(163 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard physiological monitoring parameters and calculations.
No
The device is a monitor that provides continuous non-invasive measurements of various physiological parameters (carbon dioxide concentration, respiration rate, SpO2, pulse rate, IPI, A/hr, ODI). It is used for diagnostic purposes and does not directly provide therapy.
Yes
The device is described as a "portable capnograph/pulse oximeter, intended to provide... continuous non-invasive monitoring of carbon dioxide concentration... respiration rate, arterial oxygen saturation (SpO2) and pulse rate". It also provides "integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values." These measurements and indices are used to assess physiological conditions, which directly relates to diagnostics.
No
The device description explicitly states it is a "portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device," indicating it includes hardware components for measurement and display.
Based on the provided information, the Capnostream™35 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Capnostream™35 Function: The Capnostream™35 is a monitoring device that measures physiological parameters directly from the patient's body (expired breath for CO2 and respiration rate, and arterial oxygen saturation and pulse rate via pulse oximetry). It does not analyze specimens taken from the body.
Therefore, the Capnostream™35 falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.
The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.
Product codes
CCK, DQA, MNR
Device Description
The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.
The microMediCO2 module provides the following inputs to the host monitor:
EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).
The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.
The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.
The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.
The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.
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
Adult, pediatric, and neonatal patients.
IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for patients age 22 and up.
Intended User / Care Setting
Professionally trained health care providers.
Intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.
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)
Non-clinical tests were performed to support the determination of substantial equivalence. Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met. The device has successfully undergone performance testing according to ISO 80601-2-55 and ISO 80601-2-61 as well as electrical safety, electromagnetic and environmental testing according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12 and IEC 60601-1-6. Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate devices.
Wireless communication testing was conducted according to FDA guidance document from Aug 13,2013- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff.
A hazard analysis was carried out on the Capnostream™35 monitor in compliance with ISO 14971:2012. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
Oridion Medical 1987 Ltd Ms. Dalia Givony Regulatory Affairs Manager 7 Hamarpe Street Jerusalem, Israel 9777407
Re: K150272
Trade/Device Name: Capnostream™ 35 Portable Respiratory Monitor Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, DQA, MNR Dated: June 11, 2015 Received: June 16, 2015
Dear Ms. Givony:
This letter corrects our substantially equivalent letter of July 17, 2105.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Ms. Givony
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Traditional 510(k) Submission for Capnostream®35 Portable Respiratory Monitor
001 Statement Indications for Use
Capnostream™35 Portable Respiratory Monitor (This document is not confidential)
February 1, 2015
510(k) Number (if known)
Device Name: Capnostream™35 Portable Respiratory Monitor Indications for Use:
Intended Use
The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.
The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.
Prescription Use _ X AND/OR AND/OR AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
3
510K Summary
This summary is being submitted in accordance with the requirements of 21 CFR 807.92
(This section is not confidential)
DATE THIS SUMMARY WAS PREPARED
July 15, 2015
SUBMITTER'S NAME AND ESTABLISHMENT ADDRESS:
Oridion Medical 1987 Ltd
7 Hamarpe St. P.O. Box 45025
Jerusalem, Israel 9777407
ESTABLISHMENT REGISTRATION NUMBER
8044004
CONTACT PERSON:
Dalia Givony, Regulatory Affairs Manager
Oridion Medical 1987 Ltd
7 Hamarpe St. P.O. Box 45025
Jerusalem, Israel 9777407
Telephone: +972-2-589 9235
FAX: +972-2-586-6680
4
DEVICE INFORMATION
Trade Name: Capnostream™35 Portable Respiratory Monitor; PM35MN
Common Name: Portable Respiratory Monitor
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number:
868.1400, Carbon Dioxide Analyzer (Classification CCK) Subsequent product codes: 870.2700 Pulse Oximeter (Classification DQA) 868.2375 Ventilatory Effort Recorder (Classification MNR)
PREDICATE DEVICE
Capnostream™35 is substantially equivalent to the following commercially available devices:
| Manufacturer | Device | 510(k) No. | Clearance Date |
|---|---|---|---|
| Primary predicate: | |||
| Oridion Medical 1987 | |||
| Ltd. | Capnostream20p | ||
| With Smart A/hr & | |||
| ODITM | K112368 | July 19, 2012 | |
| Secondary predicate: | |||
| Covidien, LLC | Bedside Respiratory | ||
| Patient Monitoring | |||
| System With | |||
| Respiration Rate | |||
| Software | K130320 | February 4, 2014 |
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DEVICE DESCRIPTION
The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.
The microMediCO2 module provides the following inputs to the host monitor:
EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).
The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.
The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.
The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.
The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.
INTENDED USE
The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.
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The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for patients age 22 and up. The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.
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COMPARISON TO PREDICATE DEVICE
The Capnostream™35 is substantially equivalent to the following predicate devices:
| Attribute | Primary Predicate
Device: | Secondary
Predicate Device: | Subject Device : |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Capnostream20p
With Smart A/hr &
ODI (K112368) | Bedside Respiratory
Patient Monitoring
System With
Respiration Rate
Software (K130320) | Capnostream™35
Portable Respiratory
Monitor |
| Classification | II | II | II |
| Product Code | CCK
DQA
MNR | DQA
Subsequent code:
BZQ | CCK
Subsequent code:
DQA
MNR |
| Purpose and
Function | Continuous non-
invasive monitoring of
expired and inspired
CO2, EtCO2,
respiration rate
(provided from the
Capnograph module),
SpO2 and pulse rate | Continues non-
invasive monitoring
of SpO2, pulse rate
and respiratory rate | Same as K112368
(Respiration Rate is
derived by
Capnography) |
| Target
population | Neonatal, pediatric,
and adult patients.
A/hr and ODI
indication for use is
for adult patients age
22 and up. IPI is
intended for pediatric
and adult patients
only. | SpO2, Pulse Rate:
Adult, pediatric, and
neonatal patients
during both no
motion and motion
conditions, and for
patients who are well
or poorly perfused.
Respiration Rate:
adult patients who
are well perfused
during no motion | Same as K112368.
SpO2, Pulse Rate:
same as K130320 |
| | | conditions | |
| Where used | In hospitals, hospital-
type facilities, intra-
hospital transport and
home environments | SpO2, Pulse Rate: In
hospitals, hospital-
type facilities, and
during intra hospital
transport.
Respiration Rate:
hospitals and
hospital-type
facilities. | In hospitals, hospital-
type facilities, intra-
hospital transport,
out-of-hospital
Emergency Medical
Service applications
that include ground
and air transport. |
| Fundamental
Technology | NDIR (CO2)
Spectrophotometry
and Plethysmography | Spectrophotometry
and
Plethysmography | Same as K112368 |
| Performance
Standards | ISO 21647
ISO 9919 | EN 80601-2-61 | ISO 80601-2-55
ISO 80601-2-61 |
| Main Safety
Standards | IEC/EN 60601-1
IEC/EN 60601-1-2
IEC 60601-1-8
IEC 60601-2-49 | EN 60601-1
IEC 60601-1-2
EN 60601-1-4
EN 60601-1-8
EN 60601-1-6 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-2-49
IEC 60601-1-12
IEC 60601-1-6 |
8
9
TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS
The Capnostream™35 features the same technology (NDIR, Spectrophotometry and Plethysmography) as its primary predicate K112368 and the same performance characteristics as its predicates K112368 and K130320. The capnograph module (microMediCO2) integrated in the Capnostream™35 performs as in the predicate K112368 and the SpO2 module integrated in the Capnostream™35 performs as in the predicate K130320. The device was designed to support its use in out-of-hospital Emergency Medical Service applications for which it features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m).
PERFORMANCE TESTING
Non-clinical tests were performed to support the determination of substantial equivalence. Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met. The device has successfully undergone performance testing according to ISO 80601-2-55 and ISO 80601-2-61 as well as electrical safety, electromagnetic and environmental testing according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12 and IEC 60601-1-6. Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate devices.
Wireless communication testing was conducted according to FDA guidance document from Aug 13,2013- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff.
A hazard analysis was carried out on the Capnostream™35 monitor in compliance with ISO 14971:2012. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the device.
10
Substantial Equivalence
The Capnostream™35 has the same intended use, technological characteristics and performance as its predicate devices. Compared to its predicate devices, the Capnostream™35 is intended also for out-of-hospital Emergency Medical Service applications. Its functionality in its intended environments was verified.
The Capnostream™35 has successfully undergone performance, electrical safety, electromagnetic, environmental and wireless communication testing to ensure it complies with its performance testing requirements. Testing did not raise any concerns when compared to its predicate devices therefore the subject device is substantially equivalent to its predicate devices.