(79 days)
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
Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes a Cyrix 266 MHz processor, Frame Grabber (VHS/S-VHS Input), Video out, and a Handheld controller. Software features include 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, and Segmentation of structures from 3D data.
The provided text is a 510(k) summary for the "Baby Face Digital Ultrasound Image Analysis System" (K994385). This document focuses on establishing substantial equivalence to a predicate device and describing the intended use and basic functionality. It does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment and expert involvement, which are typically found in more comprehensive clinical study reports or validation documents.
Therefore, many of the requested details cannot be extracted from this specific document.
Acceptance Criteria and Study Information (Based on Provided Text)
As thoroughly explained above, the provided 510(k) summary does not contain any information regarding acceptance criteria, specific device performance metrics, or the details of a study that proves the device meets such criteria. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device.
However, I can provide a table based on the functional description and the intended use.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The "Acceptance Criteria" and "Reported Device Performance" below are inferred from the device's stated functionality and the context of a 510(k) submission for a 3D ultrasound image analysis system. The actual performance values and detailed acceptance criteria are not present in the provided text.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred from functionality) |
|---|---|
| 3D Imaging Capability: Device should successfully acquire, process, and render 3D images from 2D ultrasound data. | "Adds 3D imaging capability to commercial 2D ultrasound imaging systems." "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." |
| Fetal Application: Device should be able to visualize features in reconstructed 3D images for fetal diagnostic ultrasound. | "Intended to be used... for 3D clinical imaging in fetal applications." "to visualize features in a reconstructed 3D image... in routine 2D fetal diagnostic ultrasound imaging examinations." |
| Communication Assistance: Device should assist in communicating diagnostic results. | "to assist them in communicating diagnostic results in a form that may be more easily understood by referring physicians and patients." |
| No Quantitative Measurements/Diagnostic Interpretations: Device should NOT provide quantitative measurements or diagnostic interpretations. | "It does not provide quantitative measurements or diagnostic interpretations." "Quantitative evaluation: No" "Measurements & calculations: No" |
The following information cannot be extracted from the provided text:
2. Sample size used for the test set and the data provenance
- Not available. The document does not describe any specific test set or clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not available. No information on ground truth experts is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not available. No information on adjudication is provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not available. No MRMC study is mentioned. This device is an image analysis system, not explicitly described as an "AI" device as we understand it today in 2023. It assists with 3D visualization, but not necessarily with automated interpretation or diagnostic aid in the sense of AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available. The device's intended use clearly states it's "intended to be used by qualified medical personnel" and "in conjunction with standard ultrasound," indicating it's not a standalone diagnostic tool. The document does not describe performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available. No mention of ground truth is made.
8. The sample size for the training set
- Not available. No training set is mentioned.
9. How the ground truth for the training set was established
- Not available. No ground truth for a training set is mentioned.
{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 FreeScanK980308 | Baby Face | |
| Basic Function | Adds 3D imaging capabilityto commercial 2Dultrasound imaging systems | Adds 3D imaging capabilityto commercial 2Dultrasound 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 acquisitionw/frame grabbing of videodata b/w while using anElectro magnetic sensorsystem | Volume data acquisitionw/frame grabbing of videodata b/w while using aGyroscopic sensor system |
| Conditioning &transformation of theacquired data into aCartesian volume | Conditioning &transformation of theacquired data into aCartesian volume | |
| Surface rendering | Surface rendering | |
| Segmentation of structuresfrom 3D data | Segmentation of structuresfrom 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
§ 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.