(35 days)
Not Found
No
The document describes a 3D visualization accessory for ultrasound systems and explicitly states it does not provide diagnostic interpretations. There are no mentions of AI, ML, or related concepts, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The device is an accessory that adds 3D visualization to 2D ultrasound systems and is intended for diagnostic imaging, not therapeutic intervention.
No
The device explicitly states, "SONOReal™ does not provide any diagnostic interpretations" and "The device does not provide diagnostic interpretation." Its purpose is to visualize features for closer examination and provide measurements, not to make a diagnosis.
No
The device description explicitly states it is an "accessory device" that adds 3D visualization capability to existing 2D ultrasound systems. This implies a hardware component or system is being added, not just software.
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 description clearly states that this device is an accessory to a standard ultrasound system and provides 3D visualization and measurement capabilities based on ultrasound imaging. Ultrasound is an in vivo imaging modality, meaning it is performed on the living body, not on samples taken from the body.
- Intended Use: The intended use describes clinical imaging applications across various anatomical sites, all of which involve imaging the body directly.
- No mention of samples: There is no mention of the device analyzing any biological samples.
Therefore, the SONOReal 3D System is an in vivo diagnostic 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 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
90IYO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
fetal, gynecological, breast, thyroid, testes, urology, neonatal, surgical, orthopedics, abdominal, oncology, adult cephalic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980308, K994385, K012084, K020068
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 (317) 849-1916 Phone: Facsimile: (317) 577-9070
| 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.
1
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.
2
510(k) Summary SONOReal 3D System - Addition of Indications for Use BioMediCom, Ltd.
| EchoTech
3D FreeScan
K980308 | BioMediCom
SONOReal 3D System
K020068 | BioMediCom
SONOReal 3D System
Addition of Indications for
Use Via this Submission | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Function | Adds 3D imaging
capability to
commercial 2D
ultrasound imaging
systems | Add 3D imaging
capability to
commercial 2D
ultrasound imaging
systems | Adds 3D imaging capability
to commercial 2D
ultrasound imaging systems |
| Hardware | Pentium II 400 MHz
Frame Grabber
(VHS/S-VHS Input)
Video out
Foot pedal | Pentium III 833 MHz
Frame Grabber
(VHS/S-VHS Input)
Video out
Handheld controller | Pentium III 833 MHz
Frame Grabber (VHS/S-
VHS Input)
Video out
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 | 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
Surface rendering
Segmentation of
structures from 3D data | Conditioning &
transformation of the
acquired data into a
Cartesian volume
Surface rendering
Segmentation of
structures from 3D
data | Conditioning &
transformation of the
acquired data into a
Cartesian volume
Surface rendering
Segmentation of structures
from 3D data |
| | Quantitative evaluation | No
Measurements &
calculations | No
Measurements &
calculations |
| Indications for Use | Cardiology/Radiology
Neurology/
Gastroenterology/
Urology/Surgery/
Orthopedics/Oncology/
Obstetrics/Gynecology | Fetal/Gynecology | Radiology/Fetal/
Gynecology/
Small organs (breast,
Thyroid, testes, etc.)/
Urology/Neonatal/Surgery/
Orthopedics/Abdominal/
Oncology (tumor volume |
Comparison Chart for Substantial Equivalence
3
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.
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 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 Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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. +972-2-679-6355 • Fax +972-2-679-6358 Web: www.biomedicom.com · E-Mail: info@biomedicom.com