(59 days)
The intended use of the LoFlo C5 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.
The LoFlo C5 CO2 sensor is designed for continuous, non-invasive sidestream monitoring of carbon dioxide. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and associated nasal cannulas are already legally marketed as accessories to the predicate device. The LoFlo C5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The LoFlo C5 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 LoFlo C5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.
The provided text is a 510(k) summary for a medical device (LoFlo C5 CO2 Sensor) and does not contain detailed information about acceptance criteria or specific study results that prove the device meets acceptance criteria. The document mainly focuses on describing the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information about acceptance criteria and study details from this document.
The following information is NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not specify any quantitative acceptance criteria or report performance metrics against such criteria.
- Sample size used for the test set and the data provenance: No information on test set sample sizes or data provenance (country of origin, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The concept of "ground truth" and expert involvement for a test set is not discussed.
- Adjudication method for the test set: No information is given regarding adjudication methods.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies and effect sizes are not mentioned.
- If a standalone study (algorithm only without human-in-the-loop performance) was done: Standalone performance testing is not detailed.
- The type of ground truth used: The establishment of ground truth is not described.
- The sample size for the training set: Training set information is not provided.
- How the ground truth for the training set was established: Ground truth establishment for a training set is not discussed.
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K 053174
JAN I 2 2006
Respironics Novametrix LLC I oFlo C5 CO2 Sensor Special 510(k) - Device Modification
Section iv - 510 (k) Summary
[ Refer to 21 C.F.R § 807.92 ]
Respironics Novametrix, LLC Submitted by: 5 Technology Drive Wallingford, CT 06484
Kevin Mader Contact Person: Q.A. and Requlatory Manager Phone: 203-697-6466
1/6/2006 Date Prepared:
LoFlo C5 CO2 sensor Proprietary Name:
Common Name: CO2 sensor
Class II, 21 C.F.R 868.1400 Classification Name:
Zoll M Series EtCO2 LoFlo Option [[510(k) K042417] Predicate Device:
The LoFlo C5 CO2 sensor is designed for continuous, non-invasive sidestream Description of Device: monitoring of carbon dioxide. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and associated nasal cannulas are already legally marketed as accessories to the predicate device. The LoFlo C5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The LoFlo C5 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 LoFlo C5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, 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 LoFlo C5 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.
LoFlo C5 CO2 sensor is a sidestream CO2 sensor that interfaces to the Technological Characteristics: patient either via an airway adapter or a nasal cannula. An 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. A nasal cannula is used for non-intubated patients. The LoFLo C5 CO2 sensor uses an infrared absorption (IR) technique for monitoring CO2.
The LoFlo C5 CO2 sensor consists of an integrated microprocessor-based data acquisition and measurement system that measures CO2 and provides a serial
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
JAN 1 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics Novametrix, LLC Mr. Kevin Mader Quality Assurance & Regulatory Affairs Manager Hospital Division Respironics Novametrix, LLC 5 Technology Drive Wallingford, Connecticut 06492-1950
Rc: K053174
Trade/Device Name: LoFlo C5 CO2 Sensor Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: December 20, 2005 Reccived: December 21, 2005
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 vour 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. 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/industry/support/index.html.
Sincerely yours,
Suyite Y. Michael Om-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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Respironics Novametrix LLC LoFlo C5 CO2 Sensor Special 510(k) - Device Modification
Section ii Indications for Use
510(k) Number (if known):
Device Name: LoFlo C5 CO2 Sensor
Indications for Use:
The intended use of the LoFlo C5 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.
Prescription Use X (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)
Surgte Y. Michlee Om-D.
053174
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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).