(228 days)
This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement
SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement.
There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.
The user interface panel has a power switch, a mode switch, a memory switch and a liquid crystal display ("LCD") for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 58 most recent measurement results.
The device measures blood pressure through the use of a automatic inflating cuff. Pressurization is automatically governed. The device has fuzzy logic function that establishes automatically initial inflation pressure according to blood pressures of patients. The cuff automatically deflates during blood pressure measurement.
The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate.
All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification.
The provided text describes a 510(k) summary for the "Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070." It doesn't contain a detailed study proving acceptance criteria. Instead, it claims substantial equivalence to a predicate device (Full Auto Blood Pressure Monitor, Model SE-7700H) based on similar technological characteristics and performance.
However, based on the general information provided for a blood pressure monitor submission, and general regulatory expectations for such devices, I can construct a hypothetical response that aligns with what would typically be required, highlighting the missing specific data points from this particular document.
It is crucial to note that the detailed "study that proves the device meets the acceptance criteria" is NOT present in the provided text. The text focuses on establishing substantial equivalence through a comparison of characteristics, not on presenting a full clinical validation study with specific performance metrics and statistical analyses.
Therefore, the following outlines what would typically be expected in such a submission, using the information available and noting where details are absent in this specific document.
This 510(k) submission for the Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070, seeks to demonstrate substantial equivalence to a predicate device (Model SE-7700H) rather than presenting a standalone study with detailed acceptance criteria and performance reports. The document focuses on comparing technological characteristics and asserting similarity in performance.
However, to provide a comprehensive answer as requested for a device like this, we can infer common acceptance criteria for blood pressure monitors and identify what information is missing from this particular submission regarding a direct performance study.
1. Table of Acceptance Criteria and Reported Device Performance
For an automatic blood pressure monitor, the primary acceptance criteria typically relate to accuracy, often benchmarked against a recognized standard like ISO 81060-2 or AAMI/ANSI/ISO 81060-2. These standards define accuracy requirements for both systolic and diastolic blood pressure measurements.
Hypothetical Acceptance Criteria (Based on ISO 81060-2/AAMI standards):
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Missing in submission) |
|---|---|
| Accuracy - Systolic Blood Pressure (SBP): | |
| Mean difference (device vs. reference) ≤ ±5 mmHg, | |
| Standard deviation ≤ 8 mmHg (AAMI/ISO 81060-2) | Not reported in the provided text. A typical submission would include a clinical validation study demonstrating: |
- Mean difference in SBP (e.g., [X] mmHg)
- Standard deviation of differences in SBP (e.g., [Y] mmHg)
- Percentage of measurements within certain absolute differences (e.g., % within 5 mmHg) |
| Accuracy - Diastolic Blood Pressure (DBP):
Mean difference (device vs. reference) ≤ ±5 mmHg,
Standard deviation ≤ 8 mmHg (AAMI/ISO 81060-2) | Not reported in the provided text. A typical submission would include a clinical validation study demonstrating: - Mean difference in DBP (e.g., [A] mmHg)
- Standard deviation of differences in DBP (e.g., [B] mmHg)
- Percentage of measurements within certain absolute differences (e.g., % within 5 mmHg) |
| Pulse Rate Accuracy:
Typically ±5% or ±5 beats per minute (whichever is greater) (e.g., from IEC 60601-2-30) | Not reported in the provided text. A typical submission would include accuracy statistics for pulse rate. |
| Clinical Validation Protocol Adherence:
Compliance with a recognized standard (e.g., AAMI/ANSI/ISO 81060-2:2018) | Implied but not detailed. The submission states "Performance: Similar" to the predicate, which would imply similar adherence to standards, but no explicit details of a validation study are provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not provided in the document. Blood pressure monitor validation standards (e.g., ISO 81060-2) typically require a minimum of 85 participants (equally distributed across various blood pressure ranges, age groups, and arm circumferences) for a validation study.
- Data Provenance: Not provided in the document. A full submission would specify the country of origin of the study participants and whether the study was prospective (specifically designed for this device validation) or retrospective. Given the device manufacturer is from Korea, a prospective study might have been conducted there, but this is speculative without the actual study details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not explicitly stated in the context of this document. For blood pressure monitor validation studies, the "ground truth" is typically established by at least two, and often three, trained and certified observers (auscultators) using a mercury or calibrated aneroid sphygmomanometer, blind to the automated device readings. These observers are highly trained in the auscultatory method.
- Qualifications of Experts: Not provided in the document. Typically, these would be medical professionals or trained technicians with specific certification in blood pressure measurement following the auscultatory method, ideally with demonstrated inter-rater reliability. The document does not mention the role or qualifications of experts for establishing ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not explicitly stated. In a blood pressure validation study, the reference measurements from the multiple observers (e.g., two or three) are statistically compared. If there are discrepancies beyond a certain limit, a third observer might be used, or the average of the closest two might be taken. The document does not describe such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done (or at least not indicated in this document). This type of study (MRMC) is generally used for diagnostic imaging devices where human readers interpret images, and the AI's effect on their diagnostic accuracy is assessed. For a blood pressure monitor, the device directly outputs a measurement, and human interpretation of the device's output is not the primary focus of effectiveness.
6. Standalone (Algorithm Only) Performance Study
- Yes, implicitly. For an automatic blood pressure monitor, the clinical validation study (if conducted) assesses the performance of the "algorithm only" (i.e., the device's automated measurement) against the gold standard auscultatory method. The results described under point 1 (mean difference, standard deviation) would typically come from such a standalone performance study. However, the details of such a study are not provided in this document. The document primarily asserts "Performance: Similar" to a predicate device.
7. Type of Ground Truth Used
- Gold Standard Reference Measurements: For blood pressure monitors, the ground truth for validation is typically established through simultaneous manual auscultatory measurements performed by trained observers using a mercury sphygmomanometer or a validated, calibrated aneroid device. This is considered the clinical gold standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
- Not applicable/Not provided. This device is an automatic blood pressure monitor that uses an oscillometric method with "fuzzy logic function." While "fuzzy logic" implies some form of algorithmic decision-making, the document does not suggest a machine learning model that requires a distinct "training set" in the modern AI sense with labeled images or data for pattern recognition. The "fuzzy logic" likely refers to predefined rules or heuristics for optimizing inflation/deflation and signal processing rather than a data-driven machine learning training process. Therefore, a separate "training set" in the context of AI development is not indicated or specified.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As stated above, a distinct "training set" as understood in AI/machine learning development is not indicated for this device's "fuzzy logic" function according to the provided text. If an earlier iteration of the algorithm or an initial calibration involved data, its collection and "ground truthing" methods are not described in this document.
§ 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).