(85 days)
None
No
The description focuses on standard 3D rendering and segmentation techniques, with no mention of AI/ML terms or capabilities.
No
The device is described as providing 3D clinical imaging for visualization purposes, not for treating conditions or ailments. It is used in conjunction with standard ultrasound systems for diagnostic imaging examinations.
No
The Intended Use/Indications for Use states that "The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations." It is intended to visualize features for closer examination in routine 2D ultrasound diagnostic imaging examinations, not to perform diagnostics itself.
No
The device description explicitly lists hardware components (Pentium III, Frame Grabber, Video out, Handheld controller) as part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SONOReal™ system is an add-on to a standard ultrasound system. It processes and visualizes ultrasound data to create 3D images. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for providing 3D clinical imaging in conjunction with ultrasound and does not provide quantitative measurements or diagnostic interpretations. It's a visualization tool for features already seen in 2D ultrasound.
Therefore, the SONOReal™ system falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.
Product codes
901YO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
fetal, gynecological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 2 6 2001
K 012084/
Page 1 of 3
510(k) Summary SONOReal 3D System BioMediCom, Ltd.
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21 CFR (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:
Contact Person: Colleen Hittle
May 25, 2001 Date:
807.92(a)(2)
Trade Name:
Common Name:
SONOReal 3D System
901YO
3D FreeScan
Digital Ultrasound Image Analysis System
System, Imaging, Pulsed Echo, Ultrasonic
Classification Name(s):
Classification Number:
807.92(a)(3)
Predicate Device(s)
EchoTech
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
SK23
1
K0/2084
Page 2 of 3
510(k) Summary SONOReal 3D System 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 standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.
2
K01208
Perz3of
510(k) Summary SONÓReal 3D System BioMediCom, Ltd.
| EchoTech | BioMediCom | |
|---|---|---|
| 3D FreeScan | SONOReal 3D System | |
| K980308 | K994385 | |
| Addition of Gynecology | ||
| Indication for Use | ||
| Basic Function | Adds 3D imaging capability | |
| to commercial 2D | ||
| ultrasound imaging systems | Adds 3D imaging capability | |
| to commercial 2D | ||
| ultrasound 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 acquisition | |
| w/frame grabbing of video | ||
| data b/w while using an | ||
| Electro magnetic sensor | ||
| system | 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 | Conditioning & | |
| transformation of the | ||
| acquired data into a | ||
| Cartesian volume | ||
| Surface rendering | Surface rendering | |
| Segmentation of structures | ||
| from 3D data | Segmentation of structures | |
| from 3D data | ||
| Quantitative evaluation | No | |
| Measurements & | ||
| calculations | No | |
| Indications for Use | Gynecology/OB, radiology, | |
| neurology, | ||
| gastroenterology, urology, | ||
| surgery, orthopedics, and | ||
| 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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized lines or strokes, possibly representing people or services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2001
BioMediCom, Ltd. % Ms. Colleen Hittle The Anson Group Official Correspondent 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K012084
Trade/Device Name: SONOReal 3D System Digital Ultrasound Image Analysis Syst Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: June 21, 2001 Received: July 3, 2001
Dear Ms. Hittle:
Jear Ms. Hittle:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your section Fro(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interscripts for the stated in the enclosure) to regary manated produced Device Americal Device Ameradments, or to commerce prior to May 20, 1970, the chaounters with the provisions of the Federal Food. Drug, devices that have been recassince in accessars val of a premarket approval application (PMA). and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, deletere, market the do roos see neguirements for annual registration, listing of general controls provisions of the free 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 It may be subject to additional controliations, 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 that I DI has made a actoring administered by other Federal agencies. You must or any I edelar statutes and rogulatents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 OF IC Ford 007), accems (20) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalerice and finis nemits your device to notification. The FDA finding of substantial equivalence or 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
r and the may of the start of the following numbers, hased on the regulatio If you desire specific advice for your device on our laboring regulation (
contact the Office 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 Additionally, for questions on the promotion and acrease of your armined, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note the regulation on Office of Compliance at (301) 394-4039. Also, produce noter. Other general information on by reference to premarket notification" (2) Cr Cr F an Cool. 7 ) " Sision of Small Maufacturers,
your responsibilities under the Act may be obtained from the Division of Smal your responsibilities under the Act may oe bolled nom and BRND) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-fire examping bron International and Coulsumer Assistance avoid decided 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):
Device Name: SonoReal 3D
Indications For Use:
Intended to be used by or under the direction of a physician and in conjunction with standard intended to be used by or under the direction on a in fetal and gynecological applications. The unfrasound system does not currently provide any quantitative measurement capabilities or SONOReal™ system does not carrently provided to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over The Counter
(Per 21 CFR, 801.109)
(Optional Format 1-2-96)
4
Nancy C. Brogdon
(Division
ision of Abdominal.
radi
3 (Ok) Nun