The Globalcare GUS622 automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

Device Description

The Globalcare GUS622 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS622 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS622 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter, and is designed for home ('OTC') use. The clinical outputs from the GUS622 Blood Pressure Monitor are: Systolic pressure (mm Hg), Diastolic pressure (mm Hg), Pulse rate (1/min), Cardiac arrhythmia (Irregular heart beat (IHB)) symbol, Level of risk, Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff deflation. Irregular heart beat (IHB) is detected by measuring the interval time between each heart beat and comparing these values with the average heart beat interval (heart beat per minutes shown on the display). If the difference between any heart beat interval and the average is higher or lower than 25 %, the device shows the cardiac arrhythmia (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS622 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during deflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements, and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heart beat is occurring.

AI/ML Overview

The provided document is a 510(k) summary for a blood pressure monitor, not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects (such as training data, expert adjudication, MRMC studies, standalone algorithm performance, etc.) are not directly applicable to the information contained in this document.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets those criteria, as described for a non-AI/ML medical device like a blood pressure monitor.

Here's the breakdown based on the provided text, focusing on the performance and validation of the Globalcare GUS622 Blood Pressure Monitor:

Acceptance Criteria and Device Performance for Globalcare GUS622 Blood Pressure Monitor

The acceptance criteria for this vital signs monitoring device are primarily based on established international standards for noninvasive sphygmomanometers, specifically ISO 81060-2:2013 and EN 1060-3:1997+A2:2009 for clinical performance. These standards define the accuracy requirements for blood pressure measurements.

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

Parameter	Acceptance Criteria (from Standards / Industry Norm)	Reported Device Performance (Table 1: Accuracy)
Blood Pressure
Pressure Accuracy	±3 mmHg	±3 mmHg
Pulse Rate
Pulse Rate Accuracy	±5%	±5%

Note: The document explicitly states that the GUS622 has been tested and found to be in compliance with ISO 81060-2:2013 and EN 1060-3:1997+A2:2009 for clinical performance. These standards inherently define the accuracy requirements. The "Accuracy" row in Table 1 directly reflects the performance against these criteria.

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

The document states "Clinical performance: ISO 81060-2:2013". ISO 81060-2 specifies requirements for the clinical investigation of non-invasive sphygmomanometers, including patient population size. While the exact number of subjects for the clinical study is not explicitly stated in this 510(k) summary, compliance with ISO 81060-2:2013 implies that the study was conducted with a sufficient number of subjects (typically a minimum of 85 subjects with specific demographic distribution as per the standard).

Test Set Sample Size: Not explicitly stated, but compliance with ISO 81060-2:2013 implies a sample size that meets the standard's requirements (typically a minimum of 85 subjects).
Data Provenance: Not explicitly stated. Clinical studies for compliance with international standards are generally prospective. The manufacturer is Globalcare Medical Technology Co., Ltd in China.

3. 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" during clinical validation is typically established by trained observers (often two or more) taking simultaneous auscultatory measurements using a mercury reference sphygmomanometer, in accordance with the protocols outlined in standards like ISO 81060-2.

Number of Experts: Not explicitly stated, but clinical validation for blood pressure monitors generally involves multiple trained observers. ISO 81060-2, for example, specifies the use of multiple observers (e.g., at least two) for reference measurements.
Qualifications of Experts: Not explicitly stated, but they would be trained according to the requirements of the standard, typically involving specific training in auscultatory blood pressure measurement.

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

For blood pressure monitor validation studies (e.g., under ISO 81060-2), ground truth is established through simultaneous measurements by multiple trained observers. The method is often a comparison of the device's readings against the average or reconciled readings from these observers.

Adjudication Method: Not explicitly detailed, but ISO 81060-2 outlines procedures for agreement between observers and handling discrepancies, implying a form of "adjudication" through simultaneous, blinded measurements.

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

N/A. This is a traditional medical device (blood pressure monitor), not an AI/ML device. MRMC studies are not applicable.

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

This device is a standalone algorithm-driven device (it operates on the oscillometric method with a software algorithm). The performance data cited (compliance with ISO 81060-2) reflects the overall device performance, which is the standalone performance in this context. The human "in the loop" is the user taking the measurement, but the measurement itself is produced by the device's internal algorithm.

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

Type of Ground Truth: Paired and simultaneous (or sequential in close proximity) reference measurements taken by trained observers using a validated reference method (e.g., mercury sphygmomanometer) in a clinical setting. This is considered the "expert consensus" or "reference measurement" gold standard for blood pressure validation.

8. The sample size for the training set

N/A. This information is for an AI/ML device's training data. For a traditional device like this, there isn't a "training set" in the AI/ML sense. The device's algorithm would have been developed and tested internally, but not based on a "training set" of patient data that is then distinct from a "test set" in the way an AI model is trained and validated.

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

N/A. See point 8.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 21, 2020

Globalcare Medical Technology Co., Ltd % Roger Grav VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 ITALY

Re: K192609

Trade/Device Name: Globalcare GUS622 Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 4, 2020 Received: March 9, 2020

Dear Roger Gray:

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.

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

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-reportingcombination-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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192609

Device Name

Globalcare GUS622 Blood Pressure Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

510(k) Summary

Device Name:	GUS622 Blood Pressure Monitor
Type of 510(k) submission:	Traditional
Date of submission:	4 March 2020
Manufacturer:	Globalcare Medical Technology Co., LtdNo.7 Factory, European Industrial ParkNo. 39 Mid Industrial Main RoadXiaolan Town, Zhongshan CityGuangdong, CHINA 528415
Phone:	+86-760-22589901
FDA Establishment Reg. Number:	3010880718
510(k) Owner and Submitter:	Globalcare Medical Technology Co., LtdNo.7 Factory, European Industrial ParkNo. 39 Mid Industrial Main RoadXiaolan Town, Zhongshan CityGuangdong, CHINA 528415
Owner/Operator Reg. Number:	10046812
510(k) Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly
Phone:Fax:Email:	+39 06 578 2665+39 06 574 3786rgray@donawa.com
FDA Product Code:	DXN
FDA Regulation Number:	21 CFR 870.1130
FDA Classification Name:	Noninvasive blood pressure measurement system
Classification Panel:	Cardiovascular
Common Name:	Upper arm blood pressure monitor
FDA Classification:	Class II
Submission Type:	510(k)
Indications for Use:	The Globalcare GUS622 automatic Blood Pressure Monitor isindicated for home use for the non-invasive measurement ofdiastolic and systolic blood pressures and pulse rate of adults bymeans of an inflatable cuff which is wrapped around the upperarm. The cuff circumference is limited to 22 to 42 cm.

{4}------------------------------------------------

Device Description:

The Globalcare GUS622 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate.

The device is powered by batteries or by a mains-connected power supply.

The Globalcare GUS622 Blood Pressure Monitor comprises the following parts:

• Blood pressure monitor main device	x1
• Upper arm cuff	x1
• 1.5 V LR03 AAA batteries	x4
• Storage bag	x1
• Instructions for use	x1
• 100-240Vac 50/60Hz power supply (optional)	x1

None of the parts included with the device are supplied in a sterile condition.

The Globalcare GUS622 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter, and is designed for home ('OTC') use.

The clinical outputs from the GUS622 Blood Pressure Monitor are:

. Systolic pressure (mm Hg)
Diastolic pressure (mm Hg)
Pulse rate (1/min) ●
Cardiac arrhythmia (Irregular heart beat (IHB)) symbol .
Level of risk ●
Hemodynamic Rest Condition (HSD) indication

The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff deflation. See Section 16 of this submission for further details of the software utilized in the device.

Irregular heart beat (IHB) is detected by measuring the interval time between each heart beat and comparing these values with the average heart beat interval (heart beat per minutes shown on the display). If the difference between any heart beat interval and the average is higher or lower than 25 %, the device shows the cardiac arrhythmia (IHB) symbol on the display.

The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous.

The GUS622 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during deflation.

The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements, and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heart beat is occurring.

Performance data:

The GUS622 has been tested and found to be in compliance with the following standards:

Safetv and EMC:

ANSI/AAMI ES60601-1:2005 / A2:2010

{5}------------------------------------------------

IEC 60601-1-11:2015 .
IEC 60601-1-2:2014 ●
IEC 80601-2-30:2009/AMD1:2013 .

Clinical performance:

ISO 81060-2:2013 ●
EN 1060-3:1997+A2:2009 ●

Cuff biocompatibility:

ISO 10993-5:2009 ●
ISO 10993-10:2010 .

Bench tests:

Internal tests to verify performance ●
- Mains and Battery comparison o
- After 500 hour Life Test has been completed o
- After 12 months storage o
- o After drop test

The results of the above testing assist in the demonstration of substantial equivalence of the subject device with the predicate device.

Substantial equivalence

The predicate device selected for comparison with the GUS622 Blood Pressure Monitor is:

Predicate Device:	Blood Pressure Monitors Models KD-927 and KD-928
Sponsor:	Andon Health Co., Ltd., China
510(k) Number:	K141984
Clearance Date:	29 April 2015
FDA Product Code:	DXN
Classification Name:	Noninvasive blood pressure measurement system
Regulation No:	21 CFR 870.1130
Class:	II

Predicate device comparison table:

The following Table 1 provides evidence of substantial equivalence of the subject device with the selected predicate device.

Table 1: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Device name	GUS622	KD-927/928	N/A
Device Manufacturer	Globalcare, China	Andon Health, China	N/A
510(k) Reference	This submission	K141984	N/A
FDA Product Code	DXN	DXN	Same
FDA Classification Name	Noninvasive blood pressure measurement system	Noninvasive blood pressure measurement system	Same
FDA Regulation Number	21 CFR 870.1130	21 CFR 870.1130	Same
Device description	Automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate via an upper arm cuff.	Automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate via an upper arm cuff.	Same
Feature	Subject device	Predicate device	Similarity
Indications foruse	The Globalcare GUS622automatic Blood PressureMonitor is indicated for home usefor the non-invasivemeasurement of diastolic andsystolic blood pressures andpulse rate of adults by means ofan inflatable cuff which iswrapped around the upper arm.The cuff circumference is limitedto 22 to 42 cm.	KD-927 and KD-928 FullyAutomatic Electronic BloodPressure Monitor are for use bymedical professionals or at homeand are non-invasive bloodpressure measurement systemintended to measure the diastolicand systolic blood pressures andpulse rate of an adult individualby using a non-invasivetechnique in which an inflatablecuff is wrapped around the upperarm. The cuff circumference islimited to 22 cm-48 cm.	Substantially equivalent
Use environment	Indoor use, home environment	Indoor use, home and healthcarefacilities environments	Difference has no effect onsafety or effectiveness
Measuringmethod	Oscillometric method, automaticinflation and measurement	Oscillometric method, automaticinflation and measurement	Same
Devicemeasurements(outputparameters)	Diastolic and systolic bloodpressurePulse rate	Diastolic and systolic bloodpressurePulse rate	Same
Additional outputindications	Irregular heart beathemodynamic instability	Irregular heart beathemodynamic instability	Same
Output resultcalculation	Software algorithm	Software algorithm	Same
Measurementrange	Cuff pressure: 0-300 mmHgSystolic: 50-280 mmHgDiastolic: 30-200 mmHgPulse: 40-199 beats/min	Cuff pressure: 0-300 mmHgSystolic: 60-260 mmHgDiastolic: 40-199 mmHgPulse: 40-180 beats/minute	Substantially equivalent:Differences have no effecton safety or effectiveness
Accuracy	Pressure: ±3 mmHgPulse rate: ±5%	Pressure: ±3 mmHgPulse rate: ±5%	Same
External PowerSupply	Input 100-240Vac 50/60Hz 0.5Amax; Output 6VDC(+/-5%) / 600mA (optional)	Input 100-240Vac 50/60Hz 0.5Amax; Output 6VDC(+/-5%) / 600 mA	Same
Unit voltage	6V dc	6V dc	Same
Batteries	4 x AAA alkaline 1.5V dc	4 x AAA alkaline 1.5 V dc	Same
Battery life	Approx 500 cycles	Approx 200 cycles	Difference has no effect onsafety or effectiveness
Standardscompliance	ANSI/AAMI ES60601-1:2005 /A2:2010IEC 60601-1-11:2015IEC 60601-1-2:2014IEC 80601-2-30:2009/AMD1:2013ISO 81060-1:2012EN 1060-3:1997+A2:2009	IEC 60601-1:2005/AC:2010IEC60601-1-2:2007/AC:2010IEC 80601-2-30:2009 +Cor.2010	Subject device complieswith more recent standards
Device Protection	IEC 60601-1: Class 2	IEC 60601-1: Class 2	Same
Application Part	IEC 60601-1: Type BF	IEC 60601-1: Type BF	Same
Memory	60 x 2 user	60 x 2 user	Same
Dimensions	L 98 mm x W 140 mm x H 53mm	L 95 mm x W 186 mm x H 56mm	Differences have no effecton safety or effectiveness
Weight	207 g device without cuff andbatteries	330 g without cuff and batteries	Difference has no effect onsafety or effectiveness
USB Port?	No	Yes	Different
Compatible PCsoftware?	No	Yes	Different

{6}------------------------------------------------

{7}------------------------------------------------

The subject device and the predicate device have many identical or similar properties or features. The differences that exist and are identified in the above table include:

Indications for use
. No USB port on subject device
. Subject device has no compatible PC software

None of the identified differences introduce new aspects of safety or effectiveness.

Conclusion

The subject and predicate devices have very similar intended uses and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent 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).