(391 days)
Not Found
No
The device description focuses on hardware components, basic microprocessor control, and standard sensor technology. There is no mention of AI, ML, or any related concepts in the provided text.
No.
The device is used for determining levels of Carbon Monoxide (CO) poisoning, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate CO poisoning.
Yes
The device is used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning, providing a non-invasive means of determining CO poisoning and Carboxyhaemoglobin (COHb), which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "handheld device" with hardware components like a microprocessor, LCD display, buttons, and a sensor, powered by batteries.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EC50 ToxCO+ Breath Carbon Monoxide Monitor measures carbon monoxide levels in breath. This is a non-invasive measurement taken directly from the patient, not a test performed on a sample in vitro (outside the body).
Therefore, while it's a medical device used for diagnosis, it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
Product codes
CCJ
Device Description
The EC50 ToxCO+ Breath Carbon Monoxide Monitor (figure 1 & 2) is a handheld device, which provides a non-invasive means of determining Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is also ideal for use during triage to ensure suspected cases of CO poisoning are not missed.
The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a microprocessor-controlled device powered by 2 AA batteries with an Alphanumerice LCD display housed in a sturdy ABS case with a synthetic rubber boot. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is designed to have an operating temperature between 0-30° C, operating humidity 10-95% non-condensing and has storage temperature requirements of 0-30° C. The sensor sensitivity is 1 pmm, has a warm up time of
§ 868.1430 Carbon monoxide gas analyzer.
(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).
0
510(k)
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
| Submitter's Identification: | Bedfont Scientific Ltd
105 Laker Road
Rochester, Kent, United Kingdom ME 1 3QX |
|-----------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Mark Sandwell |
| Telephone:
Fax: | 011 44 8700 844050
011 44 8700 844051 |
| Date of Summary: | March 30, 2007 |
| Device Name: | EC50 ToxCo + |
| Classification Name: | Analyzer, Gas, Carbon Monoxide, Gaseous-Phase |
| Product Code: | CCJ |
| Product Class: | II |
| Code of Federal Regulation: | 21 CFR 868.1430 |
Substantial Equivalence:
| Manufacturer | Trade Name | 510(k) Number |
|---|---|---|
| Bedfont Scientific | Smokerlyzer | K892841 |
| Bedfont Scientific | piCO Smokerlyzer | K000962 |
7.2 Substantial Equivalence
The Bedfont EC50 ToxCO+, Bedfont piCO and Bedfont Smokerlyzer products are all part of the EC50 family, sharing similar electrochemical gas sensors for the detection of carbon monoxide. They share similar indications for use, accuracy, accessories and operating temperature ranges. All devices have similar power sources (Alkaline batteries) and meet general electrical standards IEC 60601-1. Bench testing has been carried out to ensure that the performance of the EC50 ToxCO+ is comparable with the predicate devices. Due to these similarities the ToxCO+ does not raise any new issues concerning safety and effectiveness.
FEB 21 2008
1
1.1 Description
The EC50 ToxCO+ Breath Carbon Monoxide Monitor (figure 1 & 2) is a handheld device, which provides a non-invasive means of determining Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is also ideal for use during triage to ensure suspected cases of CO poisoning are not missed.
The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a microprocessor-controlled device powered by 2 AA batteries with an Alphanumerice LCD display housed in a sturdy ABS case with a synthetic rubber boot. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is designed to have an operating temperature between 0-30° C, operating humidity 10-95% non-condensing and has storage temperature requirements of 0-30° C. The sensor sensitivity is 1 pmm, has a warm up time of