U60 Series Wrist 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

Device Description

The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist 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 data storage and time display. These two differences will not affect the safety and effectiveness of the device.

AI/ML Overview

The provided document is a 510(k) summary for a blood pressure monitor, which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and international standards. It does not contain information about a clinical study involving human patients to directly "prove the device meets acceptance criteria" in terms of clinical accuracy or performance, as one would typically expect for a software-as-a-medical-device (SaMD) or AI-based device.

The "acceptance criteria" for this device are defined by its adherence to recognized industry standards for non-invasive sphygmomanometers, rather than specific clinical performance metrics derived from a dedicated study reported within this document.

However, I can extract the relevant information based on the context of this 510(k) and general FDA requirements for such devices:

1. Table of Acceptance Criteria and Reported Device Performance

For non-invasive blood pressure monitors, the acceptance criteria are generally defined by the accuracy requirements in standards like ANSI/AAMI/IEC 80601-2-30. The document states the device complies with this standard.

Acceptance Criteria (Based on ANSI/AAMI/IEC 80601-2-30)	Reported Device Performance (U60 Series)
Blood Pressure Accuracy: ± 3 mmHg	± 3 mmHg

Note: The document lists the pulse rate range as 40-199 bpm for the proposed device, while the predicate is 30-180 bpm. It clarifies this difference is not considered to affect substantial equivalence as the differing ranges (30-40 bpm and 180-199 bpm) are "very rare and abnormal". However, a specific accuracy for pulse rate is not explicitly stated in the table for either the criteria or performance, but it would also be covered by the ANSI/AAMI/IEC 80601-2-30 standard.

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

The document does not describe a clinical study with a "test set" in the context of patient data to assess diagnostic or predictive accuracy. Instead, it refers to "bench tests" to verify design specifications and compliance with standards. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as there is no described clinical study involving human patients and expert review to establish ground truth for a diagnostic performance assessment. The "ground truth" for the device's accuracy is its measurement against a calibrated standard (presumably, an invasive BP measurement or a validated reference device) as part of the standards compliance testing.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication is described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is an automated blood pressure monitor and does not involve human readers interpreting output that would necessitate an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The device itself is a "standalone" system in the sense that it automatically measures blood pressure and pulse rate. The document states:

"The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique."

The "standalone performance" is demonstrated through compliance with the ANSI/AAMI/IEC 80601-2-30:2009 standard, which dictates performance requirements for automated noninvasive sphygmomanometers. However, the details of the results of such testing (e.g., number of subjects, average difference, standard deviation) are not provided in this 510(k) summary; only that the device "complies."

7. Type of Ground Truth Used

For the accuracy claim of ± 3 mmHg, the ground truth would be established through comparison of the device's measurements against a standardized reference method for blood pressure measurement (e.g., auscultation with a mercury column sphygmomanometer performed by trained professionals, or more advanced invasive methods in controlled settings). This is an inherent part of the testing required by standards like ANSI/AAMI/IEC 80601-2-30. The document does not explicitly state the methodology for establishing this ground truth, but merely that the device complies with the standard.

8. Sample Size for the Training Set

This information is not applicable. The U60 Series Blood Pressure Monitor is an oscillometric device, which uses established algorithms for blood pressure determination. It is not an AI/ML device that requires a "training set" in the conventional sense of machine learning. The algorithms are typically developed and validated using physiological data but not in a way that is described as a "training set" for an AI model.

9. How 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 3, 2015

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

Re: K141683

Trade/Device Name: Electronic Blood Pressure Monitor, U60 Series including U60A and U60AH Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 16, 2015 Received: February 18, 2015

Dear 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,

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 2 Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K141683

Device Name

Electronic Blood Pressure Monitor U60 Series, including U60A and U60AH

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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Section 3 510(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: June 19, 2014
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 registered;

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

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Device Identification 4.

Proposed Device Name: Electronic Blood Pressure Monitor; Proposed Device Model: U60 Series, including U60A and U60AH

Classification Name: Cardiovascular Diagnostic Devices; Common Name: Electronic Blood Pressure Monitor; Class: Class II; Product Code: DXN: Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K070826 Product Name: Electronic Blood Pressure Monitor, KD-795 Manufacturer: Kodon (Tianjin) Electronic & Electrical Apparatus Co., Ltd
1. Device Description
  The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist 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 3-2

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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.

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.

Substantially Equivalent 8.

ITEM	U60 SeriesElectronic Blood PressureMonitor	K070826Electronic Blood PressureMonitor KD-795,	Comparison
Product Code	DXN	DXN	Same
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	Same
Class	II	II	Same
Intended Use	U60 Series Wrist Electronic Blood Pressure Monitor isintended to measure the systolicand diastolic blood pressure aswell as the pulse rate of adultperson via non-invasiveoscillometric technique inwhich an inflatable cuff iswrapped around the wrist. It canbe used at medical facilities orat home. The intended wristcircumference is 13.5-21.5 cm.	Wrist Measurement AutomaticElectronic Blood PressureMonitor is for use by medicalprofessionals or at home and is anon-invasive blood pressuremeasurement system intended tomeasure diastolic, systolic bloodpressure and pulse rate on adultindividual by using anon-invasive technique in whichan inflatable cuff is wrappedaround the wrist. The cuffcircumference is limited to6.1023 inches to 9.8425 inches.	SEAnalysis 1
Measurement Type	Wrist	Wrist	Same
Patient Population	Adult	Adult	Same
Measurement Item	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Principle	Oscillometric	Oscillometric	Same
BP Range	$0~299$ mmHg	$0~300$ mmHg	Same
BP Accuracy	$\pm 3$ mmHg	$\pm 3$ mmHg	Same
PR Range	40-199 bpm	30-180 bpm	SEAnalysis 2
Cuff Size	31 cm (length) x 8.3 cm (width)	30cm (length) x 7 cm (width)	SEAnalysis 1
Power Supply	two AAA	two AAA	Same
Software Level Concern	Moderate	Moderate	Same

Table 3-1 Substantially Equivalent Comparison

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SE Analysis 1

The intended arm circumferences (13.5-21.5 cm VS about 15.50-25 cm) and cuff size (31X 8.3cm VS 30 X 7 cm) of the proposed and predicate device are different. This difference are very slight, and the cuff size is appropriate to the claimed intended wrist circumference per ANSI/AAMI/IEC 80601-2-30. Therefore, this point is considered as substantially equivalent.

SE Analysis 2

The pulse rate measurement range of the proposed is a little different compared with that of the predicate device. (40 – 199 bpm VS 30 – 180 bpm). The difference parts, 30-40 bpm and 180-199 bpm, are 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.

The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor KD-795 (K070826), 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).