(329 days)
Blood Pressure Monitor DSK-1031 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) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
Blood Pressure Monitor DSK-1031 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 cuff that is applicable to 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 appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose to activate clock function of the device to review measured readings with measurement date and time.
The provided 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620) focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It explicitly states that no clinical tests were submitted because "differences between the subject device and the predicate devices do not affect clinical performance" (Section 6, (2) Clinical tests).
Therefore, the document does not contain the acceptance criteria or a study proving the device meets performance criteria through clinical data. The information below is extracted from the provided text, primarily relating to its equivalence claims which are based on established standards rather than a de novo clinical performance study.
Here's an attempt to answer your request based on the available information:
Acceptance Criteria and Device Performance Study for Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620)
Based on the provided 510(k) summary, the device's "acceptance criteria" for performance are not explicitly stated in terms of specific clinical accuracy thresholds (e.g., mean difference and standard deviation against a reference standard in a clinical study). Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical tests and adherence to recognized standards.
The document states that the device was evaluated "in accordance with IEC and SP-10" to demonstrate substantial equivalence and establish better safety. ANSI/AAMI SP-10 is a key standard for blood pressure monitors. While the specific numerical acceptance criteria (e.g., AAMI accuracy standards for mean difference and standard deviation) are not explicitly listed in the summary, adherence to ANSI/AAMI SP-10 implies meeting those criteria for accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria derived from clinical studies are not presented in this 510(k) summary, and no clinical performance data is reported, this table cannot be fully completed as requested.
However, based on the implicit criteria of substantial equivalence and adherence to ANSI/AAMI SP-10, the "reported performance" is that the device is expected to meet the accuracy requirements of this standard through its design and non-clinical testing.
| Acceptance Criterion (Implied by adherence to ANSI/AAMI SP-10) | Reported Device Performance (Implied from non-clinical tests and substantial equivalence) |
|---|---|
| Blood Pressure Accuracy (Systolic) | Expected to meet ANSI/AAMI SP-10 requirements |
| Blood Pressure Accuracy (Diastolic) | Expected to meet ANSI/AAMI SP-10 requirements |
| Pulse Rate Accuracy | Expected to meet relevant standards |
| Electrical Safety | Conforms to IEC 60601-1:1998 + A1:1991 + A2:1995 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 (various revisions) and CISPR 11 |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable for a clinical test set, as no clinical tests were submitted.
- Data Provenance: Not applicable for a clinical test set. The submission focuses on non-clinical engineering and performance testing against standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as no clinical test set with expert-established ground truth was submitted.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set was submitted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No MRMC comparative effectiveness study was done or reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was done
- Yes, a form of standalone performance assessment was implicitly done through the non-clinical tests demonstrating compliance with recognized standards such as ANSI/AAMI SP-10. This standard sets forth requirements for the accuracy of automated sphygmomanometers, which constitutes a standalone performance assessment for the device's core function. However, the details of the specific tests and resulting numerical accuracy are not provided in this summary.
7. The Type of Ground Truth Used
- For the non-clinical performance (accuracy) relative to standards like ANSI/AAMI SP-10, the "ground truth" would typically be established by a reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer) as specified in these standards. The specific ground truth used in the underlying tests is not detailed in the summary.
8. The Sample Size for the Training Set
- Not applicable as this is a traditional medical device submission, not an AI/ML-based device that typically involves training sets. The device uses an oscillometric method, which is a well-established algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable as this is not an AI/ML-based device using a "training set." The oscillometric algorithm's principles are based on established physiological measurements and engineering.
§ 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).