IVIEW

K053306 · Ondemandsoft · IYO · Apr 19, 2006 · Radiology

Device Facts

• Record ID: K053306
• Device Name: IVIEW
• Applicant: Ondemandsoft
• Product Code: IYO · Radiology
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The iView™ is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations. The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device. 3D image reconstructed from this software is referring use only and is not responsible for any diagnosis.

Device Story

iView is an add-on system for commercial 2D ultrasound devices; captures 2D ultrasound video signals via frame grabber; reconstructs 3D images of fetal features. Operated by medical personnel in clinical settings; triggered via foot switch. Provides 3D visualization for patient communication and adjunctive review. Does not provide diagnostic interpretations or quantitative measurements. Output viewed by clinicians to assist in explaining findings to patients.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Hardware: Pentium IV 2.4 GHz PC, frame grabber (VHS/S-VHS input), foot pedal. Sensing: Angular sensor for 3D reconstruction. Connectivity: Video out. Software: Volume data acquisition and 3D reconstruction processing. System is an add-on to existing 2D ultrasound imaging systems.

Indications for Use

Indicated for use by qualified medical personnel during prenatal monitoring to visualize fetal features in 3D as an adjunct to routine 2D diagnostic ultrasound. Not for diagnostic interpretation or quantitative measurement.

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

• SonoReal system (K023473)

Submission Summary (Full Text)

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K053306

## 510(k) Summary

APR 1 9 2006

Submitter Information OnDemandSoft 501,Tower2,DIP,2139 Dacmyung 7-Dong,Nam-gu, Daegu, Korea

Contact Eunmi Chac Phone: [phone] Fax: [phone]

Date Prepared January 23, 2006

Product Name Trade name: iView Classification Name: Ultrasonic pulsed echo imaging system. Medical Specialty: Radiology Product Code: IYO Regulation Number: 892.1560 Device Class: 2

Predicate Device

The iView is substantially equivalent to the SonoReal system marketed by Biomedicom under K023473.

| | OnDemandSoft Co. Ltd<br>(ViewLive system) | BIOMEDICOM<br>(Israel- SonoReal) (k023473) |
|-----------------------------------------------------------|-------------------------------------------|--------------------------------------------|
| 1. Scanning Time | 2 ~ 6 second | Few Second |
| 2. Scanning Method | Parallel, Fan-Like | Parallel, Fan-Like |
| 3. Sensor<br>3-1. Sensor Type<br>3-2. Sensor Installation | Angular Sensor <div> </div> | Positional Sensor <div> </div> |
| 4. | 1~2 second | Few second |

A comparison of devices is provided below:

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| Reconstruction<br>Time | | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 5. 3D<br>Reconstruction<br>Process | a. Press Foot Switch<br>b. Scan 2D image<br>c. Release Foot Switch<br>d. 3D image is shown<br>e. edit 3D image<br>f. Record complete image on CD / print out / save in HDD | a. Press a mouse button<br>b. Scan 2D image<br>c. Press a mouse button again<br>d. 3D image is shown<br>e. edit 3D image |
| 5. Provided<br>Editing Tools | YES | YES |
| Rotate | YES | YES |
| Front Cut Plane | YES | YES |
| Threshold | YES | YES |
| Contrast(Control<br>Brightness) | YES | YES |
| Zoom<br>(Control<br>Magnification) | YES | YES |
| Panning<br>(Move<br>Image) | | |
| Multi Planner<br>View<br>(Shows 4<br>plane view) | | |
| 6. Result 3D<br>Image | | |
| 6-1. Fetal<br>Face | | |
| 6-2. Fetal<br>Whole Body | | |
| 7. Basic<br>Function | Adds 3D imaging capability to commercial 2D ultrasound imaging systems | Adds 3D imaging capability to commercial 2D ultrasound imaging systems |
| 8. Hardware | Pentium IV 2.4 GHZ<br>Frame Grabber (VHS/S-VHS Input) | Pentium III 833 MHZ<br>Frame Grabber (VHS/S-VHS Input) |
| | Video Out<br>Foot Pedal | Video Out<br>Handheld Controller |
| 9. Software | Volume data acquisition w/frame | Volume data acquisition w/frame |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 9 2006

OnDemandSoft Co., Ltd. % Mr. Ian P. Gordon Senior Vice President EmergoGroup, Inc. 2519 McMullen Booth Road Suite 510-295 CLEARWATER FL 33761

Re: K053306

Trade/Device Name: OnDemandSoft iView Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: February 28, 2006 Received: March 1、2006

Dear Mr. Gordon:

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, 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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. In the center of the logo is the acronym "FDA" in a bold, stylized font, with the word "Centennial" written in cursive underneath. Three stars are arranged below the word "Centennial". The text surrounding the logo reads "Dedicated to Consumer Protection & the Science of Public Health".

ting Public S

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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.

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

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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

## 510(k) Number (if known): K053306

Device Name: OnDemandSoft iView

## Indications for Use:

The iView™ is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations.

The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device.

3D image reconstructed from this software is referring use only and is not responsible for any diagnosis.

Preserintion Use XX -(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eamiel G. Lussen

(Division Sign-O Division of Renroductive. and Radiological Devic (Dik) Number