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 is 22-32 cm.

Device Description

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

The provided text describes the 510(k) summary for an Electronic Blood Pressure Monitor (K131558). However, it focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant standards rather than detailing a specific clinical study with granular data on acceptance criteria and study design as requested.

Based on the provided information, I can extract the following:

1. Table of acceptance criteria and the reported device performance

Metric	Acceptance Criteria (per AAMI SP10)	Reported Device Performance
BP Accuracy	$\pm$ 3 mmHg	$\pm$ 3 mmHg
BP Range	Not explicitly stated as acceptance criteria, but a functional range	30 ~ 280 mmHg
PR Range	Not explicitly stated as acceptance criteria, but a functional range	40-199 bpm

Note: The text states, "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 device complies with the following standards: ... AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers."
This implies that the device achieved the accuracy requirements outlined in AAMI SP10. The value of $\pm$ 3 mmHg is explicitly listed under "BP Accuracy" in the Substantial Equivalence comparison table, indicating it's the target and achieved accuracy.

Regarding other requested information:

2. Sample size used for the test set and the data provenance: Not specified in the provided text. The text only mentions "bench tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Clinical expert involvement is not mentioned for accuracy testing.
4. Adjudication method for the test set: Not specified.
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. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the accuracy testing for the blood pressure monitor itself is a standalone test of its algorithm and hardware performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the ground truth for accuracy is typically established by comparing the device readings against a validated reference method, often auscultation by trained observers using a mercury sphygmomanometer, as outlined in standards like AAMI SP10. While not explicitly stated as "ground truth method," compliance with AAMI SP10 implies this type of reference measurement.
8. The sample size for the training set: Not applicable/Not specified. This device likely uses a deterministic algorithm based on oscillometric principles, not a machine learning model requiring a distinct "training set" in the common sense. Calibration during manufacturing takes place, but this is different from a data-driven training set.
9. How the ground truth for the training set was established: Not applicable/Not specified for the reasons above.

Summary

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Additional Information I for K131558 - Exhibit #4 510(k) Summary

Exhibit #4 510(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:

l. Date of Submission: December 20, 2012
1. Sponsor

Shenzhen Pango Electronic Co., Ltd No.25, 136 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. Submission Correspondent 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
1. Proposed Device Identification

Proposed Device Name: Electronic Blood Pressure Monitor; Proposed Device Model: PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, PG-800B6D, PG-800B6-1, PG-800B6-2, PG-800B9, PG-800B10, PG-800B11, PG-800B12, PG-800B15, PG-800B25

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

AUG 30 2013

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K131558

Additional Information I for K131558 - Exhibit #4 510(k) Summary

Common Name: Electronic Blood Pressure Monitor; Classification: 2 Product Code: DXN: Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular:

Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K102988 Product Name: Electronic Blood Pressure Monitor, PG-800B Manufacturer: Shenzhen Pango Electironic Co., Ltd
Device Description 6.
The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

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 device complies with the following standards:

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.

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8. Substantially Equivalent

Table III-1 Substantially Equivalent Comparison
ITEM	Proposed DeviceElectronic Blood Pressure Monitor	Electronic Blood PressureMonitor, PG-800B, K102988
Product Code	DXN	Same
Regulation No.	21 CFR 870.1130	Same
Class	II	Same
Intended Use	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 circumference is22-32 cm.	Same
MeasurementType	Arm	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	49.5 cm (length) x 14.9 cm (width)	Same
Power Supply	four AA or LR6 batteries	Same
Software LevelConcern	Moderate	Same

Table III-1 Substantially Equivalent Comparison

The proposed device, Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor PG-800B (K102988), in respect of safety and effectiveness.

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Public Health Service

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

August 30, 2013

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

Re: K131558

Trade/Device Names: Electrical Blood Pressure Monitor with 18 models: PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, PG-800B6D, PG-800B6-1, PG-800B6-2, PG-800B9, PG-800B10, PG-800B11, PG-800B12, PG-800B15, PG-800B25 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 9, 2013 Received: August 15, 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, 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

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Page 2 - Mr. Jeffrey D. Rongero

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Owen-Paris -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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Exhibit #3 Indications for Use

510(k) Number:

Device Name: Electronic Blood Pressure Monitor Models: PG-800BD, PG-800B-1, PG-800BD-1, PG-800B4, PG-800B4D, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, PG-800B6-1, PG-800B6-1, PG-800B9, PG-800B9, PG-800B10, PG-800B11, PG-800B12, PG-800B15, PG-800B25

Indications for Use:

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 is 22-32 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)

Digitally signed by
Owen P. Faris -S
Date: 2013.08.30
14:58:14 -04'00'

Page 1 of 1

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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).