K Number

Device Name

Vave Personal Ultrasound System

Manufacturer

Vave Health, Inc.

Date Cleared

2019-07-10

(29 days)

Product Code

IYO ITX

Regulation Number

892.1560

Intended Use

The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode. It is indicated for diagnostic ultrasound imaging in the following applications: Fetal/Obstetric, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The Vave Personal Ultrasound is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Device Description

The Vave Personal Ultrasound is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery Charger. The ultrasound probe, 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 is charged with a proprietary charging system. The Vave Personal Ultrasound is intended for use in environments where healthcare is provided by healthcare professionals, including home healthcare environments and emergency medical services, ambulance, or aircraft environments.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K140693

Reference Devices

K172385

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound image processing and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device is intended for diagnostic ultrasound imaging, not for treating any condition or disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound imaging in B-Mode" and lists various diagnostic applications.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of an Ultrasound Probe, Display Application, and Battery Charger, with the probe being a hardware component that acquires and transmits data.

IVD (In Vitro Diagnostic)

Based on the provided text, the Vave Personal Ultrasound is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging in B-Mode" and lists various anatomical applications (Fetal/Obstetric, Abdominal, Pediatric, etc.). This is consistent with in-vivo imaging, not testing samples outside the body.
Device Description: The description details a handheld ultrasound system with a probe that transmits and receives sound waves to create images of internal structures. This is the core function of an in-vivo imaging device.
Mechanism: The description of how the device works (transmitting sound waves into the body and processing reflected signals) is characteristic of ultrasound imaging, not in-vitro testing.
No mention of testing samples: There is no mention of the device being used to test blood, urine, tissue, or any other biological samples outside of the body, which is the defining characteristic of an IVD.

In summary, the Vave Personal Ultrasound is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode.

It is indicated for diagnostic ultrasound imaging in the following applications: Fetal/Obstetric, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body.

The Vave Personal Ultrasound is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Product codes (comma separated list FDA assigned to the subject device)

IYO, ITX

Device Description

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

The ultrasound probe, 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 is charged with a proprietary charging system.

The Vave Personal Ultrasound is intended for use in environments where healthcare is provided by healthcare professionals, including home healthcare environments and emergency medical services, ambulance, or aircraft environments.

Mentions image processing

Yes, "Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images of anatomic structures."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetric, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel. Also for procedural guidance of needles into the body.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare professionals, including home healthcare environments and emergency medical services, ambulance, or aircraft environments.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140693

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K172385

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

July 10, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is 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. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K191541

Trade/Device Name: Vave Personal Ultrasound Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: June 7, 2019 Received: June 11, 2019

Dear Mr. Job:

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191541

Device Name Vave Personal Ultrasound

Indications for Use (Describe)

The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode.

The Vave Personal Ultrasound is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Other
Ophthalmic	Ophthalmic
	Fetal/OB	N
	Abdominal (1)	N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N
	Small Organ (Specify)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify) (2)	N
	Cardiac Adult	N
	Cardiac Pediatric	N
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel (3)	N
Vessel	Other (Non-vascular) (4)	N

System: Vave Personal Ultrasound Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Notes:

N = new indication; P = previously cleared by FDA; E = added under this appendix

(1) Abdominal includes Gynecology, Renal and Urology

(2) Other use includes Thoracic/Pleural detection of fluid and pleural motion/sliding

(3) Peripheral Vessel includes arteries and veins
(4) Non-vascular is image guidance for freehand needle/catheter placement

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Other
Ophthalmic	Ophthalmic
	Fetal/OB	N
	Abdominal (1)	N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N
	Small Organ (Specify)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify) (2)	N
	Cardiac Adult	N
	Cardiac Pediatric	N
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel (3)	N
	Other (Non-vascular) (4)	N

Device Name: Vave Phased VP3 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Notes:

N = new indication; P = previously cleared by FDA; E = added under this appendix

(1) Abdominal includes Gynecology, Renal and Urology

(2) Other use includes Thoracic/Pleural detection of fluid and pleural motion/sliding

(3) Peripheral Vessel includes arteries and veins
(4) Non-vascular is image guidance for freehand needle/catheter placement

510(K) SUMMARY

191541 510(k) Notification K_

GENERAL INFORMATION

Applicant:

Vave Health, Inc. 2955 Campus Drive, Suite 110 San Mateo, CA U.S.A. Phone: (415)264 -5284

Contact Person:

Joseph Ko Director of Quality Assurance and Regulatory Vave Health, Inc. Phone: (415) 264 -5284 Email: Regulatory@vavehealth.com

Date Prepared:

May 13, 2019

DEVICE INFORMATION

Trade Name: Vave Personal Ultrasound

Generic/Common Name:

Ultrasound Imaging System

Classification:

Class II

Classification Name:

21 CFR Section	Classification Name	Product Code
892.1560	Ultrasonic Pulsed Echo Imaging System	90 IYO
892.1570	Diagnostic Ultrasonic Transducer	90 ITX

SUBSTANTIALLY EQUIVALENT DEVICES

. Primary Predicate Device: Vscan with Dual Probe (K140693)
. Reference Device: Clarius Ultrasound Scanner (K172385)

DEVICE DESCRIPTION

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

INDICATIONS FOR USE

The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode. It is indicated for diagnostic ultrasound imaging in the following applications: Fetal/Obstetric. Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body.

The Vave Personal Ultrasound is a transportable ultrasound system that is intended for use in environments where healthcare is provided by healthcare professionals.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The intended use including all indications for use of the Vave Personal Ultrasound are the same as the primary predicate device (K140693). The fundamental technology of the Vave Personal Ultrasound is the same as the predicate (K140693) and reference (K172385) devices. Vave Personal Ultrasound introduces no new indications for use, modes, features, or technologies relative to the predicate devices. The Vave Personal Ultrasound is substantially equivalent to the predicate devices.

Comparison Parameter	Subject Device: Vave Personal Ultrasound	Primary Predicate Device: Vscan with Dual Probe with Transducer G3S (K140693)
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body	Diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications for use	Fetal/OB	Yes
	Abdominal	Yes
	Intra-operative (Specify)	No
	Pediatric	Yes
	Small Organ	No
	Neonatal Cephalic	No
	Adult Cephalic	No
	Musculoskeletal (Conventional)	No
	Musculoskeletal (Superficial)	No
	Urology	Yes
	Gynecology	Yes
	Renal	Yes
	Thoracic/Pleural	Yes
	Cardiac adult	Yes
	Cardiac pediatric	Yes
	Fetal echo	No
	Peripheral vessel	Yes
	Carotid	No
	Needle Guidance	Yes
Environment of Use	Professional	Yes
	Home	Yes
	Emergency Medical Services	Yes
510(k) Track		Track 3
Patient-Contacting Materials		All materials with patient contact are biocompatible and can be disinfected
Transducer Technology		Piezoelectric
Transducer Types	Phased Array	Yes
	Linear Array	No
	Convex Array	No
Comparison Parameter	Subject Device:
Vave Personal Ultrasound	Primary Predicate
Device: Vscan with Dual
Probe with Transducer
G3S
(K140693)
Principle/Method of Operation	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 displayed as
images of anatomic
structures.	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 displayed as
images of anatomic
structures.
Modes of
Operation	B-Mode	Yes	Yes
	Color Doppler	No	Yes
	M-Mode	No	No
	Combined (B+CD)	No	Yes

SUMMARY OF NONCLINICAL TESTING

All necessary performance testing was conducted on the Vave Personal Ultrasound to support a determination of substantial equivalence to the predicate devices. The nonclinical testing conducted on the Vave Personal Ultrasound 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 4.0 2014-02 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 2.0 2015-01 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 1.0 2014-06 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

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
IEC 62366-1 Edition 1.0 2015-02 Medical Devices Part 1: Application Of ● Usability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)]
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 Personal Ultrasound meets the established specifications necessary for consistent performance for its intended use.

SUMMARY OF CLINICAL TESTING

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 Personal Ultrasound is substantially equivalent to the identified predicate devices. The Vave Personal Ultrasound has the same intended use and fundamental technological characteristics as the identified predicate devices.

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 Personal Ultrasound supplied sterile.

TRACK

This is a Track 3 system.