The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.

Device Description

The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa.

All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Upper Arm Electronic Blood Pressure Monitor U80 Series." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the document does not contain the detailed information typically associated with a study proving that a device meets specific acceptance criteria for AI/ML performance (e.g., number of experts, adjudication methods, MRMC studies, ground truth establishment for AI training/test sets). Instead, it relies on bench testing and comparison to an existing device.

Here's an analysis based on the available information and an explanation of why certain information requested is not present:

Context: The device is a non-invasive blood pressure monitor. The "acceptance criteria" discussed here are primarily related to meeting recognized performance standards for blood pressure measurement and demonstrating equivalence to a predicate device, not necessarily AI/ML performance criteria.

1. A table of acceptance criteria and the reported device performance

The document presents a "Substantially Equivalent Comparison" table (Table III-1) which serves as the primary way the device's performance is compared against regulatory and predicate device benchmarks. The "acceptance criteria" are implicitly defined by the predicate device's performance and relevant standards.

ITEM	Acceptance Criteria (Predicate HEM-757 / Standards)	Reported Device Performance (U80 Series)	Comparison
Product Code	DXN	DXN	Same
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	Same
Class	II	II	Same
Intended Use	Measure systolic/diastolic BP & pulse rate in adult patients with arm circumference between 7 inches to 15 inches.	Measure systolic/diastolic BP & pulse rate of adult person via non-invasive oscillometric technique; upper arm circumference 22-36 cm.	SE Analysis 1 (considered substantially equivalent despite slight arm circumference difference, justified by AAMI standard)
Measurement Type	Upper arm	Upper arm	Same
Patient Population	Adult	Adults (over 12)	Same
Measurement Item	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Principle	Oscillometric	Oscillometric	Same
BP Range	0 ~ 280mmHg	0 ~ 299 mmHg	SE Analysis 2 (slightly larger range, but difference is rare/abnormal and stated on label; considered not to affect SE conclusion)
BP Accuracy	±3 mmHg or 2% of reading	±3 mmHg	SE Analysis 3 (considered substantially equivalent, argument made that predicate's 2% of reading could be greater than ±3mmHg)
PR Range	40-180 bpm	40-199 bpm	SE Analysis 4 (slightly larger range, but difference is rare/abnormal and stated on label; considered not to affect SE conclusion)
Cuff Size	48 cm (length) x 14 cm (width)	63 cm (length) x 14.4 cm (width)	SE Analysis 1 (slight difference, but appropriate to claimed arm circumference per AAMI standard; considered SE)
Power Supply	Four AA batteries or AC adapter	Four AA batteries or AC adapter	Same
Software Level Concern	Moderate	Moderate	Same

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench tests and compliance with recognized standards for its performance evaluation, rather than a clinical "test set" in the context of AI/ML validation involving patient data.

The standards cited include:

ANSI/AAMI/IEC 80601-2-30:2009 "Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers."
ANSI/AAMI/ISO 81060-2:2009 "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

These standards outline clinical testing requirements, including sample sizes for validation studies for blood pressure monitors. For instance, ISO 81060-2 typically requires a certain number of subjects (e.g., usually around 85 subjects with specific age and BP distribution) for clinical validation. However, the specific sample size used in the company's validation study or its provenance for this specific submission is not explicitly detailed in the provided 510(k) summary. It is stated that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards." This implies the tests mandated by these standards were performed, but the summary does not include the raw results or the clinical trial specifics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not present in the document. The device is a blood pressure monitor, not an AI/ML diagnostic imaging device that requires radiologist interpretations for ground truth. The "ground truth" for a blood pressure monitor is established through a reference measurement method (e.g., auscultation by trained observers with mercury sphygmomanometers) as per the mentioned ISO/AAMI standards. The document does not detail the specifics of such clinical validation for this particular submission, only that the device "complies" with the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it pertains to expert consensus on diagnostic images, not a standard blood pressure measurement device.

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

This information is not applicable. This question refers to AI-assisted diagnostic tools. The device is an automated blood pressure monitor; there are no "human readers" interpreting its output that would be assisted by AI in this context.

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

The device itself is a "standalone" automated blood pressure monitor in that it measures blood pressure directly via an oscillometric technique. Its performance is evaluated purely on its ability to accurately measure BP, as detailed by the standards it claims compliance with (e.g., accuracy of ±3 mmHg). There isn't an "algorithm only" component separate from the integrated device for this type of product that would typically necessitate such a study as posed in the context of complex AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure monitors, the "ground truth" for clinical validation is typically established through simultaneous auscultatory measurements performed by trained human observers using a validated reference method (e.g., mercury sphygmomanometer or another agreed-upon reference device), following the protocols outlined in standards like ANSI/AAMI/ISO 81060-2. The exact specifics of how this ground truth was established for this specific device's compliance are not detailed in the provided 510(k) summary, beyond stating compliance with the standard that mandates such methods.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that undergoes training on a large dataset in the way a deep learning model would. Its "training" or development process would involve traditional engineering and calibration.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

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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

April 22, 2016

Shenzhen Urion Technology Co., Ltd. Ms. Autumn Liu Sales Manager 4th Building, Hi-tech Industrial Zone, Heping Community, Fuyong Street, Baoan Shenzhen, 518103 CN

Re: K160019

Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor U80 Series, including: U80A, U80AH, U80B, U80BH Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 28, 2015 Received: January 15, 2016

Dear Ms. Autumn Liu,

We have reviewed vour 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

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or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 (OS) 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 Stei

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160019

Device Name

Upper Arm Electronic Blood Pressure Monitor U80 Series, including: U80A, U80AH, U80B, U80BH

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K160019 Page 1 of 4

Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

1. Date of Submission: Dec 28, 2015
1. Sponsor

Shenzhen Urion Technology Co., Ltd 4th building, Hi-tech Industrial Zone, Heping Community,Fuyong street, Baoan District, Shenzhen, Guangdong, China 518103

Establishment Registration Number: not yet;

Contact Person: MS. Autumn Liu Position: Sales Manager Tel: +86-755-29231308 Fax: +86-755-27493959 Email: autumn@urion.com.cn

Submission Correspondent 3. MS. Autumn Liu Shenzhen Urion Technology Co., Ltd. 4th building, Hi-tech Industrial Zone, Heping Community, Fuyong street, Baoan District, Shenzhen, Guangdong, China 518103 Tel: (86 755) 29231308 Fax: (86 755) 27493959 Email: autumn@urion.com.cn
1. Proposed Device Identification

Proposed Device Name: Electronic Blood Pressure Monitor;

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K160019 Page 2 of 4

Proposed Device Model: U80 Series, including: U80A, U80AH, U80B, U80BH

Classification Name: System, measurement, blood-pressure, non-invasive; Common Name: Electronic Blood Pressure Monitor; Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K001670 Product Name: Electronic Blood Pressure Monitor, HEM-757 Manufacturer: Omron Healthcare, Inc
1. Device Description
  The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa.

1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

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K160019 Page 3 of 4

ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

1. Substantially Equivalent

ITEM	U80 SeriesElectronic Blood Pressure Monitor	Electronic BloodPressure MonitorHEM-757, K001670	Comparison
Product Code	DXN	DXN	Same
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	Same
Class	II	II	Same
Intended Use	U80 Series Electronic Blood PressureMonitor is intended to measure thesystolic and diastolic blood pressure aswell as the pulse rate of adult personvia non-invasive oscillometrictechnique in which an inflatable cuff iswrapped around the upper arm. It canbe used at medical facilities or athome. The intended upper armcircumference is 22-36 cm.	Measure the systolic anddiastolic blood pressureand pulse rate in adultpatients with armcircumference between7inches to 15 inches.	SEAnalysis 1
MeasurementType	Upper arm	Upper arm	Same
PatientPopulation	AdultsPersonover12	Adult	Same
MeasurementItem	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Principle	Oscillometric	Oscillometric	Same
BP Range	0 ~ 299 mmHg	0 ~ 280mmHg	SEAnalysis 2
BP Accuracy	$\u00b13$ mmHg	$\u00b13$ mmHg or 2% of reading	SEAnalysis 3
PR Range	40-199 bpm	40-180 bpm	SEAnalysis 4

Table III-1 Substantially Equivalent Comparison

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Premarket Notification 510(k) Submission	Section III 510(k) Summary	Project #: 201401K
Cuff Size	63 cm (length) x 14.4 cm (width)	48 cm (length) x 14 cm (width)SEAnalysis 1
Power Supply	Four AA batteries or AC adapter	Four AA batteries or AC adapterSame
Software LevelConcern	Moderate	ModerateSame

SE Analysis 1

The intended arm circumferences (22-36 cm VS about 17.8-38 cm) and cuff size (63 X 14.4cm VS 48 X 14 cm) of the proposed and predicate device are difference are very slight, and the cuff size is appropriate to the claimed intended arm circumference per ANSI/AAMI/IEC 80601-2-30. Therefore, this point is considered as substantially equivalent.

SE Analysis 2

The blood pressure measurement range of the proposed is a little larger than that of the predicate device. (0-299 mmHg VS 0-280 mmHg). But the difference parts of the range 280-299 mmHg are happened very rare and abnormal, and the range is clearly stated on the label of the container and instructions manual, the operator can select whether to use this product per the actual conditions. Therefore, this difference is considered to be not affect the substantially equivalent conclusion.

SE Analysis 3

The blood pressure measurement accuracy of the proposed is a little different compared with that of the predicate device. (±3 mmHg VS ±3 mmHg or 2% of reading). For the predicate device's measurement accuracy with ±3 mmHg or 2% of reading, the larger shall be taken, that is, for the actual measurement range 0-300mmHg, the accuracy is more than ±3 mmHg. Therefore, this point is considered as substantially equivalent.

SE Analysis 4

The pulse rate measurement range of the proposed is a little different compared with that of the predicate device. (40 - 199 bpm VS 40 - 180 bpm). The difference parts, 180-199 bpm, is very rare and abnormal, and the the range is clearly stated on the label of the container and instructions manual, the operator can select whether to use this product per the actual conditions. Therefore, this difference is considered to be not affect the substantially equivalent conclusion.

The proposed device, U80 Series Upper Arm Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor HEM-757 (K001670), in respect of safety and effectiveness.

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).