(610 days)
No
The document describes a device that measures and monitors physiological parameters and calculates an index based on these parameters. There is no mention of AI, ML, or any learning algorithms being used in the device's operation or the calculation of the integrated pulmonary index (IPI). The IPI is described as being "based on four parameters," suggesting a deterministic calculation rather than a learned model.
No
The device is described as a monitor that measures and displays physiological parameters, such as carbon dioxide concentration, oxygen saturation, and pulse rate. Its function is to provide information to healthcare providers, not to directly treat or interact with the body to achieve a therapeutic effect.
Yes
The device is described as a combined capnograph/pulse oximeter monitor intended for measuring and monitoring carbon dioxide concentration, respiration rate, oxygen saturation, pulse rate, carboxyhemoglobin saturation, methemoglobin saturation, and total hemoglobin concentration. These measurements provide information about a patient's physiological status, which is used by healthcare providers to assess and manage conditions. The "integrated pulmonary index (IPI)" also helps clinicians assess ventilatory status, indicating its role in providing diagnostic insights.
No
The device description explicitly states it is a "bedside monitor" consisting of hardware modules (capnography and pulse oximetry) implemented in a "host device," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, the Capnostream®20p device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Capnostream®20p Function: The Capnostream®20p device measures and monitors physiological parameters directly from the patient's body (expired breath, arterial hemoglobin saturation, etc.) using non-invasive methods. It does not examine specimens in vitro.
Therefore, the Capnostream®20p falls under the category of a non-invasive physiological monitoring device, not an IVD.
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 and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoqlobin (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 hospital-type facilities, intra-hospital transport and home environments.
Capnostream®20p is to be operated by qualified healthcare personnel only. 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.
The Capnostream20p HiFi mode provides a measurement of expired carbon dioxide and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).
Product codes (comma separated list FDA assigned to the subject device)
CCK, DQA, MNR
Device Description
The Capnostream20p bedside monitor is a 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 HiFi capnography software feature, presented in this submission, is intended to enable measurement of airway CO2 for infant/neonatal patients during high frequency oscillatory ventilation (HFOV) and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).
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, qualified healthcare personnel only; 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)
Performance testing conducted on a lung simulator system demonstrated the accuracy of the CO2 measurements in HFOV mode up to a rate of 900 BPM (breaths per minute) (15 Hz) for both passive (ventilator driven) and spontaneous breaths. The testing was conducted for a CO2 range of 16mmHg to 76 mmHg and at spontaneous respiratory rates of 30, 45, and 60 BPM.
A hazard analysis was carried out on the Capnostream host monitor displaying the HiFi 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.
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
§ 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 circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Ms Dalia Givony Regulatory Affairs Manager Oridion Medical 1987 Limited 7 Hamarpe Street Har Hotzvim Industrial Park Jerusalem, Israel 91450
Re: K123690
Trade/Device Name: Capnostream® 20p with HiFi CO2 Monitoring Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: June 15, 2014 Received: June 17, 2014
Dear Ms. Givony:
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,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Response to FDA RFI- Capnostream®20p with HiFi CO2 monitoring - K123690
Statement of Indications for Use
Capnostream®20p with HiFi CO2 monitoring (This document is not confidential)
510(k) Number (if known) K123690
Device Name: Capnostream®20p with HiFi CO2 monitoring
Intended Use/ Indication 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 non-invasive monitoring of functional oxygen saturation of arterial hemoqlobin (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 hospital-type facilities, intra-hospital transport and home environments.
Capnostream®20p is to be operated by qualified healthcare personnel only. 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.
The Capnostream20p HiFi mode provides a measurement of expired carbon dioxide and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).
Prescription Use
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oridion Medical 1987 Ltd.
Todd D. Courtney -S 2014.08.04 14:22:31 -04'00'
August 28, 2013
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Page 1 of 6
510(k) 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 31, 2014
SUBMITTER'S NAME AND ESTABLISHMENT ADDRESS:
Oridion Medical 1987 Ltd 7 HaMarpe Street, Har Hotzvim Industrial Park, Jerusalem, 91450, Israel
ESTABLISHMENT REGISTRATION NUMBER
8044004
CONTACT PERSON:
Dalia Givony, Director of Regulatory Affairs 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
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Page 2 of 6
DEVICE INFORMATION
Trade Name: Capnostream20p with HiFi CO2 monitoring Common Name: Two Parameter Bedside Monitor Classification Name: Capnograph/Pulse Oximeter/Ventilatory Effort Recorder Regulation Number: 21 CFR 868.1400, Carbon dioxide analyzer, (product code CCK) Secondary product codes: DQA and MNR.
PREDICATE DEVICE
Capnostream20p with HiFi CO2 monitoring is substantially equivalent to the following commercially available devices:
MANUFACTURER DEVICE 510(k) No. Clearance Date
Oridion 1987 Medical Ltd Capnostream20p with Smart A/hr &ODI K112368 Julv 19, 2012
DEVICE DESCRIPTION
The Capnostream20p bedside monitor is a 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 HiFi capnography software feature, presented in this submission, is intended to enable measurement of airway CO2 for infant/neonatal patients during high frequency oscillatory ventilation (HFOV) and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).
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Page 3 of 6
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 non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (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 hospital-type facilities, intra-hospital transport and home environments.
Capnostream®20p is to be operated by qualified healthcare personnel only.
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. The Capnostream20p HiFi mode provides a measurement of expired carbon dioxide and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).
6
COMPARISON TO PREDICATE DEVICE
The Capnostream20p with HiFi CO2 monitoring is substantially equivalent to the predicate Capnostream20p with Smart A/hr ODI™ .
| Attribute | Predicate Device: Capnostream20p with
Smart A/hr ODI™ (K112368) | Capnostream 20p
with HiFi CO2
monitoring |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | = | Same |
| Product
Code
& Regulation
number | 868.1400, Carbon Dioxide Analyzer
(Classification CCK)
870.2700 Pulse Oximeter (Classification
DQA)
868.2375 Ventilatory Effort Recorder
(Classification MNR) | Same |
| 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 non-invasive 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
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 | Same.
In addition:
The Capnostream20p
HiFi mode provides a
measurement of
expired carbon
dioxide and detects
spontaneous breaths
for infant/neonatal
patients ventilated
using high frequency
oscillatory ventilation
(HFOV). |
| Target
population | It is intended for use with neonatal, pediatric,
and adult patients. The Smart A/hr and ODI
indication for use is for adult patients aged
22 and higher only. | Identical target
population for
monitoring. In addition
HiFi mode is intended
for infants and
neonates only |
| Design | Equivalent to the Capnostream20 described
in K094012 | same |
| Performance
Standards | ISO 21647
ISO 9919 | same |
| Safety
Standards | IEC/EN 60601-1
IEC/EN 60601-1-2
IEC 60601-1-8
ISO 14971
EN 980 | same |
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PERFORMANCE TESTING
The Capnostream20p with HiFi is substantially equivalent to the predicate Capnostream20p with A/hr and ODI.
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 monitor and its substantial equivalence to the predicate device. The functional features and the intended use of Capnostream20p with HiFi are substantially equivalent to the predicate device.
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Page 6 of 6
Performance testing conducted on a lung simulator system demonstrated the accuracy of the CO2 measurements in HFOV mode up to a rate of 900 BPM (breaths per minute) (15 Hz) for both passive (ventilator driven) and spontaneous breaths. The testing was conducted for a CO2 range of 16mmHg to 76 mmHg and at spontaneous respiratory rates of 30, 45, and 60 BPM.
A hazard analysis was carried out on the Capnostream host monitor displaying the HiFi values. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system.
CONCLUSION
The Capnostream20p with the HiFi software feature does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. The minor differences between the Capnostream20p with HiFi and its predicate device raise no issue of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate devices with respect to safety, effectiveness, and intended use.