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510(k) Data Aggregation
(151 days)
Digital Automatic Blood Pressure Monitor BPM06 Series is for use by medical professional or at home. The BPM06 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual.
Digital Automatic Blood Pressure Monitor BPM06 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then display the readings on a digital panel.
The BPM06 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
The Digital Automatic Blood Pressure Monitor BPM06 Series is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, a electric valve and an electronic control module together with an electric pump. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture.
The provided text describes the acceptance criteria and a clinical study conducted to demonstrate the substantial equivalence of the "Digital Automatic Blood Pressure Monitor BPM06 Series" to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Predicate Device Performance | BPM06 Series Performance | Result (Compared to Predicate) |
|---|---|---|---|
| Intended Use | Same | Same | Equivalent |
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| Irregular Heartbeat Detection (IHB) | Yes | Yes | Identical |
| Patient Population | Age 16 or above | Age 16 or above | Identical |
| Blood Pressure Measurement Range | Cuff: 0-300 mmHg, Sys: 50-250 mmHg, Dia: 30-200 mmHg | Cuff: 0-300 mmHg, Sys: 50-250 mmHg, Dia: 30-200 mmHg | Identical |
| Number of Users | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 120 memory space | Identical |
| Button (Key) Type | Button Type only | Clock button: Button Type, User selection button: Sensor Type | Equivalent (same function) |
| Blood Pressure Measurement Accuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg or 2% of reading | Identical |
| Pulse Rate Measurement Range | 30 - 180 beats/min | 30 - 180 beats/min | Identical |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4x 1.5V AA-batteries; and/or AC adaptor (6V/600mA) | 4x 1.5V AA-batteries; and/or AC adaptor (6V/600mA) | Identical |
| Pressurization Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/Deflation | Automatic Exhaust/Deflation | Identical |
| Operating Condition | Temp: 10-40 °C, Hum: 30-85% R.H. max, Atm: 700-1060 kPa | Temp: 10-40 °C, Hum: 15-85% R.H. max, Atm: 700-1060 kPa | Equivalent (improved specification) |
| Storage and Transportation Condition | Temp: -20-60 °C, Hum: 10-95% R.H. max, Atm: 700-1060 kPa | Temp: -20-60 °C, Hum: 10-95% R.H. max, Atm: 700-1060 kPa | Identical |
| Anatomical Sites | 1-2 cm above joint | 1-2 cm above joint | Identical |
| Material | Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging | Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging | Identical |
| Compatibility with Environment and Other Devices | No influence | No influence | Identical |
| Applicable Standard | Various (EN 1060-1, EN 1060-3, IEC 60601-1, etc.) | Various (ISO 10993-5, ISO 10993-10, EN 1060-1, etc.) | Equivalent (change of FDA recognized standard) |
Note: The acceptance criteria for accuracy are implicitly defined by claiming "Identical" performance to the predicate device, which itself states "± 3 mmHg or 2% of reading" for blood pressure and "± 5 % of the reading" for pulse rate.
Study Proving Device Meets Acceptance Criteria
The document describes a clinical test summary to ensure clinical accuracy.
2. Sample Size and Data Provenance for Test Set
- Sample Size: One hundred patients (45 males and 55 females).
- Data Provenance: The document does not explicitly state the country of origin, but the applicant's address is listed in Shenzhen, Guangdong, People's Republic of China. The study appears to be prospective as patients were "recruited for the study."
3. Number of Experts and Qualifications for Ground Truth
- The study used the standard auscultation method as the reference blood pressure monitor. While it's a technical method for establishing ground truth, the document does not specify the number of human experts (e.g., clinicians) or their qualifications involved in performing the auscultation measurements. It only mentions "medical professional" in the intended use.
4. Adjudication Method for Test Set
- The document states that blood pressure measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ANSI/A AMI/IEC 81060-2." This implies a direct comparison method rather than an adjudication method involving multiple experts to reconcile discrepancies. There is no explicit mention of an adjudication method like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The comparison is between the device and a gold-standard measurement method (auscultation), not between human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The entire clinical test described is essentially a standalone performance study for the device (algorithm only, as there is no human-in-the-loop directly interpreting the device's output to make a diagnosis beyond reading the displayed numbers). The device's measurements were directly compared against the auscultation method.
7. Type of Ground Truth Used
- The ground truth used was established by the standard auscultation method, which is a widely accepted clinical reference standard for blood pressure measurement. It's a form of expert-performed reference measurement.
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This is expected as the BPM06 Series appears to be based on an established oscillometric methodology, similar to its predicate. The focus of the 510(k) submission is typically on validating the performance of the final device, not on the details of its internal algorithm development or training, unless it involves novel machine learning components.
9. How the Ground Truth for the Training Set Was Established
- Since no training set is explicitly mentioned, the method for establishing its ground truth is also not specified. The device likely uses algorithms and parameters that have been developed and validated over time for oscillometric blood pressure measurement.
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