(87 days)
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.
Adds 3-D imaging capability to commercial 2-D ultrasound imaging system. Hardware includes Pentium IV 2.8 GHz, Frame Grabber digital via real time memory mapping in RAM, Video out via Sonata System, System keyboard control. Software features include 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, Surface rendering, Segmentation of structures from 3-D data.
Here's an analysis of the provided 510(k) summary regarding the Sonata 3-D device, focusing on acceptance criteria and the study:
Acceptance Criteria and Device Performance for Sonata 3-D
Based on the provided documents, it is not possible to complete a table of acceptance criteria and reported device performance, nor to describe a study proving the device meets these criteria. The 510(k) submission for the Sonata 3-D primarily focuses on establishing substantial equivalence to a predicate device (Sonora Medical Systems Baby Face K994385, later updated to K1722606).
The provided text does not contain any information about:
- Specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution) for the Sonata 3-D.
- Quantitative acceptance criteria established for the device.
- Results of any clinical or technical performance studies that would measure the device's performance against such criteria.
- Details about a test set, ground truth, experts, or adjudication methods for any such study.
- Information on training sets or how their ground truth was established.
The core of this 510(k) is a comparison of technical features and intended use to a legally marketed predicate device. The FDA's decision letter (K042620) confirms substantial equivalence based on a review of the submission, but this process typically involves demonstrating that the new device is as safe and effective as the predicate, often through feature-by-feature comparison rather than independent clinical performance studies that define and meet specific acceptance criteria in the same way a de novo or PMA submission might.
Information from the Provided Documents:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not Specified) | Reported Device Performance (Not Specified) |
|---|---|
| No specific performance-based acceptance criteria are mentioned in the provided K042620 documents. | No performance data is reported in the provided K042620 documents. |
The 510(k) filing primarily aims to show that the Sonata 3-D has the "same intended use" and "same technological characteristics" as the predicate device or that differences "do not raise different questions of safety and effectiveness."
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No ground truth establishment is described for a test set.
4. Adjudication method for the test set:
- Not applicable / Not provided. No test set or ground truth adjudication process is mentioned.
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:
- No. The device described is a "3-D Visualization Tool" and a "Digital Ultrasound Imaging System" that adds 3-D imaging capability to 2-D systems. It is not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware/software system for 3D visualization, not a standalone algorithm. Performance in the context of 510(k) for this type of device is typically demonstrated through comparison to the predicate's functionality and safety.
7. The type of ground truth used:
- Not applicable / Not provided. No specific ground truth for performance evaluation is described. The "ground truth" in a 510(k) for substantial equivalence often relates to the known performance and safety profile of the predicate device, against which the new device's features and intended use are compared.
8. The sample size for the training set:
- Not applicable / Not provided. This document does not describe a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No training set is mentioned.
Summary of the Study (as described in the 510(k) documentation):
The "study" presented in these 510(k) documents is a comparison to a predicate device for the purpose of demonstrating substantial equivalence.
- Predicate Device: Sonora Medical Systems Baby Face (K994385, later referenced as K1722606).
- Methodology: A feature-by-feature comparison was conducted (as shown in "Comparison Chart for Substantial Equivalence" on page 2 of the second document). This comparison highlights:
- Basic Function: Both add 3-D imaging capability to commercial 2-D ultrasound systems.
- Hardware: Differences in processor (Cyrix 266 MHz vs. Pentium IV 2.8 GHz), frame grabber technology (VHS/S-VHS input vs. digital via real-time memory mapping in RAM), and control (handheld controller vs. system keyboard control). These hardware differences would typically be reviewed to ensure they don't introduce new safety/effectiveness concerns.
- Software Features: Both perform volume data acquisition, conditioning/transformation into a Cartesian volume, and surface rendering. Both also perform segmentation of structures from 3-D data. Importantly, both predicate and new device explicitly state "No quantitative evaluation" and "No measurements or calculations." This absence of quantitative metrics is a key point in establishing equivalence concerning performance.
- Conclusion of the Comparison: The submitter concludes, and the FDA agrees, that the Sonata 3-D is substantially equivalent to the predicate. The FDA's letter (K042620, dated Dec 23, 2004) states they "have determined the device is substantially equivalent... to legally marketed predicate devices."
In essence, the "study" for this 510(k) was a detailed technical and functional comparison against a known, legally marketed device, rather than an independent clinical trial with predefined performance acceptance criteria.
{0}------------------------------------------------
Page 1 of 2
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 SystemsBaby FaceK1722606 | Tetrad CorporationSonata 3-D | |
|---|---|---|
| Basic Function | Adds 3-D imaging capabilityto commercial 2-D ultrasoundimaging systems. | Adds 3-D imaging capability tocommercial 2-D ultrasoundimaging system. |
| Hardware | Cyrix 266 MHz | Pentium IV 2.8 GHz |
| Frame Grabber (VHS/S-VHSInput) | Frame Grabber digital via realtime memory mapping in RAM | |
| Video Out | Video out via Sonata System | |
| Hand held controller | System keyboard control | |
| Software features | Volume data acquisitionw/frame grabbing of video datab/w while using a Gyroscopicsensor system. | Volume data acquisitionw/frame grabbing of digital datab/w while scanning free-hand. |
| Conditioning andtransformation of the acquireddata into a Cartesian volume | Conditioning andtransformation of the acquireddata into a Cartesian volume | |
| Surface rendering | Surface rendering | |
| Segmentation of structuresfrom 3-D data. | Segmentation of structures from3-D data. | |
| No quantitative evaluation. | No quantitative evaluation. | |
| No measurements orcalculations | No measurements orcalculations |
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 _
§ 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.