The PG-800A Series 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.

Device Description

The proposed device, PG-800A Series 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 appearance and data storage. These two differences will not affect the safety and effectiveness of the device.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Acceptance Criterion (Claimed)	Reported Device Performance
BP Accuracy	± 3 mmHg	± 3 mmHg
BP Range	30 ~ 280 mmHg	30 ~ 280 mmHg
PR Range	40-199 bpm	40-199 bpm

Study Details:

The provided document describes non-clinical bench tests conducted to verify that the proposed device (PG-800A Series Electronic Blood Pressure Monitor) met all design specifications and was Substantially Equivalent (SE) to the predicate device (Electronic Blood Pressure Monitor PG-800A, K102920).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states that "Bench tests were conducted." It does not specify the sample size for human subjects or the number of measurements taken during these bench tests that would be considered a "test set" in the context of clinical performance. It also does not specify the origin of any data, if human data was used, nor if it was retrospective or prospective. The tests mentioned are primarily for compliance with standards.
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):
- This information is not provided in the document. The document refers to "bench tests" and compliance with standards like AAMI SP10, which typically involves comparison to a reference standard, not a panel of experts establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the study described is non-clinical bench testing for compliance. Clinical adjudication methods are not relevant here.
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, an MRMC comparative effectiveness study was not done. The device is an automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The presented data is the standalone performance of the device's measurement accuracy against the claimed specifications and relevant standards. The "bench tests" confirm the device's ability to measure blood pressure and pulse rate accurately according to the stated ranges and accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "BP Accuracy" and "PR Range" acceptance criteria, the implicit "ground truth" for the bench tests would be a highly accurate reference measurement device or method, as specified by the AAMI SP10 standard (e.g., using a mercury sphygmomanometer or highly calibrated electronic reference). The document states compliance with AAMI SP10:2002/(R) 2008 & A1:2003, which sets out requirements for accuracy testing against a reference standard.
The sample size for the training set:
- This information is not applicable as the device described is an electronic blood pressure monitor, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Its operation is based on an oscillometric principle.
How the ground truth for the training set was established:
- This information is not applicable for the reasons stated above.

Summary

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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: December 20, 2012
1. Sponsor

Shenzhen Pango Electronic Co., Ltd No.25, 156 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

Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

Proposed Device Identification 4.
..

Proposed Device Name: Electronic Blood Pressure Monitor;

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Proposed Device Model: PG-800A Series, including: PG-800AD, PG-800A-1, PG-800AD-1,

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PG-800A3, PG-800A4, PG-800A4D, PG-800A5, PG-800A5D, PG-800A6, PG-800A6D, PG-800A6-1, PG-800A6-2, PG-800A7, PG-800A7D, PG-800A9, PG-800A8, PG-800A11, PG-800A12, PG-800A15

Classification Name: System, measurement, blood-pressure, non-invasive;

Common Name: Electronic Blood Pressure Monitor;

Classification: 2

Product Code: DXN;

Regulation Number: 21 CFR 870.1130;

Review Panel: Cardiovascular;

Intended Use Statement:

PG-800A Series 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 circum ference is 13.5-19.5 cm.

Predicate Device Identification 5.
510(k) Number: K102920

Product Name: Electronic Blood Pressure Monitor, PG-800A Manufacturer: Shenzhen Pango Electronic Co., Ltd

Device Description 6.
The proposed device, PG-800A Series 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 appearance and data storage. These two differences will not affect the safety and effectiveness of the device.

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

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device complies with the following standards:

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IEC 60601-1:2005, Medical electrical equipment -- Part 1: General requirements for basic safety, and 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.

AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers.

Substantially Equivalent 8.

ITEM	PG-800A SeriesElectronic Blood Pressure Monitor	Electronic Blood PressureMonitor PG-800A, K102920
Product Code	DXN	Same
Regulation No.	21 CFR 870.1130	Same
Class	II	Same
Intended Use	PG-800A Series Electronic BloodPressure Monitor is intended to measurethe systolic and diastolic blood pressure aswell as the pulse rate of adult person vianon-invasive oscillometric technique inwhich an inflatable cuff is wrapped aroundthe wrist. It can be used at medicalfacilities or at home. The intended wristcircumference is 13.5-19.5 cm.	Same
MeasurementType	Wrist	Same
PatientPopulation	Adult	Same
MeasurementItem	SYS, DYS, Pulse Rate	Same
Principle	Oscillometric	Same
BP Range	30~280 mmHg	Same
BP Accuracy	$\pm$ 3 mmHg	Same
PR Range	40-199 bpm	Same
Cuff Size	30.8 cm (length) x 8 cm (width)	Same
Power Supply	two AAA or LR03 batteries	Same
Software LevelConcern	Moderate	Same

Table III-1 Substantially Equivalent Comparison

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K 1 3 1 569 .

The proposed device, PG-800A Series Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor PG-800A (K102920), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a stylized representation of an eagle or bird in flight, with three curved lines forming the wings and body. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

June 14, 2013

Shenzhen Pango Electronic Co., Ltd. c/o Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

Re: K131569

Trade/Device Name: Electronic Blood Pressure Monitor, PG-800A Series Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 24, 2013 Received: May 30, 2013

Dear Mr. Rongero:

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. Iisting 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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Page 2 - Mr. Jeff D. Rongero

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Owen P Earis -S

for 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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K131569

Indications for Use

510(k) Number:

Device Name: Electronic Blood Pressure Monitor

Models: PG-800A Series, including: PG-800AD, PG-800A-1, PG-800AD-1, PG-800A3, PG-800A4, PG-800A4D, PG-800A5, PG-800A5D, PG-800A6, PG-800A6-1, PG-800A6-1, PG-800A6-2, PG-800A7, PG-800A7D, PG-800A9, PG-800A8, PG-800A11, PG-800A12, PG-800A15

Indications for Use:

It can be used at medical facilities or at home.

The intended wrist circumference is 13.5-19.5 cm.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

ZOVER-THE-COUNTER USE (21 CFR 801. Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.06.14 10:03:03
-04'00'

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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).