CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

K060065 · Oridion Capnography, Inc. · DQA · May 4, 2006 · Cardiovascular

Device Facts

Record IDK060065
Device NameCAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
ApplicantOridion Capnography, Inc.
Product CodeDQA · Cardiovascular
Decision DateMay 4, 2006
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2700
Device ClassClass 2
AttributesPediatric

Intended Use

The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. The Capnostream10 is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

Device Story

Capnostream20 and Capnostream10 are bedside monitors for continuous, non-invasive patient monitoring. Capnostream20 integrates MiniMediCO2 (EtCO2) and MP100 (SpO2) modules; Capnostream10 utilizes the MiniMediCO2 module. Devices process respiratory and pulse oximetry signals to provide real-time concentration of expired/inspired CO2, respiration rate, functional oxygen saturation (SpO2), and pulse rate. Operated by physicians, nurses, and trained healthcare providers in critical care, anesthesiology, and neonatal units. Outputs are displayed on-screen with integrated alarms to alert clinicians to patient status changes. Data supports clinical decision-making regarding respiratory and circulatory status. Benefits include continuous monitoring in hospital, intra-hospital transport, and home environments.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on the use of previously cleared modules (MiniMediCO2 and MP100) and verification of device performance within the new host monitor configuration.

Technological Characteristics

Bedside monitors integrating MiniMediCO2 (EtCO2) and MP100 (SpO2) modules. Class II devices (21 CFR 868.1400, 21 CFR 870.2700). Connectivity includes nurse call integration. Power source and specific software architecture details not provided beyond module-level integration.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring continuous, non-invasive monitoring of EtCO2, respiration rate, and/or SpO2/pulse rate in hospital, clinical, or home settings. Contraindications not specified.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K060065-Reply to FDA Letter of March 2, 2006 10.1.3.2. 510(k) Summary of Safety and Effectiveness Information Capnostreamon and Capnostream ## 510(k) Summary of Safety and Effectiveness Information Capnostream20 and Capnostream10 (This document is not confidential) #### DATE THIS SUMMARY WAS PREPARED March 20, 2006 #### SUBMITTERS NAME AND ESTABLISHMENT ADDRESS: Oridion Capnography Inc. 21 Highland Circle Needham, MA 02494-3038 #### PRODUCT NAMES NOTE: This summary statement is for a bundled submission and covers the Capnostream20 and Capnostream 10 #### Capnostream20 Proprietary: Capnostream20 Common: Two Parameter Bedside Monitor #### Capnostream 10 Proprietary: Capnostream10 Common: One Parameter Bedside Monitor #### ESTABLISHMENT REGISTRATION NUMBER Establishment Registration Number: 3003941644 #### CONTACT PERSON: Sanford Brown, Regulatory Affairs Director Oridion Medical 1987 Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel Telephone: +972-2-589-9115 FAX: +972-2-586-6680 {1}------------------------------------------------ B051971 # DEVICE DESCRIPTIONS #### ళ్ళ Capnostream20 The Capnostream20 bedside monitor is a two parameter monitor consisting of an EtCO2 MiniMediCO2 module and a MP100 SpO2 module, displays and alarms. #### SUBSTANTIAL EQUIVALENCE INFORMATION - · CO2 Module (MiniMediCO2) used in legally marketed Predicate Devices: - V Oridion Polaris 2004, K040011, - > CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO2-V1 K050844 - V Larsen & Toubro Limited Star 50 Monitoring System K051608 - Pulse Oximeter Module, SpO2 Module (MP100) used in legally marketed Predicate . Devices: - > NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891 - V NPB Oximax N-550, K021090 - Nurse Call . - V NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891 - V Welch Allyn Atlas Monitor K022084 #### CLASSIFICATION #### Capnostream20 73CCK Class II This device has two modules that are classified as follows: - 21 CFR 868.1400, carbon dioxide analyzer . - . 21 CFR870.2700 Pulse Oximeter #### INTENDED USE The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. Oridion Medical 1987 Ltd. {2}------------------------------------------------ #### DEVICE DESCRIPTION The Capnostream20 Bedside Monitor is comprised of two modules used in previously FDA cleared devices with the following indications for use, which together are the indications for use for the two parameter bedside monitor: #### Capnostream20 ### 1. The MiniMediCO₂ EtCO₂ Module: ls intended for installation in host devices that: are used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal Intensive care and other health care areas where non invasive measurement of expired CO2 and inspired CO2 are of medical value. It continuously and non invasively measures and monitors carbon dioxide concentration of the expired and inspired breath and respiration rate. This module is designed to be installed in a host device, in this case the two Parameter Bedside Monitor, that is for prescription use only. #### 2. The MP100 Oximetry Module ls indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused. It is to be used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal Intensive care and other health care areas. This module is designed to be installed in a host device, in this case the two Parameter Bedside Monitor, that is for prescription use only. . #### Capnostream10 જુન #### Capnostream 10 Proprietary: Capnostream10 Common: One Parameter Bedside Monitor ### ESTABLISHMENT REGISTRATION NUMBER Establishment Registration Number: 3003941644 ### CONTACT PERSON: Sanford Brown, Regulatory Affairs Director Oridion Medical 1987 Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel {3}------------------------------------------------ Confidential FAX: +972-2-586-6680 #### DEVICE LISTING FDA FORM 2892: B051971 #### DEVICE DESCRIPTION The Capnostream ( bedside monitor is a one parameter monitor consisting of a MP100 EtCO2 module displays and alarms. #### SUBSTANTIAL EQUIVALENCE INFORMATION #### CO2 Module (MiniMediCO2) used in Predicate Devices: . - ✓ Oridion Polaris 2004, K040011. - > CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO2-V1 K050844 - > Larsen & Toubro Limited Star 50 Monitoring System K051608 #### CLASSIFICATION #### Capnostream10 73CCK Class II This device is classified as follows: - . 21 CFR 868.1400, carbon dioxide analyzer #### INTENDED USE The Capnostream o is intended for CO2 indications only. The Capnostream10 is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. {4}------------------------------------------------ #### DEVICE DESCRIPTION The Capnostream10 Bedside Monitor contains a MinMediCO2 EtCO2 module used in previously FDA cleared devices with the following indications for use. #### The MiniMediCO2 EtCO2 Module: ls intended for installation in host devices that: are used by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology. intensive care medicine, neonatal Intensive care and other health care areas where non invasive measurement of expired CO2 and inspired CO2 are of medical value. It continuously and non invasively measure and monitor carbon dioxide concentration of the expired and inspired breath and respiration rate. This module is designed to be installed in a host device, in this case the one Parameter Bedside Monitor, that is for prescription use only. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. MAY - 4 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Oridion Capnography, Incorporated C/O Mr. Stanford Brown Regulatory Affairs Director Oridion Medical 1987 Limited Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel Re: K060065 Trade/Device Name: Capnostream20 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 6, 2006 Received: April 7, 2006 Dear Mr. Brown: 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. {6}------------------------------------------------ Page 2 - Mr. Brown 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. 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 {7}------------------------------------------------ ### 10.1.3.1. Indications for Use # Two Parameter CAPNOSTREAM20 Monitor and Single Parameter Capnostream10 Monitor #### (This document is not confidential) # Indications for Use March 20, 2006 510(k) Number (if known) Device Name: Capnostream20 Indications For Use: The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. Device Name: Capnostream10 #### Indications For Use: The Capnostream10 is intended for CO2 indications only. The Capnostreamso is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and insoired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. | Prescription Use | X | AND/OR | Over-The-Counter Use | |----------------------------|---|--------|------------------------| | (Per 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 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and the 510(k) number is K060065. 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