The Electronic Blood Pressure Monitor is intended to measure the systolic 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 13.5-19.5 cm. The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).

Device Description

The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the 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.

The proposed electronic blood pressure monitor has eight models, including PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A36 and PG-800A37. All models follow the same software, measurement principle, algorithm and data storage. The main differences are product appearance.

The proposed device is intended to be used in medical facilities or at home.

AI/ML Overview

The provided text describes the 510(k) summary for the "Electronic Blood Pressure Monitor" (multiple models: PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A35, PG-800A36, PG-800A37) by Shenzhen Pango Electronic Co., Ltd. The document aims to demonstrate substantial equivalence to a predicate device (PG-800A Series Electronic Blood Pressure Monitor, Models PG-800A5, PG-800A5D, K131569).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed against recognized standards for non-invasive sphygmomanometers. The document states compliance rather than providing specific numerical results for each criterion explicitly in a performance table. However, it specifically references ISO 81060-2:2013 for clinical validation.

Acceptance Criteria (Standard)	Reported Device Performance (Compliance/Result)
Safety and Essential Performance
IEC 60601-1:2005+A1:2002 (General Requirements for basic safety and essential performance)	Complies
IEC 60601-1-11:2010 (Home Healthcare Environment)	Complies
Electromagnetic Compatibility (EMC)
IEC 60601-1-2:2007 (EMC)	Complies
Particular Requirements for Automated Non-Invasive Sphygmomanometers
IEC 80601-2-30:2009	Complies
Clinical Validation of Automated Measurement Type
ISO 81060-2:2013	Complies
Biocompatibility
ISO 10993 series standards	No cytotoxicity; No irritation to skin; No significant evidence of sensitization

It's important to note that while the document states "Complies," the specific numerical acceptance criteria (e.g., mean difference and standard deviation from reference measurements for blood pressure, as specified in ISO 81060-2) are not provided in this excerpt. The "Complies" statement indicates the device met these criteria.

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

The document states compliance with ISO 81060-2:2013, which outlines requirements for clinical validation. While the exact sample size for the test set is not explicitly stated in this summary, ISO 81060-2:2013 typically requires a minimum of 85 subjects for clinical validation studies for automated non-invasive sphygmomanometers.

The data provenance (country of origin, retrospective/prospective) is not specified in this summary. It only indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

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

For clinical validation as per ISO 81060-2, blood pressure measurements are typically taken by trained observers using a mercury sphygmomanometer or auscultatory method simultaneously or sequentially with the device under test. The standard specifies requirements for these observers, including training and demonstration of accuracy.

The number of experts/observers and their specific qualifications are not explicitly stated in this excerpt. However, it can be inferred that trained personnel, likely medical professionals, would have been involved to establish the reference measurements as per the ISO standard requirements.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method for the test set. In clinical validation studies for blood pressure monitors, the "ground truth" measurements from trained observers are generally considered the reference, and the device's readings are compared against these. There isn't typically an adjudication process in the same way as, for example, for image-based diagnostic systems.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This is a blood pressure monitor, not an AI-assisted diagnostic tool that relies on human readers interpreting cases.

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

The device is an "Electronic Blood Pressure Monitor" and measures blood pressure via an "oscillometric technique." This is inherently a standalone algorithm-only (without human-in-the-loop performance for the measurement itself) device. The algorithm processes the oscillometric signals to determine blood pressure. User interaction is for initiating the measurement and reading the displayed results. The clinical validation in ISO 81060-2 is precisely this – comparing the automated device's output against reference measurements.

7. The Type of Ground Truth Used

The ground truth used for relevant performance criteria (specifically, clinical validation) would be reference blood pressure measurements obtained by trained observers using a validated method (e.g., auscultatory method with a mercury sphygmomanometer or other validated reference device) in accordance with the ISO 81060-2:2013 standard.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For oscillometric blood pressure monitors, the core algorithm for blood pressure determination is typically developed and refined using internal data and engineering principles during the R&D phase. The information provided focuses on the validation against standards.

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

The document does not provide details on how the ground truth for any training set was established. This information is usually proprietary to the manufacturer's R&D process for algorithm development and is not typically included in FDA 510(k) summaries, which focus on compliance with recognized standards for safety and effectiveness.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 31, 2017

Shenzhen Pango Electronic Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120

Re: K161845

Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 3, 2017 Received: June 27, 2017

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

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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,

M.A. Hilleman

for 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) K161845

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

The assigned 510(k) Number: K161845

1. Date of Preparation: 7/11/2017
1. Sponsor Identification

Shenzhen Pango Electronic Co.,Ltd.

No.25, 1st Industrial Park, Fenghuang Road, Xikeng, Henggang, Longgang District, Shenzhen, Guangdong, 518115, China.

Establishment Registration Number: 3006792041

Contact Person: Ms. Xiaoyun Yang Position: Vice General Manager Tel: +86-755-33825988 Fax: +86-755-33825989 Email:sales@pan-go.com

1. Designated Submission Correspondent
  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

1. Identification of Proposed Device
  Trade Name: Electronic Blood Pressure Monitor; Common Name: Wrist Blood Pressure Monitor; PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A35, Models: PG-800A36 and PG-800A37

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

Intended Use Statement:

The 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 13.5-19.5 cm.

The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adults (at least 22 years of age).

Device Description:

The proposed device is intended to be used in medical facilities or at home.

Identification of Predicate Device 5.

510(k) Number: K131569 Product Name: PG-800A Series Electronic Blood Pressure Monitor Models: PG-800A5, PG-800A5D Manufacturer: Shenzhen Pango Electronic Co., Ltd

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Non-Clinical Test Conclusion 6.

Non clinical 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+ A1:2002, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

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, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility

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

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

Table 1 Substantially Equivalent Comparison
ITEM	Proposed Device	Predicate DeviceK131569
Models	PG-800A25, PG-800A27, PG-800A31,PG-800A32, PG-800A33, PG-800A35,PG-800A36 and PG-800A37	PG-800A5, PG-800A5D
Product Code	DXN	DXN
Class	II	II
Intended Use	The Electronic Blood Pressure Monitor isintended to measure the systolic anddiastolic blood pressure as well as thepulse rate of adult person via non-invasiveoscillometric technique in which aninflatable cuff is wrapped around thewrist. It can be used at medical facilities orat home. The intended wrist circumferenceis 13.5-19.5 cm.The patient population does not include	The PG-800A Series Electronic Blood PressureMonitor is intended to measure diastolic, systolic bloodpressure as well as the pulse rate of adult person vianon-invasive technique in which an inflatable cuff iswrapped around the wrist.It can be used at medical facilities or at home.The intended wrist circumference is 13.5cm-19.5cm.
adolescents aged 12 to <18 years of age.The patient population includes transitionadolescent B (18 to < 22 years of age buttreated like adult) and adults (at least 22years of age).
Measurement Type	Wrist	Wrist
Patient Population	Adult	Adult
Measurement Item	Systolic Pressure, Diastolic Pressure, Pulse Rate	Systolic Pressure, Diastolic Pressure, Pulse Rate
Principle	Oscillometric	Oscillometric
Component	LCD / Key / Cuff / MCU / Pump /Transducer/ Batteries	LCD / Key / Cuff / MCU / Pump /Transducer/ Batteries
Blood Pressure	30 ~ 280 mmHg	30 ~ 280 mmHg
Range
Pulse Rate	40-199 bpm	40-199 bpm
Range
Intended wristcircumference	13.5cm~19.5cm	13.5cm~19.5cm
Records Quantity	Double patients mode: 60/60 records	Single patient mode: 90 records for PG-800A5Double patient mode: 60/60 records for PG-800A5D

Operating condition	+5 °C~+40°C30%RH~80%RH;Atomospheric pressure	+5 °C~+40°C30%RH~80%RH;Atomospheric pressure


Storage condition	-20°C~+55°C;10%RH~93%RH;Atomospheric pressure	-20°C~+55°C;10%RH~93%RH;Atomospheric pressure


Patient Contact	Cuff – Nylon	Cuff – Nylon
Material	Enclosure - ABSKey - ABS	Enclosure - ABSKey - ABS
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
ParticularPerformance	Comply with IEC80601-2-30:2009 and ISO 81060-2:2013	ANSI/AAMI SP10

Substantially Equivalent 7.

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Product Comparison Summary

The propoed device and its predicate devices have the similar indented use, mechanism of action, principle of operation, algorithm and cuff. The proposed devices are different than the predicate device in that the proposed device integrates the Key function of both PG-800A5 and PG-800A5D, same Record quantity as that of PG-800A5D, different Product appareance, modified product label

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and software which is modified to applicable to the proposed devices; addtitionally the proposed device details the patient populations. The difference between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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).