(72 days)
The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard.
The BPCard™ is a non-invasive Blood Pressure Monitor. The patient population is for both male and female, pediatric and adult. The BP Card has been tested to the following standards: AAMI SP10-1992-Electronic or Automated Sphygmomanometers I FDA-1997-NIBP Monitor Guidance EN1060-1-Non-Invasive Sphygmomanometers General Requirements EN1060-3-Non-Invasive Sphygmomanometers Supplementary Requirements EN980-Symbols EN46001-Quality EN1441-Risk Analysis EN60601-1-2-EMC EN60601-1-Electrical Safety 93/42/EEC-MDD 89/336/EEC-EMC Directive 92/37/EEC-Product Safety 93/465/EEC-Conformity Assessment and CE Marking UL 2601-1-Safety US ISO 10993-1-Biological Evaluation ISO 9001:1994-Quality ISO 9001:2000-Quality ISO 13485:1996/1998-Medical Devices 21CFR Part801-Labeling 21CFR Part820-QSR FDA Blue Book Memorandum G95-1-Biocompatibility The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard. The BPCard is a Prescription Device, not life supporting or live sustaining, not an implant, supplied non-sterile with a cuff, valve and microphone that requires a Personal Computer with the following requirements: Windows 2000 Operating System 32 MB RAM 1 GB Free Hard Disc Space 133 MHz Processor
The provided text describes the BPCard™ Blood Pressure Monitor and its comparison to a predicate device for 510(k) clearance. However, it does not contain a detailed study report that would include specific acceptance criteria with reported device performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.
The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (Accutracker DX) by demonstrating conformance to the AAMI SP10 Standard for electronic or automated sphygmomanometers.
Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not available:
Acceptance Criteria and Device Performance
The core acceptance criterion implicitly stated is conformance to the AAMI SP10 Standard. The document explicitly states:
"Thus, even though the BPCard is not identical to Accutracker DX, it does comply with the SP10 Standard and we at QRS believe it should be granted substantial equivalence by its conformance to SP10."
The document also directly compares the BPCard to the Accutracker DX on the "Accuracy" row, indicating "SP10 - Trained Observer" for both, implying the BPCard also meets the accuracy requirements of SP10.
| Acceptance Criterion | Reported Device Performance (Implied by Conformance) |
|---|---|
| Conformance to AAMI SP10 Standard (specifically regarding accuracy) | "Yes" (Stated in comparison table for "SP10 Conformance" and "Accuracy") |
| Accuracy (as per AAMI SP10) | Not explicitly stated numerically in this document. Assumed to meet SP10 requirements. |
| Range Systolic | 60-250 mm Hg |
| Diastolic Range | 40-220 mm Hg |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "conformance to the SP10 Standard," which outlines testing methodologies, but the specific sample size used for the BPCard's SP10 conformance test is not reported here.
- Data Provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The comparison table mentions "SP10 - Trained Observer," suggesting that trained personnel were involved in generating the data for the SP10 conformance, but specific numbers or qualifications are not detailed.
- Qualifications of Experts: Only "Trained Observer" is mentioned, which is generic. Specific qualifications (e.g., years of experience, medical specialty) are not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a Blood Pressure Monitor, not an AI-assisted diagnostic tool for "readers." This type of study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The BPCard is described as a "non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method." It is a measurement device operated by healthcare professionals. It is not an "algorithm only" device in the context of AI performance studies. Its performance is inherent to its mechanical and electronic measurement capabilities. The "trained observer" mentioned for SP10 conformance implies human involvement in the measurement validation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure monitors, the "ground truth" or reference measurement in SP10 conformance testing typically involves simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference method. The document mentions "auscultatory method" as the technique and "trained observer" for accuracy testing, strongly suggesting this type of ground truth was used.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense. Its performance is based on its engineering design and adherence to physical measurement principles.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
§ 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).