(81 days)
The Globalcare GUS610 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 52 cm.
The Globalcare GUS610 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 adapter and is designed for home use.
The Globalcare GUS610 Blood Pressure Monitor is supplied complete with the following components:
- Blood pressure monitor main device - 1
- Upper arm cuff 22-42 cm - 1
- 1.5 V LR03 AAA batteries - 4
- Storage bag - 1
- Instructions for use - 1
- 100-240 VAC 50/60 Hz power supply (optional) - 1
None of the parts included with the device are supplied in a sterile condition.
The Globalcare GUS610 Blood Pressure Monitor main unit 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 GUS610 Blood Pressure Monitor are:
- Systolic pressure (mm Hg)
- Diastolic pressure (mm Hg)
- Pulse rate (1/min)
- Cardiac arrhythmia (Irregular heartbeat (IHB)) symbol
- Level of risk
- Hemodynamic Rest Condition (HSD) indication
The GUS610 Upper Arm Cuff, with a circumference range of 22 cm to 42 cm, is manufactured by Globalcare China. The cuff is manufactured from gray color Polyester 200D (CAS n. 80595-68-2), supplied by Anhui Wuyixing Fabric and Weaving. This is identical to the cuff provided with the predicate device cited in K222160.
The purpose of this Special 510(k) is to add to the availability of an accessory for the GUS610, this being an optional Upper Arm Cuff with an increased circumference range of 42 to 52 cm. The testing undertaken for the predicate device in accordance with ISO 81060-2:2018, 'Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type', has been repeated with the new larger cuff, with 88 subjects having upper arm circumferences between 42 and 52 cm screened, from which 259 effective analysis datasets were obtained from 87 subjects. Gender distribution met the requirements of the standard (M: 55.2 % / F 44.8 %), arm size distribution met the requirements of the standard, and blood pressure measurements met the requirements of the standard clause 5.2.4.1.2 for Criterion 1 'mean difference' and 'standard deviation' for SBP and DBP, and also for Criterion 2 for SBP and DBP 'standard. deviation'. The accuracy of the BP and pulse rate measurements also met the manufacturer's specifications for accuracy.
There were no adverse incidents during the investigation and no failed measurements. There were no protocol deviations or violations.
A third party test house (TUV SUD China) has assessed the continued compliance of the GUS610 subject device when used together with the new optional XL cuff in accordance with IEC 80601-2-30 and found that the combination continues to meet the requirements of this standard.
The FDA 510(k) clearance letter details the acceptance criteria and the study that proves the Globalcare Blood Pressure Monitor (GUS610) with the new larger cuff meets these criteria. The study focuses on adding an optional upper arm cuff with an increased circumference range (42 to 52 cm) to an already cleared device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new cuff, as per ISO 81060-2:2018, pertain to the accuracy of blood pressure and pulse rate measurements. The standard has two main criteria for accuracy, focusing on the mean difference and standard deviation of measurements compared to a reference.
Table 1: Acceptance Criteria and Reported Device Performance (Based on ISO 81060-2:2018)
| Acceptance Criterion (ISO 81060-2:2018) | Description | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Criterion 1 (Mean difference & Standard Deviation) | Mean difference between device and reference measurements, and standard deviation for SBP and DBP. | Blood pressure measurements met the requirements of the standard clause 5.2.4.1.2 for Criterion 1 'mean difference' and 'standard deviation' for SBP and DBP. | Yes |
| Criterion 2 (Standard Deviation) | Standard deviation of the differences between device and reference measurements for SBP and DBP. | Blood pressure measurements met the requirements of the standard clause 5.2.4.1.2 for Criterion 2 for SBP and DBP 'standard deviation'. | Yes |
| Accuracy of BP and Pulse Rate | Device accuracy meets manufacturer's specifications. | The accuracy of the BP and pulse rate measurements also met the manufacturer's specifications for accuracy. | Yes |
| Gender Distribution | Study population gender distribution meets standard requirements. | Gender distribution met the requirements of the standard (M: 55.2 % / F 44.8 %). | Yes |
| Arm Size Distribution | Study population arm size distribution meets standard requirements. | Arm size distribution met the requirements of the standard. | Yes |
| Adverse Events | No adverse events during the investigation. | There were no adverse incidents during the investigation. | Yes |
| Failed Measurements | No failed measurements during the investigation. | No failed measurements. | Yes |
| Protocol Deviations/Violations | No protocol deviations or violations. | There were no protocol deviations or violations. | Yes |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 88 subjects were screened, from which "259 effective analysis datasets were obtained from 87 subjects." This implies 87 successful participants contributed data to the final analysis, with multiple readings per subject.
- Data Provenance: The document does not explicitly state the country of origin where the clinical study was conducted for the new cuff, but the applicant is Globalcare Medical Technology Co., Ltd in China. It is implied to be a prospective clinical investigation as it describes the process of "testing undertaken" with new subjects.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth. For non-invasive sphygmomanometers, the ground truth is typically established by trained observers using a reference measurement method (e.g., auscultation with a mercury sphygmomanometer or validated reference device) as defined by the ISO 81060-2 standard.
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Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1). For blood pressure measurement validation, ground truth is typically established by multiple independent observers taking simultaneous reference measurements, with the average or consensus being the ground truth. The ISO 81060-2 standard outlines procedures for this, but the specific adjudication within this study is not detailed here beyond mentioning "effective analysis datasets."
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, the performance evaluated was the standalone performance of the device (Globalcare GUS610 Blood Pressure Monitor) with the new larger cuff. It measures blood pressure automatically without human interpretation being part of its core function, other than the user applying the cuff and reading the display. The "clinical investigation" assessed the device's accuracy against a recognized standard (ISO 81060-2:2018).
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The Type of Ground Truth Used:
- The ground truth was established through a "clinical investigation" following ISO 81060-2:2018, 'Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type'. This standard typically requires concurrent, independent reference measurements (e.g., using a reference sphygmomanometer and trained observers) against which the device's readings are compared. Therefore, the ground truth is expert-derived reference measurements as per a recognized international standard.
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The Sample Size for the Training Set:
- This document describes a clinical validation study for a hardware device (blood pressure monitor with a new cuff), not an AI/ML algorithm. Therefore, there is no "training set" in the sense of machine learning. The device's internal algorithms for blood pressure measurement would have been developed and "trained" during its initial design phase, prior to this specific study for the new cuff accessory. This study is solely for validation of the new cuff.
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How the Ground Truth for the Training Set Was Established:
- As this is not an AI/ML algorithm, the concept of ground truth for a training set does not apply in the context of this 510(k) submission. The device's measurement algorithms are established through engineering design and calibration, not typically by "training" on a labeled dataset in the same way an AI model would be.
§ 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).