(30 days)
No
The description focuses on standard physiological monitoring techniques (pressure drop for flow, infrared absorption for CO2) and does not mention any AI/ML terms or methodologies.
No
The device is used for monitoring spirometric and carbon dioxide levels, airflow, and airway pressure, which are diagnostic or monitoring functions, not therapeutic interventions.
Yes.
The device monitors physiological parameters (spirometry, carbon dioxide, airflow, airway pressure, volume) to provide information about a patient's respiratory status, which is used to assess and understand their health condition.
No
The device description explicitly mentions hardware components like the Mercury module, Capnostat 5 sensor, and flow sensors that connect to a patient airway circuit. It describes the physical measurement of flow and CO2 using these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states that the Mercury module with Capnostat 5 is intended for non-invasive monitoring of respiratory parameters (airflow, pressure, CO2) directly from the patient's airway. It measures these parameters in real-time as the patient breathes.
- No Specimen Analysis: The device does not analyze any biological specimens (blood, tissue, urine, etc.) taken from the patient.
Therefore, because it directly monitors physiological parameters in the patient's airway rather than analyzing specimens in vitro, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Mercury module with Capnostat 5 is to provide: spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
Product codes
BZK, CCK
Device Description
The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO ¿ during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
neonatal, pediatric and adult patients
Intended User / Care Setting
intensive care unit (ICU), anesthesia and emergency room (ER) patients, during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED)
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)
Mercury Module with Capnostat 5 CO2 sensor (K080652)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).
0
AUG 2 1 2009
Section iv - 510 (k) Summary
[ Refer to 21 C.F.R § 807.92 ]
| Submitted by: | Respironics Novametrix, LLC
5 Technology Drive
Wallingford, CT 06484 |
|----------------------|----------------------------------------------------------------------------|
| Contact Person: | Kevin Mader
Q.A. and Regulatory Manager
Phone: 203-697-6466 |
| Date Prepared: | 7/20/2009 |
| Proprietary Name: | Mercury Module with Capnostat 5 CO2 sensor |
| Common Name: | spirometer with CO2 sensor |
| Classification Name: | Class II, 21 CFR 868.1850 and 868.1400 |
| Predicate Device: | Mercury Module with Capnostat 5 CO2 sensor (K080652) |
Description of Device: The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5.
Intended Use of the Device: Mercury Module with Capnostat 5 CO2 sensor has the same intended use as the predicate device. For reference, the intended use of the Mercury Module with Capnostat 5 CO2 sensor is to provide spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).
Technological Characteristics The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO ¿ during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.
1
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 21 2009
Mr. Kevin Mader Manager of Quality Assurance and Regulatory Affairs Respironics Novametrix, Incorporated 5 Technology Drive Wallingford, Connecticut 06492-1950
Re: K092217
Trade/Device Name: Mercury Module with Capnostat 5 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK, CCK Dated: July 20, 2009 Received: July 22, 2009
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 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony C. Austin
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Respironics Novametrix LLC Modification to the Mercury Module with Capnostat 5 CO2 Sensor Special 510(k) - Device Modification
Section ii Indications for Use
1092217 510(k) Number (if known):
Device Name: Mercury Module with Capnostat 5
Indications for Use:
The intended use of the Mercury module with Capnostat 5 is to provide:
- spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
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)
L Schuttm
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: k 092217