(87 days)
No
The description focuses on traditional image processing techniques (conditioning, transformation, rendering, segmentation) and does not mention AI, ML, or related concepts. The hardware and software descriptions are consistent with conventional 3D imaging technology from that era.
No
The device is described as an add-on for 2D ultrasound systems, providing 3D clinical imaging specifically for fetal applications. Its intended use is diagnostic imaging, not therapeutic intervention.
Yes
The device is intended for "3-D clinical imaging in fetal applications" and "adds 3-D imaging capability to commercial 2-D ultrasound imaging system." Clinical imaging is used by physicians to visualize internal structures for medical diagnosis, which is a diagnostic purpose.
No
The device description explicitly states that the hardware includes a Pentium IV processor, frame grabber, and utilizes the video out and keyboard control of the connected 2D ultrasound system, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "3-D clinical imaging in fetal applications." This is a diagnostic imaging device, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose disease or other conditions.
- Device Description: The device description focuses on hardware and software for processing and rendering ultrasound data to create 3D images. This aligns with imaging technology, not in vitro testing.
- Input Imaging Modality: The input is from a "2-D ultrasound imaging system," which is an in vivo imaging modality.
- Anatomical Site: The anatomical site is "Fetal," indicating imaging of a living subject.
IVD devices are specifically designed to perform tests on biological specimens in vitro (outside the body). This device is clearly designed for in vivo imaging.
N/A
Intended Use / Indications for Use
Indications for Use: Intended to be used by or under the direction of a physician for 3-D clinical imaging in fetal applications. This is only to be used in conjunction with the 2D Ultrasound Imaging System marketed under the model name 'Sonata' or 'Telocin', labeled as 2D Ultrasound Imaging System manufactured by Tetrad Corporation.
Product codes
90IYO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or under the direction of a 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)
Sonora Medical Systems Baby Face K994385
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
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510(k) Summary Sonata 3-D Tetrad Corporation DEC 2 3 2004
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
Dennis R. Dietz, Chief Technical Officer Tetrad Corporation 357 Inverness Drive South Unit A Englewood, Colorado 80112 Phone: 303-754-2326 303-754-2329 Fax:
Contact person: Dennis R. Dietz
Date: September 7, 2004
807.92(a)(2)
Trade Name: Sonata 3-D
Common Name: Digital Ultrasound Imaging System
Classifiction Name: System, Imaging, Pulsed Echo, Ultrasonic
Classification Number: 90IYO
807(a)(3)
Predicate Device
Sonora Medical Systems Baby Face K994385
Additional substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
K042626
Page 2 of 2
510(k) Summary Sonata 3-D Tetrad Corporation
· · · · · · · · · ·
| | Sonora Medical Systems
Baby Face
K1722606 | Tetrad Corporation
Sonata 3-D |
|-------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Basic Function | Adds 3-D imaging capability
to commercial 2-D ultrasound
imaging systems. | Adds 3-D imaging capability to
commercial 2-D ultrasound
imaging system. |
| Hardware | Cyrix 266 MHz | Pentium IV 2.8 GHz |
| | Frame Grabber (VHS/S-VHS
Input) | Frame Grabber digital via real
time memory mapping in RAM |
| | Video Out | Video out via Sonata System |
| | Hand held controller | System keyboard control |
| | | |
| Software features | Volume data acquisition
w/frame grabbing of video data
b/w while using a Gyroscopic
sensor system. | Volume data acquisition
w/frame grabbing of digital data
b/w while scanning free-hand. |
| | Conditioning and
transformation of the acquired
data into a Cartesian volume | Conditioning and
transformation of the acquired
data into a Cartesian volume |
| | Surface rendering | Surface rendering |
| | Segmentation of structures
from 3-D data. | Segmentation of structures from
3-D data. |
| | No quantitative evaluation. | No quantitative evaluation. |
| | No measurements or
calculations | No measurements or
calculations |
Comparison Chart for Substantial Equivalence
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
Dennis R. Dietz, Ph.D. Chief Technical Officer Tetrad Corporation 357 Inverness Drive South, Unit A ENGLEWOOD CO 80112
Re: K042620 Trade/Device Name: Sonata 3-D Visualization Tool Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO
Dated: November 18, 2004 Received: December 7, 2004
Dear Dr. Dietz:
We have reviewed your Section 510(k) premarket notification of intent to market the device is a We have revewed your Section 510(t) promanted in the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predicato device Amendments, or to devices that have been May 28, 1976, the ellacinem and of the Federal Food, Drug, and Cosmetic Act (Act) that the feclassified in accordatics with the proval application (PMA). You may, therefore, market the Art do not require approval of a premaince approval and (The Act. The general controls provisions of the Act. device, subject to the general controls 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 if your device is classince (see above) into entrols. Existing major regulations affecting your Approval), It may be subject to such adultions, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Couverning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat I DA s issualled of a sassamments of the requirements of the Act or any
FDA has made a determination that your device complies with other requirements o F DA has made a decemination that your as a more of the Federal agencies. You must comply with all the Federal statues and regulations administer of one issues of the Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Fart 801); good mandracting product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) 1 ms letter will and your your finding of substantial equivalence of your device to a legally premarked notined.com "cresults 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 11 you dostro specifice 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 Anot process not regarment information on your responsibilities under the Act from the 807: 77). " Coamin Purers, 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.httml
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
4
Indications for Use
510(k) Number (if known): K042620
Device Name: Sonata 3-D Visualization Tool
Indications for Use: Intended to be used by or under the direction of a physician for 3-20 Inical imaging in fetal applications. This is only to be used in conjunction with the 2300 Ultrasound Imaging in rotar appensarketed under the model name 'Sonata' or 'Telocin', Iabeled as 2300 Ultrasound Imaging System manufactured by Tetrad Corporation.
Prescription Use
(Part 21 CFR 801 Subpart D)
ANDIOR
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)
David le Segura
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 14210 T 510(k) Number _