(257 days)
XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
XM-01 Automatic Electronic Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury nmometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals, and analyze those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". The sensor also detect pulse rate at the same time.
XM-01 Automatic Electronic Blood Pressure Monitor achieves its function by integrating a single-mounted device hardware to a mobile application software, which is downloadable to a mobile device such as Apple or Android phone. As the hardware itself does not include a LCD or other display components, it is necessary for the device hardware to communicate with mobile devices containing the supporting software to constitute a complete blood pressure measurement system. This communication is realized through an embedded Bluetooth module.
The single-mounted device hardware is composed of the main unit and cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and nylon/cotton/PVC shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by a 3.7V/400mAH lithium battery. The battery can be re-charged by either a DC5V 500mA charger or a USB cable.
The mobile application, downloadable to mobile devices such as Apple IOS or Android phone, receives measurement results from the single mounted device. The mobile App allows the test results to be displayed on the mobile devices (such as cell phone) for user review. It also transmits the data to the database in remote server for storage and future retrieval.
The provided document describes the XM-01 Electronic Automatic Blood Pressure Monitor and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device conforms to ISO 81060-2: Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type. This standard outlines the acceptance criteria for the clinical accuracy of automated non-invasive sphygmomanometers. While the document mentions adherence to the standard, it does not explicitly report the specific acceptance criteria outlined in ISO 81060-2 or the device's numerical performance against those criteria (e.g., mean difference and standard deviation between device and reference measurements for systolic and diastolic pressure).
Therefore, a table of specific numerical acceptance criteria and the device's reported performance against them cannot be fully constructed from the provided text. The document only generally states that "XM-01 Automatic Electronic Blood Pressure Monitor conforms to the following standards:" and lists ISO 81060-2.
2. Sample size used for the test set and the data provenance
The document mentions adherence to ISO 81060-2. This standard typically requires a minimum number of subjects for clinical validation studies. However, the specific sample size used for the actual clinical investigation mentioned in the submission is not explicitly stated in the provided text.
The data provenance (e.g., country of origin, retrospective or prospective) for the clinical investigation is not explicitly stated. The manufacturer is based in China, which might suggest the study was conducted there, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that the device's measurement method is similar to the auscultatory method. In clinical validation studies for blood pressure monitors, the "ground truth" is typically established by trained observers (experts) using a mercury sphygmomanometer or highly accurate reference method.
However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the provided text. ISO 81060-2 generally requires at least two trained observers.
4. Adjudication method for the test set
In the context of blood pressure monitor validation studies using the auscultatory method, an adjudication method usually refers to how discrepancies between multiple observers' readings are resolved. For instance, if two observers' readings differ by more than a certain threshold, a third observer might be involved.
The adjudication method used for the test set is not explicitly stated in the provided text. Although adherence to ISO 81060-2 is mentioned, the specific details of the clinical investigation are not given.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The XM-01 Automatic Electronic Blood Pressure Monitor is a standalone device for measuring blood pressure and pulse rate. It integrates hardware with a mobile application to display results. There is no indication in the document that an AI component is involved in interpreting the blood pressure measurements, nor is there any mention of human readers or a multi-reader multi-case (MRMC) comparative effectiveness study. The device's function is to measure and display, not to provide diagnostic interpretations that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The entire premise of this 510(k) submission is for the XM-01 Automatic Electronic Blood Pressure Monitor as a standalone device. The relevant standard for this standalone performance is ISO 81060-2, which specifies the clinical investigation of automated measurement type sphygmomanometers. This standard dictates that the automated device's measurements are compared against a reference standard (typically auscultation by trained observers), thus evaluating the device's accuracy in a standalone manner.
The document states: "XM-01 Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... ISO 81060-2. Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type." This indicates that a standalone performance study, compliant with ISO 81060-2, was conducted.
7. The type of ground truth used
For blood pressure monitors evaluated under ISO 81060-2, the standard ground truth for blood pressure measurements is typically expert auscultation (manual measurement by trained observers using a mercury sphygmomanometer or equivalent reference device). This is implied by the adherence to ISO 81060-2.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning or AI. Rather, the device uses an "Oscillometric method" where a "microprocessor converts tiny alterations in cuff pressure to electrical signals, and analyze those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate." This is a well-established technique that typically uses fixed algorithms rather than a dynamically trained AI model. Therefore, a separate "training set" for an AI algorithm is not applicable or mentioned for this device.
9. How the ground truth for the training set was established
As there is no explicit mention of a "training set" for an AI algorithm, or any machine learning training process, the method for establishing its ground truth is not applicable based on the provided text. The device relies on a "well-known technique in the market called the 'Oscillometric method'," which operates on established physiological principles and algorithms, likely without a separate learning phase requiring a "training set" with ground truth in the AI sense.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2015
Sky Innovation Technology (Shanghai) Limited % Charles Shen Official Correspondent Manton Business And Technology Services 37 Winding Ridge Oakland. New Jersey 07436
Re: K150908
Trade/Device Name: XM-01 Electronic Automatic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 28, 2015 Received: October 30, 2015
Dear Charles Shen:
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
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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 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 yours,
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) K150908
Device Name
XM-01 Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
| 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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Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
Sky Innovation Technology (Shanghai) Limited 9th Floor Hechuan Building, 2016 Yishan Rd, Minhang District, Shanghai Postal code: 201103, China Tel: (086) 400-9999-523 Submitter's FDA Registration Number: N/A
Contact Person 5.2
Charles Shen Manton Business and Technology Services 37 Winding Rdg, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: April 1, 2015 5.3
| 5.4 Device Name: | |
|---|---|
| Proprietary Name: | XM-01 Automatic Electronic Blood Pressure Monitor |
| Common Name: | Blood Pressure Monitor |
| Classification Name: | System, Measurement, Blood-Pressure, Non-invasive |
| Device Classification: | II |
| Regulation Number: | 21 CFR 870.1130 |
| Panel: General | Cardiovascular |
| Product Code: | DXN |
ર્ડ Predicate Device Information:
- K123669, "Transtek Wrist Blood Pressure Monitor", manufactured by (1) "Zhongshan Transtek Electronics Co., Ltd."
5.6 Device Description:
XM-01 Automatic Electronic Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
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Measurement method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury nmometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals, and analyze those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". The sensor also detect pulse rate at the same time.
XM-01 Automatic Electronic Blood Pressure Monitor achieves its function by integrating a single-mounted device hardware to a mobile application software, which is downloadable to a mobile device such as Apple or Android phone. As the hardware itself does not include a LCD or other display components, it is necessary for the device hardware to communicate with mobile devices containing the supporting software to constitute a complete blood pressure measurement system. This communication is realized through an embedded Bluetooth module.
The single-mounted device hardware is composed of the main unit and cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and nylon/cotton/PVC shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by a 3.7V/400mAH lithium battery. The battery can be re-charged by either a DC5V 500mA charger or a USB cable.
The mobile application, downloadable to mobile devices such as Apple IOS or Android phone, receives measurement results from the single mounted device. The mobile App allows the test results to be displayed on the mobile devices (such as cell phone) for user review. It also transmits the data to the database in remote server for storage and future retrieval.
5.7 Indications for Use:
XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
5.8 Design Control and Performance Testing Summary:
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the device does not raise any new questions of safety and effectiveness.
XM-01 Automatic Electronic Blood Pressure Monitor conforms to the following standards:
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- ISO 14971, Risk management to medical device
- o ISO 81060-2. Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type
- o ISO 80601-2-30, Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated noninvasive sphygmomanometers
- IEC60601-1, Electrical safety;
- o IEC6060 1-1-2, Electromagnetic compatibility
- FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations o
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and ● testing within a risk management process
XM-01 Automatic Electronic Blood Pressure Monitor conforms to the following guidance document:
- FDA guidance document Non-Invasive Blood Pressure (NIBP) Monitor Guidance (March, 1997).
5.9 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, mechanism, design, and labeling between our device and the predicate devices.
| Table 5.1: Comparison of Intended Use, Mechanism, Labeling, and Design | ||
|---|---|---|
| Description | Subject Device | Predicate Device (K123669) | Comparison |
|---|---|---|---|
| Indicationfor Use | XM-01 Automatic Electronic BloodPressure Monitor is a home usedigital monitor intended for use inmeasuring blood pressure and pulserate in adult patient population withwrist circumference ranging from13.5 cm to 19.5 cm.The device is not intended to be adiagnostic device. Contact yourphysician if hypertensive values areindicated. | Transtek Wrist Blood Pressure MonitorTMB-1014-BT is a digital monitorintended for use in measuring bloodpressure and heartbeat rate in adult patientpopulation with wrist circumferenceranging from 13.5 cm to 21.5 cm (about 51/4-S8 1/2 inches).This device detects the appearance ofirregular heartbeats during measurementand gives a warning signal with readings.The Wrist Blood Pressure Monitorcompares average blood pressure results topre-established AHA (American HeartAssociation) hypertension guideline of135/85 mm Hg.Transtek Wrist Blood Pressure Monitor,TMB-1014-BT is not intended to be a | Similar |
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| Component | Main Unit, Cuff, Battery | Main Unit, Cuff, Batterydiagnostic device. Contact your physicianif hypertensive values are indicated. | Similar |
|---|---|---|---|
| Measurement Method | Oscillographic | Oscillographic | Same |
| User Control | User controls measurement frommobile devices through mobileapplication software | User controls measurement from LCDscreen on hardware | Minordifference |
| Labelling | Company Name and Address,Specifications, Product Descriptions,Indications for Use, Contraindicationfor Use, Precautions, Warnings,Safety Terms and Conditions, SafetyAlert Description, Safety andPerformance Standards, etc. | Company Name and Address,Specifications, Product Descriptions,Indications for Use, Contraindication forUse, Precautions, Warnings, Safety Termsand Conditions, Safety Alert Description,Safety and Performance Standards, etc. | Same |
| Power Source | Rechargeable Lithium Battery | Battery | Similar |
| Cuff | Wrist warp around | Wrist warp around | Same |
| Display | Remote display on mobile devices | Local liquid crystal digital display, andremote display on mobile devices | Similar |
| Wireless Mode | Bluetooth | Bluetooth | Same |
| Data Storage | On mobile devices and on server | Mobile devices | Similar |
Our device is essentially identical to the predicate device in terms of indications for use, design, mechanism, and labeling between subject device and the predicate device. The several minor differences do not affect the safety and effectiveness of the device
5.10 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that XM-01 Automatic Electronic Blood Pressure Monitor and its predicate devices have the identical indications for use, design, mechanism, labeling, and similar performance.
The difference between the XM-01 Automatic Electronic Blood Pressure Monitor and their predicate device do not raise any question regarding its safety and effectiveness.
XM-01 Automatic Electronic Blood Pressure Monitor, as designed and manufactured, are as safe and effective as its predicate device, and therefore is substantially equivalent as its predicate device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).