(79 days)
Not Found
No
The description focuses on traditional image processing techniques (volume data acquisition, conditioning, transformation, surface rendering, segmentation) and hardware components, with no mention of AI, ML, or related concepts.
No
The device is described as adding 3D imaging capability to 2D ultrasound systems for clinical imaging and fetal applications, which is diagnostic, not therapeutic.
Yes
The device is intended for "3D clinical imaging in fetal applications" and is used "by or under the direction of a physician," which are characteristics of a diagnostic device used to obtain clinical information.
No
The device description explicitly lists hardware components (processor, frame grabber, video out, handheld controller) in addition to software features.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "3D clinical imaging in fetal applications" and is used "in conjunction with standard ultrasound." This describes a device used for imaging and visualization within the body (in vivo), not for testing samples taken from the body (in vitro).
- Device Description: The description focuses on hardware and software for acquiring, processing, and rendering ultrasound image data. This aligns with an imaging device, not a diagnostic test performed on biological samples.
- Input Imaging Modality: The input is a "Digital Ultrasound Image Analysis System," which is an imaging modality.
- Anatomical Site: The anatomical site is "fetal applications," which is an in vivo application.
IVD devices are typically used to examine specimens such as blood, urine, or tissue outside of the body to provide information for diagnosis, monitoring, or screening. This device's function is clearly related to acquiring and processing images of the fetus within the body.
N/A
Intended Use / Indications for Use
Baby Face is intended to be used by qualified medical personnel (1) to visualize features in a reconstructed 3D image that they may wish to examine more closely in routine 2D fetal diagnostic ultrasound imaging examinations, and (2) to assist them in communicating diagnostic results in a form that may be more easily understood by referring physicians and patients. It does not provide quantitative measurements or diagnostic interpretations.
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound for 3D clinical imaging in fetal applications
Product codes
90IYO
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard ultrasound (2D fetal diagnostic ultrasound imaging examinations)
Anatomical Site
fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel, 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
p 1 of 3 K 994385
MAR 1 6 2000
510(k) Summary Baby Face Sonora Medical Systems
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 Hittle, Official Correspondent | |
|---|---|
| 7992 Castleway Drive | |
| Indianapolis, IN 46250 | |
| Phone: | (317) 849-1916 |
| Facsimile: | (317) 577-9070 |
| Contact Person: | Colleen Hittle |
| Date: | December 23, 1999 |
| 807.92(a)(2) | |
| Trade Name: | Baby Face |
| 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 |
|---|---|---|
| ---------- | ------------- | --------- |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
p. 2 of 3 K 994385
510(k) Summary Baby Face Sonora Medical Systems
807.92(a)(5)
Intended Use(s)
Baby Face is intended to be used by qualified medical personnel (1) to visualize features in a reconstructed 3D image that they may wish to examine more closely in routine 2D fetal diagnostic ultrasound imaging examinations, and (2) to assist them in communicating diagnostic results in a form that may be more easily understood by referring physicians and patients. It does not provide quantitative measurements or diagnostic interpretations.
2
K 994385 P 3 of 3
510(k) Summary Baby Face Sonora Medical Systems
| EchoTech | Sonora Medical Systems | |
|---|---|---|
| 3D FreeScan | ||
| K980308 | Baby Face | |
| 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 | Cyrix 266 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 | |
Comparison Chart for Substantial Equivalence
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2000
Colleen Hittle Official Correspondent Sonora Medical Systems 1830 Boston Ave., Suite D Longmont, CO 80501
Re:
K994385 Baby Face (3-D Surface Rendering Accessory for Diagnostic Ultrasound Systems) Dated: December 23, 1999 Received: December 28, 1999 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
Indications for Use Statement
Applicant: Sonora Medical Systems
510(k) Number (if known): _ K 994385
Device Name: Baby Face
Indications For Use:
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound for 3D clinical imaging in fetal applications
(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)
Elorid C. Segner
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number