(391 days)
The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
The EC50 ToxCO+ Breath Carbon Monoxide Monitor 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 <10 seconds-90% FSD, an accuracy of ±5% of reading, a concentration range of 0-50% COHb/0-500ppm CO and an H2 Cross Interference of <40% @ 20° C. The sensor operating life is 2-3 years with a company warranty of 6 months and requires calibrations at 6-month intervals. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is an easy to use handheld device that has three clearly marked buttons: ON button, CAL calibration button, RECALL button.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: EC50 ToxCO+ Breath Carbon Monoxide Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly define a formal "acceptance criteria" table with specific thresholds that the device must meet to be deemed acceptable. Instead, it relies on comparison to predicate devices and reported specifications.
| Acceptance Criteria (Implied) | Reported Device Performance (EC50 ToxCO+) |
|---|---|
| Accuracy: Comparable to predicate devices | ±5% of reading |
| Concentration Range: Comparable to predicate devices | 0-50% COHb/0-500ppm CO |
| Sensor Sensitivity: Comparable to predicate devices | 1 ppm |
| Warm-up Time: Comparable to predicate devices | <10 seconds - 90% FSD |
| H2 Cross Interference: Comparable to predicate devices | <40% @ 20°C |
| Operating Temperature: Comparable to predicate devices | 0-30°C |
| Operating Humidity: Comparable to predicate devices | 10-95% non-condensing |
| Storage Temperature: Comparable to predicate devices | 0-30°C |
| Electrical Safety: Compliance with relevant standards | Met IEC 60601-1 |
| Electromagnetic Compatibility: Compliance with relevant standards | Met IEC 60601-1-2 |
| Biocompatibility of Mouthpiece: Compliance with relevant standards | Satisfied ISO 10993 (same as predicate) |
| Biocompatibility of Facemasks: Compliance with relevant standards | Met ISO 10993 (commercially available) |
| Sensor Operating Life: Comparable to predicate devices | 2-3 years |
| Calibration Frequency: Comparable to predicate devices | 6-month intervals |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set involving human subjects or collected data points. The assessment relies on a comparison to predicate devices and bench testing.
- Sample Size (Test Set): Not specified.
- Data Provenance: The document implies "bench testing" was performed to compare performance with predicate devices. No specific geographic origin or retrospective/prospective nature of data is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. This type of device (carbon monoxide monitor) typically relies on instrumental measurements for its core performance evaluation rather than expert interpretation of images or clinical assessments for ground truth.
4. Adjudication Method for the Test Set
Since no test set involving human interpretation or subjective assessment is described, no adjudication method (e.g., 2+1, 3+1) is mentioned or applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study involves multiple human readers and multiple cases to assess the impact of an AI system on reader performance. The EC50 ToxCO+ is a standalone diagnostic device that directly measures CO levels, not an AI-assisted diagnostic tool that aids human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The device itself is a standalone measurement instrument. Its reported performance (e.g., accuracy, sensitivity, range) is inherently its standalone performance. There is no "human-in-the-loop" component in the direct measurement of CO by the device. The reported performance metrics in the table above represent the device's standalone capabilities.
7. Type of Ground Truth Used
The ground truth for evaluating the EC50 ToxCO+ would have been instrumental reference standards for carbon monoxide concentration. For example, calibrated gas mixtures of known CO concentration would be used to test the device's accuracy. The document implicitly relies on the established performance of the predicate electrochemical gas sensors.
8. Sample Size for the Training Set
The document does not mention a training set in the context of machine learning or AI. This device uses a traditional electrochemical sensor, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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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 Ltd105 Laker RoadRochester, Kent, United Kingdom ME 1 3QX |
|---|---|
| Contact Person: | Mark Sandwell |
| Telephone:Fax: | 011 44 8700 844050011 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
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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 <10 seconds-90% FSD, an accuracy of ±5% of reading, a concentration range of 0-50% COHb/0-500ppm CO and an H2 Cross Interference of <40% @ 20° C. The sensor operating life is 2-3 years with a company warranty of 6 months and requires calibrations at 6-month intervals.
The EC50 ToxCO+ Breath Carbon Monoxide Monitor is an easy to use handheld device (figure 3) that has three clearly marked buttons:
- . ON button,
- . CAL calibration button
- RECALL button .
Indications for Use: 1.0
The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
1.2 Standards Met
The EC50 ToxCO+ Breath Carbon Monoxide Monitor has met IEC 60601-1 Electrical Safety for General Electrical Safety Standard and IEC 60601-1-2 Electromagnetic Compatibility - requirements and test. The mouthpiece used for the EC50 ToxCO+ Breath Carbon Monoxide Monitor is the same as the mouthpieces used for Bedfont EC50 Smokerlyzer Carbon Monoxide Monitor K892841 and Bedfont PICO Smokerlyzer Model EC-50 K000962 satisfying the ISO 10993 requirements. The facemasks used are commercially available for medical use and meet the requirements of ISO 10993.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES. USA
FEB 21 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bedfont Scientific Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K070259
Trade/Device Name: EC50 ToxCO+ Breath Carbon Monoxide Monitor Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCJ Dated: February 7, 2008 Received: February 8, 2008
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lehtonen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice i requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: EC50 ToxCO+ Breath Carbon Monoxide Monitor
Indications For Use:
The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poi soning.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mang Whal
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number:
59
§ 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).