(181 days)
Not Found
No
The document describes a device that calculates an "Integrated Pulmonary Index" based on four measured parameters using a defined scale. There is no mention of AI, ML, or any learning algorithms used in this calculation or any other function of the device. The calculation appears to be a deterministic combination of inputs.
No.
The device is a monitor that provides continuous, non-invasive measurements of physiological parameters for diagnostic purposes, rather than providing direct therapy or treatment.
Yes
Explanation: The device measures and monitors physiological parameters (carbon dioxide concentration, respiration rate, oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin, and total hemoglobin) to assess a patient's ventilatory status and identify changes, which are characteristic functions of a diagnostic device.
No
The device description explicitly states it is a "bedside monitor" consisting of hardware modules (capnography and pulse oximetry) implemented in a "host device." While software is integral to the operation of these modules and the host, the device is clearly a combination of hardware and software, not software-only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Capnostream®20p monitor measures physiological parameters directly from the patient's body through non-invasive means (capnography and pulse oximetry). It analyzes expired breath and arterial hemoglobin saturation.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of specimens taken from the body. It measures parameters on the body.
The device is classified as a Carbon Dioxide Analyzer and a Pulse Oximeter, which are typically considered patient monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate, and with continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor). methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments.
The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DQA, CCK76
Device Description
The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and/or 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 device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.
This device has two modules that are classified as follows:
- 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
- . 21 CFR 870.2700 Pulse Oximeter (Classification DQA).
Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20p device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds.
The microMediCO2 module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index).
The Masimo MX1 SpO2 module, integrated in the Capnostream20 p monitor presented in this submission, provides the following parameters to the host for display: SpO2 (functional oxygen saturation of arterial hemoglobin), pulse rate, SpCO (carboxyhemoglobin saturation in blood), SpMet (methemoglobin saturation in blood) and SpHb (total hemoglobin concentration in blood).
The host monitor will display this data to the user in numerics via a screen, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.
The three measurements will be available both real time and in trend summaries.
In addition, the MX1 board provides a Perfusion Index (PI) indicating the relative pulsatile strength at the sampling site is provided to the host monitor for display.
The host displays the Rainbow SET parameters values on the screen alongside the four IPI (Integrated Pulmonary Index) parameters and the IPI value as presented on the predicate device.
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
neonatal, pediatric, and adult
Intended User / Care Setting
professionally trained health care providers / hospital-type facilities, intra-hospital transport and home environments. 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.
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)
Software testing was performed to validate the performance of the new monitor software and its substantial equivalence to the predicate device. The functional features and the intended use of Capnostream20p with Masimo MX1 board are substantially equivalent to the predicate devices.
A hazard analysis was carried out on the Capnostream host monitor displaying the Rainbow SET values. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness Information
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
(This section is not confidential)
DATE THIS SUMMARY WAS PREPARED
July 1681, 2010
SUBMITTER'S NAME AND ESTABLISHMENT ADDRESS:
Oridion Capnography Inc. 160 Gould Street Needham, MA 02494
ESTABLISHMENT REGISTRATION NUMBER
3003941644
CONTACT PERSON:
Rachel Weissbrod, Director of Regulatory Affairs Oridion Medical 1987 Ltd. Har Hotzvim Science Park POB 45025 91450 Jerusalem, Israel Telephone: +972-2-589-9115 Fax: +972-2-586-6680 Email: rachel.weissbrod@oridion.com
DEVICE INFORMATION
Trade Name: Capnostream20p with Masimo MX1 SpO2 board. . Common Name: Two Parameter Bedside Monitor Classification Name: Capnograph/Pulse Oximeter Requlation Number: 868.1400. Carbon Dioxide Analyzer (Classification CCK) 870.2700 Pulse Oximeter (Classification DQA) Device Listing Number:
1
Traditional 510(k) Submission for CAPNOSTREAM®20p with Masimo MX1 SpO2 Board PREDICATE DEVICE
Capnostream20 with SET parameters is substantially equivalent to the following commercially available devices:
| Manufacturer | Device | 510(k) No. | Clearance Date |
|---|---|---|---|
| Oridion 1987 | |||
| Medical Ltd | Capnostream20 | K094012 | February 9, 2010 |
| Masimo Corporation | Masimo Rainbow SET | ||
| Radical 7 Pulse CO- | |||
| Oximeter | K080238 | May 12, 2008 |
DEVICE DESCRIPTION
The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and/or 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 device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.
This device has two modules that are classified as follows:
- 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
- . 21 CFR 870.2700 Pulse Oximeter (Classification DQA).
Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20p device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds.
The microMediCO2 module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index).
2
Traditional 510(k) Submission for CAPNOSTREAM®20p with Masimo MX1 SpO2 Board The Masimo MX1 SpO2 module, integrated in the Capnostream20 p monitor presented in this submission, provides the following parameters to the host for display: SpO2 (functional oxygen saturation of arterial hemoglobin), pulse rate, SpCO (carboxyhemoglobin saturation in blood), SpMet (methemoglobin saturation in blood) and SpHb (total hemoglobin concentration in blood).
The host monitor will display this data to the user in numerics via a screen, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.
The three measurements will be available both real time and in trend summaries.
In addition, the MX1 board provides a Perfusion Index (PI) indicating the relative pulsatile strength at the sampling site is provided to the host monitor for display.
The host displays the Rainbow SET parameters values on the screen alongside the four IPI (Integrated Pulmonary Index) parameters and the IPI value as presented on the predicate device.
INTENDED USE
The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments.
The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10,
4
3
Traditional 510(k) Submission for CAPNOSTREAM®20p with Masimo MX1 SpO2 Board where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
COMPARISON TO PREDICATE DEVICES
The Capnostream20p with Masimo MX1 board is equivalent to the predicate Capnostream20 with microMediCO2 CO2 board with the exception of the addition of the three Rainbow SET parameters (SpCO, SpMET and SpHb).
The new device meets the safety and performance standards met by the predicate devices.
Software testing was performed to validate the performance of the new monitor software and its substantial equivalence to the predicate device. The functional features and the intended use of Capnostream20p with Masimo MX1 board are substantially equivalent to the predicate devices.
A hazard analysis was carried out on the Capnostream host monitor displaying the Rainbow SET values. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system.
| Attribute | Capnostream20p with Masimo
MX1 SpO2 board, software
version 6.1. | Predicate Device:
Capnostream Bedside
Monitor with microMediCO2:
K094012, software version
5.6 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The Capnostream®20p combined
capnograph/pulse oximeter monitor
and its accessories are intended to
provide professionally trained health
care providers with continuous, non-
invasive measurement and
monitoring of carbon dioxide
concentration of the expired and
inspired breath and respiration rate,
and with continuous noninvasive
monitoring of functional oxygen
saturation of arterial hemoglobin | The Capnostream®20p
combined capnograph/pulse
oximeter monitor is intended to
provide professionally trained
health care providers with
continuous, non-invasive
measurement and monitoring
of carbon dioxide concentration
of the expired and inspired
breath and respiration rate, and
with continuous non-invasive
monitoring of functional oxygen |
4
Traditional 510(k) Submission for CAPNOSTREAM®20p with Masimo MX1 SpO2 Board
(SpO2) and pulse rate. It is also indicated for continuous noninvasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport and home environments. The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI).
The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospitaltype facilities, intra-hospital transport and home environments.
The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
5
| Target
population | Identical | It is intended for use with
neonatal, pediatric, and adult
patients |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Equivalent to the Capnostream20
described in K094012 | See K094012. |
| Where Used | 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. | 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. |
| Performance
Standards | ISO 21647
ISO 9919 | ISO 21647
ISO 9919 |
| Safety
Standards | IEC/EN 60601-1
IEC/EN 60601-1-2
IEC 60601-1-8
ISO 14971
EN 980 | IEC/EN 60601-1
IEC/EN 60601-1-2
IEC 60601-1-8
UL 60601-1
ISO 14971
EN 980 |
| Biocompatibility | There are no issues of
biocompatibility for this device and
no biocompatibility testing was
performed. | There are no issues of
biocompatibility for this device
and no biocompatibility testing
was performed. |
| Sterility | This device does not require
sterilization | This device does not require
sterilization |
Traditional 510(k) Submission for CAPNOSTREAM®20p with Masimo MX1 SpO2 Board
The Capnostream20p with Masimo MX1 SpO2 board enables the measurement of three additional parameters, which are available in the predicate device MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER (K080238):
- SpCO: carboxyhemoglobin saturation in blood .
- SpMet: methemoglobin saturation in blood .
- SpHb: total hemoglobin concentration in blood . These parameters have been clinically validated by Masimo Corporation.
6
Traditional 510(k) Submission for CAPNOSTREAM®20p with Masimo MX1 SpO2 Board CONCLUSION
Capnostream20p with Masimo MX1 SpO2 board functionality does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Therefore, the device is substantially equivalent to the predicate devices with respect to safety, effectiveness, and intended use.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three parallel, angled lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Rachel Weissbrod Director of Regulatory Affairs Oridion Capnography, Incorporated 160 Gould Street Needham Heights. Massachusetts 02494
JAN 1 1 2011
Re: K101995 Trade/Device Name: Capnostream20p Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, CCK76 Dated: January 4, 2011 Received: January 7, 2011
Dear Ms. Weissbrod:
.
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.
8
Page 2- Ms. Weissbrod
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 (OS) 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Statement of Indications for Use
CAPNOSTREAM®20p with Masimo MX1 SpO2 Board (This document is not confidential)
Indications for Use
November 24, 2010
510(k) Number (if known): K101995
Device Name: Capnostream20p
Indications for Use:
The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate, and with continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor). methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments.
The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Prescription Use ________________ (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF | |
|---|---|
| NEEDED) |
(Division Sibar-তাঁদ (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospices Division of Anton of Anton Devices
Oridion Medical 1987 Ltd.
510(k) Number: __