(179 days)
Not Found
No
The device calculates an "Integrated Pulmonary Index (IPI)" based on a fixed formula using four standard physiological parameters (end tidal CO2, respiration rate, SpO2, and pulse rate). This calculation is deterministic and does not involve learning from data or adapting its algorithm over time, which are characteristics of AI/ML. The summary explicitly states the IPI is "based on four parameters" and is an "integer value ranging from 1-10 based on" these parameters, indicating a rule-based or formulaic approach rather than an AI/ML model.
No.
The device is a monitor that measures and displays physiological parameters (carbon dioxide concentration, respiration rate, oxygen saturation, and pulse rate) and calculates an integrated pulmonary index (IPI). It is used for monitoring, not for treating a disease or condition.
Yes
The device is described as a combined capnograph/pulse oximeter monitor intended for the continuous, non-invasive measurement and monitoring of carbon dioxide concentration, respiration rate, functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. These are all diagnostic measurements. Additionally, it calculates an Integrated Pulmonary Index (IPI) based on these parameters, which is a single index of a patient's ventilatory status, further solidifying its diagnostic purpose of assessing patient physiological conditions. The device is classified as a Carbon Dioxide Analyzer and Pulse Oximeter, both of which are diagnostic devices.
No
The device description explicitly states it is a "bedside monitor" consisting of hardware modules (capnography and pulse oximetry modules) implemented in a "host device." While it contains software, it is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device is a monitor that measures physiological parameters directly from the patient's body (carbon dioxide in breath, oxygen saturation and pulse rate from the skin).
The device description and intended use clearly indicate that it is a patient monitoring device, not a device that analyzes samples in a laboratory setting. The classifications provided (Carbon Dioxide Analyzer and Pulse Oximeter) are also for patient monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
The Capnostream 20 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 transport and home environments.
The Capnostream 20 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
DQA, CCK
Device Description
The Capnostream 20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 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 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 Capnostream 20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes the ability to receive SpO2 and pulse rate values from a pulse oximetry module and to calculate an integrated pulmonary index (IPI) which provides a simple and clear single parameter representation of the patient's ventilatory status. The IPI, is an integer value ranging from 1-10 based on end tidal CO2, respiration rate, SpO2 (oxygen saturation of arterial hemoglobin) and pulse rate. The calculated IPI is then provided to a host device (the Capnostream 20 device in the case of this submission). The host displays the index value on the screen alongside the four parameters presented on the predicate device. The IPI feature is not intended for use in the monitoring of children aged less than one year or neonates and the feature is disabled when neonatal mode is selected by the user. However, the monitor itself may continue to be used, in a manner that is identical to the predicate device in all respects, for all patient populations.
The MiniMediCO2 module software is designed to enable the index to be calculated by accepting SpO2 and heart rate values supplied at the required rate (once a second) by any type of pulse oximetry module implemented in a host device. The miniMediCO2 module with IPI software may be implemented in any other pulse oximetry enabled host monitor after making the required changes to the host software to allow provision of SpO2 and pulse rate values to the module and display of the IPI by the host. The host will continue to display the four reference parameters and any other parameters provided by the monitor with the IPI as an addition.
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 patients
Intended User / Care Setting
professionally trained health care providers... in hospital type facilities, intra-hospital transport and home environments.
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 software and its substantial equivalence to the predicate device. A clinical evaluation was performed to ensure that the modified device meets user requirements. A safety and effectiveness evaluation was performed to demonstrate that the IPI identified all instances in which clinical intervention was required and alerted the practitioner to these changes.
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
§ 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
2. 510(k) Summary of Safety and Effectiveness
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)
FEB - 9 2009
DATE THIS SUMMARY WAS PREPARED
August 5, 2008
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: Capnostream 20 with Integrated Pulmonary Index Common Name: Two Parameter Bedside Monitor Classification Name: Capnograph/Pulse Oximeter Regulation Number: 868.1400, Carbon Dioxide Analyzer (Classification CCK)
870.2700 Pulse Oximeter (Classification DQA)
Device Listing Number: B051971
1
PREDICATE DEVICE
Capnostream 20 with the Integrated Pulmonary Index (IPI) software is substantially equivalent to the following commercially available device:
Manufacturer Oridion 1987
Device
510(k)No. K072295
Clearance Date
October 11th, 2007
Medical Ltd
Capnostream 20
DEVICE DESCRIPTION
The Capnostream 20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 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 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 Capnostream 20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes the ability to receive SpO2 and pulse rate values from a pulse oximetry module and to calculate an integrated pulmonary index (IPI) which provides a simple and clear single parameter representation of the patient's ventilatory status. The IPI, is an integer value ranging from 1-10 based on end tidal CO2, respiration rate, SpO2 (oxygen saturation of arterial hemoglobin) and pulse rate. The calculated IPI is then provided to a host device (the Capnostream 20 device in the case of this submission). The host displays the index value on the screen
2
alongside the four parameters presented on the predicate device. The IPI feature is not intended for use in the monitoring of children aged less than one year or neonates and the feature is disabled when neonatal mode is selected by the user. However, the monitor itself may continue to be used, in a manner that is identical to the predicate device in all respects, for all patient populations.
The MiniMediCO2 module software is designed to enable the index to be calculated by accepting SpO2 and heart rate values supplied at the required rate (once a second) by any type of pulse oximetry module implemented in a host device. The miniMediCO2 module with IPI software may be implemented in any other pulse oximetry enabled host monitor after making the required changes to the host software to allow provision of SpO2 and pulse rate values to the module and display of the IPI by the host. The host will continue to display the four reference parameters and any other parameters provided by the monitor with the IPI as an addition.
INTENDED USE
The Capnostream 20 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 hospital type facilities, intra-hospital transport and home environments.
The Capnostream 20 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.
3
COMPARISON TO PREDICATE DEVICE
The Capnostream 20 with IPI is equivalent to the predicate Capnostream 20 (miniMediCO2 software version 2.31) with the exception of the software changes to the miniMediCO2 capnography module and the changes to the Capnostream 20 host software.
The new device meets the safety and performance standards met by the predicate device.
Software testing was performed to validate the performance of the new software and its substantial equivalence to the predicate device. A clinical evaluation was performed to ensure that the modified device meets user requirements. A safety and effectiveness evaluation was performed to demonstrate that the IPI identified all instances in which clinical intervention was required and alerted the practitioner to these changes. The functional features and the intended use of Capnostream 20 with IPI are substantially equivalent to the predicate device.
A hazard analysis was carried out on the module with the IPI functionality and on the Capnostream 20 host monitor displaying the IPI 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 | Capnostream 20 Bedside Monitor
with MiniMediCO2 EtCO2 module
with IPI software (version 2.51) | Predicate Device- Capnostream
20 Bedside Monitor K072295 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The indications for use are identical to the
indications for use in the predicate device
with the addition of the following:
The Capnostream 20 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, | The Capnostream 20 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 |
| | oxygen saturation and heart 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 for use with neonatal,
pediatric and adult patients in
hospitals, hospital type facilities, intra
hospital transport and home
environments. |
| Target
population | intended to replace, vital sign monitoring.
It is intended for use with neonatal,
pediatric, and adult patients. | It is intended for use with neonatal,
pediatric, and adult patients. |
| Design | Identical to the Capnostream 20
described in K072295 with the exception
of the software changes in both the
EtCO2 module and host monitor
described in this submission | See K072295 |
| 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(2001)
IEC 60601-1-8
UL 60601-1
ISO 14971 | IEC/EN 60601-1
IEC/EN 60601-1-2(2001)
IEC 60601-1-8
UL 60601-1
ISO 14971 |
| Biocompatibility | There are no issues of biocompatibility for
this device and no biocompatibility testing
was done. | There are no issues of biocompatibility
for this device and no biocompatibility
testing was done. |
| Sterility | This device does not require sterilization
and is shipped marked non-sterile. | This device does not require
sterilization and is shipped marked
non-sterile. |
4
.
.
. .
:
and the state of the state of the states of the states and
5
CONCLUSION
Capnostream 20 with the IPI functionality does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed device. Therefore, the device is substantially equivalent to the predicate device with respect to safety, effectiveness, and intended use.
.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB - 9 2009
Ms. Rachel Weissbrod Director of Regulatory Affairs Oridion Capnography, Incorporated c/o Oridion Medical 1987 Limited Har Hotzvim Science Park, POB 45025 Jerusalem Israel 91450
Re: K082268
Trade/Device Name: Capnostream20 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, CCK Dated: January 9, 2009 Received: January 27, 2009
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.
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.
7
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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suttle G. Michael Davis
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
8
1. Statement of Indications for Use
TWO PARAMETER CAPNOSTREAM 20 MONITOR WITH INTEGRATED PULMONARY INDEX (IPI)
(This document is not confidential) Indications for Use
August 15, 2008
510(k) Number (if known): K082268_
Device Name: Capnostream 20
Indications for Use:
The Capnostream 20 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 hemodlobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments.
The Capnostream 20 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)
ZmZ
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
12082268 510(k) Number: