(10 days)
This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.
Digital Blood Pressure Monitors SE-9000, SE-9200 and SE-9400 are intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panels of SE-9200 and SE-9400 have power button, mode button, memory button and liquid crystal display ("LCD") except that SE-9000 has power button, mode/pressure button, memory button, start button. SE-9000, SE-9200 and SE-9400 have memory capacity to store the 140 most recent measurement results. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
The provided document does not contain any information regarding specific acceptance criteria for performance, nor does it detail a study proving the device meets said criteria.
The document is a 510(k) summary for a blood pressure monitor, focusing on establishing substantial equivalence to a predicate device. It briefly touches on device characteristics, intended use, and general safety and effectiveness.
Therefore, I cannot provide the requested information. The document explicitly states:
- "This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)"
- The table in Paragraph 14 only compares technological characteristics and states "Identical" or "Similar" for categories like "Performance," "Design," and "Human factors." It does not provide quantitative performance metrics or acceptance criteria.
To answer your questions, I would need a different type of document, such as a performance study report or a detailed test plan with acceptance criteria.
§ 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).