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 upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~~32 cm and 32 cm~~42 cm.

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 upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm.

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

The product is provided non-sterile, and not to be sterilized by the user prior to use.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for an Electronic Blood Pressure Monitor (K200716).

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a separate section, but it does list specifications the device claims to meet, which serve as acceptance criteria. The device's reported performance is directly stated as meeting these specifications or being identical to the predicate device.

Acceptance Criteria (from Proposed Device Specifications)	Reported Device Performance
Blood Pressure Range	30~280mmHg
Blood Pressure Accuracy	±3mmHg
Pulse Rate Range	40~199 bpm
Measurement Method	Oscillometric
Measured Items	Systolic Pressure, Diastolic Pressure, Pulse Rate
Measurement Site	Upper arm
Patient Population	Adult
Arm Circumference	22cm~~32cm and 32cm~~42cm
Electrical Safety	Comply with IEC 60601-1
EMC (Electromagnetic Compatibility)	Comply with IEC 60601-1-2
Particular Performance (Sphygmomanometers)	Comply with IEC 80601-2-30:2009
Home Healthcare Environment	Comply with IEC 60601-1-11:2010 (implied, as the standard is listed)
Power Supply Safety (Rechargeable Battery)	Meets the requirements of IEC 62133 (for PG-800B51 model)
Software Level Concern	Moderate
General Safety and Essential Performance	Met all design specifications (as verified by non-clinical tests)

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

The document explicitly states: "No Clinical study is included in this submission" for the proposed device (K200716). Therefore, there is no sample size for a test set, nor data provenance information for a clinical study of this specific device.

The basis for proving substantial equivalence to the predicate device (K170151) is that the blood pressure measurement function, including the measurement principle and NIBP algorithm, and cuff size are identical. The predicate device did conduct a clinical study according to ISO 81060-2 (as noted in the comparison table), but the details of that study (sample size, provenance) are not provided in this document.

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)

Since no clinical study was conducted for the proposed device (K200716), there were no experts used to establish ground truth for a test set for this submission.

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

Not applicable, as no clinical study was conducted for the proposed 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

Not applicable. The device is an automated blood pressure monitor and does not involve AI assistance for human readers/operators in its primary function of blood pressure measurement.

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

For the proposed device (K200716), a standalone performance evaluation in a clinical setting was not done. Its performance is asserted as identical to the predicate device (K170151) due to shared measurement principles and algorithms.

Non-clinical tests were conducted to verify design specifications and compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 62133), which can be considered "standalone" technical evaluations.

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

For the proposed device (K200716) submission, no new clinical ground truth was established. The submission relies on the ground truth established by the predicate device's clinical study (which was "conducted according to ISO 81060-2"). ISO 81060-2 defines the clinical investigation of non-invasive sphygmomanometers, which typically involves comparing the device's readings against a reference measurement (e.g., auscultatory method performed by trained observers).

8. The sample size for the training set

Not applicable. There is no mention of a training set for a machine learning model, as this is an automated blood pressure monitor based on an established oscillometric algorithm, not an AI/ML-based diagnostic device in the context of typical training sets. The comparison focuses on the measurement algorithm being identical to the predicate.

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

Not applicable, as there is no training set mentioned or implied for this device.

Summary

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December 4, 2020

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

Re: K200716

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: November 4, 2020 Received: November 5, 2020

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. 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.

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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 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-reporting-

combination-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200716

Device Name Electronic Blood Pressure Monitor

Indications for Use (Describe)

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 upper arm. It can be used at medical facilities or at home.

The intended arm circumference includes 22 cm~~32 cm and 32 cm~~42 cm.

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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Tab #6 510(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:

1. Date of Preparation: 2/20/2020
Sponsor Identification 2.

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: 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: 360 925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Electronic Blood Pressure Monitor Common Name: Arm Blood Pressure Monitor; Models: PG-800B18, PG-800B19, PG-800B19L, PG-800B28, PG-800B29 and PG-800B51

Regulatory Information

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

Indications for Use:

Device Description

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

The product is provided non-sterile, and not to be sterilized by the user prior to use.

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ર . Identification of Predicate Device
510(k) Number: K170151 Product Name: Electronic Blood Pressure Monitor Model: PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B43 and PG-800B42 Manufacturer: Shenzhen Pango Electronic Co., Ltd.
1. Non-Clinical Test Conclusion
  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+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment -Part 1: General requirements for basic safety, and essential performance
A 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
A 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
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.
1. Clinical Test Conclusion

No Clinical study is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151).

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device, Electronic Blood PressureMonitor	Predicate Device, K170151Electronic Blood Pressure Monitor
Product Code	DXN	DXN
Regulation Number	21 CFR 870.1130	21 CFR 870.1130
Class	II	II
Indications for Use	The Electronic Blood Pressure Monitor isintended to measure the systolic and diastolicblood pressure as well as the pulse rate of adultperson via non-invasive oscillometrictechnique in which an inflatable cuff iswrapped around the upper arm. It can be usedat medical facilities or at home. The intendedarm circumference includes: 22 cm~~32 cm and32 cm~~42 cm.	The Electronic Blood Pressure Monitor isintended to measure the systolic anddiastolic blood pressure as well as the pulserate of adult person via non-invasiveoscillometric technique in which aninflatable cuff is wrapped around the upperarm. It can be used at medical facilities or athome. The intended arm circumferenceincludes: 22 cm~~32 cm and 32 cm~~42 cm.
Measurement Site	Upper arm	Upper arm
Patient Population	Adult	Adult
Measurement Item	Systolic Pressure, Diastolic Pressure, PulseRate	Systolic Pressure, Diastolic Pressure, PulseRate
MeasurementMethod	Oscillometric	Oscillometric
Component	LCD / Key / Cuff / MCU / Pump / Batteries	LCD / Key / Cuff / MCU / Pump / Batteries
Blood Pressure Range	30~280mmHg/	30 ~ 280 mmHg
Blood Pressure Accuracy	3mmHg	3 mmHg
Pulse Rate Range	40 ~ 199 bpm	40 ~ 199 bpm
Data storage	SYS, DIA, Pulse Rate, Measurement Time,Memory Number.	SYS, DIA, Pulse Rate, Measurement Time,Memory Number.
WHO BP Classification	Model PG-800B18, PG-800B19,PG-800B19L, PG-800B28, PG 800B29 hasWHO BP Classification Per WHOClassificationModel PG-800B51 has not WHO BPClassification	All models provide WHO Classification
Power Supply	4 x 1.5V Batteries (LR03 or AAA) for modelsPG-800B18, PG-800B19,PG-800B19L ,PG-800B28, PG-800B29Rechargeable Li-ion Battery PL 652035HC formodel: PG-800B51	4x 1.5V Battery (AA or LR6 batteries)
Records Quantity	Single patient records quantity:90 for E)formodels PG-800B18, PG-800B19, PG-800B28,PG-800B29, PG-800B51	Single patient records quantity:90 forElectronic Blood Pressure Monitor(PG-800B42)
	Doulbe patient records quantity: 90/90 for r for	Doulbe patient records quantity:60/60 for
	model :PG PG-800B19L	Electronic Blood Pressure Monitor
		(PG-800B22, PG-800B23, PG-800B26,
		PG-800B27, PG-800B31, PG-800B32,
		PG-800B33, PG-800B35, PG-800B36,
		PG-800B37, PG-800B43)
Arm circumference	22~~32cm and 32~~42cm	22~~32cm and 32~~42cm
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Particular	Comply with IEC	Comply with IEC
Performance	80601-2-30:2009	80601-2-30:2009
Clinical study	Not conducted	Conducted according to ISO 81060-2
Patient Contact Material	Cuff - Nylon Brush Tricot	Cuff - Nylon
	Enclosure - ABS	Enclosure - ABS
	Key - ABS	Key - ABS
Software Level Concern	Moderate	Moderate

Table 1 Comparison of Technology Characteristics

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By comparisons, there are mainly four differences between proposed device and predicated device. which are power supply, voltage, record quantities and clincial study.

SE Analysis 1-WHO BP classification

Majority models of proposed device have WHO BP classification which is identical to predicated device except model PG-800B51. Yet the WHO BP classification indicating is only for reference, it cannot be used as diagnosis criteria. This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.

SE Analysis 2- Power supply

The difference between proposed device and predicated device (K170151) is the batteries , the proposed device use 4 x 1.5V Batteries (for models: PG-800B18, PG-800B19, PG-800B19L PG-800B28, PG-800B29) and Rechargeable Li-ion Battery PL 652035HC for model: PG-800B51 while the predicate device use four AA or LR6 batteries, but the power supply safety of proposed device is justified by the IEC60601-1 electricity test reports, and the rechargeable battery of the proposed device meets the requirements of IEC 62133. thus This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.

SE Analysis 3 -Record quantities

For single patient model, the proposed device has the same record quantities as predicate device. For double patient model, the records quantities of proposed device is 90/90 while for predicated device is 60/60 , yet the proposed device adopt same measurement principle and NIBP algorithm as predicated device, software function is justified by the software documents. This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.

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SE Analysis 4- Clinical study

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).