← Product Code [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK) · K080652 # MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (K080652) _Respironics Novametrix, LLC · BZK · Jun 20, 2008 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K080652 ## Device Facts - **Applicant:** Respironics Novametrix, LLC - **Product Code:** [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK.md) - **Decision Date:** Jun 20, 2008 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 868.1850 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **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 monitors respiratory airflow, airway pressure, and CO2; inputs derived from patient airway circuit via Capnostat 5 sensor; flow calculated by measuring pressure drop across known resistance; CO2 measured via infrared light absorption; output provides continuous physiological data for clinicians in anesthesia, ICU, and ED settings; assists in respiratory status assessment and clinical decision-making; benefits include non-invasive, real-time monitoring of patient ventilation. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Module for flow and CO2 monitoring; uses infrared absorption for CO2 and pressure drop across resistance for flow; connects to patient airway circuit; compatible with adult, pediatric, and neonatal sensors; standalone module component. ## Regulatory 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 - NICO monitor, Model 7300 ([K030886](/device/K030886.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Respironics Novametrix LLC Mercury Module with Capnostat 5 CO2 Sensor Special 510(k) - Device Modification K080652 ## JUN 2 0 2008 ## Section iv - 510 (k) Summary [ Refer to 21 C.F.R § 807,92 ] | Submitted by: | Respironics Novametrix, LLC
5 Technology Drive
Wallingford, CT 06492 | |----------------------|----------------------------------------------------------------------------| | Contact Person: | Kevin Mader
Q.A. and Regulatory Manager
Phone: 203-697-6466 | | Date Prepared: | 6/13/2008 | | 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: | NICO monitor, Model 7300 [510(k) K030886] | 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 intention norminds for monthsive non emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the flow and carbon dioxide monitoring component of the NICO monitor Intended Use of the Device: Mercury Module with Capnostat 5 CO2 sensor has the same intended use as the predicate device. For reference, the inter of the Mercury Module with Capnostal 5 CO2 sensor is to provide spirometric, and carbon dioxide monitoring in neonatal, pediatric and addit patients during general anesthesia and in the internation in heolidar, pediative and addit (CU) (ED). Technological Characteristics The Mercury module with Capnostat 5 is the flow and carbon dioxide monitoring component of the presently 510(k) cleared NICO with MARS monitor. It has been designed to include all of the functionality of the flow and carbon dioxide monitoring components of NCO with CO massurament workilling for a with Capnostat 5 is intended to provide all of the existing flow and CO2 measurement capabilities of the NICO Model 7300 of continuous monitoring of respiratory flow and pressure, and CO2 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 Capnostal 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}------------------------------------------------ Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 0 2008 Mr. Kevin Mader Quality Assurance and Regulatory Manager Respironics Novametrix, LLC 5 Technology Drive Wallingford, Connecticut 06492 Re: K080652 ﺔ ﺍﻟﻤﺘﺤﺪﺓ Trade/Device Name: Mercury Module with Capnostat 5 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK Dated: May 27, 2008 Received: May 28, 2008 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 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 vours. Suitte Y. Michie Ons. 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}------------------------------------------------ ## Section ii Indications for Use 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 ___________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) Min. Vdnd Page 1 of __ (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number. K080652 Page 41 of 168 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K080652](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K080652) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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