(284 days)
The Inbody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm.
The models of BP170, BP160 and BP160B are designated as both Prescription use and Over-the-counter use.
The model of BPBIO250 is designated as Prescription use only.
All models have this common feature: Automatic blood pressure measurement using the oscillometric technique. This is the same method as our predicate. We have employed essentially the same technology as we used in our previous model (the predicate) but have packaged the unit differently in order to make it more portable. Instead of having a built in blood pressure cuff, we have moved that component outside of the unit so that now it plugs in to the measurement unit in the same way a large number of similar devices are designed. Instead of AC line operation only, the units can run on primary or on rechargeable batteries. The predicate device used an 8 bit microcontroller with 128Kbytes of in-system programmable flash memory. The BP170 series and the BPBIO250 use 32 bit microcontrollers with 128Kbytes of programmable flash. Most of the measurement software has been re-used from our predicate device and is virtually the same between the two new sets of models.
The BP170 is a fully automatic portable battery operated blood pressure monitor using the oscillometric technique which comes with batteries, a standard cuff, a storage pouch, and a user's manual.
BPBIO250 This product is a professional automatic blood pressure monitor used by medical professionals. 5 measurement modes can be selected according to various medical environments. Rechargeable batteries can be used without replacing batteries. The User can measure blood pressure even in dark environments. - This blood pressure monitor has cuffs of various sizes. So, User can measure the blood pressure and measure pulse rate to children and adult patients whose arm circumferences are between 17 cm and 42 cm.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Criteria Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Pressure) | Maximum mean error of measurement: 5 mmHg (according to ANSI/AAMI SP10) | BP170: Pressure: ±3 mmHg |
| BPBIO250: Pressure: Within ±3 mmHg | ||
| (General statement later: Pressure: ± 2mmHg) | ||
| Accuracy (Standard Deviation of Pressure) | Maximum experimental standard deviation: 8 mmHg (according to ANSI/AAMI SP10) | Not explicitly stated for standard deviation in the provided text, but the device performance for mean error is well within the 5mmHg criterion. |
| Accuracy (Pulse Rate) | Not explicitly stated in the provided text for acceptance criteria | BP170: Pulse: Within ±3% |
| BPBIO250: Pulse: Within ±3% | ||
| (General statement later: Pulse: Within ± 1.5%) | ||
| Measurement Range (Blood Pressure) | 40-300mmHg (Predicate Device) | BP170: 0-300 mmHg |
| BPBIO250: 0-300mmHg | ||
| Measurement Range (Pulse Rate) | 30-240bpm (Predicate Device) | BP170: 30-240 bpm |
| BPBIO250: 30-240 bpm | ||
| Arm Circumference Range | 17cm - 42cm | 17cm - 42cm |
| Safety and Essential Performance | Conformity to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 80601-2-30, IEC 60601-1-2, IEC 62304 | All proposed new models were tested and found to conform to these international standards. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- BP170 Series: 106 subjects
- BPBIO250: 104 subjects with 312 observations
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "Separate clinical investigations were performed". Given it's a 510(k) submission for a new medical device, clinical studies are typically prospective.
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- The document states that the comparison was to "manual blood pressure measurement". This implies human observers. However, it does not specify the number of experts, their qualifications, or how many were involved in establishing the ground truth (e.g., if multiple readings were taken and averaged). The implicit standard for manual blood pressure measurement would be trained medical professionals using a mercury manometer and stethoscope.
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Adjudication Method for the Test Set:
- The document implies a direct comparison between the device's measurement and a manual blood pressure measurement (using a mercury manometer and stethoscope). It does not describe any specific adjudication method among multiple manual readers (e.g., 2+1, 3+1).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This study focused on the accuracy of the device against a gold standard (manual measurement), not on how humans using AI assistance improve their performance.
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Standalone Performance:
- Yes, a standalone performance study was done. The study directly compared the accuracy of the automated Non-Invasive Blood Pressure (NIBP) monitor (the algorithm/device) against a manual blood pressure measurement (the ground truth).
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Type of Ground Truth Used:
- Expert Consensus (Implicit): The ground truth was established by "manual blood pressure measurement" using a mercury manometer and stethoscope. While not explicitly stated as "expert consensus," this method inherently relies on trained human observers performing the measurement, which can be considered an expert-derived ground truth. The text states: “InBody has compared the accuracy between mercury manometer using the stethoscope and the non-invasive automatic sphygmomanometers.”
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Sample Size for the Training Set:
- The document does not provide details about a specific training set for the device's algorithm. It focuses on the clinical testing for regulatory clearance. Given that the software "Most of the measurement software has been re-used from our predicate device," it's likely previous data or general engineering principles informed the algorithm, rather than a specific, new training set for these models.
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How the Ground Truth for the Training Set Was Established:
- As no specific training set is mentioned for these new models, the method for establishing its ground truth is not described. The re-use of software from a predicate device suggests that the core algorithm was developed and validated previously.
§ 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).