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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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Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023 are non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate by using an inflating cuff which is wrapped around the upper arm or wrist. The device is indicated for use in adults only.

Non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate for adults only.

Model BK6001 is a semi-auto digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by a manual air pump.

Model BK6002 is an automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated automatically by an electrical air pump.

Model BK6023 is a wrist automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the wrists. The cuff is inflated automatically by a electrical air pump.

The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled rapidly and automatically released by a electric valve at a constant rate after the measurement. The measurement results including diastolic, systolic pressure and heart pulse rate are displayed on the LCD. Besides the real-time display, the blood pressure and pulse values are also averaged, stored, and recalled from the last data.

The provided 510(k) summary for the Bokang Digital Blood Pressure Monitors (Models BK6001, BK6002, BK6023) indicates that the devices were tested to meet the requirements of the ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure Monitor Guidance."

Here's an attempt to break down the information, acknowledging that specific numerical acceptance criteria and a detailed study report are not explicitly provided in the given text. The document states that clinical studies were performed and "evaluated clinical bias, clinical uncertainty and clinical repeatability per the Bokang Clinical Test Protocol outline and meet the requirement of AAMI SP10." However, the exact performance values like accuracy (mean difference and standard deviation) or sensitivity/specificity are not presented.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on AAMI SP10):
While not explicitly stated in the document with specific numerical thresholds, the AAMI SP10 standard for non-invasive sphygmomanometers typically requires:

• Mean Difference (Bias): For systolic and diastolic blood pressure, the mean difference between the device and a reference standard (e.g., auscultation by trained observers) should be within ±5 mmHg.
• Standard Deviation (Precision): For systolic and diastolic blood pressure, the standard deviation of the differences should be no greater than 8 mmHg.

Reported Device Performance:
The document states that the devices "meet the requirement of AAMI SP10" and that "clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability." However, the actual numerical values for bias, standard deviation, clinical uncertainty, or repeatability are not provided in this summary. Therefore, a table with specific performance numbers cannot be created from the given text.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: "Controlled human clinical studies were conducted." The country of origin for the studies is not explicitly stated, but the company is located in Wenzhou, China, suggesting the studies were likely conducted there. The studies were prospective as they are described as "controlled human clinical studies."

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

• The document implies that the ground truth for blood pressure measurements in clinical studies would have been established by trained medical professionals (e.g., physicians or nurses) using a reference standard (such as auscultation). However, the number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not mentioned in the provided 510(k) summary.

4. Adjudication Method for the Test Set

• The specific adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth in the clinical studies is not described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done as described for typical AI device evaluations. This document describes a traditional medical device (blood pressure monitor) validation, not an AI system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, a standalone performance assessment was effectively done. The Bokang Digital Blood Pressure Monitors are standalone devices designed to automatically measure and display blood pressure and pulse rate. The clinical studies evaluated the device's performance without human intervention in the measurement process itself (beyond applying the cuff and initiating the measurement), comparing its output to a reference standard. The results of these tests, by demonstrating compliance with AAMI SP10, reflect the standalone performance of the algorithm.

7. The Type of Ground Truth Used

• The ground truth used for validating blood pressure monitors in clinical studies compliant with AAMI SP10 is typically reference blood pressure measurements obtained through auscultation (e.g., by a trained observer using a stethoscope and sphygmomanometer), often with multiple readings and potentially averaged. This is a form of expert standard or clinical gold standard rather than pathology or outcome data.

8. The Sample Size for the Training Set

• This device is a traditional non-invasive blood pressure monitor, not an AI/machine learning algorithm that requires a "training set." Therefore, the concept of a separate training set is not applicable to this device. The development and calibration would typically involve engineering tests and internal validation, but not a "training set" in the context of machine learning.

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

• As mentioned above, the concept of a "training set" and associated ground truth establishment is not applicable to this traditional medical device.

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