The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm~~22cm, 22cm~~32cm, 32cm~42cm.

Device Description

The subject device 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 and the pulse rate of adult 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 software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.

AI/ML Overview

This document describes a 510(k) submission for an Electronic Sphygmomanometer (Model: WBP100, WBP201, WBP202) by Guangdong Biolight Meditech Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K131558).

Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:

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

The document explicitly states that the clinical study was conducted to evaluate if the device meets the accuracy requirements of ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."

While the document references this standard as the acceptance criterion, it does not provide a table of the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from ISO 81060-2:2013, nor does it present the reported device performance with those specific numbers. It only states that the device "meets the accuracy requirements."

To fully answer this question, one would need to refer to ISO 81060-2:2013 to determine its specific accuracy criteria and then examine the full clinical study report (which is not provided in this excerpt) for the device's measured performance against those criteria.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document mentions a "clinical study" but does not explicitly state the sample size used for the test set (i.e., the number of subjects enrolled in the clinical validation). ISO 81060-2:2013 typically specifies minimum sample sizes for clinical validation (e.g., usually 85 subjects for Phase 1 and Phase 2 combined, or similar, depending on the specific method).
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for medical devices are typically prospective in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For non-invasive blood pressure monitors, the "ground truth" for blood pressure measurements in a clinical validation study typically involves simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer, often with a "double stethoscope" setup to ensure independent readings.

The document does not specify the number of experts (observers) used or their qualifications (e.g., "trained observers" or "physicians with X years of experience"). ISO 81060-2:2013 outlines detailed requirements for the training and procedures for these observers to ensure accurate reference measurements.

4. Adjudication method for the test set:

In the context of blood pressure validation studies, "adjudication" usually refers to managing discrepancies between simultaneous reference measurements (e.g., if two observers get slightly different readings). ISO 81060-2:2013 specifies procedures for this, often involving taking the average of the two observer readings if they are within a certain range, or a third observer if they are too disparate.

The document does not explicitly state the adjudication method used for the test set, but it would have followed the methodology defined in ISO 81060-2:2013.

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 device is an Electronic Sphygmomanometer, a direct measurement device, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable to this type of device, and the concept of "human readers improving with AI assistance" does not apply.

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

The device itself is an automated non-invasive sphygmomanometer. Its operation is inherently "standalone" in the sense that the device's algorithm performs the measurement and calculation of blood pressure without human intervention during the measurement process. The clinical validation outlined by ISO 81060-2:2013 evaluates this automated performance against reference measurements. So, the clinical study is effectively a standalone performance assessment of the automated device.

7. The type of ground truth used:

The ground truth for non-invasive blood pressure measurement devices validated against ISO 81060-2:2013 is typically established by simultaneous, direct auscultatory measurements performed by trained human observers using a calibrated reference device (e.g., mercury sphygmomanometer). This is considered the "gold standard" for clinical validation of these devices. It is not pathology or outcomes data.

8. The sample size for the training set:

This device is a hardware product with a measurement algorithm, not a machine learning model that requires a "training set" in the conventional sense of AI development. The "algorithm" here refers to the oscillometric method's logic and the device's internal programming for calculating BP. Therefore, the concept of a separate "training set" for an AI model does not apply to this medical device submission as described.

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

As mentioned above, the concept of a "training set" and establishing ground truth for it does not apply in the context of this traditional medical device validation. The "ground truth" is relevant for the clinical validation (test set) to ensure the accuracy of the device's measurements against accepted reference methods.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles forming a bird-like shape, often referred to as the "Human Services Symbol."

November 3, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K160349

Trade/Device Name: Electronic Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 25, 2016 Received: September 28, 2016

Dear Diana Hong:

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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

Minda Jellison

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160349

Device Name Electronic Sphygmomanometer

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Tab #4 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K160349

1. Date of Preparation: 10/31/2016
Sponsor Identification 2.

Guangdong Biolight Meditech Co.,Ltd. Innovation First Road, Technical Innovation Coast, Zhuhai, 519085,China

Establishment Registration Number: 3007305624

Contact Person: Ms. Liang, jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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1. Identification of SubjectDevice
  Trade Name: Electronic Sphygmomanometer Common Name: Electronic Blood Pressure Monitor; Model: WBP100, WBP201, WBP202

Regulatory Information Classification Name: Noninvasive blood pressure measurement system Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Indications for use:

1. Identification of Predicate Device
  510k Number: K131558 Product Name: Electronic Blood Pressure Monitor, PG-800B Manufacturer: Shenzhen Pango Electronic Co., Ltd
Q. Reference Device Identification
510k Number: K131763 Product Name: Truscope Patient Monitor Manufacturer: Guangdong Biolight Meditech Co.,Ltd.
1. Device Description
  The subjectdevice 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 and the pulse rate of adult 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 software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.

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8. Non-Clinical Test Conclusion

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

IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance, including the US National Differences

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.

IEC 60601-1-2:2007, EN 60601-1-2:2007+AC:2010, IEC 60601-1-11:2010 Clause 12, EN 60601-1-11: 2010 Clause 12, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility

IEC 80601-2-30:2009+A1:2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

1. Clinical Test Conclusion
  The clinical study was to evaluate the subjectElectronic Sphygmomanometer meets the accuracy requirements of the following standard:

ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type.

1. Substantially Equivalent

	Subject Device	Predicate Device
ITEM	WBP100, WBP201, WBP202Electronic Sphygmomanometerr	PG-800B, K131558Electronic Blood Pressure Monitor
Product Code	DXN	DXN
Class	II	II
Intended Use	The device is intended to measure diastolic, systolicblood pressure and the pulse rate of an adult patientvia non-invasive technique in which an inflatablecuff is wrapped around the upper arm. It is intendedto be used at home. The intended arm circumference	Electronic Blood Pressure Monitor isintended to measure diastolic, systolic bloodpressure as well as the pulse rate of adultperson via non-invasive technique in whichan inflatable cuff is wrapped around the

Table 1 Substantially Equivalent Comparison between the Subject Device and Predicate Device

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	is 17cm~~22cm, 22cm~~32cm, 32cm~42cm.	upper arm. It can be used at medical facilitiesor at home. The intended arm circumferenceis 22cm~32cm.
Measurement Type	Upper arm	Upper arm
Patient Population	Adult	Adult
Measurement Item	Systolic Pressure, Diastolic Pressure, Pulse Rate	Systolic Pressure, Diastolic Pressure, Pulse Rate
Principle	Oscillometric	Oscillometric
Component	Main unit, cuff, battery	Main unit, cuff, battery
Nominal (operating)ranges for measuredparameteers	0-300 mmHg for blood pressure	Unknown
Measurement rangesfor measuredparameteers	10-255 mmHg for blood pressure30 - 255 mmHg (SYS),10 -220 mmHg (DIA))40-240 bpm for pulse rate	30-280 mmHg for blood pressure40-199 bpm for pulse rate
Patient ContactMaterial	Cuff - Polyester fabric, Raised fabric	Cuff – Nylon
Bicompatibility	Comply with ISO10993 series standardsNo cytotoxicity;No irritation to skin;No significant evidence of sensitization	Comply with ISO10993 series standardsNo cytotoxicity;No irritation to skin;No significant evidence of sensitization
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2:2007	Comply with IEC 60601-1-2:2007
Accuracy clinicalinvestigation	ISO 81060-2:2013	SP 10
Software LevelConcern	Moderate	Moderate

The subject device and its predicate devices have the idented use, components, principle and similar performance. The difference between the subject device and the predicate device do not raise any question regarding its safety and effectiveness.

ITEM	Subject deviceElectronic Sphygmomanometer	Reference Device, K131763Truscope Patient Monitor,
Models	WBP100, WBP210, WBP202	Truscope Elite A8
Manufacturer	Guangdong Biolight Meditech Co.,Ltd.	Guangdong Biolight Meditech Co.,Ltd.
Patient ContactMaterial	Component: Shell of main unitMaterial: Polycarbonate andacrylonitrile-butadiene-styrene	Component: Shell of main unitMaterial: Polycarbonate andacrylonitrile-butadiene-styrene

Table 2 Main Unit Material Comparison between the Subject Device and Reference Device

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The device (K131763) was selected as the reference device is used to demonstrate the biocompatibility of the patient contact material of the subject device.

The subject device and reference device are all manufactured by Biolight Company. The materials of shell of main unit of the subject device, acrylonitrile-butadiene-styrene and Polycarbonate, are identical to the materials of shell of Biolight product, Truscope Patient Monitor, as it was approved in K131763, in formulation, processing and sterilization, and no other chemicals have been added.

Therefore the biocompatibility of the main unit of the subject device is acceptable.

The subject device, WBP series Electronic Sphygmomanometer, is determined to be Substantially Equivalent (SE) to the predicate device (K131558), and reference device (K131763) 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).