MedWand

K212975 · Medwand Solutions, Inc. · MWI · Jul 22, 2022 · Cardiovascular

Device Facts

• Record ID: K212975
• Device Name: MedWand
• Applicant: Medwand Solutions, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

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 Story

Handheld telemedicine device; inputs include SpO2/pulse rate (photoelectric sensor), forehead temperature (non-contact IR), auscultation sounds (transducer microphone), and visual images (camera). Device connects via USB-C to user-supplied mobile/computing platform (MCP) running proprietary Client App. App manages session, displays readings, and records data. Stethoscope sounds filtered for heart, lungs, abdomen. Used in home/non-acute clinical settings by lay users or HCPs. Data transmitted to remote HCP via telemedicine integration. Benefits include remote patient assessment and spot-checking vital signs without continuous monitoring.

Clinical Evidence

Two clinical studies conducted. 1) Controlled hypoxia study (n=14) validated SpO2 accuracy per ISO 80601-2-61:2017; ARMS results: 3.00% (70-80%), 1.62% (80-90%), 1.37% (90-100%), 2.05% (70-100%). 2) Outpatient clinic study (n=158, ages 18-81) validated thermometer accuracy and pulse oximeter agreement against cleared devices; 37% of subjects were febrile. Results demonstrated clinical bias, limits of agreement, and repeatability consistent with standards.

Technological Characteristics

Handheld device; polycarbonate/PBT blend housing. Sensing: photoelectric (SpO2/PR), non-contact IR (temp), transducer microphone (stethoscope). Connectivity: USB-C to MCP. Power: 5V/2.0A via host. IP22 ingress protection. Biocompatible per ISO 10993-1/5/10. Non-sterile. Software: Moderate LOC.

Indications for Use

Indicated for adult patients in home and non-acute clinical settings for intermittent measurement of SpO2, pulse rate, infrared forehead temperature, amplified auscultation sounds (heart, lungs, abdomen), and visual assessment via camera. Intended for use by trained adults proficient with mobile/computing devices. Not for self-diagnosis; requires HCP interpretation. No continuous monitoring or alarms.

Regulatory Classification

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.

Predicate Devices

• Vitals360® Multi-Vitals Mobile Monitor (K210086)
• Doctorgram Stethoscope DES I (K210736)
• Loop System (K181352)

Reference Devices

• Exergen TAT thermometer (K011291)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------|
| <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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.<br>23162 Arroyo Vista<br>Rancho Santa Margarita, CA 92688 USA |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Natalie J. Kennel<br>Consultant<br>NJK & Associates, Inc.<br>13721 Via Tres Vista<br>San Diego, CA 92129 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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:

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)

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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.

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.

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)<br>Holder | Clearance Date | Scope of safety and<br>effectiveness comparison |
|---------|-----------------------------------------------|------------------|----------------|-----------------------------------------------------------------------------|
| K210086 | Vitals360® Multi-<br>Vitals Mobile<br>Monitor | VoCare,<br>Inc. | May 20, 2021 | Primary predicate (covers<br>all functions but<br>stethoscope) |
| K210736 | Doctorgram<br>Stethoscope DES I | GV<br>Concepts | July 27, 2021 | Secondary predicate<br>(covers stethoscope<br>function) |
| K181352 | Loop System | Spry Health | March 29, 2019 | Reflectance sensor<br>geometry for SpO2 |
| K011291 | Exergen TAT<br>thermometer | Exergen | July 12, 2001 | Reference clinical<br>thermometer (same<br>reference body site -<br>rectum) |

#### Table 1 Predicate and Reference Device Information

# PRODUCT 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.

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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.
- 2. 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
- 3. 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.
- 4. 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.
- 5. 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.
- 6. 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.
- 7. 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<br>(K210086) | Secondary Predicate -<br>doctorgram™<br>Stethoscope DES-I<br>(K210736) | Comparison Evaluation |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | MedWand Solutions, Inc. | VoCare, Inc. | GV Concepts | N/A |
| Classification<br>Regulation | 21 CFR 870.2300<br>21 CFR 870.1875 | 21 CFR 870.2300 | 21 CFR 870.1875 | Subject device covered by combination of<br>predicates, with secondary predicate<br>covering the stethoscope. |
| Classification and<br>Code | Class II<br>MWI, DQA, DQD, FLL, ERA | Class II<br>MWI, DQA, DSH, DXN, FLL | Class II<br>DQD | Subject device covered by combination of<br>predicates. Subject device does not have<br>NIBP so DXN code is not applicable.<br>Secondary predicate covers DQD. ERA –<br>510(k) exempt. |
| Common name | Multi-function vital signs device (patient<br>monitor) | Multi-function vital signs device<br>(patient monitor) | Electronic stethoscope | Subject device and primary predicate are<br>the same. The secondary predicate covers<br>the stethoscope function. |
| Intended Use | Multi-function device that measures, displays,<br>records, and provides vital signs in home and<br>non-acute clinical environments and to remote<br>HCP | Multi-function device that measures,<br>displays, records, and provides vital<br>signs in home and non-acute clinical<br>environments and to remote HCP | Electronic stethoscope that<br>measures, records, and<br>provides these sounds to<br>remote HCP | Subject device and primary predicate have<br>same intended use. Secondary predicate<br>covers the same intended use but only<br>with a stethoscope. |
| Characteristic | Subject Device – MedWand™ Device | Primary Predicate - Vitals 360<br>(K210086) | Secondary Predicate -<br>doctorgram™<br>Stethoscope DES-I<br>(K210736) | Comparison Evaluation |
| Indications for Use | The MedWand™ Device, in combination with<br>the MedWand™ Software Application installed<br>on an attached mobile device or computing<br>system, is an intermittent vital sign measuring<br>and examination system intended to collect,<br>record, and display the following information:<br>Oxygen saturation (SpO2) Pulse rate (PR),<br>Infrared body temperature (TEMP), Amplified<br>auscultation sounds filtered for heart, lungs,<br>and abdomen (STETH), Photographs of areas<br>needing assessment (CAMERA).<br>The device is intended for use by adult lay<br>users independently or guided by a health<br>care professional (HCP) in home and non-<br>acute clinical environments. The MedWand™<br>Device is intended for use by trained adults<br>only who can use smart phones, tablets, or<br>computers proficiently. Collected information<br>is not intended for self-diagnosis.<br>Interpretation and assessment of results<br>should be performed by an HCP. Collected<br>information can be provided to an HCP when<br>used as a standalone device.<br>Additionally, the MedWand™ Device can<br>integrate with external data communications<br>systems (not part of the MedWand™ Device)<br>through a programming interface. This<br>integration will facilitate interactions between<br>the lay user and HCP for telemedicine. The<br>device is intended for spot-checking and does<br>not have continuous monitoring capability or<br>alarm features. | Vitals360® device is intended to be<br>used for measuring, displaying,<br>reviewing, and storing of non-invasive<br>blood pressure (NIBP), non-invasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2), pulse rate (PR), forehead<br>temperature (TEMP), ECG, weight<br>and height in adults no less than 18<br>years of age.<br>This VITALS360® device is intended<br>for use by trained adults only who can<br>use smartphones proficiently.<br>This VITALS360® device is intended<br>for use in a clinical or home<br>environment.<br>This VITALS360® device is a<br>reusable device following thorough<br>cleaning between uses. | The doctorgram™<br>Stethoscope DES-I is an<br>electronic stethoscope that<br>enables amplification,<br>filtering, and transmission<br>of auscultation sound data<br>(heart, lungs, bowel,<br>arteries, and veins),<br>whereby a clinician at one<br>location on network can<br>listen to the auscultation<br>sounds of a patient on site<br>or at a different location on<br>the network. The<br>doctorgram™ Stethoscope<br>DES-I is intended for use<br>on pediatric and adult<br>patients. The doctorgram™<br>Stethoscope DES-I is<br>intended to be used by<br>professional users in a<br>clinical environment or by<br>lay users in a nonclinical<br>environment. The device is<br>not intended for self-<br>diagnosis. | Subject device and primary and secondary<br>predicates have similar indications for use<br>in regard to users and use environment.<br>Both subject and primary predicate<br>provide the functions of temperature,<br>SpO2, and pulse rate. The primary<br>predicate has functions for capturing<br>NIBP, ECG, weight, and height, which the<br>subject device does not do. The subject<br>device and secondary device have a<br>stethoscope function.<br>Subject device is substantially equivalent<br>to the predicate devices' indications for<br>use. |
| Characteristic | Subject Device – MedWandTM Device | Primary Predicate - Vitals 360<br>(K210086) | Secondary Predicate -<br>doctorgramTM<br>Stethoscope DES-I<br>(K210736) | Comparison Evaluation |
| | | General Device Characteristics | | |
| Parameters<br>Monitored | Blood oxygen saturation (SpO2) and pulse<br>rate (PR) non-invasively by the photoelectric<br>method.<br>Body temperature (TEMP) by the infrared<br>radiation energy technology. | Blood oxygen saturation (SpO2) and<br>pulse rate (PR) non-invasively by the<br>photoelectric method.<br>Non-invasive blood pressure (NIBP,<br>the pressures of systolic and<br>diastolic) by the oscillating method.<br>Body temperature (TEMP) by the<br>infrared radiation energy technology.<br>Additionally, it can record single lead<br>ECG signal. | Amplified auscultation<br>sounds filtered for heart,<br>lungs, abdomen, and<br>arteries and veins | Subject device and primary device both<br>can measure SpO2, PR, and TEMP.<br>Subject device and secondary device both<br>can measure amplified auscultation<br>sounds 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-acute<br>clinic | Same |
| Rx or OTC | Rx | Rx | OTC | Subject device and primary predicates are<br>both prescription use only. |
| Platform for<br>software | Windows based computer, laptop or Android<br>tablet or smartphone | Smart phone or tablet (iPhone or<br>Android) | Mobile computing platform<br>with iOS smartphone or<br>tablet | Similar. Subject device has a client app<br>software for both Windows and Android<br>based computing platforms whereas<br>primary predicate has only iOS- and<br>Android-based capabilities, and secondary<br>predicate has only iOS. Differences do not<br>raise different issues of safety or<br>effectiveness. |
| Power Supply | Supplied by the patient-supplied mobile<br>computing platform via USB cord | Battery or AC | Battery | Different: Subject device receives power<br>from computing platform. Subject and both<br>predicates meet electrical safety, so this<br>difference does not raise different issues<br>of safety or effectiveness. |
| Power requirement | 5 V, 2.0A | (100-240) VAC, 50/60Hz, 0.5A,<br>Rechargeable lithium battery,<br>3.7VDC | Rechargeable lithium<br>battery,<br>3.7VDC | Similar: Subject and both predicates are<br>low voltage, low power requiring devices. |
| Characteristic | Subject Device – MedWand™ Device | Primary Predicate - Vitals 360<br>(K210086) | Secondary Predicate -<br>doctorgram™<br>Stethoscope DES-I<br>(K210736) | Comparison Evaluation |
| Connection | USB Type C cord (included)…