SONOREAL 3D

K023473 · Bio Medi Com · IYO · Nov 20, 2002 · Radiology

Device Facts

• Record ID: K023473
• Device Name: SONOREAL 3D
• Applicant: Bio Medi Com
• Product Code: IYO · Radiology
• Decision Date: Nov 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

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 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 Story

SONOReal 3D System is an accessory to standard 2D ultrasound systems; adds 3D/multi-planar visualization capabilities. Input: 2D ultrasound video signals (VHS/S-VHS) captured via frame grabber. Operation: Gyroscopic sensor tracks probe movement; system performs data acquisition, conditioning, and transformation into Cartesian volumes; enables surface rendering and structure segmentation. Output: 3D/multi-planar images displayed to clinician; allows linear, area, and volumetric measurements. Used in clinical settings (radiology, surgery, etc.) by physicians or under their direction. Does not provide diagnostic interpretation; assists in visualizing features for closer examination during routine 2D exams. Benefits: enhanced spatial visualization of anatomy and pathology for improved clinical assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to previously cleared predicate devices.

Technological Characteristics

Hardware: Pentium III 833 MHz processor, frame grabber (VHS/S-VHS input), handheld controller, gyroscopic sensor system. Function: 3D/multi-planar reconstruction from 2D ultrasound video. Software: Cartesian volume transformation, surface rendering, structure segmentation, measurement tools (linear, area, volume). Connectivity: Video output. Sterilization: Not applicable (accessory device).

Indications for Use

Indicated for use by or under physician direction to provide 3D and multi-planar imaging in radiology, fetal, gynecological, small organ (breast, thyroid, testes), urological, neonatal, surgical, orthopedic, abdominal, oncological (tumor volume), and adult cephalic applications. No specific age or gender contraindications stated.

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)
• BioMediCom SonoReal 3D System (K020068)

Submission Summary (Full Text)

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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 [phone] Phone: Facsimile: [phone]

| 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

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.

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.

| EchoTech<br>3D FreeScan<br>K980308 | BioMediCom<br>SONOReal 3D System<br>K020068 | BioMediCom<br>SONOReal 3D System<br>Addition of Indications for<br>Use Via this Submission | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Function | Adds 3D imaging<br>capability to<br>commercial 2D<br>ultrasound imaging<br>systems | Add 3D imaging<br>capability to<br>commercial 2D<br>ultrasound imaging<br>systems | Adds 3D imaging capability<br>to commercial 2D<br>ultrasound imaging systems |
| Hardware | Pentium II 400 MHz<br>Frame Grabber<br>(VHS/S-VHS Input)<br>Video out<br>Foot pedal | Pentium III 833 MHz<br>Frame Grabber<br>(VHS/S-VHS Input)<br>Video out<br>Handheld controller | Pentium III 833 MHz<br>Frame Grabber (VHS/S-<br>VHS Input)<br>Video out<br>Handheld controller |
| Software features | Volume data acquisition<br>w/frame grabbing of<br>video data b/w while<br>using an Electro<br>magnetic sensor system | Volume data<br>acquisition w/frame<br>grabbing of video<br>data b/w while using<br>a Gyroscopic 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<br>Surface rendering<br>Segmentation of<br>structures from 3D data | Conditioning &<br>transformation of the<br>acquired data into a<br>Cartesian volume<br>Surface rendering<br>Segmentation of<br>structures from 3D<br>data | Conditioning &<br>transformation of the<br>acquired data into a<br>Cartesian volume<br>Surface rendering<br>Segmentation of structures<br>from 3D data |
| | Quantitative evaluation | No<br>Measurements &<br>calculations | No<br>Measurements &<br>calculations |
| Indications for Use | Cardiology/Radiology<br>Neurology/<br>Gastroenterology/<br>Urology/Surgery/<br>Orthopedics/Oncology/<br>Obstetrics/Gynecology | Fetal/Gynecology | Radiology/Fetal/<br>Gynecology/<br>Small organs (breast,<br>Thyroid, testes, etc.)/<br>Urology/Neonatal/Surgery/<br>Orthopedics/Abdominal/<br>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 | [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

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#### Indications for 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 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.

David k. Symm

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

*Prescription Use*

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BIOMEDICOM - Creative Biomedical Computing Ltd. Building 1/1 High-Tech Village, PO Box 39026, Givat-Ram, Jerusalem 91390, Israel Tel. [phone] • Fax [phone] Web: www.biomedicom.com · E-Mail: [e-mail]