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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Vu-Path Ultrasound System (K203657). It outlines the device's purpose, comparison to a predicate device, and the non-clinical performance data submitted to demonstrate substantial equivalence.

Critically, the document explicitly states: "The subject of this premarket submission, the Vu-Path Ultrasound System, did not require clinical studies to support substantial equivalence."

This means that the information requested regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details), as it pertains to clinical performance studies, is explicitly not applicable to this submission. The substantial equivalence was established through non-clinical bench testing and software validation.

Therefore, I cannot provide a table of acceptance criteria for clinical performance or details about a clinical study, as none were conducted or required for this 510(k) clearance.

However, I can extract the information regarding the non-clinical testing and general regulatory compliance:

1. A table of acceptance criteria and the reported device performance:

Based on the provided text, the acceptance criteria for the non-clinical tests were that the "predetermined acceptance criteria were met" and that "all risk mitigations were satisfactorily verified and validated." The reported performance is summarized as follows:

Acceptance Criteria Category	Reported Device Performance
Electrical and Mechanical Safety	Compliant with AAMI 60601-1
Ultrasound Performance	compliant with IEC 60601-2-37
Software Performance	Compliant with IEC 62304 (including off-the-shelf software and cybersecurity features); verification and validation testing completed, and test cases related to off-the-shelf software and cybersecurity features were included.
Risk Management	Identified and analyzed risks according to ISO 14971, mitigations implemented and tested.
Electromagnetic Compatibility	Compliant with IEC 60601-1-2
Packaging Validation	Compliant with ISO 11607-1:2019 and ISO 11607-2:2019
Biocompatibility	Compliant with ISO 10993

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document mentions "Performance testing with a statistically significant sample size was conducted," but does not specify the exact sample sizes for any of the non-clinical tests (e.g., how many units were tested for electrical safety, how many cycles for software testing, etc.).
The data provenance is implied to be from internal company testing (Crystalline Medical) as part of their Design Control process in compliance with 21 CFR Part 820.30. No country of origin or retrospective/prospective nature is specified for test data, as these are bench tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. Ground truth as typically established by experts (e.g., radiologists, pathologists) is relevant for clinical validation studies, which were not required or performed. Non-clinical tests establish "ground truth" based on engineering specifications and compliance with recognized standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no clinical study or expert consensus for ground truth was performed or required.

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 submission explicitly states, "The subject of this premarket submission, the Vu-Path Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study, AI assistance performance, or human reader improvement was assessed or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not explicitly detailed for software performance, but the software testing was done in compliance with IEC 62304. The "needle guidance technology... provides them with visual tools for passive tracking of a needle," implying it is an assistance tool, not a fully standalone diagnostic algorithm. However, the clearance was based on demonstrating substantial equivalence to a predicate, not on demonstrating standalone diagnostic performance improvements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For non-clinical testing, the "ground truth" is typically defined by:

Engineering Specifications: The device met pre-defined technical specifications (e.g., output power, image resolution, accuracy of needle tracking mechanism within a phantoms/bench setup).
Compliance with Industry Standards: The device's performance was measured against established criteria in recognized standards (e.g., IEC 60601 series for safety and performance, IEC 62304 for software lifecycle processes).

8. The sample size for the training set:

Not applicable, as this device's clearance was based on substantial equivalence to a predicate device through non-clinical testing, not on the performance of a machine learning model that would require a distinct training set for clinical performance validation. While there is software on the device, the summary does not indicate that it is a deep learning or AI model in the sense that would require a large "training set" for its core functionality validation. The software validation followed IEC 62304 standards.

9. How the ground truth for the training set was established:

Not applicable, as no described training set was used for a machine learning model.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K203657

Device Name Vu-Path Ultrasound System

Indications for Use (Describe)

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 Medical48890 Milmont Drive,Suite 106DFremont 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:

REF #	Description
BF-100	Vu-Path Beamformer
TW-200	Vu-Path Transducer
NG-100	Sterile Needle Guide

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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 DeviceSite-Rite 6 UltrasoundSystem (K142443)Manufactured by C.T, Bard,Inc.	Subject DeviceVu-Path Ultrasound System	Comments
Regulationnumber	21CFR 892.1560 and 892.1570	21CFR 892.1550, 892.1560,892.1570	The difference has noimpact to safety andeffectiveness.
Regulationdescription	Ultrasonic imaging system;Diagnostic ultrasonictransducer	Ultrasonic imaging system;Diagnostic ultrasonictransducer	Same
Review panelProduct code(s)	Radiology(IYO, ITX)	Radiology(IYN, IYO, ITX)	SameThe difference has noimpact to safety andeffectiveness.
Number oftransducers	1 linear transducer	1 linear transducer	Same
Transducercharacteristics	Linear	Linear Phased Array	The difference has noimpact to safety andeffectiveness.
Modes	B Mode, Needle GuidanceImaging	B Mode, Needle GuidanceImaging, Color Doppler	The difference has noimpact to safety andeffectiveness.
Needle guidecapability	Yes	Yes	Same

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Means ofproviding visualtools	Magnetic resonance sensor +software	Known mechanicalrelationship + software	The difference has noimpact to safety andeffectiveness.
Electrical Safety	60601-1	60601-1	Same
ElectromagneticCompatibility	60601-1-2	60601-1-2	Same
PerformanceStandard	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 andessential performance
IEC 60601-1-2	Electromagnetic disturbances
IEC 60601-2-37	Particular Requirements For The Basic Safety And EssentialPerformance Of Ultrasonic Medical Diagnostic And MonitoringEquipment
IEC 62304	Medical device software - Software life-cycle processes
ISO 10993	Biological Evaluation Of Medical Devices - Part 1: Evaluation AndTesting Within A Risk Management Process
ISO 11607-1:2019	Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems and packagingsystems
ISO 11607-2:2019	Packaging for terminally sterilized medical devices - Part 2: Validationrequirements 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

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acceptance criteria were met. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:

1. Bench testing for electrical and mechanical safety in compliance with the standards cited above
1. Bench testing for ultrasound in compliance with the standards cited above
1. 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.

Regulation Number and Section

§ 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.