(182 days)
The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.
The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Vital Signs Monitor, Model PC-900A:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria for a new clinical trial. However, it does list performance specifications and accuracy claims for the device. These can be interpreted as the functional acceptance criteria the manufacturer aims for, by comparing them to predicate devices.
| Parameter | Acceptance Criteria (Implied by equivalence and typical performance claims) | Reported Device Performance (PC-900A) |
|---|---|---|
| SpO₂ Measurement Range | Similar to predicate devices (e.g., 1%-100%) | 70%~99% |
| SpO₂ Accuracy | Similar to predicate devices (e.g., Adult/Pediatric: ±2% (70-100%), Neonate: ±3% (70-100%)) | Adult and Pediatric: ± 3% (during 70%~99%) |
| Undefined (during 0~70%) | ||
| SpO₂ Alarms | High and lower alarms, adjustable limits | High and lower alarms. The limits are adjustable. |
| Pulse Rate Display Range | Similar to predicate devices (e.g., 20 bpm ~ 250 bpm) | 30 bpm~240 bpm |
| Pulse Rate Accuracy | Similar to predicate devices (e.g., ±3 bpm) | ± 2bpm or ± 2% (whichever is greater) |
| Pulse Rate Alarms | High and lower alarms, adjustable limits | High and lower alarms. The limits are adjustable. |
| CO₂ Module | Use of previously cleared modules (e.g., Respironics LoFlo™ EtCO2, CAPNOSTAT 5 EtCO2) | Respironics LoFlo™ EtCO2 (Side-stream) Module(K053174) and CAPNOSTAT 5 EtCO2 (Main-stream) Module(K042601) |
| CO₂ Measurement Method | Infrared absorption method | Infrared absorption method |
| CO₂ Measure Mode | Sidestream or Mainstream | Sidestream or Mainstream |
| CO₂ Response Time | Sidestream: |
§ 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).