(196 days)
No
The description details a standard oscillometric blood pressure monitor using a microprocessor and pressure sensor to analyze signals, which is a well-established, non-AI/ML technique. There is no mention of AI, ML, or related concepts.
No
The device is intended to measure blood pressure and pulse rate, which are diagnostic functions, not therapeutic.
Yes
The device measures physiological parameters (blood pressure and pulse rate) and detects irregular heartbeats, which are used to assess a health condition or state.
No
The device description explicitly lists hardware components such as a main unit, cuff unit (inflatable bladder and shell), microprocessor, pressure sensor, power on/off key, rubber bulb, exhaust valve, and battery. While it includes software (APP) for data display and storage, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device measures blood pressure and pulse rate directly from the patient's upper arm using a non-invasive cuff. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use and device description clearly state it's a non-invasive blood pressure monitor. The method described is the oscillometric technique, which is a physical measurement of pressure changes in the cuff, not a diagnostic test performed on a sample.
- The clinical validation is against a manual blood pressure monitor (Mercury Sphygmomanometer), not a laboratory or diagnostic test.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.
Product codes
DXN
Device Description
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm. Our 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 manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the rubber bulb, exhaust valve, bluetooth tranismision and cuff. The subject devices are powered by Li-ion Polymer Battery.
The device has irregulae heart beat (IHB) indicator which is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
The subject device includes bluetooth tranismision which can tranfer data to APP installed in smart phone. The APP can display, store and review the measurement data including the systolic and diastolic blood pressure and pulse rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult population
Intended User / Care Setting
Home and hospital facilities
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)
Clinical Investigation: In this clinical investigation, 85 patients (38 males and 47females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: +/- 3mmHg; Pulse: +/- 2 bpm
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 19, 2019
Shenzhen Viatom Technology Co., Ltd. % Lucy Yan Consultant Shenzhen Joyantech Consulting Co, Ltd. 1122#, International Mayor Communication Center, Baishizhong Nanshan district, Shenzhen, 518000 Cn
Re: K190207
Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 24, 2019 Received: July 15, 2019
Dear Lucy Yan:
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.
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
1
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 (OS) 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 medical devices and radiation-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,
LT Stephen Browning 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
2
Indications for Use
510(k) Number (if known) K190207
Device Name Blood Pressure Monitor
Indications for Use (Describe)
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | Dec. 26, 2018 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: Shenzhen Viatom Technology Co., Ltd. |
| Address: 4E, Building 3, Tingwei Industrial Park, No.6 | |
| Liufang Road, Block 67, Xin'an Street, Baoan District, | |
| Shenzhen, 518101, Guangdong, China |
Contact person: Zhou Saixin
TEL: +86-0755-86638929
FAX: +86-0755-22649904
E-Mail: zhousaixin@viatomtech.com |
| Submission
Correspondent | Contact person: Miss Lucy. Yan
E-Mail: Lucy@cefda.com
Shenzhen Joyantech Consulting Co., Ltd.
1122# , International Mayor Communication Center,
Baishizhong Road 55#, Nanshan District, Shenzhen,
Guangdong, P.R.China.
Contact person: Mr. Field.Fu
E-Mail: field@cefda.com
Shenzhen Joyantech Consulting Co., Ltd.
1122# , International Mayor Communication Center,
Baishizhong Road 55#, Nanshan District, Shenzhen,
Guangdong, P.R.China |
| Image | Image: [logo]卓远天成 |
| Establishment
registration number | NA |
2 Device Information
| Common name of the device | System, Measurement, Blood-Pressure, Non-Invasive |
|---|---|
| Trade name of the device | Blood Pressure Monitor |
| Type/Model of the device | BP1, BP1A |
| Classification | Classification panel: Cardiovascular |
4
Shenzhen Viatom Technology Co., Ltd.
| Product: NIBP | ||
|---|---|---|
| information | Classification name: System, Measurement, Blood- | |
| Pressure, Non-Invasive | ||
| Regulation Number: 870.1130 | ||
| Device Class: II | ||
| Product Code: DXN | ||
| Type of submission | 510(k) | Traditional |
3 Predicate Device Information
| Sponsor: | Andon Health Co., Ltd. |
|---|---|
| Device: | KD-391 Semi Automatic Electronic Blood |
| Pressure Monitor | |
| 510(K) Number: | K080326 |
4 Device Descriptions
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm. Our 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 manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the rubber bulb, exhaust valve, bluetooth tranismision and cuff. The subject devices are powered by Li-ion Polymer Battery.
The device has irregulae heart beat (IHB) indicator which is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
The subject device includes bluetooth tranismision which can tranfer data to APP installed in smart phone. The APP can display, store and review the measurement data including the systolic and diastolic blood pressure and pulse rate.
5 Intended Use/ Indications for Use
The subject device intended to measure the diastolic, systolic blood
5
Product: NIBP
pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.
6 SE Comparisons
| Characteris
tics | Subject device | Predicate
(K080326)
device | Remark |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Device
Name | Ultra-Portable
Smart
Blood Pressure Monitor | KD-391 Semi Automatic
Electronic Blood Pressure
Monitor | NA |
| Device
Model | BP1, BP1A | KD-391 | NA |
| Manufactur
er | Shenzhen
Viatom
Technology Co., Ltd. | Andon Health Co., Ltd. | NA |
| Intended
Use/
Indication
for Use | The subject device
intended to measure the
diastolic, systolic blood
pressures and pulse rate
for adult population in
home and hospital
facilities by using a non-
invasive
oscillometric
technique with a single
upper arm cuff (22-42 cm).
The device detects the
appearance of irregular
heart
beats
during
measurement and gives a
warning signal with
readings. | KD-391 Semi Automatic
Electronic Blood Pressure
Monitor is for use by
medical professionals or at
home and is a non-invasive
blood pressure
measurement system
intended to measure the
diastolic and systolic blood
pressures and pulse rate of
an adult individual by using
a non-invasive technique in
which an inflatable cuff is
wrapped around the upper
arm. The cuff circumference
is limited to 22cm-48cm. | Similar
Note01 |
| Intended
Population | adult | adult | same |
| Intended
Anatomical
site | upper arm | upper arm | same |
| Prescriptio
n & OTC | OTC | OTC | same |
| Working
Principle | Oscillometric method | Oscillometric method | same |
| Pump
Mode | manual inflation and
measurement | manual inflation and
measurement | same |
| Internal
Power
supply | Rechargeable lithium-
polymer battery | 4*AA alkaline Batteries | Different
Note02 |
| Cuff Size | 220mm420mm | 220mm480mm | Refer to
Note01 |
| | | | |
| Measuring
range | Pressure: 0 to 300 mmHg
Pulse: 40 to 200 beat/minute | Pressure: (0mmHg300mmHg)40°C | 10
Pulse: (40-199) beats/minute | SE |
| Accuracy | Pressure: $\pm$ 3mmHg;
Pulse: $\pm$ 2 bpm | Pressure: $\pm$ 3mmHg;
Pulse $\pm$ 5%. | Different
Note03 |
| Irregular
Heartbeat
Detection | Yes | Yes | same |
| Operating
Environment | 540°C | Similar70°C | -20~50°C | |
Note04 |
| Storage
Environment | -25
| Bluetooth
transmission | The device has wireless function with bluetooth LE. | No. | Different
Note05 |
Table 1. Substantial Equivalence Comparison
6
Shenzhen Viatom Technology Co., Ltd.
Product: NIBP
Note01: The subject devices have the smaller cuff circumference than predicate device, but the subject devices have been passed the test of ISO81060-2 and IEC 80601-2-30. Note02: The power supply the subject device is different from the predicate device. The subject device is powered by rechargeable lithium-polymer battery which can be charged. The rechargeable lithium-polymer battery has been verified by the IEC62133 standard. It passed the tests.
Note03: The pulse accuracy is different from the predicate device. The subject device is tested by bench test. The subject device has been verified by the required accuracy. It passed the tests.
Note04: The subject device has a smaller measuring range of operating temperature and larger measuring range of storage temperature than predicate device, but the subject devices have been validated all the full claimed range.
Note05: The subject device has bluetooth function but the predicated device has no wireless function. FCC test and wireless coexistence about the wireless performance have been validated.
The subject device is as same as predicate device in Working Principle, Intended patient population, intended application site, measuring accuracy. Only their Cuff size, power supply and operating/storage environment are a little bit different (refer to Note01 to Note03) which had been validated by FCC and wireless coexistence. The subject device has a bluetooth function (Note04) which had been validated.
Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US.
7 Brief discussions of the non-clinical tests
The subject device conforms to the following guidances and standards:
K190207 Page 4 of 6
7
Product: NIBP
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance ゃ
- � 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 60601-1-11: 2010 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;
- ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: ゃ Tests for In Vitro cytotoxicity;
- ゃ ISO 10993-10: 2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
- IEC 80601-2-30: 2013 Medical electrical equipment Part 2-30: Particular ゃ requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
- CFR 47 FCC PART 15. Subpart B/C Unintentional Radiators/ Miscellaneous ゃ Wireless Commutations Service
8 Brief discussions of clinical tests
- や ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type;
In this clinical investigation, 85 patients (38 males and 47females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect.
The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
9 Other information (such as required by FDA guidance)
No other information.
8
11 Conclusions
The subject device:
Blood Pressure Monitor, manufactured by Shenzhen Viatom Technology Co., Ltd. is respectively substantially equivalent to the predicate device (KD-391 Semi Automatic Electronic Blood Pressure Monitor) manufactured by Andon Health Co., Ltd. (K080326).