(168 days)
The Bpump Blood Pressure Cuff, Model: BC1000, BC8000, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
The proposed device, Bpump Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should be connected to a Non Invasive Blood Pressure Monitor to complete the function. There are two sizes for different arm range as follows:
| Model | Arm range |
|---|---|
| BC1000 | 22cm |
| BC8000 | 32cm |
Here's a breakdown of the acceptance criteria and study information for the Bpump Blood Pressure Cuff, based on the provided FDA 510(k) summary:
- Device Name: Bpump Blood Pressure Cuff, Model: BC1000, BC8000
- Submission K-Number: K151810
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Table of Acceptance Criteria and Reported Device Performance
The document states that the device "met all applicable requirements of the standard" during clinical testing. The primary standard for clinical validation of automated non-invasive sphygmomanometers is ANSI/AAMI/ISO 81060-2. This standard sets out accuracy requirements for blood pressure measurement devices. While the exact numerical acceptance criteria from the standard are not explicitly listed in the provided text, the conclusion affirms compliance.
Acceptance Criteria (Based on ANSI/AAMI/ISO 81060-2) Reported Device Performance Unspecified (Meets applicable requirements of standard for accuracy) Met all applicable requirements of the standard -
Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The submitting company is from China (Shenzhen, PEOPLE'S REPUBLIC OF CHINA), but the location of the clinical test is not mentioned. The test is described as "Clinical test has been done," suggesting it was prospective but this is not explicitly stated.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For blood pressure devices, "ground truth" (reference measurements) are typically established by trained observers using a validated reference sphygmomanometer, often with specific training and certification for such measurements.
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Adjudication Method for the Test Set
This information is not provided in the document.
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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 versus without AI assistance
This is not applicable. This device is a blood pressure cuff, not an AI-powered diagnostic imaging device. Therefore, an MRMC study and analysis of AI assistance effect size are not relevant to this submission.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a blood pressure cuff intended to be used with a "non-invasive blood pressure monitor system." The clinical validation was for the automated measurement type according to ANSI/AAMI/ISO 81060-2, which validates the device's ability to accurately measure blood pressure. This essentially represents the "standalone" performance of the cuff and the non-invasive blood pressure monitor as a system, separate from human interpretation of complex outputs.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For blood pressure devices, the ground truth is typically established by simultaneous or near-simultaneous measurements using a recognized reference standard sphygmomanometer (e.g., mercurial or validated aneroid device) performed by trained observers. While not explicitly detailed, compliance with ANSI/AAMI/ISO 81060-2 implies adherence to these ground truth methodologies.
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The Sample Size for the Training Set
This information is not applicable. Blood pressure cuffs do not typically involve "training sets" in the machine learning sense. The device's underlying algorithm (if it uses one for interpretation of oscillometric pulses) is developed and then validated.
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How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this traditional medical device.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).