(242 days)
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.
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.
The provided document is a 510(k) summary for the Xandar Kardian Vital Sign Monitoring Sensor (Model XK300). It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. Therefore, some information requested in the prompt, such as specific acceptance criteria for performance, detailed study designs, sample sizes for test sets, expert qualifications, and ground truth establishment methods, are not explicitly provided in the text.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "performance testing has confirmed that this difference does not affect the performance of the Vital Signs Monitoring Sensor." This implies that the device's performance, despite having different measurement ranges than the predicate, was deemed acceptable. However, specific, quantifiable acceptance criteria (e.g., accuracy, precision, bias) for heart rate and respiration rate, and the corresponding reported performance values from a dedicated study, are not provided. The comparison table (Table 5-1) mainly focuses on technical specifications and intended use comparison with the predicate, not performance metrics against acceptance criteria.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated in document | Not explicitly stated in document |
| (Inferred: Performance within acceptable limits for intended use, similar to predicate) | (Inferred: Met performance expectations, as stated "performance testing has confirmed that this difference does not affect the performance of the Vital Signs Monitoring Sensor.") |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "performance testing" was conducted, but it does not specify the sample size used for this testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth in performance testing.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
The document does not mention an MRMC comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document implies standalone performance testing was done, as it discusses "performance testing" of the device itself and its ability to measure heart rate and respiration rate. The description of the device as a "sensor" that detects minute displacements and converts them into rates suggests it operates autonomously. However, it does not explicitly label a study as a "standalone" study with detailed methodology.
7. The Type of Ground Truth Used:
The document implying heart rate and respiration rate measurement suggests the ground truth for performance testing would likely be established using reference medical devices (e.g., ECG for heart rate, capnography or spirometry for respiration rate) that are considered gold standards for these physiological measurements. However, the document does not explicitly state the type of ground truth used.
8. The Sample Size for the Training Set:
The document does not mention a training set or its sample size. This is common in a 510(k) submission where the focus is on substantial equivalence to a predicate rather than a de novo approval requiring extensive AI model validation. The device description suggests a sensor-based measurement system rather than a deep learning algorithm that typically requires a large training set.
9. How the Ground Truth for the Training Set Was Established:
Since a training set is not mentioned, the method for establishing its ground truth is also not provided.
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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.
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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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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
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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
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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 | Comparison | |
|---|---|---|---|
| 510(k) Number | K202464 | K082626 | - |
| Device Name | Vital Sign Monitoring Sensor(Model: XK300) | Patient Assessment Monitor(PAM™3000) | - |
| Common Name | Heart Rate and Respiration RateMonitor | Heart Rate and Respiration RateMonitor | - |
| Manufacturer | XANDAR KARDIAN INC. | Wireless 2000 RF & UWBTechnologies Ltd. | - |
| Intended Use | The Vital Sign Monitoring Sensor(Model XK300) is intended tomeasure heart rate and respirationrate in adult patients in a generalcare hospital environment includingnursing homes. The Vital SignMonitoring Sensor can be used forhome healthcare for data collectionto inform patient care but not toacutely treat a patient. XK300monitors the presence or absence ofa patient in a detection area ofwithin 7 meters. The XK300 alsomonitors the length of continuouspatient motion or absence of patientmotion. | The PAM™3000 system isintended to measure heart rate andrespiration rate in adult patients, ina general care hospital environmentincluding nursing homes. Thesystem will also monitor presenceor absence of a patient in bed (bedexit). | Same |
| Component | SensorUSB micro b cable | Bed Sensor PanelRepeater Base StationsCentral Computer StationCentral Base Station | Different |
| Patient Type | Adult | Adult | Same |
| UseEnvironment | General Care Hospital Environmentincluding Nursing Homes | General Care Hospital Environmentincluding Nursing Homes | Same |
| Heart RateMeasurementRange | 60-120 beats per minute | Normal: 45-115 beats per minuteElevated: 85-170 beats per minute | Different |
| RespiratoryRateMeasurementRange | 6-55 breaths per minute | Normal: 3-30 breaths per minuteElevated: 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)
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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.
§ 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).