(460 days)
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No
The summary describes a simple accessory (nasal cannula) for a CO2 analyzer and contains no mention of AI, ML, or related concepts.
No
The device is an accessory to a carbon dioxide analyzer and is used to measure exhaled carbon dioxide, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to "measure the percentage of exhaled carbon dioxide," which is a form of physiological measurement used for diagnosis or monitoring.
No
The device description and intended use clearly describe a physical medical device (nasal cannula) used as an accessory to a carbon dioxide analyzer, not a software-only device.
Based on the provided information, the Ventlab End-Tidal CO2 Nasal Cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description states the device is an accessory to a carbon dioxide analyzer used to measure exhaled carbon dioxide from a nonintubated patient. This is a measurement taken directly from the patient's breath, not from a sample taken from the patient.
Therefore, the Ventlab End-Tidal CO2 Nasal Cannula is a device used for in vivo measurement (measurement within the living body), not in vitro measurement (measurement outside the living body).
N/A
Intended Use / Indications for Use
The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.
Product codes
CCK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2008
Mr. James A. Cochie Director, Regulatory Affairs Ventlab Corporation 155 Boyce Drive Mocksville, North Carolina 27028
Re: K063813
Trade/Device Name: Ventlab End-Tidal CO2 Nasal Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: March 13, 2008 Received: March 14, 2008
Dear Mr. Cochie:
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. Cochie
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 (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) 276-0115. 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,
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): $0638 3
Device Name: _Ventlab End-Tidal CO2 Nasal Cannula
Indications for Use:
The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.
Ques
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _K c638
X 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 OF NEEDED)