(257 days)
No
The description details a standard oscillometric blood pressure monitor using a microprocessor to analyze pressure signals, which is a well-established technique, and does not mention any AI or ML components.
No
The device is clearly stated as "not intended to be a diagnostic device," and its primary function is to measure blood pressure and pulse rate for monitoring purposes, not for treating or preventing a condition.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device is not intended to be a diagnostic device."
No
The device description explicitly states that the system is composed of a "single-mounted device hardware" and a "mobile application software". It details the components of the hardware unit, including a cuff, microprocessor, sensor, pump, valve, and battery. The software is described as receiving data from this hardware. Therefore, it is not a software-only medical device.
Based on the provided text, the XM-01 Automatic Electronic Blood Pressure Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The device is not intended to be a diagnostic device."
- Nature of Measurement: The device measures blood pressure and pulse rate using a non-invasive technique on the wrist. IVD devices typically involve testing samples taken from the body (like blood, urine, or tissue) in vitro (outside the body) to diagnose conditions.
- Purpose: The device is intended for home use to monitor blood pressure and pulse rate, not to perform diagnostic tests on biological samples.
Therefore, the XM-01 Automatic Electronic Blood Pressure Monitor falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Product codes
DXN
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.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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adult
Intended User / Care Setting
Home use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 870.1130 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).
0
Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like element beneath them. The logo is black and white.
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
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 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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3
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.
4
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 |
|---|---|---|---|
| Indication | |||
| 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. | Transtek Wrist Blood Pressure Monitor
TMB-1014-BT is a digital monitor
intended for use in measuring blood
pressure and heartbeat rate in adult patient
population with wrist circumference
ranging from 13.5 cm to 21.5 cm (about 5
1/4-S8 1/2 inches).
This device detects the appearance of
irregular heartbeats during measurement
and gives a warning signal with readings.
The Wrist Blood Pressure Monitor
compares average blood pressure results to
pre-established AHA (American Heart
Association) hypertension guideline of
135/85 mm Hg.
Transtek Wrist Blood Pressure Monitor,
TMB-1014-BT is not intended to be a | Similar |
6
| Component | Main Unit, Cuff, Battery | Main Unit, Cuff, Battery
diagnostic device. Contact your physician
if hypertensive values are indicated. | Similar |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Measurement Method | Oscillographic | Oscillographic | Same |
| User Control | User controls measurement from
mobile devices through mobile
application software | User controls measurement from LCD
screen on hardware | Minor
difference |
| Labelling | Company Name and Address,
Specifications, Product Descriptions,
Indications for Use, Contraindication
for Use, Precautions, Warnings,
Safety Terms and Conditions, Safety
Alert Description, Safety and
Performance Standards, etc. | Company Name and Address,
Specifications, Product Descriptions,
Indications for Use, Contraindication for
Use, Precautions, Warnings, Safety Terms
and 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, and
remote 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.