comparing the new device (with the added measurement function) to predicate devices already on the market. The comparison chart primarily details hardware and software features, not specific performance metrics against pre-defined acceptance criteria for the measurement function itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text.

Based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report performance data for the measurement function. The "Comparison Chart for Substantial Equivalence" implies that the new device's measurement capabilities are considered equivalent to those of the predicate devices. However, no quantitative performance metrics (e.g., accuracy, precision) for these measurements are provided, nor are specific acceptance criteria for these metrics.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on functional equivalence to predicate devices, implying that the measurement accuracy and precision are considered acceptable based on the existing market.	No specific performance data (e.g., accuracy, precision of measurements) is reported for the new measurement function. The document primarily compares features and capabilities with predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified. The document does not describe a test set or study conducted for the measurement function.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

Adjudication Method: Not specified, as no test set or expert review process for performance is detailed.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed.

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

Standalone Performance: Not explicitly mentioned or detailed. The measurement function is integrated into a system intended for use by a physician, implying human interaction.

7. The type of ground truth used:

Type of Ground Truth: Not specified, as no specific performance study with a defined ground truth is described.

8. The sample size for the training set:

Sample Size for Training Set: Not specified. This submission is for an addition of a measurement function to an existing device, and the details of how that measurement function was developed or trained (if it involved machine learning which is unlikely given the date) are not provided.

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

Ground Truth Establishment for Training Set: Not specified.

Summary of Study (Based on the Document's Content):

The document K020068 is a 510(k) Summary for the SONOReal 3D System - Addition of Measurement Function by BioMediCom, Ltd. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not primarily a detailed performance study with quantitative acceptance criteria for the added measurement function.

The "study" presented is a comparison of features and intended use between the modified SONOReal 3D System (with measurement function) and existing predicate devices (EchoTech 3D FreeScan K980308 and BioMediCom Baby Face K994385, and the original SonoReal 3D K012084).

The core argument for equivalence is that:

The basic function (adding 3D imaging capability to 2D ultrasound) is the same.
The hardware specifications are similar or improved (Pentium III 833 MHz vs. Pentium II 400 MHz).
The software features are largely comparable, with the key update being the addition of measurement and calculations to the SONOReal 3D system, making it functionally similar to the EchoTech 3D FreeScan which already had "Measurements & calculations".
The intended uses for fetal and gynecological applications are maintained and aligned with the capabilities being added.

The FDA's letter (K020068) confirms that, based on this information, the device is considered substantially equivalent to already marketed predicate devices for the stated indications for use. This means the FDA did not require a separate, detailed clinical performance study with explicit acceptance criteria and corresponding data to be submitted for this particular modification, as the functional addition (measurements) was deemed comparable to existing, legally marketed devices.

Summary

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K020068
Page 1 of 3

4 2002 MAR

510(k) Summary SONOReal 3D System -- Addition of Measurement Function BioMediCom, Ltd.

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

Colleen Densmore Contact Person:

December 20, 2001 Date:

807.92(a)(2)

SONOReal 3D System Trade Name:

Digital Ultrasound Image Analysis System Common Name:

System, Imaging, Pulsed Echo, Ultrasonic Classification Name(s):

90IYO Classification Number:

807.92(a)(3)

Predicate Device(s)

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

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

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K0 20068
Page 2 of 3

510(k) Summary SONOReal 3D System - Addition of Measurement Function BioMediCom, Ltd.

807.92(a)(5)

Intended Use(s)

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K020068
page 3 of 3

510(k) Summary 910(k) Sammary
SONOReal 3D System - Addition of Measurement Function BioMediCom, Ltd.

	EchoTech	BioMediCom
	3D FreeScan	SONOReal 3D System
	K980308	K994385
		Addition of MeasurementFunction
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	Measurement andcalculations
		Via this submission
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 and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three parallel lines forming the wings and a snake-like form at the bottom. The logo is encircled by the text "U.S. Department of Health & Human Services - USA".

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

4 2002 MAR

BioMediCom, Ltd. % Ms. Colleen Densmore Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46205 Re: K020068

Trade/Device Name: SONOReal™ 3D System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: January 2, 2002 Received: January 9, 2002

Dear Ms. Densmore:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becately on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualed in the encreativent of 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 I ou may, disreleve, mains of the Act include requirements for annual registration, listing 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 11 you assnowly 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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Indications for Use Statement

Applicant: BioMediCom, Ltd.

510(k) Number (if known): K020068

Device Name: SonoReal 3D

Indications For Use:

Intended to be used by or under the direction of a physician and in conjunction with a standard
ed the sunder the contribution of this began in fetal and genecological Intended to be used by or uner the circulture of comment some in tetal and gyncological
ultrasound system to provide 3D and Multi-planar clinical in feal and wish to exami ultrasound system to provide 3D alls intention intreasonal the user may wish to examine
applications. SONOReal™ is intended to visualize exampations. The user is offered the applications. SONOReal ™ is michled to visually insumerations. The user is offered the more closely in routine 2D ultrasound ulagnosic cannonts of the subject being scanned.
capability to perform linear, area and volumetric measurements of the subject being sca Capability to perform missany diagnostic interpretations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over The Counter_ Prescription Use_ V

(Per 21 CFR, 801.109)

(Optional Format 1-2-96)

Yavid C. Seymon

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.