PG-800A 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 Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It 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. The device has the data storage function. It has an bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PG-800A Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document states that "Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006" was conducted. This standard outlines acceptance criteria for non-invasive automated sphygmomanometers. While the specific numerical acceptance criteria for mean difference and standard deviation are not explicitly listed in the provided text, the successful completion of the test per this standard implies that the device met its requirements. The "reported device performance" would be the results obtained from this clinical verification test; however, these specific numerical results (e.g., mean difference and standard deviation of blood pressure measurements) are not detailed in the provided document.

Therefore, I can present the information as follows, indicating where details are inferred or missing:

Acceptance Criteria (ANSI/AAMI SP10:2002+A1:2003+A2:2006)	Reported Device Performance (Implied by meeting standard)
Blood Pressure Measurement Accuracy
Mean difference between device and reference method	Met the specified limits (exact values not provided)
Standard deviation of differences	Met the specified limits (exact values not provided)
Pulse Rate Accuracy	(Not explicitly detailed, but usually part of performance verification)
Mean difference between device and reference method	Met the specified limits, if applicable (exact values not provided)
Standard deviation of differences	Met the specified limits, if applicable (exact values not provided)

Study Details

Based on the provided text:

Sample size used for the test set and the data provenance: The document states that a "Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006" was performed. This standard typically mandates a minimum number of subjects (e.g., 85 subjects with specific demographic and blood pressure distribution) for clinical testing. However, the exact sample size used for the test set is not explicitly stated in the provided 510(k) summary. The data provenance (country of origin, retrospective/prospective) is also not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For blood pressure monitors, the "ground truth" is typically established by trained observers taking auscultatory measurements using a mercury sphygmomanometer or another validated reference method. The ANSI/AAMI SP10 standard specifies requirements for these observers (e.g., being blinded, trained according to specific protocols). However, the number of experts and their specific qualifications are not explicitly stated in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: For blood pressure measurement validation studies, ground truth is often established by multiple observers (e.g., two observers taking simultaneous measurements, with a third observer for adjudication if there's a discrepancy). While this is common practice for AAMI SP10 studies, the specific adjudication method used is not detailed in the provided text.
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 device is an electronic blood pressure monitor, not an AI-assisted diagnostic tool for imaging or complex data interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this type of device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described "Performance and Clinical Verification Test per ANSI/AAMI SP10" is a standalone performance test for the device (algorithm only), assessing its accuracy against a reference standard without human-in-the-loop interaction for interpretation, beyond the initial cuff placement and operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for blood pressure measurement accuracy studies conforming to ANSI/AAMI SP10 is established through simultaneous auscultatory measurements taken by trained expert observers using a validated reference mercury sphygmomanometer (or an equivalent validated oscillometric device).
The sample size for the training set: This device is a traditional electronic medical hardware device based on an oscillometric technique, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense of AI development. Therefore, the concept of a "training set" and its sample size is not applicable to this device.
How the ground truth for the training set was established: As the concept of a "training set" is not applicable, establishing ground truth for a training set is also not applicable. The device's measurement principle is based on established oscillometric algorithms, which are determined through physical and mathematical modeling, not empirical data training in the AI sense.

Summary

{0}------------------------------------------------

K102920

OCT 1 5 2010

PANGAO®

Premarket Notification promission Promission
Traditional Sec. 510(L) Submission
PG-800A Ellectronic Blood Pressure Monitor
Sec. III 510(k) Summary

OCT 15 2016

IH-1

Sec. III 510(k) Summary

This 510(k) Summary is prepared per the request of 21 CFR 807.92. The Assigned 510(k) Number is:
Date	20 JUL 2010
Sponsor	Shenzhen Pango Electronic Co., Ltd
	No.25, 1st Industrial Park, Fenghuang Road, Xikeng Village, Henggang Town,
	Longgang District, Shenzhen, Guangdong, 518115, China
	Contact Person: Ms. Xiaoyun Yang, Vice General Manager
	T: +86-755-33825988 F: +86-755-33825989 E: sales@pan-go.com
Submission	MS. Diana Hong / MR. Lee Fu
Correspondent	Shanghai Mid-Link Consulting Co., Ltd
	P.O.BOX 237-023, Shanghai, 200237, China
Proposed Device	Electronic Blood Pressure Monitor, PG-800A
Classification	System, Measurement, Blood-pressure, Non-invasive DXN 21 CFR 870.1130 Class II
Intended Use	PG-800A 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 Electronic Blood Pressure Monitor, is a battery driven automatic
	non-invasive blood pressure monitor. It 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. The device has the data storage function. It has an bar indicating function, which can
	indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood
	pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
Testing	Electric Safety per IEC 60601-1:1988+A1:1991+A2:1995 / EMC per IEC 60601-1-2:2001+A1:2004
	Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006
	Biocompatibility per ISO 10993-5:2006 / ISO 10993-10:2002+AMD:2006
Predicate Device	KD-795 Blood Pressure Monitor as cleared in K070826
SE Conclusion	The proposed device, PG-800A Electronic Blood Pressure Monitor, measures the blood pressure via
	same principle, oscillometric, at the same site, wrist, as the predicate device. Both of them are
	driven by batteries. The patient contact materials of both are Nylon and ABS. Therefore, the
	proposed device, PG-800A Electronic Blood Pressure Monitor, is claimed to be Substantially
	Equivalent (SE) to the predicate device, KD795 Blood Pressure Monitor as cleared in K070826, in
	aspect of safety and effectiveness

Shenzhen Pango Electronic Co., Ltd
Report SN: SHA01420100715-01

्

. •

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes above a wavy line, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Shenzhen Pango Electronic Co., Ltd. c/o Mr. Ned Devine Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062

OCT 1 5 2010

Re: K102920

Trade/Device Name: Electronic Blood Pressure Monitor, Model PG-800A Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: September 20, 2010 Received: October 1, 2010

Mr. Devine:

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.

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.

{2}------------------------------------------------

Page 2 - Mr. Ned Devine

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 (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/CDRH/CDRHOffices/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 yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

PANGAO®

Premarket Notification Traditional Sec. 510(k) Submission PG-800A Electronic Blood Pressure Monitor Sec. II Indication for Use

1 5 2010 OCT

Sec. II Indication for Use Statement

510(k) Number:

Device Name: PG-800A Electronic Blood Pressure Monitor

Indications for Use:

PG-800A Electronic Blood Pressure Monitor is intended to measure the systelic 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

(Division Sign-Off)
Division of Cardiovascular Devices

Page _ I_ of

510(k) Number K102920

Shenzhen Pango Electronic Co., Ltd Report SN: SHA01420100715-01

II-1

ﻋﻠﻰ ﺍ --ﺔ ﺍﻟﻘ

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).