(308 days)
No
The summary describes a device that collects vital signs and images/sounds for remote interpretation by a healthcare professional. There is no mention of any algorithms or processing within the device or its associated software that would suggest the use of AI or ML for analysis, interpretation, or diagnosis. The performance studies focus on the accuracy of the vital sign measurements compared to reference methods and predicate devices, not on the performance of any AI/ML model.
No
The device is intended for measurement and collection of vital signs and examination information, not for treatment or therapy.
No
The device is intended for collecting, recording, and displaying vital sign information (oxygen saturation, pulse rate, infrared body temperature, auscultation sounds, and photographs), which is then provided to a healthcare professional (HCP) for interpretation and assessment. The "Intended Use" specifically states, "Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP." This indicates it gathers data for diagnosis by an HCP, rather than performing the diagnosis itself.
No
The device description explicitly states that the MedWand™ Device includes embedded firmware and is a handheld telemedicine device with physical sensors (SpO2, thermometer, camera, stethoscope). While it relies on software for operation and communication, it is not solely software.
Based on the provided information, the MedWand™ Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- MedWand™ Device Function: The MedWand™ Device measures vital signs (SpO2, pulse rate, temperature) and collects physical examination data (auscultation sounds, photographs) directly from the patient's body. It does not analyze specimens in vitro.
- Intended Use: The intended use clearly states the device is for collecting, recording, and displaying vital sign and examination information. It explicitly states that collected information is not intended for self-diagnosis and interpretation should be performed by an HCP. This aligns with a device used for physical assessment and data collection, not laboratory analysis of specimens.
Therefore, the MedWand™ Device falls under the category of a medical device used for physical examination and vital sign monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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)
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, FLL, DQD, ERA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CAMERA (Photographs)
Anatomical Site
Oxygen saturation (SpO2) and pulse rate (PR) are measured from the finger.
Infrared body temperature (TEMP) is measured from the forehead.
Amplified auscultation sounds (STETH) are collected from the heart, lungs, and abdomen (chest or abdomen).
Photographs (CAMERA) are taken of "areas needing assessment."
Indicated Patient Age Range
Adults
The MedWand™ Device is intended for use by trained adults only.
Intended User / Care Setting
Intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical 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
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. Controlled hypoxia was induced with a breath-by-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.
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, well-established 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 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. Following this particular standard, the first MedWand 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies cohorts were conducted 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.
-
Controlled hypoxia or desaturation study (SpO2 validation):
- Study Type: Clinical study for pulse oximeter validation.
- Sample Size: Fourteen (14) healthy volunteer subjects.
- Key Results: According to equation 1 in ISO 80601-2-61:2017, 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.
-
Outpatient health clinic study (Thermometer and Pulse Oximeter clinical agreement):
- Study Type: Clinical study for thermometer function validation and additional clinical agreement data for pulse oximeter function.
- Sample Size: One hundred fifty-eight (158) subjects.
- Key Results (Thermometer): Clinical bias, limits of agreement, and clinical repeatability were calculated. These data are published in the device user manual and are similar to other published temperature data for IR thermometers.
- Key Results (SpO2 and PR): 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 ARMS: 3.00% (70-80% SaO2), 1.62% (80-90% SaO2), 1.37% (90-100% SaO2), 2.05% (70-100% SaO2).
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.
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.
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
§ 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).
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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
1
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)
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)
Prescription Use (Part 21 CFR 801 Subpart D) |
---|
Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Vista
Rancho Santa Margarita, CA 92688 USA |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Natalie J. Kennel
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129 USA
Phone: (858) 705-0350
Fax: (858) 764-9739
Email: 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:
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)
4
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)
Holder | Clearance Date | Scope of safety and
effectiveness comparison |
|---------|-----------------------------------------------|------------------|----------------|-----------------------------------------------------------------------------|
| K210086 | Vitals360® Multi-
Vitals Mobile
Monitor | VoCare,
Inc. | May 20, 2021 | Primary predicate (covers
all functions but
stethoscope) |
| K210736 | Doctorgram
Stethoscope DES I | GV
Concepts | July 27, 2021 | Secondary predicate
(covers stethoscope
function) |
| K181352 | Loop System | Spry Health | March 29, 2019 | Reflectance sensor
geometry for SpO2 |
| K011291 | Exergen TAT
thermometer | Exergen | July 12, 2001 | Reference clinical
thermometer (same
reference body site -
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.
5
The MedWand™ Device works as part of the MedWand™ Ecosystem. The MedWand™ Ecosystem consists for following elements:
-
- MedWand™ Device including its embedded firmware This device is provided to the patient or other user who is physically present with the patient.
-
- 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
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
6
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 |
| Classification
Regulation | 21 CFR 870.2300
21 CFR 870.1875 | 21 CFR 870.2300 | 21 CFR 870.1875 | Subject device covered by combination of
predicates, with secondary predicate
covering the stethoscope. |
| Classification and
Code | Class II
MWI, DQA, DQD, FLL, ERA | Class II
MWI, DQA, DSH, DXN, FLL | Class II
DQD | Subject device covered by combination of
predicates. Subject device does not have
NIBP so DXN code is not applicable.
Secondary predicate covers DQD. ERA –
510(k) exempt. |
| Common name | Multi-function vital signs device (patient
monitor) | Multi-function vital signs device
(patient monitor) | Electronic stethoscope | Subject device and primary predicate are
the same. The secondary predicate covers
the stethoscope function. |
| Intended Use | Multi-function device that measures, displays,
records, and provides vital signs in home and
non-acute clinical environments and to remote
HCP | Multi-function device that measures,
displays, records, and provides vital
signs in home and non-acute clinical
environments and to remote HCP | Electronic stethoscope that
measures, records, and
provides these sounds to
remote HCP | Subject device and primary predicate have
same intended use. Secondary predicate
covers the same intended use but only
with 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 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 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. | Vitals360® device is intended to be
used for measuring, displaying,
reviewing, and storing of non-invasive
blood pressure (NIBP), non-invasive
monitoring of functional oxygen
saturation of arterial hemoglobin
(SpO2), pulse rate (PR), forehead
temperature (TEMP), ECG, weight
and height in adults no less than 18
years of age.
This VITALS360® device is intended
for use by trained adults only who can
use smartphones proficiently.
This VITALS360® device is intended
for use in a clinical or home
environment.
This VITALS360® device is a
reusable device following thorough
cleaning between uses. | The doctorgram™
Stethoscope DES-I is an
electronic stethoscope that
enables amplification,
filtering, and transmission
of auscultation sound data
(heart, lungs, bowel,
arteries, and veins),
whereby a clinician at one
location on network can
listen to the auscultation
sounds of a patient on site
or at a different location on
the network. The
doctorgram™ Stethoscope
DES-I is intended for use
on pediatric and adult
patients. The doctorgram™
Stethoscope DES-I is
intended to be used by
professional users in a
clinical environment or by
lay users in a nonclinical
environment. The device is
not intended for self-
diagnosis. | Subject device and primary and secondary
predicates have similar indications for use
in regard to users and use environment.
Both subject and primary predicate
provide the functions of temperature,
SpO2, and pulse rate. The primary
predicate has functions for capturing
NIBP, ECG, weight, and height, which the
subject device does not do. The subject
device and secondary device have a
stethoscope function.
Subject device is substantially equivalent
to the predicate devices' indications for
use. |
| Characteristic | Subject Device – MedWandTM Device | Primary Predicate - Vitals 360
(K210086) | Secondary Predicate -
doctorgramTM
Stethoscope DES-I
(K210736) | Comparison Evaluation |
| | | General Device Characteristics | | |
| Parameters
Monitored | Blood oxygen saturation (SpO2) and pulse
rate (PR) non-invasively by the photoelectric
method.
Body temperature (TEMP) by the infrared
radiation energy technology. | Blood oxygen saturation (SpO2) and
pulse rate (PR) non-invasively by the
photoelectric method.
Non-invasive blood pressure (NIBP,
the pressures of systolic and
diastolic) by the oscillating method.
Body temperature (TEMP) by the
infrared radiation energy technology.
Additionally, it can record single lead
ECG signal. | Amplified auscultation
sounds filtered for heart,
lungs, abdomen, and
arteries and veins | Subject device and primary device both
can measure SpO2, PR, and TEMP.
Subject device and secondary device both
can measure amplified auscultation
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
clinic | Same |
| Rx or OTC | Rx | Rx | OTC | Subject device and primary predicates are
both prescription use only. |
| Platform for
software | Windows based computer, laptop or Android
tablet or smartphone | Smart phone or tablet (iPhone or
Android) | Mobile computing platform
with iOS smartphone or
tablet | Similar. Subject device has a client app
software for both Windows and Android
based computing platforms whereas
primary predicate has only iOS- and
Android-based capabilities, and secondary
predicate has only iOS. Differences do not
raise different issues of safety or
effectiveness. |
| Power Supply | Supplied by the patient-supplied mobile
computing platform via USB cord | Battery or AC | Battery | Different: Subject device receives power
from computing platform. Subject and both
predicates meet electrical safety, so this
difference does not raise different issues
of safety or effectiveness. |
| Power requirement | 5 V, 2.0A | (100-240) VAC, 50/60Hz, 0.5A,
Rechargeable lithium battery,
3.7VDC | Rechargeable lithium
battery,
3.7VDC | Similar: Subject and both predicates are
low 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 Smart
wireless data link | Bluetooth Smart wireless
data link
(USB Type C for recharging
battery only) | Similar: Subject and primary predicate can
be connected by USB. Both predicates
also 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 are
the same. |
| Physical dimension
(mm) / weight (kg) | H x W x L: 2.40in x 2.5in x 5.00in (61 x 64 x
127mm) | 145mm (L) x 80mm (W) x 25mm (H)
(w/o NIBP cuff) | Not stated (from User
Manual and website
pictures - about 3 x 6 x 3
in.) | Similar: Subject and both predicates are
similar sizes. |
| Weight | 5.75oz (163g) | 8.8 oz (250g) (w/o NIBP cuff) | Not stated | Similar: Subject and primary predicate are
similar. |
| Display | Display on patient-supplied mobile computing
platform (computer, laptop, tablet,
smartphone) | 3.66 inch | Display on patient-supplied
tablet or smartphone | Similar. Subject device can be displayed
on a laptop or other computer screen,
thereby providing even larger display |
| Type, Degree of
protections against
electric shock | Type BF applied part | Class II with internal electric power
supply.
SpO2/NIBP/TEMP: Type BF applied
part. | Type BF | Same |
| Operating
Temperature | 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 to
40°C) | Subject device operating range is wider
than primary predicate range, particularly
for TEMP. Secondary predicate has a
lower end of operating temperature but not
necessary for home use. |
| Operating RH | 20% to 95% non-condensing | 40% to 70% | 0% to 90% | Ranges are similar with subject device and
secondary device being wider than
primary predicate. Subject device range
sufficient and more appropriate for home
environment. |
| 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 same89%) | Displayed range: 70%
(stated differently), and both meet home
use standard. |
| Storage
Temperature | -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 to
55°C) | Similar, differences are slight and no
impact on device use |
| Storage RH | 5% to 95% non-condensing | 10% to 95% | 15% to 93% | Similar, differences are slight and no
impact on device use |
| Splash/Water/ Dust
Ingress | IP22 under IEC 60529 | IP22 under IEC 60529 | Not stated | Same |
| Electric Safety &
EMC Standard
Applied | ANSI/AAMI/IEC 60601-1:2005 +C1:2006
+C2:2007+A1:2012
IEC 60601-1-2:2014
IEC 60601-1-11:2015 | IEC 60601-1:2005 +C1:2006
+C2:2007+A1:2012
IEC 60601-1-2:2014
IEC 60601-1-11:2015 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | Same (note: secondary predicate didn't list
the years but assume they are the same
given it's a 2021 clearance) |
| | | Pulse Oximetry Function | | |
| Scientific Principle | Detection of light collected from LEDs of
varying wavelengths through blood to
measure blood oxygen saturation based on
amount of light absorbed by hemoglobin in the
blood. | Detection of light collected from LEDs
of varying wavelengths through blood
to measure blood oxygen saturation
based on amount of light absorbed by
hemoglobin in the blood. | N/A | Same |
| Sensor geometry | Reflectance | Transmittance | N/A | Different: Both devices meet the particular
standard. Reference predicate K181352
with reflectance sensor geometry |
| SpO2
measurement
range & accuracy | Displayed range: 70%100%100%),
±2% (during 90
±3% (during 70100%100%),
±2% (during 90
±4% (during 7089%) | N/A | Similar, subject device and predicate107.6°F (33.9°C
device have same range, both meet
standard, and subject device meets FDA
guidance, which is more stringent. |
| Pulse rate
measurement
range | 25 to 200 bpm | 30 to 150 bpm | N/A | Similar, subject device is slightly wider
range. |
| Pulse rate
accuracy | ± 2 bpm or ± 2% (whichever is greater) | ± 2 bpm or ± 2% (whichever is
greater) | 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 reference
clinical thermometer in clinical study.
Subject and reference predicate have
same reference body site -rectum. |
| Operating mode | Adjusted mode: Device automatically converts
surface IR temp to predicted body temp | Adjusted mode: Device automatically
converts surface IR temp to predicted
body 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 measurement
range (body) | 93°F42.0°C) | 93.2°F109.4°F (34.0°C ~43.0°C) | N/A | Subject and primary predicate have
slightly different body temperature
measurement ranges, but subject range
well covers any expected body
temperature. |
| Temperature measurement
accuracy | ± 0.5°F (± 0.3°C) | ± 0.5°F (± 0.3°C) | N/A | Same |
| Particular Standard
Applied | 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 |
| Frequency
response range | 5Hz to 1.5kHz | N/A | 20 Hz to 2kHz | Different: Subject and predicate have
some minor differences in frequency
range, but these differences do not raise
different issues of safety and
effectiveness. |
| Selectable audio
filters | Heart (low pass), Lungs (high pass), and
Abdomen (wide band pass) | N/A | Heart, Lungs, Bowels
(Abdomen), Arteries and
veins | Similar: predicate offers one more filter
than subject device. |
| Signal Input
Method | Sound waves collected via transducer electro
microphone | N/A | Sound waves collected via
transducer electro
microphone | Same |
| Audio Output
Method | Headphones recommended | N/A | 3.5mm earbud headphone | Same |
| Data storage | Recorded in MedWand application as WAV
file | N/A | Transmitted wirelessly | Similar |
| Biological Safety | | | | |
| Materials | Patient & user contact surfaces:
polycarbonate/polycarbonate-polybutylene
terephthalate blend | Not stated | Body: ABS (Acrylonitrile
Butadiene Styrene) | Similar materials - thermoplastics;
differences do not raise different issues of
safety or effectiveness (all meet
biocompatibility). |
| Biocompatibility for
patient contacting
areas | Biocompatible according to:
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Biocompatible according to:
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Biocompatible according to:
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
| Cleaning/
Disinfection | Clean/disinfect between uses and patients. (4
commonly available agents recommended) | Clean/disinfect between uses and
patients (recommends 70% ethanol) | Clean/disinfect between
uses and patients
(recommends 70% ethanol) | Same. Subject device recommends 4
options instead of 1 for convenience |
| Sterility | Non-sterile and not intended to be sterilized | Non-sterile and not intended to be
sterilized | Non-sterile and not
intended 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.