(162 days)
Blood Pressure Monitor DSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines display of body movement detection and two memory account to save measurement results.
Blood Pressure Monitor DSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the nylon cuffs, regular size cuff for arm circumference between 8.7 and 12.6 inches (between 220 and 320 mm) and large size cuff for arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm), and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
The provided text describes a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1011. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report that establishes clinical efficacy against specific acceptance criteria.
The acceptance criteria for blood pressure monitors are typically defined by recognized standards such as the ANSI/AAMI/ISO 81060-2 standard (or its predecessors, such as ANSI/AAMI SP10). However, the document states that no clinical test report was submitted because "differences between the subject device and the predicate devices do not affect clinical performance." Instead, non-clinical tests were performed.
Therefore, this response will outline the typical acceptance criteria for blood pressure monitors (as implied by the referenced standards) and explain that the provided document does not directly present the results of a study proving the device meets these criteria through clinical testing. It relies on non-clinical testing and substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
Since no direct clinical study results with specific performance metrics are provided in the document, I will outline the typical acceptance criteria for automated sphygmomanometers (based on standards like ISO 81060-2, which is what "IEC and SP-10" likely refer to for blood pressure monitors) and note that the document claims the device meets these standards through non-clinical testing and substantial equivalence.
| Acceptance Criteria (Typical for Automated Sphygmomanometers per e.g., ISO 81060-2) | Reported Device Performance (as implied by the document) |
|---|---|
| Accuracy (Mean Difference) | The device was evaluated in accordance with "IEC and SP-10" (referring to standards like ANSI/AAMI SP-10, which specifies accuracy requirements for automated sphygmomanometers). The conclusion from non-clinical tests states "the subject device is not only as safe and as effective as the predicate devices but is also safer and more effective than the predicate devices." This implies that the device meets the accuracy requirements specified in these standards for both systolic and diastolic blood pressure. |
| Accuracy (Standard Deviation) | (See above) Implied to meet the standard deviation requirements as per "IEC and SP-10". |
| Cuff Pressure Accuracy | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Pressure Indication Range | 3 to 300 mmHg. (This is a specification, not a performance criterion, but tested against the device's stated capabilities.) The document indicates this range was tested and found acceptable during non-clinical tests. |
| Pulse Rate Accuracy | Implied to meet accuracy requirements as per "IEC and SP-10" since it determines pulse rate. |
| Electromagnetic Compatibility (EMC) | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Electrical Safety | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Mechanical Safety | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Biocompatibility of Patient Contacting Materials | Passed. The patient contacting materials had been used with predicate devices and do not go through any different process, implying their biocompatibility has been previously established. |
| Software Verification and Validation | Passed. (Though not explicitly detailed, implicitly covered under "non-clinical tests" to ensure device functionality, including features like irregular pulse rhythm detection, body movement detection, and memory functions, perform as intended.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (N/A) – No clinical test set data is provided in this document. The submission states, "No clinical test report is submitted."
- Data provenance: N/A
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A – No clinical test data is provided. For blood pressure monitor clinical studies (which were not submitted here), ground truth is typically established by trained technicians or clinicians using a reference standard device (e.g., a mercury sphygmomanometer) following a rigorous protocol (like the auscultatory method).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A – No clinical test data is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A – This document is for a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in effect, a standalone evaluation was performed, albeit via non-clinical testing and substantial equivalence arguments. The device itself is an automated, standalone blood pressure monitor. The submission concludes, based on non-clinical tests against recognized standards ("IEC and SP-10") and comparison to predicate devices, that the device is "as safe and as effective" as its predicates. This implies the device's algorithm and hardware were validated in a standalone capacity to meet the performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" refers to the established reference values and performance metrics defined by the "IEC and SP-10" standards (e.g., accuracy requirements against a precisely calibrated pressure source or a clinical reference standard). The device was tested to conform to these predefined standard requirements.
8. The sample size for the training set
- N/A – This document does not describe a machine learning algorithm that requires a separate training set. The device uses an oscillometric method, which is a well-established principle for blood pressure measurement, not typically "trained" in the manner of deep learning models.
9. How the ground truth for the training set was established
- N/A – Not applicable as there is no mention of a training set for a machine learning model.
§ 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).