(192 days)
Not Found
No
The document describes standard ultrasound technology and image processing without mentioning AI or ML. The needle guidance is described as "passive tracking" and uses a physical guide.
No.
This device is an ultrasound system intended for guidance during medical procedures, which is a diagnostic/interventional aid, not a therapeutic device. It helps in the placement of needles and catheters but does not treat or cure any condition itself.
No
The device is intended for ultrasound guidance for the placement of needles and catheters and imaging of vascular structures, not for diagnosing a medical condition.
No
The device description explicitly mentions hardware components like a beamformer, transducer, and a needle guide that attaches to the transducer. While it includes software, it is not solely software.
Based on the provided information, this device 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.
- Device Function: The Vu-Path Ultrasound System uses ultrasound technology to create images of internal structures (vascular structures) and guide procedures (needle/catheter placement). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a procedure performed on the patient using imaging guidance, not a test performed on a sample from the patient.
Therefore, the Vu-Path Ultrasound System falls under the category of a medical imaging device used for guidance during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vu-Path Ultrasound System with associated probe and accessories provide ultrasound guidance for the placement of needles and catheters in vascular structures adults aged 22 and older. Ultrasound imaging of vascular structures and surrounding tissue may also be performed. The ultrasound probe is only intended to be placed on the surface of the skin and should not be advanced percutaneously. The device provides B-Mode and Color Doppler modes of operation.
The Vu-Path Ultrasound system needle guidance technology is indicated for use by appropriately-trained healthcare professionals to provide them with visual tools for passive tracking of a needle with respect to ultrasound image data.
Product codes
IYN, IYO, ITX
Device Description
The Vu-Path Ultrasound System employs the same core scientific technology as the other ultrasound devices: digital acquisition, processing, analysis and display capability. Piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and shown on the device display. The Vu-Path is designed primarily to assist physicians in gaining vascular access to major veins and arteries. The system consists of a beamformer and a transducer that operates in two modes, B-Mode and Color Doppler. A single USB connection transfers the information between the beamformer and a user provided computer with display. The application software is installed on the user provided computer. The Vu-Path needle guide attaches over the sheathed transducer and has an integral needle channel that provides a path for a needle to be introduced into the target location.
Mentions image processing
digital acquisition, processing, analysis and display capability.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
vascular structures
Indicated Patient Age Range
adults aged 22 and older
Intended User / Care Setting
appropriately-trained healthcare professionals
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
Bench testing for electrical and mechanical safety in compliance with the standards cited above.
Bench testing for ultrasound in compliance with the standards cited above.
Software testing, consisted of verification and validation testing in compliance with ISO 62304, including test cases related to off the shelf software, as well as cybersecurity features.
The subject of this premarket submission, the Vu-Path Ultrasound System, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Crystalline Medical % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K203657
Trade/Device Name: Vu-Path Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 16, 2021 Received: June 17, 2021
Dear Prithul Bom:
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
June 25, 2021
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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) K203657
Device Name Vu-Path Ultrasound System
Indications for Use (Describe)
The Vu-Path Ultrasound System with associated probe and accessories provide ultrasound guidance for the placement of needles and catheters in vascular structures adults aged 22 and older. Ultrasound imaging of vascular structures and surrounding tissue may also be performed. The ultrasound probe is only intended to be placed on the skin and should not be advanced percutaneously. The device provides B-Mode and Color Doppler modes of operation.
The Vu-Path Ultrasound system needle guidance technology is indicated for use by appropriately-trained healtheare professionals to provide them with visual tools for passive tracking of a needle with respect to ultrasound image data.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------- |
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510(k) Summary - K203657 Prepared June 8, 2021
| Sponsor: | Crystalline Medical
48890 Milmont Drive,
Suite 106D
Fremont CA 94538 |
|-----------------------|-------------------------------------------------------------------------------|
| Contact Person: | Ivan Ma |
| Telephone: | 510-270-8234 |
| Submission Date: | June 8, 2021 |
| Device Name: | Vu-Path Ultrasound System |
| Common Name: | Ultrasonic imaging system; Diagnostic ultrasonic transducer |
| Trade Name: | Vu-Path Ultrasound System |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | 21CFR 892.1550, 892.1560 and 892.1570 (IYN, IYO, ITX) |
| Classification Panel: | Radiology |
A. Legally Marketed Predicate Devices
The predicate device is the Site 6 Ultrasound System (K142443) Manufactured by C.R. Bard, Inc.
B. Device Description and List Of Device Components and Accessories:
The Vu-Path Ultrasound System employs the same core scientific technology as the other ultrasound devices: digital acquisition, processing, analysis and display capability. Piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and shown on the device display. The Vu-Path is designed primarily to assist physicians in gaining vascular access to major veins and arteries. The system consists of a beamformer and a transducer that operates in two modes, B-Mode and Color Doppler. A single USB connection transfers the information between the beamformer and a user provided computer with display. The application software is installed on the user provided computer. The Vu-Path needle guide attaches over the sheathed transducer and has an integral needle channel that provides a path for a needle to be introduced into the target location.
| REF # | Description |
|---|---|
| BF-100 | Vu-Path Beamformer |
| TW-200 | Vu-Path Transducer |
| NG-100 | Sterile Needle Guide |
4
C. Indications for Use/Intended Use
The Vu-Path Ultrasound System with associated probe and accessories provide ultrasound guidance for the placement of needles and catheters in vascular structures adults aged 22 and older. Ultrasound imaging of vascular structures and surrounding tissue may also be performed. The ultrasound probe is only intended to be placed on the surface of the skin and should not be advanced percutaneously. The device provides B-Mode and Color Doppler modes of operation.
The Vu-Path Ultrasound system needle guidance technology is indicated for use by appropriately-trained healthcare professionals to provide them with visual tools for passive tracking of a needle with respect to ultrasound image data.
D. Discussion of Similarities or Differences
The follow tables compare key characteristics of the predicate device and the subject device.
| | Predicate Device
Site-Rite 6 Ultrasound
System (K142443)
Manufactured by C.T, Bard,
Inc. | Subject Device
Vu-Path Ultrasound System | Comments |
|---------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|
| Regulation
number | 21CFR 892.1560 and 892.1570 | 21CFR 892.1550, 892.1560,
892.1570 | The difference has no
impact to safety and
effectiveness. |
| Regulation
description | Ultrasonic imaging system;
Diagnostic ultrasonic
transducer | Ultrasonic imaging system;
Diagnostic ultrasonic
transducer | Same |
| Review panel
Product code(s) | Radiology
(IYO, ITX) | Radiology
(IYN, IYO, ITX) | Same
The difference has no
impact to safety and
effectiveness. |
| Number of
transducers | 1 linear transducer | 1 linear transducer | Same |
| Transducer
characteristics | Linear | Linear Phased Array | The difference has no
impact to safety and
effectiveness. |
| Modes | B Mode, Needle Guidance
Imaging | B Mode, Needle Guidance
Imaging, Color Doppler | The difference has no
impact to safety and
effectiveness. |
| Needle guide
capability | Yes | Yes | Same |
5
| Means of
providing visual
tools | Magnetic resonance sensor +
software | Known mechanical
relationship + software | The difference has no
impact to safety and
effectiveness. |
|---------------------------------------|-----------------------------------------|---------------------------------------------|-----------------------------------------------------------------|
| Electrical Safety | 60601-1 | 60601-1 | Same |
| Electromagnetic
Compatibility | 60601-1-2 | 60601-1-2 | Same |
| Performance
Standard | 60601-2-37 | 60601-2-37 | Same |
Performance testing demonstrates that the differences in technological characteristics between the subject device and the predicate device, do not raise additional questions of safety or effectiveness.
E. Performance Data
Performance testing with a statistically significant sample size was conducted to demonstrate equivalent performance of the subject device to the predicate.
The comparison of specifications and the performance data submitted demonstrate that the technological characteristics of the subject device are substantially equivalent to the predicate device and do not raise new issues of safety and efficacy.
| ISO 14971 | Application of risk management to medical devices |
|---|---|
| AAMI 60601-1 | Medical electrical equipment- General requirements for basic safety and |
| essential performance | |
| IEC 60601-1-2 | Electromagnetic disturbances |
| IEC 60601-2-37 | Particular Requirements For The Basic Safety And Essential |
| Performance Of Ultrasonic Medical Diagnostic And Monitoring | |
| Equipment | |
| IEC 62304 | Medical device software - Software life-cycle processes |
| ISO 10993 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And |
| Testing Within A Risk Management Process | |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: |
| Requirements for materials, sterile barrier systems and packaging | |
| systems | |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2: Validation |
| requirements for forming, sealing and assembly processes |
Summary of Non-Clinical Tests
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Crystalline Medical certifies that all verification and validation activities provided in this submission were performed by designated individuals and results demonstrate that predetermined
6
acceptance criteria were met. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:
-
- Bench testing for electrical and mechanical safety in compliance with the standards cited above
-
- Bench testing for ultrasound in compliance with the standards cited above
-
- Software testing, consisted of verification and validation testing in compliance with ISO 62304, including test cases related to off the shelf software, as well as cybersecurity features
Summary of Clinical Tests:
The subject of this premarket submission, the Vu-Path Ultrasound System, did not require clinical studies to support substantial equivalence.
F. Conclusion
Potential risks were identified according to the ISO 14971 Standard process. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above. All risk mitigations were satisfactorily verified and validated. Where there were technological differences from the predicate, these were shown not to result in any new issues of safety or efficacy according to the performance data submitted.