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510(k) Data Aggregation
(68 days)
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module; the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitors:
Based on the provided 510(k) summary, the device's performance is not reported against specific acceptance criteria in a detailed table as requested. However, it states that the device "conforms to the following standards," which define the performance expectations for such devices. The primary standard for blood pressure monitors is AAMI SP10.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria in a quantitative table with corresponding reported performance for this specific device are not explicitly provided in the executive summary. Instead, the document states conformity to relevant standards.
Implicit Acceptance Criteria (based on AAMI SP10:2002)
| Criteria Category | General Performance Acceptance (AAMI SP10) | Reported Device Performance (from K091739 summary) |
|---|---|---|
| Accuracy (Blood Pressure) | Mean difference between device and reference standard ± 5 mmHg, with standard deviation ≤ 8 mmHg (for both systolic and diastolic pressure). This is a common requirement in AAMI SP10. The sum of the absolute differences between the device and reference for any 5 mmHg interval should not exceed 25% for 30 or more subjects. | Not explicitly stated with specific numerical results (mean difference, standard deviation) for blood pressure accuracy. The document states that the device "conforms to the following standards," including AAMI SP10:2002, AAMI/ANSI SP10:2002/A1:2003, and AAMI/ANSI SP10:2002/A2:2006. This implies that the device met the accuracy requirements outlined in these standards. |
| Accuracy (Pulse Rate) | Typically, within ± 5% or ± 5 beats/min (whichever is greater) of a reference standard. | Not explicitly stated with specific numerical results. The document notes that the "pulse rate range is changed from 30-180 times/min to 40-180 times/min" for the new devices compared to the predicate, but this is a range change, not an accuracy claim. The conformity to AAMI SP10 would imply meeting its pulse rate accuracy requirements. |
| Cuff Pressure Range | Typically specified pressure range. | "The performance parameter of cuff pressure range... are different from the predicted device KD-391." Actual range for KD-3917/KD-3909 not explicitly stated, but conformity to AAMI SP10 indicates it meets the standard's requirements for the stated use. |
| Overpressure Limit | Device should not exceed a safe overpressure limit (e.g., typically 300 mmHg for adult blood pressure monitors). | "The performance parameter of... overpressure limit are different from the predicted device KD-391." Actual limit for KD-3917/KD-3909 not explicitly stated, but conformity to AAMI SP10 indicates it meets the standard's requirements for safety. |
| Environmental Parameters | Operational range for temperature and humidity. | The operational range for humidity is "<90%" for the new devices, changed from "<80%" for the predicate device. This implies the device was tested and found to perform effectively within this new range and still be compliant with the relevant safety and performance standards. |
| Safety Standards | Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and mechanical safety standards. | The devices conform to: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC). Mechanical safety is listed as "Identical" to the predicate device, which also conformed to these standards. |
| Biocompatibility | Materials in patient contact are biocompatible. | Listed as "Similar" to the predicate device, which would have met biocompatibility standards. "Patients contact Materials" is listed as "Identical" on a separate comparison table, suggesting the same materials are used and thus prior biocompatibility assessments for the predicate device apply. |
| Cuff Circumference | Specified range. | "The cuff circumference is limited to 22cm-48cm." |
| Irregular Heartbeat Detection | If a feature exists, it should be accurately indicated according to its intended functionality. | "If any irregular heartbeat is detected, it can be shown on the LCD." The accuracy of this detection is not numerically quantified but implied to meet performance expectations by adhering to relevant standards (if any apply to this specific feature within the general BP monitor standards). |
| Memory Function | Functionality validation. | KD-3909 has 2x60 times memory, KD-3917 has 60 times memory. KD-3909 also averages the last three measurements. The functionality of these features would have been tested implicitly under "Performance - Similar" and "Function - Similar" categories compared to the predicate, and against general device functional verification. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on the specific clinical or performance test executed to demonstrate conformity to standards. It states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness."
Typically, for a blood pressure monitor to comply with AAMI SP10, a clinical validation study involving a minimum of 85 subjects (some interpretations allow for 30 subjects for initial validation, but 85 is often preferred or required for full compliance) would be performed. However, this document does not explicitly state the sample size.
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical validation for such devices is almost always prospective to ensure standardized measurement protocols against a reference.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For blood pressure monitor validation studies (e.g., against AAMI SP10), the ground truth is typically established by two or three trained observers using a mercury sphygmomanometer or an equivalent reference standard, who are blinded to the device's readings. Their consistency is a crucial part of the validation process.
- Number of Experts: Not explicitly stated, but typically 2 or 3 trained observers.
- Qualifications of Experts: Not explicitly stated. For AAMI SP10, these are typically trained and certified human observers (e.g., clinical staff, nurses, physicians) proficient in auscultatory blood pressure measurement.
4. Adjudication Method for the Test Set
For blood pressure validation studies using multiple observers, an adjudication method is used to establish the "reference" blood pressure. Common methods include:
- Averaging: Averaging the readings of the two or three observers.
- Deviation Check: If two observers' readings differ by more than a pre-defined threshold (e.g., 4 mmHg), a third observer's reading might be used, or the measurement might be discarded/repeated.
The specific adjudication method is not stated in the provided summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically relevant for medical imaging AI devices where multiple human readers interpret cases with and without AI assistance.
- This is not applicable to a standalone semi-automatic electronic blood pressure monitor. The device is not designed to assist human readers in interpreting complex cases, but rather to directly provide a measurement. Therefore, no MRMC study would have been performed or reported.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done. The statement that the device "conforms to the following standards" (including AAMI SP10) means that the device's accuracy and performance were tested independently against a reference standard without human intervention in the measurement process (beyond applying the cuff and starting the device). The goal is to ensure the algorithm only (the device's measurement method) provides accurate readings.
7. Type of Ground Truth Used
For blood pressure monitors conforming to AAMI SP10, the ground truth is established by expert auscultatory measurements (typically using a mercury sphygmomanometer or an equivalent reference device) taken simultaneously or in close succession by trained human observers. This is effectively an expert consensus based on direct physiological measurement.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device is a traditional medical device (semi-automatic electronic blood pressure monitor) that operates based on established oscillometric principles and fixed algorithms, not machine learning or AI models that require training data. Therefore, there is no "training set" in the context of an AI/ML device. The device's algorithms are developed and refined through engineering and validation, not through learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
As stated above, there is no "training set" for this type of device. The ground truth for developing and verifying the underlying algorithms would come from extensive physiological research, engineering principles, and validation studies performed during the development phase of oscillometric technology itself, rather than a specific "training set" for this particular device model.
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