(191 days)
No
The summary mentions "image processing software" to define anatomical features, but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of the technology is limited to standard image processing techniques.
No
The device is described as an ultrasound imaging system for visualization and evaluation, and there is no mention of it being used for treatment or therapy.
Yes
The device is described as an "ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures," which indicates its purpose in aiding physicians in diagnosing conditions or assessing anatomical structures.
No
The device description explicitly states the system is comprised of a console, monitor, and a transducer imaging probe (Beluga1™), in addition to control software. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the SonoVision™ Ultrasound Imaging System 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.
- SonoVision™ Function: The SonoVision™ system is an ultrasound imaging system. It uses sound waves to create images of internal anatomical structures in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "visualization and evaluation of nerves, vascular and other anatomical structures" and provides "imaging assistance in spinal procedure applications." This is consistent with diagnostic imaging, not in vitro testing.
Therefore, the SonoVision™ Ultrasound Imaging System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications.
Product codes
IYN, IYO, ITX
Device Description
The SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe is a general purpose, Track 1, ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The Beluga1™ is an ultrasound imaging probe that has been ergonomically designed for use in intraoperative procedures.
The system is comprised of the SonoVision™ console & monitor, 10 MHz transducer imaging probe (Beluga1™), and control software. The system includes image processing software that can be used to define anatomical features in an ultrasound B-mode image. The Beluga1™ Imaging Probe has been developed for specific application in spine procedures.
Mentions image processing
The system includes image processing software that can be used to define anatomical features in an ultrasound B-mode image.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
nerves, vascular and other anatomical structures (specifically in spinal procedure applications)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician / intraoperative procedures
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
In vivo testing was conducted to demonstrate performance of the device in human applications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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March 12, 2020
Tissue Differentiation Intelligence, LLC % Lorry Huffman Principal Consultant, Regulatory Affairs Qserve Group, US, Inc. 303 Twin Dolphin, Suite 600 REDWOOD SHORES CA 94065
Re: K192388
Trade/Device Name: SonoVision™ Ultrasound Imaging System with Beluga1™ Ultrasound Probe Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 5, 2020 Received: February 7, 2020
Dear Lorry Huffman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192388
Device Name
SonoVision™ Ultrasound Imaging System with Beluga1™ Ultrasound Probe
Indications for Use (Describe)
The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
TDi, LLC March 6, 2020
Section 5: 510(k) Summary – [21 cFR 807.92]
Image /page/3/Picture/3 description: The image shows the alphanumeric string 'K192388' in a bold, sans-serif font. The string is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, with the 'K' being the only letter and the rest being numerical digits.
807.92(a)(1), (2), (3)
| Date Prepared: | March 6, 2020 | |
|---|---|---|
| Submitter's Name: | Tissue Differentiation Intelligence, LLC | |
| Christian Zaal, Vice President Operations | ||
| 234 NE 4th Avenue | ||
| Delray Beach, FL 33486 | ||
| +1-305-351-2011 | ||
| Device Trade Name: | SonoVision™ Ultrasound System with Beluga1™ Ultrasound Probe | |
| Common Name: | Ultrasound pulsed doppler imaging system | |
| Review Panel: | OIR | |
| Classification Name: | Ultrasound pulsed doppler imaging system: 892.1550 | |
| Classification Code: | IYN: Ultrasound pulsed doppler imaging system | |
| IYO: Ultrasonic pulsed echo imaging system | ||
| ITX: Diagnostic ultrasonic transducer | ||
| Predicate Device(s): | ||
| Primary Predicate | Reference Predicate | |
| Accuro™ 3000 Ultrasound System | Esaote 6200 and 6250 Ultrasound System | |
| 510(k) Number | K132736 | K153277 |
| Classification Code | IYO, ITX | IYN, IYO, ITX |
| Regulation | 892.1550 | 892.1550 |
Device Description 807.92(a)(4):
The SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe is a general purpose, Track 1, ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The Beluga1™ is an ultrasound imaging probe that has been ergonomically designed for use in intraoperative procedures.
The system is comprised of the SonoVision™ console & monitor, 10 MHz transducer imaging probe (Beluga1™), and control software. The system includes image processing software that can be used to define anatomical features in an ultrasound B-mode image. The Beluga1™ Imaging Probe has been developed for specific application in spine procedures.
Intended Use 807.92(a)(5):
The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications.
4
Technological Characteristics 807.92(a)(6):
The SonoVision™ Ultrasound Imaging System has the same fundamental technological characteristics as the primary and reference predicates. Similar features are as follows:
- Intraoperative clinical use ●
- Spine application
- B-mode imaging
- Doppler (echographic image)/color flow mapping
- Real-time 2-D bone and tissue scanning (differentiation)
- . Radiofrequency (RF) energy for its internal function resulting in very low RF emissions
- Non-user adjustable acoustic output
- Proprietary software performance
- Data capture and external storage
- Electrical safety/EMC/acoustic output meets standards ●
- . Reusable probe
Summary of Non-Clinical Test - Performance and Safety Testing 807.92(b)(1)
The SonoVision™ Ultrasound Imaging System was evaluated for performance, acoustic output, biocompatibility, cleaning and sterilization as well as thermal, electromagnetic, and mechanical safety, and found to conform with the following FDA recognized standards:
- IEC 60601-1-2: 4th edition (19-8) Medical Electrical Equipment Part 1-2: general requirements . for basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests
- IEC 60601-1-1: 2005/(R)2012 And A1:2012 (19-4) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: general requirements [including: corrigendum 1 (2011)]
Acoustic output
- . IEC 60601-2-37 ED 2.1 2015 medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . IEC 62359 Ed 2.1 2017-09 Ultrasonics - field characterization - test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including: technical corrigendum 1 (2011)]
- NEMA UD 2 revision 3 2009 Acoustic output measurement standard for diagnostic ultrasound equipment
Temperature rise of the device is in accordance with:
- IEC 60601-2-37 ED 2.1 2015 medical electrical equipment Part 2-37: Particular requirements ● for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
5
TDi, LLC March 6, 2020
Biocompatibility
ISO 10993-1 5th edition 2018-08 for limited exposure, external communicating device. ISO 10993-1 Annex A Table A.1 – Evaluation tests for consideration indicate biological effects cytotoxicity, sensitization, irritation or intracutaneous reactivity be evaluated for the medical device category of the transducer.
Sterilization
ISO 14937:2009 Sterilization of healthcare products-General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
Summary of Clinical Tests 807.92(b)(1)
In vivo testing was conducted to demonstrate performance of the device in human applications.
Conclusion 807.92(b)(1):
SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe and the Accuro™ 3000 Ultrasound System both provide general purpose ultrasound tissue imaging, ability to highlight and enhance bone anatomy and state of the art features such as reusable probe, touchscreen operation, and data capture and external storage. Doppler imaging and intraoperative features are supported by the reference predicate Esaote 6000/6250.
The predicate comparison table and performance and safety testing provided in this 510(k) is sufficient to demonstrate that SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe is substantially equivalent to preamendment devices, Accuro™ 3000 ultrasound system, and Esaote 6000/6250 Ultrasound System and meets requirements for Track 1 as described in FDA Final Guidance Marketing Clearance of Diagnostic Ultrasound Systems and Transducers-June 27, 2019.