(59 days)
Not Found
No
The description details a microprocessor-based system using infrared absorption and standard data processing techniques (parameter calculation, zeroing, corrections) without mentioning AI or ML.
No
The device is a monitor, not a therapeutic device. It measures carbon dioxide levels but does not provide any treatment or therapy.
Yes
The device provides carbon dioxide monitoring which is used to diagnose or monitor a patient's respiratory status.
No
The device description explicitly details hardware components such as an integrated microprocessor, SRAM, EEPROM, and PROM, and describes physical measurement techniques (infrared absorption). It is a hardware device with embedded software.
Based on the provided information, the LoFlo C5 CO2 sensor is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide carbon dioxide monitoring to a host monitoring system during various medical procedures and care settings. This involves measuring CO2 directly from the patient's airway.
- Device Description: The device description clearly states it's a "continuous, non-invasive sidestream monitoring of carbon dioxide" using an infrared absorption technique on-airway.
- Lack of In Vitro Activity: IVDs are designed to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. The LoFlo C5 CO2 sensor is measuring a physiological parameter (CO2) directly from the patient's breath in vivo (within the body).
Therefore, the LoFlo C5 CO2 sensor is a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
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.
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zoll M Series EtCO2 LoFlo Option [510(k) K042417]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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.
2
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
3
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
Page 1 of _