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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Aneroid Sphgmomanometer, Models BK2002, BK2002-3001, BK2002a, BK2002a-3001, BK2015, BK2015-3001, are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL BK2002-3001, BK2015, BK2015-3001 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model BK2002-3001 and BK2015-3001 include additional stethoscope. It is conjunction with Stethoscope when use.

This document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. It declares the device's substantial equivalence to a predicate device. For devices like this, the acceptance criteria and proof of meeting them are primarily based on established regulatory standards and bench testing, rather than studies involving AI algorithms or human reader performance.

Here's a breakdown of the requested information based on the provided text, focusing on how this type of medical device demonstrates compliance:

1. Table of Acceptance Criteria and Reported Device Performance

For an aneroid sphygmomanometer, the primary performance criterion is accuracy.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission." This indicates that the performance validation was primarily through bench testing and adherence to recognized standards. Therefore, an explicit "test set" in the sense of patient data is not applicable here. The provenance of any internal testing data would be from the manufacturer's own facilities in Wenzhou, Zhejiang, China, and would be prospective testing against the defined standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable as this is not a study involving interpretation of complex data (like medical images) requiring expert consensus for ground truth. Ground truth for a sphygmomanometer's accuracy is established by highly accurate reference pressure devices.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI. This device is a manual measurement tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not contain an AI algorithm. Its performance is inherent to its mechanical and material properties. The accuracy testing ("standalone" in a very literal sense for a mechanical device) would have been performed on the device itself against calibrated reference equipment.

7. The Type of Ground Truth Used

For device accuracy: Comparison against a highly accurate and calibrated reference pressure measurement system.
For biocompatibility: Adherence to ISO standards and material testing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and thus has no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary of Acceptance Criteria and Study for This Device (Aneroid Sphygmomanometer):

The acceptance criteria for this device are primarily based on established international and national standards for blood pressure measuring devices and medical device safety.

• Acceptance Criteria:

  • Accuracy: Maintain a pressure accuracy of +/- 3 mmHg of reading. This is a critical performance characteristic.
  • Environmental Compatibility: Function correctly within specified temperature and humidity ranges.
  • Biocompatibility: Materials in contact with the patient's skin must meet ISO 10993 series standards for biological evaluation of medical devices.
  • Mechanical and Functional Integrity: The device must inflate, deflate, and hold pressure reliably.
  • Design and Materials: Any changes in design or materials (e.g., PVC bulb, Nylon cuff) must be shown not to negatively impact safety or effectiveness.

• Study Proving Device Meets Acceptance Criteria:

  • Type of Study: The document explicitly states "No clinical study is included in this submission." The "study" here refers to Non-Clinical Testing, specifically bench testing and compliance with recognized standards.
  • Methods:
    • Performance Testing (Bench Testing): The device (and its modified components) underwent testing to verify its pressure accuracy against calibrated standards (consistent with ISO 81060-1). This includes tests for pressure measurement accuracy, repeatability, and potentially rapid deflation and overpressure protection.
    • Biocompatibility Testing: Materials used for the device that contact the patient's skin were tested and demonstrated compliance with ISO 10993 standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
    • Comparison to Predicate Device: The submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K043286). Performance specifications, materials, and intended use were compared. Any differences (e.g., optional PVC bulb, various cuff sizes/materials, wider target population including children) were evaluated to ensure they did not introduce new safety or effectiveness concerns, and were supported by the non-clinical testing results.
  • Ground Truth: For accuracy, the ground truth is derived from highly accurate and calibrated reference pressure measurement equipment. For material safety, the ground truth is defined by the toxicological and biocompatibility profiles established in the ISO 10993 standards.
  • Sample Size: Not explicitly stated for bench testing, but typically involves a statistically relevant sample of manufactured devices tested against the defined criteria.
  • Data Provenance: Testing was conducted by the manufacturer (Wenzhou Bokang Instruments Co., Ltd.) in China, likely at their in-house or contracted testing facilities, and would be considered prospective testing.

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