(142 days)
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.
Adds 3D imaging capability to commercial 2D ultrasound imaging systems
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is a 510(k) summary for the OnDemandSoft iView, which focuses primarily on establishing substantial equivalence to a predicate device (SonoReal system). It includes a comparison table of features between the two devices, but it does not specify any acceptance criteria, performance metrics, or details of a clinical study designed to demonstrate the device meets acceptance criteria.
Specifically, the document lacks information for the following points:
- A table of acceptance criteria and the reported device performance: This is entirely missing. The comparison table is for features, not performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The 510(k) summary generally highlights the device's technical specifications and how they compare to a previously cleared device, focusing on "substantial equivalence" rather than presenting detailed performance study results against predefined acceptance criteria.
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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: 82-53-652-9764 Fax: 82-53-652-9765
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(ViewLive system) | BIOMEDICOM(Israel- SonoReal) (K023473) | |
|---|---|---|
| 1. Scanning Time | 2 ~ 6 second | Few Second |
| 2. Scanning Method | Parallel, Fan-Like | Parallel, Fan-Like |
| 3. Sensor3-1. Sensor Type3-2. Sensor Installation | Angular Sensor | Positional Sensor |
| 4. | 1~2 second | Few second |
A comparison of devices is provided below:
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| ReconstructionTime | ||
|---|---|---|
| 5. 3DReconstructionProcess | a. Press Foot Switchb. Scan 2D imagec. Release Foot Switchd. 3D image is showne. edit 3D imagef. Record complete image on CD / print out / save in HDD | a. Press a mouse buttonb. Scan 2D imagec. Press a mouse button againd. 3D image is showne. edit 3D image |
| 5. ProvidedEditing Tools | YES | YES |
| Rotate | YES | YES |
| Front Cut Plane | YES | YES |
| Threshold | YES | YES |
| Contrast(ControlBrightness) | YES | YES |
| Zoom(ControlMagnification) | YES | YES |
| Panning(MoveImage) | ||
| Multi PlannerView(Shows 4plane view) | ||
| 6. Result 3DImage | ||
| 6-1. FetalFace | ||
| 6-2. FetalWhole Body | ||
| 7. BasicFunction | 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 GHZFrame Grabber (VHS/S-VHS Input) | Pentium III 833 MHZFrame Grabber (VHS/S-VHS Input) |
| Video OutFoot Pedal | Video OutHandheld 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 (800) 638-2041 or (301) 443-6597 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
§ 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.