(242 days)
Not Found
No
The summary describes a device using radar technology to measure physiological parameters based on physical displacement, with no mention of AI/ML terms, training/test data, or performance metrics typically associated with AI/ML models.
No
The device is intended to monitor heart rate and respiration rate and collect data, not to provide therapy or directly treat a patient.
No
The device measures vital signs (heart rate, respiration rate) and patient presence/motion, and is intended for data collection to inform patient care, but not for acute treatment or diagnosis.
No
The device description explicitly states it uses Impulse Radio Ultra-Wideband (IR UWB) radar technology to measure vital signs, indicating it includes hardware components beyond just software. The performance studies also include hardware-related standards (e.g., IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vital Sign Monitoring Sensor (Model XK300) measures physiological parameters (heart rate, respiration rate, movement) directly from the patient's body using radar technology. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring vital signs and patient presence/motion, not performing diagnostic tests on biological samples.
Therefore, the XK300 falls under the category of a vital signs monitor, which is a different type of medical device than an IVD.
N/A
Intended Use / 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.
Product codes
DRT, BZQ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Impulse Radio Ultra-Wideband (IR UWB) radar technology
Anatomical Site
Chest
Indicated Patient Age Range
adult patients
Intended User / Care Setting
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.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +82-70-8822-0309 Email: sam(@xkcorp.com Website: https://xkcorp.com/
2. Submission Contact Person
Brennan Sullivan 1 Grant Street, Suite 400 Framingham, MA 01702 Tel: 617.678.1028 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
on |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| 510(k) Number | K202464 | K082626 | - |
| Device Name | Vital Sign Monitoring Sensor
(Model: XK300) | Patient Assessment Monitor
(PAM™3000) | - |
| Common Name | Heart Rate and Respiration Rate
Monitor | Heart Rate and Respiration Rate
Monitor | - |
| Manufacturer | XANDAR KARDIAN INC. | Wireless 2000 RF & UWB
Technologies Ltd. | - |
| 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 the 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. | The PAM™3000 system is
intended to measure heart rate and
respiration rate in adult patients, in
a general care hospital environment
including nursing homes. The
system will also monitor presence
or absence of a patient in bed (bed
exit). | Same |
| Component | Sensor
USB micro b cable | Bed Sensor Panel
Repeater Base Stations
Central Computer Station
Central Base Station | Different |
| Patient Type | Adult | Adult | Same |
| Use
Environment | General Care Hospital Environment
including Nursing Homes | General Care Hospital Environment
including Nursing Homes | Same |
| Heart Rate
Measurement
Range | 60-120 beats per minute | Normal: 45-115 beats per minute
Elevated: 85-170 beats per minute | Different |
| Respiratory
Rate
Measurement
Range | 6-55 breaths per minute | Normal: 3-30 breaths per minute
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.