(48 days)
Not Found
No
The device is a simple colorimetric indicator that changes color based on CO2 concentration, with no mention of computational analysis or learning algorithms.
No
Explanation: The device is a diagnostic tool that provides a semi-quantitative visualization of CO2. It does not perform any therapeutic function.
Yes
The device is described as an "adjunct to clinical assessment when verifying correct ET tube placement and respiration," and it provides a "semi-quantitative visualization of the CO2 in the patient airway," which are actions related to diagnosing or monitoring a patient's physiological state.
No
The device description clearly describes a physical, single-use, non-sterile colorimetric indicator with an integral luer-lock connector and colorimetric media, indicating it is a hardware device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to provide a "semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient." This involves analyzing a biological sample (exhaled breath, which contains CO2) to provide information about the patient's physiological state (respiration and ET tube placement).
- Device Description: It explicitly states that the device "detect[s] exhaled CO2" using a "colorimetric media." This media reacts with the CO2 in the exhaled breath, producing a color change that indicates the presence and approximate concentration of CO2. This is a classic example of an in vitro diagnostic test, where a reagent (the colorimetric media) interacts with a biological sample (exhaled breath) outside of the body to provide diagnostic information.
While the device is used in conjunction with a patient's airway, the diagnostic process itself (the reaction of the colorimetric media with the exhaled gas) occurs within the device, which is outside of the patient's body. This aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. It is an adjunct to clinical assessment when verifying correct ET tube placement and respiration.
Product codes
CCK
Device Description
A non-sterile, single use, colorimetric carbon dioxide indicator with integral luer-lock connector, for placement in a gas sampling ported component, located between a tracheal tube and the breathing circuit, to detect exhaled CO2.
Pressure in the breathing circuit causes a low flow of breathing gas to pass into and through the indicator and vent to the atmosphere. The colorimetric media in the center window of the device indicates the presence of carbon dioxide in exhaled breath on a breath-by-breath basis.
The colorimetric media in the center window is blue when no carbon dioxide is present, green at intermediate concentrations and yellow when approximately 5% carbon dioxide is present. A breath-by-breath color change reflects ventilation of the patient. A permanent blue or blue-green color indicates absence of exhaled carbon dioxide. A damaged indicator will exhibit a permanent yellow or white color.
The indicator has a color scale against which the actual color may be compared to provide an approximate carbon dioxide concentration. Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, Transport
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
scolak
:
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
MAR 1 - 2005
January 7, 2005
| Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, CO 80112
(A division of Vital Signs, Inc.) | Tel - (303) 790-4835 ext. 412
Fax - (303) 799-0210 |
| -------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------- |
|---|
| Official Contact: | Tom Dielmann, Vice President of RA/QA |
|---|---|
| Proprietary or | |
| Trade Name: | C-CO2 TM |
| Common/Usual Name: | Colorimetric Carbon Dioxide Indicator |
| Classification Name: | 73 CCK - Analyzer, Gas, Carbon Dioxide, Gaseous Phase |
| Subsection 868.1400 | |
| Intended Device: | Colorimetric CO2 Indicator |
| Predicate Device: | BreGas AB CO2 Clip - K023820 |
| Device Description: | A non-sterile, single use, colorimetric carbon dioxide |
| indicator with integral luer-lock connector, for placement in | |
| a gas sampling ported component, located between a | |
| tracheal tube and the breathing circuit, to detect exhaled | |
| CO2. | |
| Pressure in the breathing circuit causes a low flow of | |
| breathing gas to pass into and through the indicator and | |
| vent to the atmosphere. The colorimetric media in the | |
| center window of the device indicates the presence of | |
| carbon dioxide in exhaled breath on a breath-by-breath | |
| basis. | |
| The colorimetric media in the center window is blue when | |
| no carbon dioxide is present, green at intermediate | |
| concentrations and yellow when approximately 5% carbon | |
| dioxide is present. A breath-by-breath color change reflects | |
| ventilation of the patient. A permanent blue or blue-green | |
| color indicates absence of exhaled carbon dioxide. A | |
| damaged indicator will exhibit a permanent yellow or white | |
| color. | |
| The indicator has a color scale against which the actual | |
| color may be compared to provide an approximate carbon | |
| dioxide concentration. Normal breathing gases, anesthetic | |
| gases, or water vapor do not affect the indicator. |
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510(k) SUMMARY OF SAFETY & EFFECTIVENESS (cont.)
| Indicated Use: | The C-CO2 colorimetric carbon dioxide indicator provides
a semi-quantitative visualization of the CO2 in the patient
airway or in the gas exhaled from a patient. It is an adjunct
to clinical assessment when verifying correct ET tube
placement and respiration. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Targeted Population: | Patients with a tidal volume greater than or equal to 150ml
and with a minute volume greater than or equal to
3L/minute, and with a breathing rate less than or equal to
35 breaths per minute. |
| Environment of Use: | Hospital, Transport |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Public Health Service
MAR 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas W. Dielmann Vice President, Regulatory Affairs/Quality Assurance Marquest Medical Products, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112
Re: K050066
Trade/Device Name: C-CO2TM Colorimetric CO2 Indicator Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: January 7, 2005 Received: January 14, 2005
Dear Mr. Dielmann:
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. Dielmann
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 requirements as set forth in the quality systems (OS) 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.
100
Sincerely yours,
Sina Russo
Chiu Lin, Ph.D.
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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: .
. :
| 510(K) NUMBER: | K |
|---|---|
| DEVICE NAME: | C-CO2 TM COLORIMETRIC CO2 INDICATOR |
| INDICATIONS FOR USE: | The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. At is an adjunct to clinical assessment when verifying correct ET tube placement and respiration. |
| Prescription Use | X | and/or | Over-The-Counter Use |
|---|---|---|---|
| (per 21 CFR 801 Subpart D) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Signature-On: | |
|---|---|
| Division of Anesthesiology General Hospital, | |
| Infection Control. Dental Devices | |
| 510(k) Number | K050066 |
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