(253 days)
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No
The document does not mention AI, ML, or related terms, and the device description focuses on standard physiological parameter measurement.
No
The device is described as a "Health Monitor" intended for measuring, reviewing, and storing physiological parameters. Its purpose is data collection and not to provide treatment or therapy.
No
The device explicitly states "This device is not intended to substitute for a hospital diagnostic ECG device" and "This device is not intended to be a hospital diagnostic ECG device". It is described as a "Health Monitor" used for "measuring, displaying, reviewing and storing of multiple physiological parameters," rather than for diagnosing conditions.
No
The device description explicitly states it is a "lightweight, portable health monitor" and describes its physical capabilities for measuring various physiological parameters, indicating it is a hardware device with integrated software.
Based on the provided text, the Checkme Pro Health Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The text describes the Checkme Pro as measuring physiological parameters directly from the patient (ECG, oxygen saturation, pulse rate, and temperature). It does not mention analyzing blood, urine, tissue, or any other bodily fluid or sample.
- The intended use and device description focus on direct patient monitoring. The device measures and displays real-time or recorded physiological data from the individual.
Therefore, the Checkme Pro Health Monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DPS, FLL, DRT
Device Description
The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adults only for continuous data collection and recording of ECG, oxygen saturation and pulse rate. Adults and pediatrics for spot checking of oxygen saturation and pulse rate.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Performance testing provided for the Checkme Pro Health Monitor consists of:
- ECG Testing: The ECG algorithm used in the Checkme Pro Health Monitor has been tested according to the requirements of IEC 60601-2-47. Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
- SpO2 Testing: The Checkme Pro Health Monitor has been tested and shown to comply with the requirements of ISO 80601-2-61. Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- Thermometer Testing: The Checkme Pro has been tested and shown to comply with the requirements of the FDArecognized standard ISO 80601-2-56:2009: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- Home Healthcare Testing: The Checkme Pro has been tested and shown to comply with the following FDA-recognized standard: IEC 60601-1-11 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.
- System Level Testing: Viatom conducted system level performance testing to demonstrate that the device meets its specifications. The device passed all tests and performed according to specifications.
- Biocompatibility Testing: The patient contacting materials were testing in accordance with ISO 10993-1: 2009/AC 2010.
- Software Verification and Validation: The software level of concern for the Checkme Pro Health Monitor is MODERATE. Required software documentation has been provided.
- EMC and Electrical Safety: Performed IEC 60601-1: 2005 + Corrigendum 1 + Corrigendum 2 + AM1 (2012) and EN 60601-1-2: 2007 + AC: 2010. The results demonstrate electrical safety and electromagnetic compatibility.
- Battery Safety Testing: Conducted in accordance with IEC 62133:2012. The battery passed all required tests and has been shown to be safe for the proposed intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ECG Accuracy: Heart Rate (HR) 30~250 bpm, +/-2 bpm or +/-2% whichever is larger.
SpO2 Accuracy: Integrated Sensor 70%-100%: +/- 3% (Arms:2.11), 70-80%: +/- 3%, 80-90%: +/- 3%, 90-100%: +/- 2%. 0% - 69% not defined.
PR Accuracy: 30-250 BPM, +/- 2 bpm or +/- 2% whichever is larger.
Body mode Accuracy: +/-0.4°F.
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.
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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).
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Viatom Technology Co., Ltd. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, Virginia 22314
Re: K150869
Trade/Device Name: CheckMe Pro Health Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: November 6, 2015 Received: November 10, 2015
Dear Donna-Bea Tillman:
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. 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 statutes and regulations administered by other Federal agencies. You must comply
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150869
Device Name Checkme Pro Health Monitor
Indications for Use (Describe)
The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).
| 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
| Device Common Name: | Multiparameter Monitor |
|---|---|
| Device Trade Name: | Checkme Pro Health Monitor |
| Applicant: | Viatom Technology Co., Ltd. |
| C607,Languang Park, No. 7 Xinxi Road, Hi-Tech | |
| Park(north) Nanshan, Shenzhen, 518057, P.R.China | |
| www.viatomtech.com | |
| Contact: | Zhou Saixin |
| General Manager | |
| Viatom Technology Co., Ltd. | |
| C607,Languang Park, No. 7 Xinxi Road, Hi-Tech | |
| Park(north) Nanshan, Shenzhen, 518057, P.R.China | |
| Phone: +86 755 86638929 | |
| Fax: +86 755 22649904 | |
| Email: zhousaixin@viatomtech.com | |
| Prepared by: | Donna-Bea Tillman, Ph.D. |
| Senior Consultant, Devices | |
| Biologics Consulting Group, Inc. | |
| Phone: 410-531-6542 | |
| Email: dtillman@bcg-usa.com | |
| Date Prepared: | November 6, 2015 |
| Classification Regulation: | 21 CFR 870.2300 – Cardiac Monitor |
| Panel: | Cardiovascular |
| Product Code: | MWI, Physiological Patient Monitor |
| Secondary Product Codes: | DQA (21 CFR 870.2700) |
| DPS (21 CFR 870.2340) | |
| FLL (21 CFR 880.2910) | |
| DRT (21 CFR 870.2300) | |
| Predicate Device: | K131762, M800 Handheld Monitor |
| Secondary Predicates: | K062894, InstantCheck RTD-ECG Monitor |
| K100953, Microlife Non-Contact Infrared Forehead |
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Indications for Use:
The Checkme Pro Health Monitor is intended to be used for measuring, displaying, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to substitute for a hospital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardiodefibrillators (ICDs).
Device Description:
The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.
| Functions | Measured parameters | Features |
|---|---|---|
| ECG | ECG waveform | |
| Heart Rate (HR) | Cable or cable-free, four modes, 30s waveform | |
| replay, voice memo, 100 measurements storage | ||
| Pulse Oximeter: | ||
| Spot-check | Pleth waveform | |
| SpO2, Pulse Rate (PR) | Cable or cable-free, 20 second measurement, 100 | |
| measurements storage | ||
| Pulse Oximeter: | ||
| Continuous | ||
| Recording | ||
| (adult only) | Total duration, 10 M Ohm | > 20 M Ohm |
| Input dynamic range | +/- 3 mV | +/- 3 mV |
| Bandwidth | 0.05 – 40 Hz | 0.1 - 40 Hz |
| A/D conversion | 16 bit | 12 bit |
| Sampling Rate | 500 samples/sec | 250 samples/sec |
| Measurement Time | 30 seconds | 30 seconds |
| Display | 400*240 Dot-matrix LCD display | 240 X 128 Dot-matrix LCD display |
| Input | Dry conduction electrodes and/or | |
| external auxiliary electrodes | Dry conduction electrodes and/or external | |
| auxiliary electrodes | ||
| Heart rate Range | 30~250 bpm, ±2 bpm or ±2% | |
| whichever is larger | 45 to 180 bpm | |
| Subject Device | Predicate Device | |
| 510(k) Number | K150869 | K131762 |
| Device Name | Checkme Pro Health Monitor | M800 Handheld Monitor |
| Classification | ||
| Regulation | 870.2300 - Physiological Patient | |
| Monitor | 870.2300 - Physiological Patient | |
| Monitor | ||
| Display Data | SpO2, Pulse Rate (PR) | SpO2, Pulse Rate (PR) |
| Mode | Continuous Recording and Spot-Check | Continuous Recording and Spot-Check |
| Sensor Types | Integrated and external | External |
| Population | Adult and Pediatric (continuous | |
| recording only for adult) | Adult, Pediatric and Neonate | |
| SpO2 Display Range | 0 - 100% | 0 - 100% |
| Accuracy | Integrated | |
| Sensor | ||
| 70%-100%: | ||
| $\pm$ 3% | ||
| (Arms:2.11) | ||
| 70-80%: $\pm$ 3% | ||
| 80-90%: $\pm$ 3% | ||
| 90-100%: $\pm$ 2% | ||
| 0% - 69% not | ||
| defined | External Sensor | |
| 70%-100%: $\pm$ 2% | ||
| (Arms:1.88) | ||
| 70-80%: $\pm$ 3% | ||
| 80-90%: $\pm$ 2% | ||
| 90-100%: $\pm$ 2% | ||
| 0% - 69% not | ||
| defined | 70% - 100%: $\pm$ 2% | |
| 0% - 69% not defined | ||
| Resolution | 1% | 1% |
| PR range | 30-250 BPM | 25-250 BPM |
| PR Accuracy | 30-250 BPM, $\pm$ 2 bpm or $\pm$ 2% | |
| whichever is larger | 25-250 BPM, $\pm$ 1 bpm or $\pm$ 2% | |
| whichever is larger | ||
| Resolution | 1bpm | 1bpm |
| Subject Device | Predicate Device (Additional) | |
| 510(k) Number | K150869 | K100953 |
| Applicant | Viatom Technology Co. Ltd. | Microlife Intellectual Property, GMBH |
| Device Name | Checkme Pro Health Monitor | Microlife Non-Contact Infrared |
| Forehead Thermometer | ||
| Classification | ||
| Regulation | 870.2300 - Physiological Patient Monitor | 880.2910 - Thermometer, Electronic, |
| Clinical | ||
| Measurement | ||
| technique | infrared sensor (thermopile) | infrared sensor (thermopile) |
| Measurement | ||
| site | Forehead | Forehead |
| Unit | °F | °C/°F |
| Body mode | ||
| measuring | ||
| range | 93.2°F to 108.0°F | 34°C to 42.2°C (93.2°F to 108.0°F) |
| Body mode | ||
| Accuracy | ±0.4°F | 36°C to 39°C (96.8°F to 102.2°F): +/- |
| 0.2°C /0.4°F | ||
| 34.0°C to 35.9°C (93.2°F to 96.6°F), | ||
| 39.1 °C to 42.2°C (102.4°F to 108.0°F): |
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The Comparison of Pulse Oximeter Measurement and Analysis table below provides a more detailed comparison of the pulse oximetry feature of the Checkme device with the primary predicate, theM800 Handheld Monitor.
Comparison of Pulse Oximeter Measurement and Analysis
The Comparison of Temperature Measurement and Analysis table below provides a more detailed comparison of the Checkme and the additional predicate for temperature measurement, the Microlife Non-Contact Infrared Forehead Thermometer (K100953).
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Comparison of Temperature Measurement and Analysis
Substantial Equivalence Conclusion:
The primary predicate device for the Checkme Pro Health Monitor is M800 Handheld Monitor cleared in K131762. The M800 is also a handheld device for monitoring physiological parameters in the home or health care environment.
The Checkme Pro Health Monitor has three primary medical device functions, and each of these has been compared to a predicate device. While there are some minor differences in technological characteristics, this do not raise different questions of safety and effectiveness. Each function has been tested in accordance with the appropriate standards, and the results of testing demonstrate that the Checkme Pro Health Monitor complies with the standards and has equivalent performance to the reference predicate devices.
Therefore, the Checkme Pro Health Monitor has been shown to be substantially equivalent to the M800 Handheld Monitor.