(28 days)
The KP-7770 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff wrapped around the arm. It is indicated for use in adults.
The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arm Blood Pressure Monitor Model KP-7770:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance regarding blood pressure accuracy (e.g., mean difference and standard deviation compared to a reference method). Instead, it states compliance with recognized consensus standards.
Acceptance Criteria (Implied by Compliance with Standards):
| Criterion | Source / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Blood Pressure Accuracy | AAMI/ANSI SP10 (2002 / A1:2003) | "The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards..." | Compliance with AAMI/ANSI SP10 implies that the device meets the accuracy requirements outlined in that standard (e.g., mean difference ≤ 5 mmHg and standard deviation ≤ 8 mmHg for both systolic and diastolic blood pressure when compared to a reference standard). However, specific accuracy metrics are not provided in this document. |
| Electrical Safety | IEC 60601-1 (1988) | "The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards..." | The device adheres to general requirements for safety of medical electrical equipment. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (2002) | "The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards..." | The device meets requirements related to electromagnetic emissions and immunity for medical electrical equipment. |
| Electromagnetic Immunity (Specific) | EN61000-4-2 (1995) | "The KP-7770 also complies with the following additional standards-" | Adheres to electrostatic discharge immunity requirements. |
| Electromagnetic Immunity (Specific) | EN61000-4-3 (2002) | "The KP-7770 also complies with the following additional standards-" | Adheres to radiated, radio-frequency, electromagnetic field immunity requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical performance of the modified device is remain unchanged; therefore another clinical trial for this device, KP-7770, is not required."
This indicates that no new clinical test set was used for the KP-7770 model as its clinical performance was deemed unchanged from its predicate. Therefore, information regarding sample size and data provenance for a new test set is not applicable to this specific submission for the KP-7770.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As no new clinical test set was conducted for the KP-7770, this information is not provided. The substantial equivalence argument relies on the predicate device's established performance.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was conducted for the KP-7770.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. Blood pressure monitors are typically evaluated for accuracy against a reference standard in clinical studies, not through MRMC studies which are more common for diagnostic imaging or interpretation tasks.
6. Standalone Performance (Algorithm Only)
The document focuses on the overall device (Arm Blood Pressure Monitor Model KP-7770), which is an integrated system. "Standalone" performance in the sense of an algorithm separate from human interaction isn't directly applicable for this type of device. Its performance is measured as the device's output (systolic, diastolic BP, pulse rate) against a clinical reference. The document states the device "can use MOMI or fuzzy logic method to measure blood pressure," implying the algorithm is intrinsic to the device's operation, and its performance is assessed via compliance with AAMI/ANSI SP10.
7. Type of Ground Truth Used
For devices complying with standards like AAMI/ANSI SP10, the ground truth is typically established by simultaneous measurements by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or another validated oscillometric device) in a clinical setting. While not explicitly stated in this document for the KP-7770, compliance with AAMI/ANSI SP10 implies such a methodology was used for the predicate device(s) that established the "unchanged" clinical performance.
8. Sample Size for the Training Set
The document does not provide information on the training set for the KP-7770's algorithms (MOMI or fuzzy logic) or the predicate devices. This type of detail is often proprietary and generally not included in 510(k) summaries unless a novel algorithm is being introduced that requires specific clinical validation. Given the reliance on predicate devices and established methods (fuzzy logic), it's likely the algorithms were developed and validated internally during product development, possibly using simulated data or internal clinical data, but no specifics are given here.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, this information is not provided in the 510(k) summary. For blood pressure measurement algorithms, ground truth for training would typically involve large datasets of reference blood pressure measurements (e.g., from auscultation or highly accurate invasive methods) paired with the corresponding oscillometric waveforms.
§ 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).