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 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 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-800A18, PG-800A19, PG-800A28, PG-800A51, PG-800A52, PG-800A11-1, PG-800A36-1 and PG-800A37-1. 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 document is a 510(k) Summary for an Electronic Blood Pressure Monitor (K223291), seeking substantial equivalence to a predicate device (K161845). It includes information about non-clinical and clinical testing performed to demonstrate device performance and safety.

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Electronic Blood Pressure Monitor are related to its accuracy in measuring blood pressure and pulse rate, and its compliance with relevant medical device standards.

Table 1: Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Standard)	Reported Device Performance	Remarks
Accuracy of Systolic Pressure	Mean error ≤ ±5 mmHg (ISO 81060-2:2018)	Mean error: Not explicitly stated, but meets the criteria.	"For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less."
Accuracy of Diastolic Pressure	Mean error ≤ ±5 mmHg (ISO 81060-2:2018)	Mean error: Not explicitly stated, but meets the criteria.	"For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less."
Accuracy Standard Deviation (BP)	Standard deviation ≤ 8 mmHg (ISO 81060-2:2018)	Standard deviation: Not explicitly stated, but meets the criteria.	"For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less."
Pulse Rate Measurement Range	40-199 bpm (aligns with predicate)	40-199 bpm	Same as predicate device.
Blood Pressure Measurement Range	30 ~ 280 mmHg (aligns with predicate)	30 ~ 280 mmHg	Same as predicate device.
Biocompatibility	Comply with ISO 10993 series standards; no cytotoxicity, irritation, or sensitization.	Complies with ISO10993 series standards; no cytotoxicity, irritation to skin, no significant evidence of sensitization.	Confirmed through non-clinical testing.
Electrical Safety	Comply with IEC 60601-1 (2005, COR1:2006, COR2:2007, AMD1:2012)	Complies with IEC 60601-1	Confirmed through non-clinical testing.
Electromagnetic Compatibility (EMC)	Comply with IEC 60601-1-2:2014	Complies with IEC 60601-1-2:2014	Updated standard version compared to predicate, but still meets requirements.
Particular Performance	Comply with IEC 80601-2-30 and ISO 81060-2	Complies with IEC 80601-2-30 and ISO 81060-2	Confirmed through non-clinical testing and clinical testing.

Study Proving Device Meets Acceptance Criteria

The document describes both non-clinical and clinical testing.

Clinical Testing (Performance Study)

The clinical test was conducted to verify that the proposed device met the requirements of the ISO 81060-2:2018 standard.

Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated in the provided text. The ISO 81060-2 standard typically requires a minimum of 85 subjects with specific demographic balance (e.g., age, sex, arm circumference, and blood pressure distribution) for a full validation.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it is a clinical test for device validation, it is generally assumed to be prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for blood pressure monitor validation studies. Ground truth in such studies is typically established by simultaneous measurements using a validated reference method (e.g., auscultatory method by trained observers with a mercury sphygmomanometer) as per the ISO 81060-2 standard, not by expert consensus on images or data interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth is established by simultaneous reference measurements, not by expert interpretation requiring adjudication. ISO 81060-2 involves multiple trained observers for reference measurements.
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 is not an AI-assisted device for diagnostic interpretation; it is a direct measurement device. Therefore, an MRMC study is not relevant or applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "clinical test" is essentially the "standalone" performance of the device (algorithm and hardware combined) against a reference standard. The device operates automatically once initiated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure monitor validation (as per ISO 81060-2) is established by simultaneous auscultatory measurements performed by trained observers using a validated reference method (e.g., mercury sphygmomanometer with a stethoscope). This is generally considered a highly reliable and direct physiological measurement.
The sample size for the training set:
- This device is an Electronic Blood Pressure Monitor using an oscillometric technique, not a machine learning/AI model that typically requires a separate "training set" in the conventional sense. The "algorithm" for blood pressure calculation from oscillometric pulses is built into the device. Therefore, a distinct "training set" like those used for AI models is not applicable or specified.
How the ground truth for the training set was established:
- Not applicable for the reason stated above. The underlying oscillometric principle and algorithms are well-established.

Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. These tests covered various aspects of safety and performance.

Testing Standards:
- ISO 10993-1:2018 (Biological evaluation - risk management)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2010 (Irritation and delayed-type hypersensitivity)
- IEC 60601-1:2005 + A1:2012 (Medical electrical equipment - general requirements for basic safety and essential performance)
- IEC 60601-1-11:2015 (Home healthcare environment)
- IEC 60601-1-2:2014 (EMC)
- IEC 80601-2-30:2018 (Automated non-invasive sphygmomanometers)

The document concludes that the non-clinical tests and the clinical test demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.

Summary

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June 14, 2023

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

Re: K223291

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: October 19, 2022 Received: October 26, 2022

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.

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

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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality 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)

K223291

Device Name

Electronic Blood Pressure Monitor

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.

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

The assigned 510(k) Number: _K223291

1. Date of Preparation: 10/19/2022
1. Sponsor Identification

Shenzhen Pango Medical Electronics Co., Ltd.

No.25 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, 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. Xingqi Wang (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: Wrist Electronic Blood Pressure Monitor Models: PG-800A18, PG-800A19, PG-800A28, PG-800A51, PG-800A52, PG-800A11-1, PG-800A36-1 and PG-800A37-1

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.

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Identification of Predicate Device ર.

Predicate Device 510(k) Number: K161845 Product Name: Wrist Blood Pressure Monitor Models: PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A35, PG-800A36 and PG-800A37 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:
ISO 10993-1:2018 Biological evaluation of medical device- Part 1: Evaluation and testing within a risk management process.
A ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Test for in vitro cytotoxicity.
ISO10993-10:2010 Biological evaluation of medical devices-Part10: Test for irritation and delayed-type hypersensitivity.
A IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 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 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

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7. Comparison of Technological characteristics

Item	Proposed Device	Predicate DeviceK161845	Remarks
Code	DXN	DXN	Same
Classification No.	21 CFR 870.1130	21 CFR 870.1130	Same
Class	II	II	Same

Table 1 Comparison for Electronic Blood Pressure Monitor

Item	Proposed Device	Predicate DeviceK161845	Remark
Product Code	DXN	DXN	Same
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	Same
Class	II	II	Same
Indication for Use	The Electronic Blood PressureMonitor is intended tomeasure the systolic anddiastolic blood pressure aswell as the pulse rate of adultperson via non-invasiveoscillometric technique inwhich an inflatable cuff iswrapped around the wrist. Itcan be used at medicalfacilities or at home. Theintended wrist circumferenceis 13.5-19.5 cm.The patient population doesnot include adolescents aged12 to <18 years of age. Thepatient population includestransition adolescent B (18 to< 22 years of age but treatedlike adult) and adults (at least22 years of age).	The Electronic Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulse rateof adult person via non-invasiveoscillometric technique in whichan inflatable cuff is wrappedaround the wrist. It can be usedat medical facilities or at home.The intended wristcircumference is 13.5-19.5 cm.The patient population does notinclude adolescents aged 12 to<18 years of age. The patientpopulation includes transitionadolescent B (18 to < 22 yearsof age but treated like adult) andadults (at least 22 years of age).	Same
Measurement Type	Wrist	Wrist	Same
Patient Population	Adult	Adult	Same
Measurement Item	Systolic Pressure, DiastolicPressure, Pulse Rate	Systolic Pressure, DiastolicPressure, Pulse Rate	Same
Principle	Oscillometric	Oscillometric	Same
Main Component	LCD / Key / Cuff / MCU /Pump /Transducer/ Batteries	LCD / Key / Cuff / MCU /Pump /Transducer/ Batteries	Same
Blood PressureRange	30 ~ 280 mmHg	30 ~ 280 mmHg	Same
Pulse Rate Range	40-199 bpm	40-199 bpm	Same
Intended wristcircumference	13.5cm~19.5cm	13.5cm~19.5cm	Same
Cuff size	Length: 290±5mmWidth: 72±5mm	Length: 310±5mmWidth: 80±5mm	Analysis 1
Records Quantity	Double patients mode: 90/90records	Double patients mode: 60/60records	Analysis 2
Power Supply	Two AAA or LR03 batteriesfor models PG-800A18,PG-800A19,PG-800A28,PG-800A52	Two AAA or LR03 batteries	Analysis 3
	3.7V for models PG-800A51,
	PG-800A11-1,PG-800A36-1,P
	G-800A37-1

Operating condition	+5°C~+40°C	+5°C~+40°C;	Same
	30%RH~80%RH	30%RH~80%RH;
	Atmospheric pressure	Atomospheric pressure
Storage condition	-20°C~+55°C	-20°C~+55°C;	Same
	10%RH~93%RH	10%RH~93%RH;
	Atmospheric pressure	Atomospheric pressure
Patient ContactMaterial	Cuff - Nylon	Cuff - Nylon	Same
	Enclosure - ABS	Enclosure - ABS
	Key - ABS	Key - ABS
Biocompatibility	Comply with ISO10993 seriesstandards	Comply with ISO10993 seriesstandards	Same
	No cytotoxicity;	No cytotoxicity;
	No irritation to skin;	No irritation to skin;
	No significant evidence ofsensitization	No significant evidence ofsensitization


Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
EMC	Comply with IEC 60601-1-2:2014	Comply with IEC60601-1-2:2007	Analysis 4

ParticularPerformance	Comply with IEC80601-2-30 and ISO 81060-2	Comply with IEC80601-2-30 and ISO 81060-2	Same

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Analysis 1 Cuff size

The cuff size of the proposed device is different from the predicate device. However, the size of the cuff did not affect the function of measuring blood pressure. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

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Analysis 2 Records Quantity

For double patient model, the records quantity of proposed device is 90/90 while for predicated device is 60/60, yet the proposed device adopted 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.

Analysis 3- Power supply

The difference between proposed device and predicated device (K161845) is the batteries, the proposed device use 2 x 1.5V Batteries (for models: PG-800A19, PG-800A28, PG-800A28, PG-800A52) and Rechargeable Li-ion Battery PL 552233 for model: PG-800A11-1, PG-800A11-1, PG-800A36-1 and PG-800A37-1 while the predicate device use two AAA or LR03 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.

Analysis 4- EMC

The difference between proposed device and predicate device (K161845) is the standard version of EMC test. The new version of the standard can override the requirements of the old version of the standard. In addition, the EMC of proposed device is justified by IEC 60601-1-2: 2014. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

1. Summary of Clinical Testing
  The clinical test was conducted to verify that the proposed device met the requirements of the ISO 81060-2:2018. For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less.
1. Conclusion
  The conclusions drawn from the nonclinical tests and clinical test demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K161845, Wrist Blood Pressure Monitor.

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).