SONOREAL 3D SYSTEM

K020068 · Bio Medi Com · IYO · Mar 4, 2002 · Radiology

Device Facts

• Record ID: K020068
• Device Name: SONOREAL 3D SYSTEM
• Applicant: Bio Medi Com
• Product Code: IYO · Radiology
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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 Story

SONOReal 3D System is an add-on for standard 2D ultrasound systems; enables 3D and multi-planar imaging. Input: 2D ultrasound video data (VHS/S-VHS) captured via frame grabber; spatial tracking provided by gyroscopic sensor system. Processing: conditioning and transformation of acquired data into Cartesian volume; surface rendering; segmentation of structures from 3D data; calculation of linear, area, and volumetric measurements. Output: 3D visualizations and quantitative measurements displayed to the clinician. Used in clinical settings by physicians or under their direction. Benefits: provides enhanced visualization of features identified during routine 2D exams; allows for closer examination and quantification of fetal and gynecological structures. Device does not provide diagnostic interpretations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and functional comparison to predicate devices.

Technological Characteristics

Hardware includes Pentium III 833 MHz processor, frame grabber for VHS/S-VHS input, and handheld controller. Sensing principle utilizes a gyroscopic sensor system for spatial tracking during volume data acquisition. Software performs data conditioning, transformation to Cartesian volume, surface rendering, structure segmentation, and quantitative measurements. System is an add-on to existing 2D ultrasound imaging systems.

Indications for Use

Indicated for fetal and gynecological applications in patients undergoing routine 2D ultrasound diagnostic imaging. Intended for use by or under the direction of a physician.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EchoTech 3D FreeScan (K980308)
• BioMediCom Baby Face (K994385)
• BioMediCom SonoReal 3D (K012084)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] Phone: [phone] 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.

{1}------------------------------------------------

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)

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.

{2}------------------------------------------------

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 Measurement<br>Function |
| Basic Function | Adds 3D imaging capability<br>to commercial 2D<br>ultrasound imaging systems | Adds 3D imaging capability<br>to commercial 2D<br>ultrasound imaging systems |
| Hardware | Pentium II 400 MHz | Pentium III 833 MHz |
| | Frame Grabber (VHS/S-<br>VHS Input) | Frame Grabber (VHS/S-<br>VHS Input) |
| | Video out | Video out |
| | Foot pedal | Handheld controller |
| Software features | Volume data acquisition<br>w/frame grabbing of video<br>data b/w while using an<br>Electro magnetic sensor<br>system | Volume data acquisition<br>w/frame grabbing of video<br>data b/w while using a<br>Gyroscopic sensor system |
| | Conditioning &<br>transformation of the<br>acquired data into a<br>Cartesian volume | Conditioning &<br>transformation of the<br>acquired data into a<br>Cartesian volume |
| | Surface rendering | Surface rendering |
| | Segmentation of structures<br>from 3D data | Segmentation of structures<br>from 3D data |
| | Quantitative evaluation | No |
| | Measurements &<br>calculations | Measurement and<br>calculations |
| | | Via this submission |
| Indications for Use | Gynecology/OB, radiology,<br>neurology,<br>gastroenterology, urology,<br>surgery, orthopedics, and<br>oncology | Fetal/ Gynecology |

## Comparison Chart for Substantial Equivalence

{3}------------------------------------------------

### 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.

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

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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