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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a Blood Pressure Monitor, seeking clearance from the FDA. It compares the device to a predicate device and outlines the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this blood pressure monitor is its accuracy. The standard referenced is ISO 81060-2:2013, which specifies requirements for the clinical validation of automated non-invasive sphygmomanometers.

The document states the following for the subject device:

Acceptance Criterion	Reported Device Performance
Pressure Accuracy (based on clinical validation)	"The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2." (Page 7)
Pressure Accuracy (bench test specification)	± 3mmHg (Page 6)
Pulse Accuracy (bench test specification)	± 2 bpm (Page 6)
Operating Temperature Range	5~40°C (validated for full claimed range) (Page 6, 7)
Storage Temperature Range	-25~70°C (validated for full claimed range) (Page 6, 7)
Cuff Circumference Range	22-42 cm (validated by ISO 81060-2) (Page 5, 6)

Note: The document only provides a high-level statement for clinical accuracy (meeting ISO 81060-2 requirements). It does not provide the specific numerical results of the clinical endpoints for systolic and diastolic blood pressure differences required by ISO 81060-2 (e.g., mean difference and standard deviation, or cumulative percentages within 5, 10, 15 mmHg for individual differences). It only indicates that the device passed the tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Test Set: 85 patients (38 males and 47 females) (Page 7)
Data Provenance: The document does not explicitly state the country of origin for the clinical data. However, given the manufacturer's location (Shenzhen, China) and the consultants' locations (Shenzen, China), it is highly probable the study was conducted in China. The study was a prospective clinical investigation as it involved patients participating in a study to collect data for the device's validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The provided document does not explicitly state the number or qualifications of experts involved in establishing the ground truth for the clinical test set.

For ISO 81060-2 validation: "The manual Mercury Sphygmomanometer was used as a reference device." This implies measurements were taken by trained operators, but their specific qualifications (e.g., physicians, nurses, technicians) and their adjudication process (if any, beyond simultaneous measurement) are not detailed.

4. Adjudication Method for the Test Set

The document states: "Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device." (Page 7)

This describes a direct comparative measurement method for ground truth, where the device under test and the reference manual sphygmomanometer are used on the same arm, sequentially. This method inherently reduces inter-arm variability but relies on the accuracy of the sequential measurements and the operator's technique. There is no indication of an "adjudication method" in the sense of multiple independent expert readers reviewing data and resolving discrepancies (e.g., 2+1 or 3+1 consensus), as this typically applies to image-based diagnostic systems, not direct physiological measurement devices like blood pressure monitors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their performance. A blood pressure monitor is a direct measurement device; its performance is validated against a reference standard, not against human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the core of the clinical validation (ISO 81060-2) is a standalone performance test for the device's accuracy. The device (algorithm) measures blood pressure, and this measurement is directly compared to a reference standard (manual mercury sphygmomanometer). This is an "algorithm only" performance, as the human interaction is primarily in operating the device and the reference, not in interpreting the device's output and making a diagnosis.

7. The Type of Ground Truth Used

The ground truth used was comparative measurements against a validated reference device: "The manual Mercury Sphygmomanometer was used as a reference device." (Page 7). This method is specified by the ISO 81060-2 standard for clinical validation of automated blood pressure devices, which compares the device's readings to those obtained by a "gold standard" auscultatory method.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This is typical for direct measurement devices validated against a known standard. AI/ML-based diagnostic devices often have explicit training sets, but this device appears to rely on a traditional oscillometric method and its validation is based on direct clinical comparison, not a machine learning model developed with a large training dataset.

9. How the Ground Truth for the Training Set was Established

As no training set is discussed or mentioned, the method for establishing its ground truth is not applicable or detailed in this document.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K190207

Device Name Blood Pressure Monitor

Indications for Use (Describe)

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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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
Manufacturerinformation	Submitter's Name: Shenzhen Viatom Technology Co., Ltd.Address: 4E, Building 3, Tingwei Industrial Park, No.6Liufang Road, Block 67, Xin'an Street, Baoan District,Shenzhen, 518101, Guangdong, ChinaContact person: Zhou SaixinTEL: +86-0755-86638929FAX: +86-0755-22649904E-Mail: zhousaixin@viatomtech.com
SubmissionCorrespondent	Contact person: Miss Lucy. YanE-Mail: Lucy@cefda.comShenzhen Joyantech Consulting Co., Ltd.1122# , International Mayor Communication Center,Baishizhong Road 55#, Nanshan District, Shenzhen,Guangdong, P.R.China.Contact person: Mr. Field.FuE-Mail: field@cefda.comShenzhen 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
Establishmentregistration 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

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Shenzhen Viatom Technology Co., Ltd.

Product: NIBP
information	Classification name: System, Measurement, Blood-Pressure, Non-InvasiveRegulation Number: 870.1130Device Class: IIProduct Code: DXN
Type of submission	510(k)	Traditional

3 Predicate Device Information

Sponsor:	Andon Health Co., Ltd.
Device:	KD-391 Semi Automatic Electronic BloodPressure Monitor
510(K) Number:	K080326

4 Device Descriptions

5 Intended Use/ Indications for Use

The subject device intended to measure the diastolic, systolic blood

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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

Characteristics	Subject device	Predicate(K080326)device	Remark
DeviceName	Ultra-PortableSmartBlood Pressure Monitor	KD-391 Semi AutomaticElectronic Blood PressureMonitor	NA
DeviceModel	BP1, BP1A	KD-391	NA
Manufacturer	ShenzhenViatomTechnology Co., Ltd.	Andon Health Co., Ltd.	NA
IntendedUse/Indicationfor Use	The subject deviceintended to measure thediastolic, systolic bloodpressures and pulse ratefor adult population inhome and hospitalfacilities by using a non-invasiveoscillometrictechnique with a singleupper arm cuff (22-42 cm).The device detects theappearance of irregularheartbeatsduringmeasurement and gives awarning signal withreadings.	KD-391 Semi AutomaticElectronic Blood PressureMonitor is for use bymedical professionals or athome and is a non-invasiveblood pressuremeasurement systemintended to measure thediastolic and systolic bloodpressures and pulse rate ofan adult individual by usinga non-invasive technique inwhich an inflatable cuff iswrapped around the upperarm. The cuff circumferenceis limited to 22cm-48cm.	SimilarNote01
IntendedPopulation	adult	adult	same
IntendedAnatomicalsite	upper arm	upper arm	same
Prescription & OTC	OTC	OTC	same
WorkingPrinciple	Oscillometric method	Oscillometric method	same
PumpMode	manual inflation andmeasurement	manual inflation andmeasurement	same
InternalPowersupply	Rechargeable lithium-polymer battery	4*AA alkaline Batteries	DifferentNote02
Cuff Size	220mm~420mm	220mm~480mm	Refer toNote01

Measuringrange	Pressure: 0 to 300 mmHgPulse: 40 to 200 beat/minute	Pressure: (0mmHg~300mmHg)Pulse: (40-199) beats/minute	SE
Accuracy	Pressure: $\pm$ 3mmHg;Pulse: $\pm$ 2 bpm	Pressure: $\pm$ 3mmHg;Pulse $\pm$ 5%.	DifferentNote03
IrregularHeartbeatDetection	Yes	Yes	same
OperatingEnvironment	5~40°C	10~40°C	SimilarNote04
StorageEnvironment	-25~70°C	-20~50°C
Bluetoothtransmission	The device has wireless function with bluetooth LE.	No.	DifferentNote05

Table 1. Substantial Equivalence Comparison

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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

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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.

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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).

Regulation Number and Section

§ 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).