The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, roadlair ambulance and other environments where is provided. The Vave Charger is to be used in a stationary setting.

It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetall Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The operating modes are B mode, M mode, B+M, B+C, CD mode.

Device Description

The Vave Wireless Ultrasound System is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery, and Batterv Charger.

The ultrasound probe (Model VA-0192), including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery (Model VA-0175). The battery is charged with a proprietary charging system (Model VCG).

AI/ML Overview

The provided text describes the Vave Wireless Ultrasound System, its intended use, and a comparison to predicate devices, along with non-clinical testing conducted. However, it explicitly states that no clinical testing was done because the device introduces "no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of clinical performance, as such a study was not conducted or reported for this submission. The information provided is primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

To address the prompt as much as possible with the provided information, I will focus on what was done (non-clinical testing) and explicitly state what was not done (clinical study to prove acceptance criteria).

Based on the provided FDA 510(k) summary (K241051), there was no clinical study conducted to prove the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and non-clinical testing.

The summary explicitly states: "The Vave Wireless Ultrasound system introduces no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, many of the requested details regarding a clinical study (e.g., sample size, ground truth establishment, expert qualifications, MRMC study, effect size) are not applicable or provided in this document.

Below, I will outline what is available regarding non-clinical acceptance criteria and testing, and explicitly mention where clinical information is not provided.

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for this device, as implied by the non-clinical testing section, are based on compliance with various international and national standards related to medical electrical equipment, electromagnetic compatibility, usability, battery safety, software life cycle, and biocompatibility. The "reported device performance" in this context is the successful demonstration of compliance with these standards.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Acceptance Criteria Category	Specific Standards / Requirements	Reported Device Performance
Electrical Safety & Essential Performance	- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD)	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful compliance with these standards.)
Electromagnetic Compatibility (EMC)	- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful compliance with these standards.)
Home Healthcare Environment Use	- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION – Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful compliance with these standards.)
Emergency Medical Services (EMS) Use	- IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful compliance with these standards.)
Ultrasonic Performance	- IEC 60601-2-37 Edition 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	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful compliance with this standard for ultrasonic imaging specific performance.)
Usability Engineering	- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful completion of usability engineering processes and associated tests.)
Battery Safety	- IEC 62133-2 Edition1.0 2017-02 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells. And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful compliance with this standard for the Li-ion battery.)
Software Life Cycle Processes	- ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes [Including Amendment 1 (2016)]	"The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use." (Implies successful application of defined software life cycle processes.)
Biocompatibility	- ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process	"All materials with patient contact are biocompatible and can be disinfected." (Explicitly stated in the comparison table, confirmed via ISO 10993-1 testing, as per the Non-Clinical Testing section listing this standard.)
Quality Assurance Measures	- Risk Analysis, Product Specifications, Design Reviews, Verification and Validation	Quality assurance measures applied to the system design and development, confirming the processes were followed, contributing to meeting specifications. (No specific performance metrics are given, but implies internal acceptance criteria were met through these processes.)

Information Not Available (Due to No Clinical Study Conducted)

Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set was used for performance evaluation (only non-clinical compliance testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 applicable. The device is an ultrasound system, and the submission does not mention any AI assistance features or human-in-the-loop performance studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm for performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable, as no clinical training set was mentioned or implied for performance evaluation of a clinical algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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August 30, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vave Health, Inc % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K241051

Trade/Device Name: Vave Wireless 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: August 26, 2024 Received: August 26, 2024

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and

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production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-report-medicaldevice-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/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.

Marjan Nabili-S

for

Yanna Kang Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241051

Device Name

Vave Wireless Ultrasound System

Indications for Use (Describe)

The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

he-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

510(k) Notification K241051

GENERAL INFORMATION

Applicant:

Vave Health, Inc. 3031 Tisch Way, 110 Plaza West San Jose, CA U.S.A. 95128 Phone: 510-366-2466

Contact Person:

Sandhya Mitnala Sr. Director of Quality Assurance and Regulatory Vave Health, Inc. Phone: 510-366-2466 Email: sandhya@vavehealth.com

Date Prepared:

August 30th, 2024

DEVICE INFORMATION

Trade Name:

Vave Wireless Ultrasound System

Generic/Common Name:

Wireless Ultrasound System

Classification and Product Codes:

21 CFR Section	Classification Name	Product Code
892.1550	Ultrasonic pulsed Doppler imaging system.	IYN
892.1560	Ultrasonic Pulsed Echo Imaging System	IYO
892.1570	Diagnostic Ultrasound Transducer	ITX

PREDICATE DEVICES

Primary Predicate Device: Vave Personal Ultrasound (K191541) ●
Reference Device: Clarius Ultrasound Scanner (K192107) ●

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Image /page/4/Picture/0 description: The image shows the logo for Vave. The logo consists of a stylized icon on the left and the word "vave" in lowercase letters on the right. The icon is a gray triangle with a white and gray design inside. The word "vave" is written in a sans-serif font and is also gray.

DEVICE DESCRIPTION

The Vave Wireless Ultrasound System is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery, and Batterv Charger.

CHANGES IMPLEMENTED

The present submission is an expansion based on the previous clearance - K191541. The subject device changes of this new submission are the addition of a new transducer model, the Vave Linear Array probe ("Vave Linear") with upgraded hardware to the Vave Wireless Ultrasound System. The Vave Phased transducer model and the clinical indications supported were cleared under K191541. The Vave Linear transducer model supports additional clinical indications as described in the Indications for Use for the Linear array probe, which are the same as the reference device Clarius Ultrasound Scanner (K192107). Appropriate changes have been made to mitigate risks and ensure the safety and effectiveness of these new features.

INTENDED USE/INDICATIONS FOR USE

The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, road/air ambulance and other environments where healthcare is provided. The Vave Charger is to be used in a stationary setting.

It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetal/Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body.

The operating modes are B mode, M mode, B+M, B+C, CD mode.

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Image /page/5/Picture/0 description: The image shows the logo for Vave. The logo consists of a stylized triangle shape on the left, with three curved lines inside. To the right of the triangle is the word "vave" in lowercase letters. The logo and text are in a dark gray color, set against a white background.

PRESCRIPTION STATUS

This is a prescription device. The prescription device statement appears in the labeling.

STERILIZATION SITE(S)

Not applicable. There are no components in the Vave Wireless Ultrasound System supplied sterile.

TRACK

The Vave Wireless Ultrasound System will be following Track 3 outlined in the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued February 21, 2023.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The intended use including all indications for use of the Vave Wireless Ultrasound System are the same as the predicate device. The fundamental technology of the Vave Wireless Ultrasound System is the same as the primary (K191541) and reference (K192107). Vave Wireless Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate device. The Vave Wireless Ultrasound System is substantially equivalent to the predicate device.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following table provides a detailed comparison of the intended use, indications for use and the device specifications between the subject device (Vave Wireless Ultrasound system) and the predicate and reference devices. All indications for use introduced by the subject device are similar to predicate and the reference device.

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a vove

Comparison Parameter	Subject Device:Vave WirelessUltrasound System	PrimaryPredicate:Vave PersonalUltrasoundSystem (K191541)	Clarius UltrasoundScanner(K192107)
Intended Use	The Vave Probe isintended fordiagnosticultrasound imagingor fluid flowanalysis of thehuman body.	The Vave Probe isintended for diagnosticultrasound imaging orfluid flow analysis of thehuman body.	Diagnostic ultrasoundimaging and fluid flowanalysis
Indications foruse	Ophthalmic	Yes	No	Yes
	Fetal/OB	Yes	Yes	Yes
	Abdominal	Yes	Yes	Yes
	Intra-operative(Abdominal organsand Vascular)	No	No	Yes
	Pediatric	Yes	Yes	Yes
	Small Organ(Thyroid, Scrotum,Breast)	Yes	No	Yes
	Adult Cephalic	No	No	Yes
	Trans-rectal	No	No	Yes
	Trans-vaginal	No	No	Yes
	Musculo-skeletal(Conventional)	Yes	No	Yes
	Musculo-skeletal(Superficial)	Yes	No	Yes
	Urology	Yes	Yes	Yes
	Gynecology	Yes	Yes	Yes
	Renal	Yes	Yes	No
	Thoracic/Pleural	Yes	Yes	No
	Cardiac adult	Yes	Yes	No
	Cardiac pediatric	Yes	Yes	No
	Peripheral vessel	Yes	Yes	Yes
	Carotid	No	No	Yes
	Needle Guidance	Yes	Yes	Yes
Comparison Parameter		Subject Device:Vave WirelessUltrasound System	PrimaryPredicate:VavePersonalUltrasound(K191541)	Reference device:Clarius UltrasoundScanner (K192107)
Environmentof Use	Professional	Yes	Yes	Yes
	Home	Yes	Yes	No
	Emergency MedicalServices	Yes	Yes	No
510(k) Track		Track 3	Track 3	Track 3
Modes ofOperation	B-Mode	Yes	Yes	Yes
	Color Doppler	Yes	Yes	Yes
	M-Mode	Yes	Yes	Yes
	Combined (B+CD)	Yes	Yes	Yes
Patient-Contacting Materials		All materials withpatient contact arebiocompatible and canbe disinfected	All materials withpatient contact arebiocompatible and canbe disinfected	All materials with patientcontact arebiocompatible and canbe disinfected
Principle/Method of Operation		Piezoelectric material inthe transducer is used asan ultrasound source totransmit sound wavesinto the body. Soundwaves are reflectedback to the transducerand converted toelectrical signals thatare processed anddisplayed as images ofanatomicstructures.	Piezoelectric material inthe transducer is used asan ultrasound source totransmit sound wavesinto the body. Soundwaves are reflectedback to the transducerand converted toelectrical signals that areprocessed and displayedas imagesof anatomic structures.	Piezoelectric material inthe transducer is used asan ultrasound source totransmit sound wavesinto the body. Soundwaves are reflected backto the transducer andconverted to electricalsignals that are processedand displayed as imagesof anatomic structures.
Transducer Technology		Piezoelectric	Piezoelectric	Piezoelectric
TransducerTypes	Phased Array	Yes	Yes	Yes
	Linear Array	Yes	No	Yes
	Convex Array	No	No	Yes
Probe Connection to Display		Wireless	Wireless	Wireless
	Image export	Yes	Yes	Yes
	Measurements	Yes	Yes	Yes
	Annotations	Yes	Yes	Yes
Portability		Portable UltrasoundSystem	PortableUltrasound System	Portable UltrasoundSystem
Power Source		Removable battery (Li-ion)	Removable battery (Li-ion)	Removable battery (Li-ion)
Display		iOS or Android mobiledevice	iOS or Android mobiledevice	iOS or Android mobiledevice
Comparison Parameter		Subject Device:Vave WirelessUltrasound System	Primary Predicate:Vave PersonalUltrasound(K191541)	Reference device:ClariusUltrasoundScanner(K192107)
Wireless Capability		Communicateswirelesslyvia Wi-Fi andBluetooth	Communicateswirelesslyvia Wi-Fi and Bluetooth	Communicateswirelessly via Wi-Fi andBluetooth
Cybersecurity	Data at rest	- 256-Bit AES- HTTPS TLS 1.2	- 256-Bit AES- HTTPS TLS 1.2	- RSA256- 128-Bit AES- HTTPS TLS 1.2
	Data in transit	- WPA2 (AES)	- WPA2 (AES)	- WPA2 (AES)
	User security	- Authenticationservices providedby AmazonCognito;- Password resettokens followNIST standards.- NIST approvedone-waycryptographichash with salt	- Authenticationservices providedby AmazonCognito;- Password resettokens follow NISTstandards.NIST approved one-way cryptographichash with salt	- Two-factor authentication(Cloud only)- Passwords followNIST standards

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NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the Vave Wireless Ultrasound System to support a determination of substantial equivalence to the predicate device. The nonclinical testing conducted on the Vave Wireless Ultrasound System includes:

� ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION � Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION � Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
. IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

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IEC 60601-2-37 Edition 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
o IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION

Medical devices - Part 1: Application of usability engineering to medical devices

IEC 62133-2 Edition1.0 2017-02 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells. And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems
ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software -Software Life Cycle Processes [Including Amendment 1 (2016)]
ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation Of Medical ● Devices - Part 1: Evaluation And Testing Within A Risk Management Process

The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use.

SUMMARY OF CLINICAL TESTS

The Vave Wireless Ultrasound system introduces no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

QUALITY ASSURANCE MEASURES

Quality assurance measures applied to the system design and development include, but are not limited to:

Risk Analysis -
Product Specifications -
-Design Reviews
Verification and Validation -

CONCLUSION

The Vave Wireless Ultrasound System is substantially equivalent to the identified predicate device. The Vave Wireless Ultrasound system has the same intended use and fundamental technological characteristics as the identified predicate device.

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.