MERCURY VCO2

K092217 · Respironics Novametrix, Inc. · BZK · Aug 21, 2009 · Anesthesiology

Device Facts

• Record ID: K092217
• Device Name: MERCURY VCO2
• Applicant: Respironics Novametrix, Inc.
• Product Code: BZK · Anesthesiology
• Decision Date: Aug 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1850
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Module provides non-invasive monitoring of inspired/expired airflow, airway pressure, and CO2; used in ICU, anesthesia, and ER settings. Flow sensors connect to patient airway circuit; module calculates flow via pressure drop across known resistance; CO2 measured via infrared light absorption. Output provides continuous respiratory data to clinicians for patient management. Modification increases neonatal flow/CO2 sensor upper limit from 25 to 30 LPM to match ventilator specifications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Module measures airway flow, pressure, volume, and CO2. Flow sensing via pressure drop across resistance; CO2 sensing via infrared light absorption. Neonatal sensor specification updated to 30 LPM. Connectivity via patient airway circuit sensors.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring spirometric and CO2 monitoring during general anesthesia, in the ICU, or in the emergency department.

Regulatory Classification

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.

Predicate Devices

• Mercury Module with Capnostat 5 CO2 sensor (K080652)

Submission Summary (Full Text)

{0}------------------------------------------------

K092217

AUG 2 1 2009

## Section iv - 510 (k) Summary

[ Refer to 21 C.F.R § 807.92 ]

| Submitted by: | Respironics Novametrix, LLC<br>5 Technology Drive<br>Wallingford, CT 06484 |
|----------------------|----------------------------------------------------------------------------|
| Contact Person: | Kevin Mader<br>Q.A. and Regulatory Manager<br>Phone: [phone] |
| 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 [phone] or [phone] 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