(214 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using algorithms for calculation and IHB detection based on fixed thresholds, with no mention of AI or ML.
No.
The device is used for measurement and monitoring of blood pressure and pulse rate, not for therapeutic intervention.
Yes
Explanation: The device is considered a diagnostic device because it measures and displays clinical outputs such as systolic pressure, diastolic pressure, pulse rate, and detects cardiac arrhythmia (Irregular Heart Beat), which are used to assess a person's health status.
No
The device description explicitly lists hardware components such as the main device, upper arm cuff, batteries, storage bag, and optional power supply. While it contains software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Globalcare GUS622 automatic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by using an inflatable cuff on the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive measurement".
Therefore, the device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
No imaging modality involved.
Anatomical Site
Upper arm
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home use / Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The GUS622 has been tested and found to be in compliance with the following standards:
Safety and EMC:
- ANSI/AAMI ES60601-1:2005 / A2:2010
- 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
- After 500 hour Life Test has been completed
- After 12 months storage
- After drop test
The results of the above testing assist in the demonstration of substantial equivalence of the subject device with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Pressure: ±3 mmHg
Pulse rate: ±5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
Device Name
Globalcare GUS622 Blood Pressure Monitor
Indications for Use (Describe)
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.
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)
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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., Ltd |
| No.7 Factory, European Industrial Park | |
| No. 39 Mid Industrial Main Road | |
| Xiaolan Town, Zhongshan City | |
| Guangdong, CHINA 528415 | |
| Phone: | +86-760-22589901 |
| FDA Establishment Reg. Number: | 3010880718 |
| 510(k) Owner and Submitter: | Globalcare Medical Technology Co., Ltd |
| No.7 Factory, European Industrial Park | |
| No. 39 Mid Industrial Main Road | |
| Xiaolan Town, Zhongshan City | |
| Guangdong, CHINA 528415 | |
| Owner/Operator Reg. Number: | 10046812 |
| 510(k) Contact: | Mr Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome | |
| Italy | |
| Phone: | |
| Fax: | |
| Email: | +39 06 578 2665 |
| +39 06 574 3786 | |
| rgray@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 is |
| indicated for home use 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. |
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 for | |||
| use | The Globalcare GUS622 | ||
| automatic Blood Pressure | |||
| Monitor is indicated for home use | |||
| 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. | KD-927 and KD-928 Fully | ||
| Automatic Electronic Blood | |||
| Pressure Monitor are for use by | |||
| medical professionals or at home | |||
| and are non-invasive blood | |||
| pressure measurement system | |||
| intended to measure the diastolic | |||
| and systolic blood pressures and | |||
| pulse rate of an adult individual | |||
| by using a non-invasive | |||
| technique in which an inflatable | |||
| cuff is wrapped around the upper | |||
| arm. The cuff circumference is | |||
| limited to 22 cm-48 cm. | Substantially equivalent | ||
| Use environment | Indoor use, home environment | Indoor use, home and healthcare | |
| facilities environments | Difference has no effect on | ||
| safety or effectiveness | |||
| Measuring | |||
| method | Oscillometric method, automatic | ||
| inflation and measurement | Oscillometric method, automatic | ||
| inflation and measurement | Same | ||
| Device | |||
| measurements | |||
| (output | |||
| parameters) | Diastolic and systolic blood | ||
| pressure | |||
| Pulse rate | Diastolic and systolic blood | ||
| pressure | |||
| Pulse rate | Same | ||
| Additional output | |||
| indications | Irregular heart beat | ||
| hemodynamic instability | Irregular heart beat | ||
| hemodynamic instability | Same | ||
| Output result | |||
| calculation | Software algorithm | Software algorithm | Same |
| Measurement | |||
| range | Cuff pressure: 0-300 mmHg | ||
| Systolic: 50-280 mmHg | |||
| Diastolic: 30-200 mmHg | |||
| Pulse: 40-199 beats/min | Cuff pressure: 0-300 mmHg | ||
| Systolic: 60-260 mmHg | |||
| Diastolic: 40-199 mmHg | |||
| Pulse: 40-180 beats/minute | Substantially equivalent: | ||
| Differences have no effect | |||
| on safety or effectiveness | |||
| Accuracy | Pressure: ±3 mmHg | ||
| Pulse rate: ±5% | Pressure: ±3 mmHg | ||
| Pulse rate: ±5% | Same | ||
| External Power | |||
| Supply | Input 100-240Vac 50/60Hz 0.5A | ||
| max; Output 6VDC | |||
| (+/-5%) / 600mA (optional) | Input 100-240Vac 50/60Hz 0.5A | ||
| max; 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 on |
| safety or effectiveness | |||
| Standards | |||
| compliance | ANSI/AAMI ES60601-1:2005 / | ||
| A2:2010 | |||
| IEC 60601-1-11:2015 | |||
| IEC 60601-1-2:2014 | |||
| IEC 80601-2-30:2009/ | |||
| AMD1:2013 | |||
| ISO 81060-1:2012 | |||
| EN 1060-3:1997+A2:2009 | IEC 60601-1:2005/AC:2010 | ||
| IEC60601-1-2:2007/AC:2010 | |||
| IEC 80601-2-30:2009 + | |||
| Cor.2010 | Subject device complies | ||
| with 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 53 | ||
| mm | L 95 mm x W 186 mm x H 56 | ||
| mm | Differences have no effect | ||
| on safety or effectiveness | |||
| Weight | 207 g device without cuff and | ||
| batteries | 330 g without cuff and batteries | Difference has no effect on | |
| safety or effectiveness | |||
| USB Port? | No | Yes | Different |
| Compatible PC | |||
| software? | 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.