Vital Sign Monitoring Sensor (Model :XK300)

K202464 · Xandar Kardian, Inc. · DRT · Apr 26, 2021 · Cardiovascular

Device Facts

• Record ID: K202464
• Device Name: Vital Sign Monitoring Sensor (Model :XK300)
• Applicant: Xandar Kardian, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Apr 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in detection area of within 7 meters. The XK30 also monitors the length of continuous patient motion or absence of patient motion.

Device Story

Device uses Impulse Radio Ultra-Wideband (IR UWB) radar to detect minute chest displacements; converts displacements into heart rate and respiration rate; monitors patient presence/absence and motion within 7-meter radius. Used in general care hospitals, nursing homes, and home settings; provides data to inform patient care. Healthcare providers view output to monitor patient status; device does not provide acute treatment. Benefits include non-contact vital sign monitoring and motion tracking.

Clinical Evidence

Bench testing only. Testing included IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/62366-1 (usability), IEC 60601-1-11 (home healthcare environment), IEC 62304 (software lifecycle), and environmental testing (shock/vibration). Software validation and usability testing confirmed device performance meets design specifications.

Technological Characteristics

Impulse Radio Ultra-Wideband (IR UWB) radar sensor. Measures chest displacement for heart/respiration rate. Connectivity via USB micro-B cable. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 62366-1, 62304, and IEC 60068 series for environmental testing.

Indications for Use

Indicated for adult patients in general care hospital environments, nursing homes, and home healthcare settings for heart rate and respiration rate monitoring, patient presence/absence detection, and motion monitoring. Not for acute treatment.

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

• Patient Assessment Monitor (PAM™3000) (K082626)

Submission Summary (Full Text)

{0}------------------------------------------------

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

April 26, 2021

Xandar Kardian Inc. % Brennan Sullivan Official Correspondent Alira Health 1 Grant Street Suite 400 Framingham, Massachusetts 01702

Re: K202464

Trade/Device Name: Vital Sign Monitoring Sensor (Model: XK300) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: DRT Dated: March 24, 2021 Received: March 25, 2021

Dear Brennan Sullivan:

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K202464

#### Device Name

Common Name: Heart Rate and Respiration Rate Monitor Classification Name: Monitor, Cardiotachometer & Rate Alarm) & Monitor, Breathing Frequency Trade Name: Vital Sign Monitoring Sensor (Model: XK300)

#### Indications for Use (Describe)

The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in detection area of within 7 meters. The XK30 also monitors the length of continuous patient motion or absence of patient motion.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <b> <span style="font-family: Symbol;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

{3}------------------------------------------------

# 510(k) Summary for the Xandar Kardian Vital Signs Monitoring Sensor (per 21CFR 807.XXX)

### Date: August 26, 2020 1. 510K Applicant / Submitter:

Xandar Kardian Inc. #309, Seongsuil-Ro 10-Gil Seongdong-gu, Seoul. 04793 Republic of Korea Tel: [phone] Email: sam(@xkcorp.com Website: https://xkcorp.com/

### 2. Submission Contact Person

Brennan Sullivan 1 Grant Street, Suite 400 Framingham, MA 01702 Tel: [phone] E-mail: brennan.sullivan(@alirahealth.com

### 3. Subject Device

Trade Name: Vital Sign Monitoring Sensor (Model: XK300) Classification Name: Monitor, Cardiac (incl Cardiotachometer & Rate Alarm) & Monitor, Breathing Frequency Regulation Number: 21 CFR 872.2300 & 868.2375 Regulation Name: Heart Rate and Respiration Rate Monitor Regulatory Class: II Product Code: DRT & BZQ

#### 4. Predicate Device

Trade Name: Patient Assessment Monitor (PAM™3000) 510(k) Number: K082626 Classification Name: Monitor, Cardiac (incl Cardiotachometer & Rate Alarm) & Monitor, Breathing Frequency Regulation Number: 21 CFR 872.2300 & 868.2375 Regulation Name: Heart Rate and Respiration Rate Monitor

{4}------------------------------------------------

Regulatory Class: II Product Code: DRT & BZQ

## 5. Description:

The Vital Sign Monitoring Sensor (Model XK300) measures heart rate, respiratory rate (breathing rate), and movement of people with very little or no movement (rest mode) using Impulse Radio Ultra-Wideband (IR UWB) radar technology. The heart rate and respiratory rate are measured by detecting minute displacements of the chest and converting the movement into the number of breaths and heart beats per minute. Figure 5-1 is a representative graph produced by the Vital Sign Monitoring Sensor.

Image /page/4/Figure/3 description: The image shows a graph of a vital signal over time. The x-axis represents time in seconds, ranging from 0 to 20. The y-axis represents the signal strength, ranging from -3x10^4 to 2x10^4. The graph shows a periodic signal, which is described as a signal from respiration and heartbeat measured by sensors.

### 6. Indications for Use

The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in a detection area of within 7 meters. The XK300 also monitors the length of continuous patient motion or absence of patient motion.

# 7. Substantial Equivalence Discussion:

The Vital Sign Monitoring Sensor (VSMS) (Model XK300) is substantially equivalent to the Wireless 2000 RF & UWB Technologies Ltd. Patient Assessment Monitor (PAM 3000) subject of K082626 in both indications for use and technological characteristics.

The Vital Sign Monitoring Sensor (Model XK300) has similiar indications for use as the predicate device in that they are both indicated to measure heart rate and respiration rate in adult patients in a general care hospital environment including, nursing homes. Both devices also monitor the presence of a patient in bed (bed exit). Unlike the PAM 3000, the Vital Sign Monitoring System can also be used in a home to collect data but may not be used to acutely treat a patient. This additional indication is only used to inform treatment. The subject device and predicate device differ in heart rate measurement range and respiratory

{5}------------------------------------------------

measurement range in that the XK300 has a radius of up to 7 meters. However, performance testing has confirmed that this difference does not affect the performance of the Vital Signs Monitoring Sensor. Table 5-1 compares the indications for use and characteristics of Vital Signs Monitoring System with the predicate.

| | Candidate Device | Predicate Device | Comparis<br>on |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| 510(k) Number | K202464 | K082626 | - |
| Device Name | Vital Sign Monitoring Sensor<br>(Model: XK300) | Patient Assessment Monitor<br>(PAM™3000) | - |
| Common Name | Heart Rate and Respiration Rate<br>Monitor | Heart Rate and Respiration Rate<br>Monitor | - |
| Manufacturer | XANDAR KARDIAN INC. | Wireless 2000 RF & UWB<br>Technologies Ltd. | - |
| Intended Use | The Vital Sign Monitoring Sensor<br>(Model XK300) is intended to<br>measure heart rate and respiration<br>rate in adult patients in a general<br>care hospital environment including<br>nursing homes. The Vital Sign<br>Monitoring Sensor can be used for<br>home healthcare for data collection<br>to inform patient care but not to<br>acutely treat a patient. XK300<br>monitors the presence or absence of<br>a patient in a detection area of<br>within 7 meters. The XK300 also<br>monitors the length of continuous<br>patient motion or absence of patient<br>motion. | The PAM™3000 system is<br>intended to measure heart rate and<br>respiration rate in adult patients, in<br>a general care hospital environment<br>including nursing homes. The<br>system will also monitor presence<br>or absence of a patient in bed (bed<br>exit). | Same |
| Component | Sensor<br>USB micro b cable | Bed Sensor Panel<br>Repeater Base Stations<br>Central Computer Station<br>Central Base Station | Different |
| Patient Type | Adult | Adult | Same |
| Use<br>Environment | General Care Hospital Environment<br>including Nursing Homes | General Care Hospital Environment<br>including Nursing Homes | Same |
| Heart Rate<br>Measurement<br>Range | 60-120 beats per minute | Normal: 45-115 beats per minute<br>Elevated: 85-170 beats per minute | Different |
| Respiratory<br>Rate<br>Measurement<br>Range | 6-55 breaths per minute | Normal: 3-30 breaths per minute<br>Elevated: 3-50 breaths per minute | Different |

| Table 5-1: Side by Side Comparison Table of Vital Sign Monitoring System with PAM3000 | | | |
|---------------------------------------------------------------------------------------|--|--|--|
| | | | |

# 8. Performance Tests (Non-clinical)

{6}------------------------------------------------

The following testing has been performed using the XK 300:

- IEC 60601-1:2005/A1:2012 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-6:2010/A1:2013 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering . to medical devices
- IEC 62304:2006/A1:2015 Medical device software Software life cycle processes ●
- IEC 60068-2-27:2008 Environmental testing Part 2-27: Tests Test Ea and ● guidance: Shock
- . IEC 60068-2-6:2007 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)
- IEC 60068-2-34:2008/A1:2019 Environmental testing Part 2-64: Tests Test Fh: . Vibration, broadband random and guidance

In addition to the testing above, software validation and usability testing were also conducted. This testing showed that the XK300 performed and functioned as intended and according to the design specifications.

# 9. Conclusion:

Based on the information provided in this 510(k) premarket notification, Xandar Kardian Inc. concludes that the Vital Sign Monitoring Sensor (Model XK300) is substantially equivalent to the Patient Assessment Monitor (PAM™3000) (K082626) predicate device.