(56 days)
No
The description details a microprocessor-based system using infrared absorption for CO2 measurement and standard data processing techniques (data acquisition, parameter calculation, zeroing, heater control, corrections). There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No
The device is a monitoring device that measures carbon dioxide levels and does not provide therapy or treatment.
No
The device monitors carbon dioxide levels, which is a physiological measurement, but the text does not state that it is used to diagnose a medical condition or disease.
No
The device description explicitly states it is a "sensor" and an "integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface," indicating it includes hardware components for physical measurement and data processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Capnostat 5 CO2 sensor is described as a non-invasive device that measures carbon dioxide directly on the airway. It does not analyze a sample taken from the body.
The device's function is to monitor a physiological parameter (CO2 levels in exhaled breath) in real-time, which falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Product codes
CCK
Device Description
The Capnostat 5 CO2 sensor is designed for continuous, non-invasive monitoring of carbon dioxide .. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters are already legally marketed as accessories to the predicate device. The Capnostat 5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The Capnostat 5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the Capnostat 5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for NoO. O2 and barometric pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal and adult
Intended User / Care Setting
anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
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
Respironics Novametrix LLC Capnostat 5 CO2 Sensor Special 510(k) - Device Modification
NOV 1 9 2004
Section iv - 510 (k) Summar
[ Refer to 21 C.F.R § 807.92 ]
- Submitted by: Respironics Novametrix, LLC 5 Technology Drive Wallingford, CT 06492
- Kevin Mader Contact Person: Q.A. and Requiatory Manager Phone: 203-697-6466
- Date Prepared: 9/22/2004
- Capnostat 5 CO2 sensor Proprietary Name:
- Common Name: CO2 sensor
- Classification Name: Class II, 21 C.F.R 868.1400
- Capnostat III sensor in Tidal Wave Sp. Model 710/715 [510(k) K032971] Predicate Device:
Description of Device: The Capnostat 5 CO2 sensor is designed for continuous, non-invasive monitoring of carbon dioxide .. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters are already legally marketed as accessories to the predicate device. The Capnostat 5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The Capnostat 5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the Capnostat 5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for NoO. O2 and barometric pressure.
- Intended Use of the Device: This sensor has the same intended use as the predicate device. For reference, the intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Technological Characteristics. Capnostat 5 CO2 sensor is a mainstream CO2 sensor that attaches to an airway adapter (also referred to as a cuvette) and in which the patient's inspired and expired breath passes. The airway adapter is attached to a mouthpiece or mask, or to the breathing circuit between the endotracheal tube and ventilator circuit wye, if the patient is intubated. It is designed to use neonatal and adult CO2 airway adapters. The Capnostat CO2 sensor uses an infrared absorption (IR) technique for monitoring CO2. IR based methods have endured and evolved in the clinical setting for over two decades, and remain the most popular and versatile technique today. The principle is based on the fact that CO2 molecules
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absorb infrared light energy at specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When the IR light beam is passed through a gas sample containing CO2, the electronic signal from the photodetector can be obtained. This signal is then compared to the energy of the IR source, and calibrated to accurately reflect CO2 concentration in the sample. To calibrate, the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory. Solid state CO2 sensors (such as the Capnostat) use a beam splitter to simultaneously measure the IR light at two wavelengths: one which is absorbed by CO2 and one which is not. The wavelength which is not absorbed by CO2 is related to the intensity of the IR light source. Also, the IR light source is electronically pulsed (rather than interrupting the IR beam with a chopper wheel) in order to eliminate effects of changes in electronic components.
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, facing to the right. The image is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Mr. Kevin Mader Manager of Quality Assurance and Regulatory Affairs Respironics Novametrix, Incorporated 5 Technology Drive Wallingford, Connecticut 06492-1950
Re: K042601
Trade/Device Name: Capnostat 5 CO2 Sensor Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 1, 2004 Received: November 2, 2004
Dear Mr. Mader:
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 Eederal Register.
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Page 2- Mr. Mader
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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
Clair Liu, 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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Section ii Indications for Use
KO42601 ______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):
Device Name: Capnostat 5 CO2 Sensor
Indications for Use:
The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
X Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The -Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aure Sylvion
(Division Sign(Off) (Division SignQlil)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number. K
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