(48 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called "C-CO2™ Colorimetric Carbon Dioxide Indicator." However, it does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed validation section of a 510(k) submission.
This document is primarily a summary of safety and effectiveness, an official FDA clearance letter, and the indications for use. It mentions performance characteristics in the device description (e.g., color changes indicating CO2 concentration), but it does not present quantifiable acceptance criteria or the results of a study designed to test against such criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader studies based on the provided text.
Here's what I can extract from the provided text based on your request, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantifiable thresholds (e.g., "sensitivity must be >X%"). The device description generally describes expected color changes.
- Reported Device Performance:
- Qualitative Description: "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."
- Functionality: "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."
- Interference: "Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator."
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The device's operation is based on a chemical reaction indicating CO2, not on expert interpretation of complex data.
4. Adjudication method for the test set:
- Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not done. This device is a simple colorimetric indicator, not an AI-powered diagnostic system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not mentioned. The device itself is the "standalone" indicator, but no performance study in the context of an "algorithm" is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly, the ground truth would be precise measurements of CO2 concentration (e.g., using a reference capnograph) and observation of the C-CO2 device's color change. This is not explicitly detailed as "ground truth" in the provided text.
8. The sample size for the training set:
- Not applicable/Not mentioned. This is a chemical indicator, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
In summary: The provided document is insufficient to answer most of your detailed questions regarding acceptance criteria and performance studies. It is a regulatory clearance document that primarily focuses on the device description, indications for use, and substantial equivalence to a predicate device, rather than providing the detailed technical validation data.
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scolak
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510(k) SUMMARY OF SAFETY & EFFECTIVENESS
MAR 1 - 2005
January 7, 2005
| Marquest Medical Products, Inc.11039 East Lansing CircleEnglewood, CO 80112(A division of Vital Signs, Inc.) | Tel - (303) 790-4835 ext. 412Fax - (303) 799-0210 |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------- |
| Official Contact: | Tom Dielmann, Vice President of RA/QA |
|---|---|
| Proprietary orTrade Name: | C-CO2 TM |
| Common/Usual Name: | Colorimetric Carbon Dioxide Indicator |
| Classification Name: | 73 CCK - Analyzer, Gas, Carbon Dioxide, Gaseous PhaseSubsection 868.1400 |
| Intended Device: | Colorimetric CO2 Indicator |
| Predicate Device: | BreGas AB CO2 Clip - K023820 |
| Device Description: | A non-sterile, single use, colorimetric carbon dioxideindicator with integral luer-lock connector, for placement ina gas sampling ported component, located between atracheal tube and the breathing circuit, to detect exhaledCO2.Pressure in the breathing circuit causes a low flow ofbreathing gas to pass into and through the indicator andvent to the atmosphere. The colorimetric media in thecenter window of the device indicates the presence ofcarbon dioxide in exhaled breath on a breath-by-breathbasis.The colorimetric media in the center window is blue whenno carbon dioxide is present, green at intermediateconcentrations and yellow when approximately 5% carbondioxide is present. A breath-by-breath color change reflectsventilation of the patient. A permanent blue or blue-greencolor indicates absence of exhaled carbon dioxide. Adamaged indicator will exhibit a permanent yellow or whitecolor.The indicator has a color scale against which the actualcolor may be compared to provide an approximate carbondioxide concentration. Normal breathing gases, anestheticgases, 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 providesa semi-quantitative visualization of the CO2 in the patientairway or in the gas exhaled from a patient. It is an adjunctto clinical assessment when verifying correct ET tubeplacement and respiration. |
|---|---|
| Targeted Population: | Patients with a tidal volume greater than or equal to 150mland with a minute volume greater than or equal to3L/minute, and with a breathing rate less than or equal to35 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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§ 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).