(110 days)
The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring.
The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse. Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. The device incorporates a battery state indicator and provides a visual indication of low battery.
Here's a breakdown of the acceptance criteria and the study information for the SB100II Finger Pulse Oximeter, based on the provided documents:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate or Regulatory Standard) | Reported Device Performance (SB100II) |
|---|---|---|
| SpO2 Accuracy | +/-2% 70-99% (from K082641, K013171) | +/-3% 70-99% |
| Pulse Accuracy | ±2% or 2 bpm whichever is greater (from K082641, K013171) | +/-3 bpm |
| SpO2 Range | 35-99% (from K082641) | 35-99% |
| SpO2 Resolution | 1% | 1% |
| Pulse Range | 30-250 bpm (from K082641) | 30-250 bpm |
| Pulse Resolution | 1 bpm | 1 bpm |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, ISO 9919 | Meets current revisions of IEC 60601-1:1988+A1+A2, IEC 60601-1-2:2001+A1, and ISO 9919:2005 |
| Ingress Protection | Meets FDA guidance for protection against ingress of water (not specified in predicates) | IPX1 and ISO 9919 Clause 44 |
| Electrical Safety | Unknown (for predicates) | Type BF |
Discussion of Performance vs. Criteria:
- SpO2 Accuracy: The SB100II reports an accuracy of +/-3% in the 70-99% range. The document states this is "Similar, actual Arms 2.5 Meets FDA guidance for non-motion ≤ 3.0 % Meets ISO 9919 for non-motion
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).