(149 days)
The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.
The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are lightemitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood.
As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.
The provided text describes the 510(k) summary for reprocessed pulse oximeter sensors. It outlines the device, its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard (Stated or Implied) | Reported Device Performance | Meets? |
|---|---|---|---|
| Functional Oxygen Saturation (SpO2) Accuracy | A_rms (average root mean squared) for SpO2 under no motion conditions less than 3.0%, conforming to Clause 201.12.1.101.1 of ISO 80601-2-61:2011 and Table 3 of "Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff." (Implied acceptance standard as part of regulatory guidance and ISO.) | A_rms for SpO2 under no motion conditions: 2.04% (non-woven tape), 2.11% (woven tape) over the range of 70-100%. | Yes |
| Pulse Rate Accuracy (No Motion) | Implied to be acceptable if the device performs comparably to predicate devices. Predicate specifications: ±3 bpm (30-200 bpm). | Subject Device: ±3 bpm (30-200 bpm) | Yes (Matches predicate) |
| Pulse Rate Accuracy (Low Perfusion) | Implied to be acceptable if the device performs comparably to predicate devices. Predicate specifications: ±3 bpm (25-240 bpm). | Subject Device: ±3 bpm (30-200 bpm) | Yes (Comparable to predicate range within overlap) |
| Continuity Testing | Passed (Implied) | Conducted and satisfied requirements (Stated) | Yes |
| Sensitivity Testing | Passed (Implied) | Conducted and satisfied requirements (Stated) | Yes |
| Monitor Compatibility | Compatible with pulse oximeter consoles (Implied) | Conducted and satisfied requirements (Stated) | Yes |
| Non-clinical Bench Testing (SpO2, Pulse Rate) | Satisfied performance specifications (Implied) | Conducted and satisfied requirements (Stated) | Yes |
| Clinical Validation (Healthy Adult Volunteers) | A_rms |
§ 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).