(48 days)
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
The device comproses tubing attached to a soft ineastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive sphygmomaniometer.
Here's an analysis of the provided 510(k) summary regarding the Aneroid Sphygmomanometer BK2002, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI standard SP-9, "Non-automated sphygmomanometer" | "The Aneroid Sphygmomanometer BK2002 has been tested to conform to the ANSI/AAMI standard SP-9, Non-automated sphygmomanometer." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the device "has been tested to conform to the ANSI/AAMI standard SP-9." To fully understand the rigor of the testing, one would need to refer to the full test report for the ANSI/AAMI SP-9 standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The ANSI/AAMI SP-9 standard outlines specific requirements for clinical validation, including the number of subjects and, by extension, the number of reference measurements from qualified observers. However, the summary itself does not detail these aspects.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a medical instrument (sphygmomanometer), not an AI-powered diagnostic tool that typically involves human readers interpreting outputs.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable to the device described. The Aneroid Sphygmomanometer BK2002 is a manual device, and its function involves human operation for inflation and detection of Korotkoff sounds. There is no "algorithm only" component in the traditional sense of AI/software-as-a-medical-device studies.
7. Type of Ground Truth Used
The ground truth for evaluating an aneroid sphygmomanometer against ANSI/AAMI SP-9 typically involves comparison against a highly accurate reference method (e.g., a mercury sphygmomanometer) during a clinical study, with measurements taken by trained observers. The summary states the device is compliant with the standard, implying this type of ground truth was established during the testing required by the standard.
8. Sample Size for the Training Set
This is not applicable as the Aneroid Sphygmomanometer BK2002 is a mechanical device and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
Summary of Device Performance and Compliance
The 510(k) summary declares that the Aneroid Sphygmomanometer BK2002 has been tested and found to conform to the ANSI/AAMI standard SP-9 for non-automated sphygmomanometers. This standard sets the performance requirements for accuracy and other aspects of manual blood pressure devices. The submission indicates substantial equivalence to a predicate device (Nihon Seimitsu Sokki Co.,Ltd's model HT-110, K012194) based on similar technological characteristics and compliance with this recognized standard. The intended use specifies manual operation and detection of Korotkoff sounds.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).