The MedWand™ Device, in combination with the MedWand™ Software Application installed on an attached mobile device or computing system, is an intermittent vital sign measuring and examination system intended to collect, record, and display the following information:

· Oxygen saturation (SpO2),
· Pulse rate (PR),
· Infrared body temperature (TEMP)
· Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH)
· Photographs of areas needing assessment (CAMERA)

The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments.

The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently.

Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP. Collected information can be provided to a HCP when used as a standalone device.

Additionally, the MedWand™ Device can integrate with external data communications systems (not part of the MedWand™ Device) through a programming interface. This integration will facilitate interactions between the lay user and HCP for telemedicine. The device is intended for spot-checking and does not have continuous monitoring capability or alarm features.

Device Description

The MedWand™ Device is a handheld telemedicine device that allows measurement of SpO2. pulse rate, and stethoscope along with a camera. The device is intended to be used by lay people or clinical personnel. The patient applies their finger to the sensor on the top of the device designed for measuring SpO2 and pulse rate. The thermometer is a non-contact IR thermometer that is pointed to the patient's forehead. The camera can be pointed to the particular body part at the (remote) Health Care Professional's (HCP) direction. The stethoscope is contacted directly to the patient's chest or abdomen to provide auscultation sounds to the (remote) HCP.

The MedWand™ Device works as part of the MedWand™ Ecosystem. The MedWand™ Ecosystem consists for following elements:

1. MedWand™ Device including its embedded firmware This device is provided to the patient or other user who is physically present with the patient.
1. USB-C cable provided with the device. This cable physically connects the MedWand™ Device to the mobile device or computing platform to provide power, communications, and control for the MedWand™ Device
1. Client App Software Proprietary software that is provided to the patient or user to run on their mobile device or computing platform (MCP). This software is available for both Windows-based and Android-based devices. This software supports the local operation of the MedWand™ Device and the use of the device in the context of a telemedicine system. This software contains the user interface to the MedWand™ Device. This software provides the user with the concept of a session in which the user activates one or more sensors, collects readings for temperature and pulse oximeter, photos from the camera, and recordings from the stethoscope.
1. Device Communications Module (DCM) The DCM runs on the MCP incorporated as a library in the Client App. The DCM manages the serial communications between the MedWand™ Device and MCP. The DCM is also known as the Software Developer's Kit (SDK), as it provides a controlled programming interface to enable integration with thirdparty telemedicine systems.
1. A mobile device (e.g., laptop, tablet or smartphone) or computing platform (laptop or computer) (collectively Mobile Computing Platform (MCP)) – The MCP is supplied by the patient or user, not by MedWand. The Client App proprietary software runs the MCP. The MCP is not part of the medical device.
1. A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not supplied by MedWand and not part of the medical device). As described in the cited FDA guidance, this platform and any clinician interface are not part of the medical device.
1. Commercial Telemedicine systems provides real-time voice and video communications between the HCP and the MedWand™ Device user (as patient) in a virtual live visit. These external software systems would be classified as Medical Device Data Systems, which FDA no longer considers medical devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MedWand™ Device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides performance details for individual functions (SpO2, Pulse Rate, Temperature) but explicitly states that the MedWand™ Device met "the more stringent required acceptance criteria from the FDA guidance for reflectance pulse oximeters" and that thermometer results are "similar to other published temperature data for IR thermometers." The exact numerical acceptance criteria from the FDA guidance or standards are not fully specified for all metrics in this document, but the device's performance against them is confirmed.

Function/Metric	Acceptance Criteria (where explicitly stated or implied)	Reported Device Performance (MedWand™ Device)
SpO2 Accuracy (ARMS)	ISO 80601-2-61:2017 & FDA guidance for reflectance pulse oximeters (more stringent)	70-80%: 3.00%80-90%: 1.62%90-100%: 1.37%70-100%: 2.05%
SpO2 Displayed Range	70%~100% (Implied by predicate comparison)	70%~100%
Pulse Rate Measurement Range	30 to 150 bpm (Implied by predicate comparison)	25 to 200 bpm
Pulse Rate Accuracy	± 2 bpm or ± 2% (whichever is greater)	± 2 bpm or ± 2% (whichever is greater)
Temperature Measurement Range (body)	93.2°F~109.4°F (34.0°C ~43.0°C) (Implied by predicate comparison)	93°F~107.6°F (33.9°C ~42.0°C)
Temperature Measurement Accuracy	± 0.5°F (± 0.3°C)	± 0.5°F (± 0.3°C)
Thermometer Febrile Subjects	30-50% febrile (from associated particular standard)	37% (59/158 subjects)
Electrical Safety & EMC	IEC 60601 3.1 edition standards, including ANSI/AAMI/ES60601 with U.S. deviations, ANSI/AAMI/IEC 60601-1-11:2015, and IEC 60601-1-2:2014	Complies with all requirements
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10	Biocompatible
Software Level of Concern (LOC)	Moderate	Moderate LOC

2. Sample Sizes and Data Provenance

For SpO2 Accuracy Study (Controlled Hypoxia):

Sample Size: 14 healthy volunteer subjects
Test Set Description: Ages 21-40; 6/14 male (42%); range of ethnicities, including at least 28% (4/14) with dark skin tones.
Data Provenance: Not explicitly stated, but the nature of a "controlled hypoxia" study strongly suggests prospective clinical data collected specifically for this validation in a controlled environment. Country of origin not specified.

For Thermometer & Additional SpO2/PR Clinical Agreement Study:

Sample Size: 158 subjects
Test Set Description: Patients from an outpatient health clinic; ages 18-81 (median 35, mean 37); 64/158 male (41%); skin tones 1-6 (dark) with median 2; 59/158 (37%) presented febrile symptoms.
Data Provenance: Not explicitly stated, but implies prospective clinical data collected from an outpatient health clinic. Country of origin not specified.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the test sets. However, it references established methods:

For SpO2: Arterial blood samples were measured for SaO2 on a cooximeter, which is a highly accurate reference method. This implicitly relies on the calibration and proper operation of the cooximeter.
For Temperature: A "well-established reference clinical thermometer" was used, specifically mentioning the Exergen TAT thermometer (K011291) as a reference predicate in the comparison table, which uses rectal as the reference body site.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test sets. The ground truth was established using objective, established reference methods (cooximetry for SpO2, reference clinical thermometer for temperature).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The studies described are device performance studies against reference standards.

6. Standalone Performance Study

Yes, the clinical studies evaluate the performance of the MedWand™ Device in a standalone manner against established reference methods. For example, the SpO2 data from the MedWand™ pulse oximeter was compared directly to SaO2 results from a cooximeter. Similarly, MedWand™ temperature readings were compared to a reference clinical thermometer.

7. Type of Ground Truth Used

For SpO2: Physiological ground truth established by arterial blood gas analysis (SaO2 measured by cooximeter).
For Temperature: Physiological ground truth established by a reference clinical thermometer (Exergen TAT thermometer, K011291, with rectal as the reference body site).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size for the device's algorithms. The clinical studies described are explicitly for validation of the finished device.

9. How Ground Truth for Training Set Was Established

Since a separate "training set" with ground truth establishment is not described in the context of machine learning (which might use such a set for model development), this information is not provided. The performance data presented is from validation studies comparing the device to accepted medical reference standards.

Summary

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July 22, 2022

MedWand Solutions, Inc. % Natalie Kennel RA/QA Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129

Re: K212975

Trade/Device Name: MedWand™ Device Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, FLL, DQD, ERA Dated: June 20, 2022 Received: June 21, 2022

Dear Natalie Kennel:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices 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) K212975

Device Name MedWand™ Device

Indications for Use (Describe)

· Oxygen saturation (SpO2),
· Pulse rate (PR),
· Infrared body temperature (TEMP)
· Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH)
· Photographs of areas needing assessment (CAMERA)

The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments.

The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently.

Collected information is not intended for self-diagnosis. Interpretation and assessment of

results should be performed by an HCP. Collected information can be provided to a HCP when used as a standalone device.

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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K212975

Image /page/3/Picture/1 description: The image shows the logo for MedWand Solutions. The logo features a green heartbeat symbol on the left, followed by the text "MedWand" in a combination of gray and green. Below the text is the word "SOLUTIONS" in smaller, gray font.

510(k) Summary

Sponsor:	MedWand Solutions, Inc.23162 Arroyo VistaRancho Santa Margarita, CA 92688 USA
Contact Person:	Ms. Natalie J. KennelConsultantNJK & Associates, Inc.13721 Via Tres VistaSan Diego, CA 92129 USAPhone: (858) 705-0350Fax: (858) 764-9739Email: nkennel@njkconsulting.com
Date Prepared:	July 19, 2022

DEVICE INFORMATION:

MedWand™ Device Proprietary Name: Monitor, Physiological, Patient (without Arrhythmia Detection or Alarms) Common Name: Classification: Class II Product Codes: MWI, DQA, FLL, DQD, ERA 21 CFR 870.2300, 21 CFR 870.1875 Regulations: Classification Panel: Cardiovascular

INDICATIONS FOR USE:

· Oxygen saturation (SpO2),
· Pulse rate (PR),
· Infrared body temperature (TEMP)
· Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH)
· Photographs of areas needing assessment (CAMERA)

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K212975

The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments. The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently. Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP. Collected information can be provided to an HCP when used as a standalone device.

For prescription use only.

PREDICATE DEVICES:

The Sponsor selected the following predicate and reference devices for the MedWand™ Device using the FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff", issued on July 28, 2014.

510(k)	Product Name	510(k)Holder	Clearance Date	Scope of safety andeffectiveness comparison
K210086	Vitals360® Multi-Vitals MobileMonitor	VoCare,Inc.	May 20, 2021	Primary predicate (coversall functions butstethoscope)
K210736	DoctorgramStethoscope DES I	GVConcepts	July 27, 2021	Secondary predicate(covers stethoscopefunction)
K181352	Loop System	Spry Health	March 29, 2019	Reflectance sensorgeometry for SpO2
K011291	Exergen TATthermometer	Exergen	July 12, 2001	Reference clinicalthermometer (samereference body site -rectum)

Table 1 Predicate and Reference Device Information

PRODUCT DESCRIPTION:

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The MedWand™ Device works as part of the MedWand™ Ecosystem. The MedWand™ Ecosystem consists for following elements:

1. MedWand™ Device including its embedded firmware This device is provided to the patient or other user who is physically present with the patient.
1. USB-C cable provided with the device. This cable physically connects the MedWand™ Device to the mobile device or computing platform to provide power, communications, and control for the MedWand™ Device
1. Client App Software Proprietary software that is provided to the patient or user to run on their mobile device or computing platform (MCP). This software is available for both Windows-based and Android-based devices. This software supports the local operation of the MedWand™ Device and the use of the device in the context of a telemedicine system. This software contains the user interface to the MedWand™ Device. This software provides the user with the concept of a session in which the user activates one or more sensors, collects readings for temperature and pulse oximeter, photos from the camera, and recordings from the stethoscope.
1. Device Communications Module (DCM) The DCM runs on the MCP incorporated as a library in the Client App. The DCM manages the serial communications between the MedWand™ Device and MCP. The DCM is also known as the Software Developer's Kit (SDK), as it provides a controlled programming interface to enable integration with thirdparty telemedicine systems.
1. A mobile device (e.g., laptop, tablet or smartphone) or computing platform (laptop or computer) (collectively Mobile Computing Platform (MCP)) – The MCP is supplied by the patient or user, not by MedWand. The Client App proprietary software runs the MCP. The MCP is not part of the medical device.
1. A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not supplied by MedWand and not part of the medical device). As described in the cited FDA guidance, this platform and any clinician interface are not part of the medical device.
1. Commercial Telemedicine systems provides real-time voice and video communications between the HCP and the MedWand™ Device user (as patient) in a virtual live visit. These external software systems would be classified as Medical Device Data Systems, which FDA no longer considers medical devices.

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SUBSTANTIAL EQUIVALENCE

The Sponsor has compared the technical and performance characteristics of the subject and predicate devices in a substantial equivalence analysis in Table 2.

Table 2 Comparison to Predicate Device(s)

Characteristic	Subject Device – MedWand™ Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgram™Stethoscope DES-I(K210736)	Comparison Evaluation
Applicant	MedWand Solutions, Inc.	VoCare, Inc.	GV Concepts	N/A
ClassificationRegulation	21 CFR 870.230021 CFR 870.1875	21 CFR 870.2300	21 CFR 870.1875	Subject device covered by combination ofpredicates, with secondary predicatecovering the stethoscope.
Classification andCode	Class IIMWI, DQA, DQD, FLL, ERA	Class IIMWI, DQA, DSH, DXN, FLL	Class IIDQD	Subject device covered by combination ofpredicates. Subject device does not haveNIBP so DXN code is not applicable.Secondary predicate covers DQD. ERA –510(k) exempt.
Common name	Multi-function vital signs device (patientmonitor)	Multi-function vital signs device(patient monitor)	Electronic stethoscope	Subject device and primary predicate arethe same. The secondary predicate coversthe stethoscope function.
Intended Use	Multi-function device that measures, displays,records, and provides vital signs in home andnon-acute clinical environments and to remoteHCP	Multi-function device that measures,displays, records, and provides vitalsigns in home and non-acute clinicalenvironments and to remote HCP	Electronic stethoscope thatmeasures, records, andprovides these sounds toremote HCP	Subject device and primary predicate havesame intended use. Secondary predicatecovers the same intended use but onlywith a stethoscope.
Characteristic	Subject Device – MedWand™ Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgram™Stethoscope DES-I(K210736)	Comparison Evaluation
Indications for Use	The MedWand™ Device, in combination withthe MedWand™ Software Application installedon an attached mobile device or computingsystem, is an intermittent vital sign measuringand examination system intended to collect,record, and display the following information:Oxygen saturation (SpO2) Pulse rate (PR),Infrared body temperature (TEMP), Amplifiedauscultation sounds filtered for heart, lungs,and abdomen (STETH), Photographs of areasneeding assessment (CAMERA).The device is intended for use by adult layusers independently or guided by a healthcare professional (HCP) in home and non-acute clinical environments. The MedWand™Device is intended for use by trained adultsonly who can use smart phones, tablets, orcomputers proficiently. Collected informationis not intended for self-diagnosis.Interpretation and assessment of resultsshould be performed by an HCP. Collectedinformation can be provided to an HCP whenused as a standalone device.Additionally, the MedWand™ Device canintegrate with external data communicationssystems (not part of the MedWand™ Device)through a programming interface. Thisintegration will facilitate interactions betweenthe lay user and HCP for telemedicine. Thedevice is intended for spot-checking and doesnot have continuous monitoring capability oralarm features.	Vitals360® device is intended to beused for measuring, displaying,reviewing, and storing of non-invasiveblood pressure (NIBP), non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2), pulse rate (PR), foreheadtemperature (TEMP), ECG, weightand height in adults no less than 18years of age.This VITALS360® device is intendedfor use by trained adults only who canuse smartphones proficiently.This VITALS360® device is intendedfor use in a clinical or homeenvironment.This VITALS360® device is areusable device following thoroughcleaning between uses.	The doctorgram™Stethoscope DES-I is anelectronic stethoscope thatenables amplification,filtering, and transmissionof auscultation sound data(heart, lungs, bowel,arteries, and veins),whereby a clinician at onelocation on network canlisten to the auscultationsounds of a patient on siteor at a different location onthe network. Thedoctorgram™ StethoscopeDES-I is intended for useon pediatric and adultpatients. The doctorgram™Stethoscope DES-I isintended to be used byprofessional users in aclinical environment or bylay users in a nonclinicalenvironment. The device isnot intended for self-diagnosis.	Subject device and primary and secondarypredicates have similar indications for usein regard to users and use environment.Both subject and primary predicateprovide the functions of temperature,SpO2, and pulse rate. The primarypredicate has functions for capturingNIBP, ECG, weight, and height, which thesubject device does not do. The subjectdevice and secondary device have astethoscope function.Subject device is substantially equivalentto the predicate devices' indications foruse.
Characteristic	Subject Device – MedWandTM Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgramTMStethoscope DES-I(K210736)	Comparison Evaluation
		General Device Characteristics
ParametersMonitored	Blood oxygen saturation (SpO2) and pulserate (PR) non-invasively by the photoelectricmethod.Body temperature (TEMP) by the infraredradiation energy technology.	Blood oxygen saturation (SpO2) andpulse rate (PR) non-invasively by thephotoelectric method.Non-invasive blood pressure (NIBP,the pressures of systolic anddiastolic) by the oscillating method.Body temperature (TEMP) by theinfrared radiation energy technology.Additionally, it can record single leadECG signal.	Amplified auscultationsounds filtered for heart,lungs, abdomen, andarteries and veins	Subject device and primary device bothcan measure SpO2, PR, and TEMP.Subject device and secondary device bothcan measure amplified auscultationsounds with stethoscope.
Patient population	Adults	Adults	Adults	Same
Use Environment	Home use or non-acute clinic	Home use or non-acute clinic	Home use or non-acuteclinic	Same
Rx or OTC	Rx	Rx	OTC	Subject device and primary predicates areboth prescription use only.
Platform forsoftware	Windows based computer, laptop or Androidtablet or smartphone	Smart phone or tablet (iPhone orAndroid)	Mobile computing platformwith iOS smartphone ortablet	Similar. Subject device has a client appsoftware for both Windows and Androidbased computing platforms whereasprimary predicate has only iOS- andAndroid-based capabilities, and secondarypredicate has only iOS. Differences do notraise different issues of safety oreffectiveness.
Power Supply	Supplied by the patient-supplied mobilecomputing platform via USB cord	Battery or AC	Battery	Different: Subject device receives powerfrom computing platform. Subject and bothpredicates meet electrical safety, so thisdifference does not raise different issuesof safety or effectiveness.
Power requirement	5 V, 2.0A	(100-240) VAC, 50/60Hz, 0.5A,Rechargeable lithium battery,3.7VDC	Rechargeable lithiumbattery,3.7VDC	Similar: Subject and both predicates arelow voltage, low power requiring devices.
Characteristic	Subject Device – MedWand™ Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgram™Stethoscope DES-I(K210736)	Comparison Evaluation
Connection	USB Type C cord (included)	USB Type C or Bluetooth Smartwireless data link	Bluetooth Smart wirelessdata link(USB Type C for rechargingbattery only)	Similar: Subject and primary predicate canbe connected by USB. Both predicatesalso have wireless connections.
Alarm	No alarms	No alarms	No alarms	Same
Use Life	3 years	3 years	Not stated in 510(k)summary or user manual	Same: Subject and primary predicate arethe same.
Physical dimension(mm) / weight (kg)	H x W x L: 2.40in x 2.5in x 5.00in (61 x 64 x127mm)	145mm (L) x 80mm (W) x 25mm (H)(w/o NIBP cuff)	Not stated (from UserManual and websitepictures - about 3 x 6 x 3in.)	Similar: Subject and both predicates aresimilar sizes.
Weight	5.75oz (163g)	8.8 oz (250g) (w/o NIBP cuff)	Not stated	Similar: Subject and primary predicate aresimilar.
Display	Display on patient-supplied mobile computingplatform (computer, laptop, tablet,smartphone)	3.66 inch	Display on patient-suppliedtablet or smartphone	Similar. Subject device can be displayedon a laptop or other computer screen,thereby providing even larger display
Type, Degree ofprotections againstelectric shock	Type BF applied part	Class II with internal electric powersupply.SpO2/NIBP/TEMP: Type BF appliedpart.	Type BF	Same
OperatingTemperature	61°F to 104°F (16°C to 40°C)	68°F to 82.4°F (20°C to 28°C)(TEMP, NIBP)51°F to 95°F (5°C to 35°C) (ECG,SpO2)	50°F to 104°F (10°C to40°C)	Subject device operating range is widerthan primary predicate range, particularlyfor TEMP. Secondary predicate has alower end of operating temperature but notnecessary for home use.
Operating RH	20% to 95% non-condensing	40% to 70%	0% to 90%	Ranges are similar with subject device andsecondary device being wider thanprimary predicate. Subject device rangesufficient and more appropriate for homeenvironment.
Characteristic	Subject Device – MedWand™ Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgram ™Stethoscope DES-I(K210736)	Comparison Evaluation
Operating Altitude	Sea level to at least 3,000 m (~10,000 ft)	70 kPa to 106 kPa	1 atm	Subject and primary predicate are same(stated differently), and both meet homeuse standard.
StorageTemperature	-4°F to 122°F (-20°C to 50°C)	-4°F to 140°F (-20°C to 60°C)	-40°F to 131°F (-40°C to55°C)	Similar, differences are slight and noimpact on device use
Storage RH	5% to 95% non-condensing	10% to 95%	15% to 93%	Similar, differences are slight and noimpact on device use
Splash/Water/ DustIngress	IP22 under IEC 60529	IP22 under IEC 60529	Not stated	Same
Electric Safety &EMC StandardApplied	ANSI/AAMI/IEC 60601-1:2005 +C1:2006+C2:2007+A1:2012IEC 60601-1-2:2014IEC 60601-1-11:2015	IEC 60601-1:2005 +C1:2006+C2:2007+A1:2012IEC 60601-1-2:2014IEC 60601-1-11:2015	IEC 60601-1IEC 60601-1-2IEC 60601-1-11	Same (note: secondary predicate didn't listthe years but assume they are the samegiven it's a 2021 clearance)
		Pulse Oximetry Function
Scientific Principle	Detection of light collected from LEDs ofvarying wavelengths through blood tomeasure blood oxygen saturation based onamount of light absorbed by hemoglobin in theblood.	Detection of light collected from LEDsof varying wavelengths through bloodto measure blood oxygen saturationbased on amount of light absorbed byhemoglobin in the blood.	N/A	Same
Sensor geometry	Reflectance	Transmittance	N/A	Different: Both devices meet the particularstandard. Reference predicate K181352with reflectance sensor geometry
SpO2measurementrange & accuracy	Displayed range: 70%~~100%±2% (during 90~~100%),±3% (during 70~89%)	Displayed range: 70%~~100%±2% (during 90~~100%),±4% (during 70~89%)	N/A	Similar, subject device and predicatedevice have same range, both meetstandard, and subject device meets FDAguidance, which is more stringent.
Pulse ratemeasurementrange	25 to 200 bpm	30 to 150 bpm	N/A	Similar, subject device is slightly widerrange.
Pulse rateaccuracy	± 2 bpm or ± 2% (whichever is greater)	± 2 bpm or ± 2% (whichever isgreater)	N/A	Same
Characteristic	Subject Device – MedWand™ Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgram™Stethoscope DES-I(K210736)	Comparison Evaluation
Particular Standard	ISO 80601-2-61:2017	ISO 80601-2-61:2017	N/A	Same
Thermometer Function
Scientific principle	Non-contact infrared technology	Non-contact infrared technology	N/A	Same
Measuring site	Forehead skin over temporal artery	Forehead skin over temporal artery	N/A	Same
Reference Body site	Rectum	Not stated in 510(k) summary or User Manual	N/A	Unknown if different. Reference predicate:Exergen K011291 used for referenceclinical thermometer in clinical study.Subject and reference predicate havesame reference body site -rectum.
Operating mode	Adjusted mode: Device automatically convertssurface IR temp to predicted body temp	Adjusted mode: Device automaticallyconverts surface IR temp to predictedbody temp	N/A	Same
Unit of Measurement	°C or °F	°C or °F	N/A	Same
Temperature resolution	0.1°F or °C	0.1°F or °C	N/A	Same
Temperature measurementrange (body)	93°F~107.6°F (33.9°C ~42.0°C)	93.2°F~109.4°F (34.0°C ~43.0°C)	N/A	Subject and primary predicate haveslightly different body temperaturemeasurement ranges, but subject rangewell covers any expected bodytemperature.
Temperature measurementaccuracy	± 0.5°F (± 0.3°C)	± 0.5°F (± 0.3°C)	N/A	Same
Particular StandardApplied	ISO 80601-2-56:2017	ISO 80601-2-56:2017	N/A	Same
Stethoscope Function
Characteristic	Subject Device – MedWand™ Device	Primary Predicate - Vitals 360(K210086)	Secondary Predicate -doctorgram™Stethoscope DES-I(K210736)	Comparison Evaluation
Frequencyresponse range	5Hz to 1.5kHz	N/A	20 Hz to 2kHz	Different: Subject and predicate havesome minor differences in frequencyrange, but these differences do not raisedifferent issues of safety andeffectiveness.
Selectable audiofilters	Heart (low pass), Lungs (high pass), andAbdomen (wide band pass)	N/A	Heart, Lungs, Bowels(Abdomen), Arteries andveins	Similar: predicate offers one more filterthan subject device.
Signal InputMethod	Sound waves collected via transducer electromicrophone	N/A	Sound waves collected viatransducer electromicrophone	Same
Audio OutputMethod	Headphones recommended	N/A	3.5mm earbud headphone	Same
Data storage	Recorded in MedWand application as WAVfile	N/A	Transmitted wirelessly	Similar
Biological Safety
Materials	Patient & user contact surfaces:polycarbonate/polycarbonate-polybutyleneterephthalate blend	Not stated	Body: ABS (AcrylonitrileButadiene Styrene)	Similar materials - thermoplastics;differences do not raise different issues ofsafety or effectiveness (all meetbiocompatibility).
Biocompatibility forpatient contactingareas	Biocompatible according to:ISO 10993-1ISO 10993-5ISO 10993-10	Biocompatible according to:ISO 10993-1ISO 10993-5ISO 10993-10	Biocompatible according to:ISO 10993-1ISO 10993-5ISO 10993-10	Same
Cleaning/Disinfection	Clean/disinfect between uses and patients. (4commonly available agents recommended)	Clean/disinfect between uses andpatients (recommends 70% ethanol)	Clean/disinfect betweenuses and patients(recommends 70% ethanol)	Same. Subject device recommends 4options instead of 1 for convenience
Sterility	Non-sterile and not intended to be sterilized	Non-sterile and not intended to besterilized	Non-sterile and notintended to be sterilized	Same

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PERFORMANCE DATA

The Sponsor subjected the MedWand™ Device to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, system/bench testing, and biocompatibility. All design control activities were done within the context of the risk management process. These tests verified and validated the proper operation of the system. All patient-contacting components and accessories have been tested to demonstrate appropriate biocompatibility. No part of the system components or accessories are provided sterile or can be sterilized. Cleaning and disinfection instructions are justified and are included in the labeling for the system and accessories. All non-clinical testing required for demonstrating compliance to the applicable particular standards has been successfully conducted. Human factors engineering and usability were evaluated and improved within a risk management process, culminating in a device which can be used safely and effectively according to the intended uses.

CLEANING, DISINFECTION & SHELF-LIFE TESTING

The MedWand™ is a home-use reusable device. The device is not provided sterile and is not intended to be sterilized by users. The device is intended to be cleaned and disinfected between uses and users. Four common EPA-certified cleaning/disinfecting agents that are readily available in the home have been specified for this cleaning/disinfection step.

The Sponsor has validated that the MedWand™ Device can tolerate repeated applications of all four options of cleaning/disinfection agents specified in the User Manual.

The product has a low probability of time-dependent degradation and is not provided sterile. Therefore, the MedWand™ Device and its package do not need a shelf life or expiration date.

The Sponsor validated that in its shelf box and shipping box, the MedWand™ Device and its packaging can tolerate the expected shipping stresses to get the device directly to home use customers.

The User Manual warns users against use of a damaged device and to inspect the device for signs of damage before use. The Sponsor also states the expected use life of the device in the User Manual.

BIOCOMPATIBILITY

The Sponsor evaluated device biocompatibility within the risk management framework and in compliance with ISO 10993 standards. This device evaluation included relevant data sources related to biological safety of finished device testing and component material history of safe biological use and testing. This biocompatibility evaluation establishes the biological safety of patient-contacting surfaces of the MedWandTM Device.

SOFTWARE

The software and firmware in the MedWand™ Device and System, including both customdeveloped firmware and OTS software, have been verified and validated and have been demonstrated to be safe and effective for its intended use. The software is a Moderate Level of Concern (LOC) per FDA guidance. All required items related to software as required by FDA guidance for moderate LOC have been included in this submission.

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ELECTRICAL SAFETY & EMC

The MedWand "M Device complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601 3.1 edition standards, including the ANSI/AAMI/ES60601 with the U.S. deviations, ANSI/AAMI/IEC 60601-1-11:2015, and the 4th edition of collateral standard for EMC, IEC 60601-1-2:2014. The requested information from FDA guidance to support a claim of EMC of electrically powered medical devices has been provided.

ANIMAL STUDIES

No animal studies were conducted to demonstrate performance or substantial equivalence.

CLINICAL STUDIES

Two clinical studies cohorts were conducted and have been included in this submission to demonstrate substantial equivalence. In all cases, the clinical studies were conducted to evaluate one or more MedWand™ Device functions in comparison to cleared, well-established medical devices which perform that function or reference method following FDA recognized standards where applicable.

One clinical study, a controlled hypoxia or desaturation study, was conducted to provide human validation data of pulse oximeters according to ISO 80601-2-61:2017 and FDA guidance on pulse oximeters. The study included fourteen (14) healthy volunteer subjects, ages 21- 40 and 6/14 identified as male (42%) with a range of ethnicities. The 14 subjects had a range of skin tones, including at least 28% (4/14) with dark skin tones, thus exceeding the requirements in the standard and FDA guidance of at least 2 or 15%. Controlled hypoxia was induced with a breathby-breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of hypoxia. Oxygen saturation was determined once with air breathing and then at one of the six (6) levels, e.g., 94%, 90%, 85%, 80%, 75%, and 70% saturation for about 30-60 seconds at each level. During the study, two arterial blood samples were obtained from an indwelling catheter 30 seconds apart at the end of each hypoxic plateau. A total of 327 blood samples were obtained at the saturation plateaus across the span. The blood samples were measured for SaO2 on a cooximeter.

The MedWand pulse oximeter data were taken as 5-second averages at each plateau to arterial blood analysis for comparison. According to equation 1 in ISO 80601-2-61:2017 [1], ARMS for the MedWand SpO2 was calculated for each range of the following SaO2 ranges of 70-80%, 80-90%, 90-100% and 70-100%. The results were 3.00%, 1.62%, 1.37%, and 2.05%, respectively. The MedWand ™ Device met the more stringent required acceptance criteria from the FDA guidance for reflectance pulse oximeters.

To validate the MedWand™ Device thermometer function to a well-established reference clinical thermometer according to ISO 80601-2-56:2017 and to provide additional clinical agreement data for the MedWand™ Device pulse oximeter function with a cleared, wellestablished pulse oximeter, one hundred fifty-eight (158) subjects from an outpatient health clinic were enrolled. Subjects ranged in age from 18 to 81 years old with median of 35 and mean

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of 37 and 64/158 (41%) identified as male. Skin tones ranged from 1 to 6 out of 6 (dark) with a median of 2. Fifty-nine (59) of the one hundred fifty-eight (158) subjects (37%) presented febrile symptoms, thus meeting the requirement of 30-50% being febrile from the associated particular standard for thermometers. Following this particular standard, the first Med Wand temperature replicate was compared to the reference clinical thermometer to evaluate accuracy. The three (3) replicates of MedWand temperature were used to calculate the clinical repeatability. This data was used to calculate clinical bias, limits of agreement, and clinical repeatability, according to the particular standard for thermometers. These data are published in the device user manual. The results are similar to other published temperature data for IR thermometers.

The MedWand Device SpO2 and pulse rate measurements were compared to the cleared pulse oximeter using root-mean-square (RMS) calculation to provide additional clinical agreement data in humans. These results were comparable to other results published for similar devices.

CONCLUSION

The Sponsor believes that the MedWand™ Device is substantially equivalent to its primary and secondary predicate devices. The intended use, general design, and performance characteristics are the same or similar. The primary predicate covers all of the functions except the stethoscope, and the secondary predicate covers the stethoscope function. The minor differences in choice of materials, specifications and characteristics do not raise different issues of safety and effectiveness.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).