(91 days)
The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.
The Mobil-O-Graph NG ABPM (24 hour Automatic Blood Pressure Monitor) is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.
This 510(k) summary states that the Mobil-O-Graph NG ABPM is substantially equivalent to a predicate device (ABPM Mobil-O-Graph Blood Pressure Monitor, K964235) manufactured by the same company. The basis for this equivalency is stated to be similar intended use, general design, materials, components, and performance characteristics.
When a device is determined to be substantially equivalent to a predicate device, it typically means that specific new clinical studies to prove effectiveness are often not required if the new device does not raise new questions of safety or effectiveness. Instead, the focus is on demonstrating that the new device performs as well as, or better than, the predicate device through comparative data.
However, the provided text does not contain any specific acceptance criteria or details of a study with performance data that directly measure device accuracy (e.g., against a reference standard like intra-arterial blood pressure measurements) or clinical effectiveness. The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use.
Here's an analysis based on the provided text, while noting the absence of detailed study information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document. For blood pressure monitors, acceptance criteria typically involve accuracy standards (e.g., ISO 81060-2 or AAMI/ANSI SP10) for mean difference and standard deviation between the device and a reference method for systolic and diastolic blood pressure.
- Reported Device Performance: Not reported in the document. The document states that the new device "has the same general design and performance characteristics as the predicate device," implying similar performance to the already cleared predicate. However, no specific performance metrics are provided for the Mobil-O-Graph NG.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, as no specific performance study is detailed in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable, as no specific performance study with expert ground truth establishment is described.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary, as it's not relevant for a blood pressure monitor.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- The document implies that performance is expected to be similar to the predicate device due to shared technological characteristics. However, a specific standalone performance study for the Mobil-O-Graph NG is not described in this summary. Blood pressure monitors are inherently "standalone" in their measurement function, but validation typically involves comparison to a gold standard.
7. The Type of Ground Truth Used
- Not applicable, as no specific performance study with ground truth is described. For blood pressure devices, the "ground truth" for accuracy studies is typically intra-arterial blood pressure measurement or auscultation by trained observers using a mercury sphygmomanometer, according to recognized standards.
8. The Sample Size for the Training Set
- Not applicable, as this device's clearance appears to be based on substantial equivalence to a predicate device, rather than a de novo algorithm development that would involve a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
In conclusion, the document emphasizes that the Mobil-O-Graph NG ABPM is substantially equivalent to a previously cleared predicate device due to shared fundamental characteristics. While this is sufficient for 510(k) clearance in many cases, this specific summary does not provide details about a performance study with acceptance criteria, reported performance, sample sizes, or ground truth establishment for the Mobil-O-Graph NG itself. The assumption is that the predicate device met the necessary performance standards, and thus, the substantially equivalent new device will also perform adequately.
§ 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).