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).

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).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Capnostream® 20p with HiFi CO2 monitoring, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
CO2 Measurement Accuracy (HiFi Mode)	Not explicitly stated in the provided text as a quantitative acceptance criterion. However, the implicit acceptance is that the device accurately measures CO2.	Demonstrated accuracy of CO2 measurements in HFOV mode up to 900 BPM (15 Hz).
CO2 Range (HiFi Mode)	Not explicitly stated as a quantitative acceptance criterion.	Tested range: 16 mmHg to 76 mmHg.
Spontaneous Respiratory Rate Detection (HiFi Mode)	Not explicitly stated as a quantitative acceptance criterion.	Tested at spontaneous respiratory rates of 30, 45, and 60 BPM.
Safety	Meets safety standards (IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-8, ISO 14971, EN 980).	Hazard analysis concluded residual risks were acceptable. No new potential safety risks identified.
Performance Standards	Meets ISO 21647, ISO 9919.	Meets performance standards.
Substantial Equivalence	To predicate device: Capnostream20p with Smart A/hr & ODI (K112368).	Functionally and in intended use, substantially equivalent. Minor differences raise no safety/effectiveness issues.

2. Sample Sizes and Data Provenance for the Test Set

Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The testing was performed on a "lung simulator system."
Data Provenance: The testing was conducted on a "lung simulator system," indicating it was not performed on human subjects. This suggests a controlled laboratory environment rather than retrospective or prospective clinical data from a specific country of origin.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable as the ground truth was established through a "lung simulator system" rather than expert interpretation of biological data. The "ground truth" would be the known, controlled CO2 and respiratory rate inputs of the simulator.

4. Adjudication Method for the Test Set

Not applicable. Since the testing was done on a lung simulator, comparison would have been to the known, programmed values of the simulator, not requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a measurement instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting output. The study focused on the accuracy of the device's measurements.

6. Standalone Performance Study

Yes, a standalone performance study was done. The performance testing on the lung simulator system assessed the algorithm's (Capnostream20p with HiFi) ability to accurately measure CO2 and detect breaths independently of human interpretation.

7. Type of Ground Truth Used (Test Set)

The ground truth used was the known, controlled parameters established by the "lung simulator system." This would include the programmed CO2 concentrations and respiratory rates (both passive and spontaneous).

8. Sample Size for the Training Set

The document does not explicitly state a training set sample size. Given the nature of a capnograph/pulse oximeter, its core algorithms are typically based on physiological models and physical principles (e.g., infrared absorption for CO2). While there might be internal tuning or calibration processes that could be considered "training" in a broad sense, it's not described as a machine learning model with a distinct training dataset in the same way as an image recognition AI. The focus is on the validation of the HiFi software feature.

9. How the Ground Truth for the Training Set was Established

Not explicitly described in the document. As mentioned above, for this type of device, "training" might not involve a distinct ground truth dataset in the way a modern AI algorithm would. Its development would likely rely on physical laws, engineering specifications, and possibly internal testing to refine signal processing and detection algorithms within the device.

Summary

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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.

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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

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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

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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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

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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).

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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 withSmart A/hr ODI™ (K112368)	Capnostream 20pwith HiFi CO2monitoring
Classification	=	Same
ProductCode& Regulationnumber	868.1400, Carbon Dioxide Analyzer(Classification CCK)870.2700 Pulse Oximeter (ClassificationDQA)868.2375 Ventilatory Effort Recorder(Classification MNR)	Same
Intended use	The Capnostream®20p combinedcapnograph/pulse oximeter monitor and itsaccessories are intended to provideprofessionally trained health care providerswith continuous, non-invasive measurementand monitoring of carbon dioxideconcentration of the expired and inspiredbreath and respiration rate, and withcontinuous non-invasive monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate. It is alsoindicated for continuous non-invasivemonitoring of carboxyhemoglobin saturation(measured by an SpCO/SpMet/SpHbsensor),methemoglobin saturation (measured by anSpCO/SpMet/SpHb sensor) and totalconcentration (measured by anSpCO/SpMet/SpHb sensor). It is intendedforuse with neonatal, pediatric, and adultpatients in hospitals, hospital-type facilities,intra-hospital transport and homeenvironments.The Capnostream®20p monitor provides theclinician with an integrated pulmonary index(IPI). The IPI is based on four parametersprovided by the monitor: end tidal carbon	Same.In addition:The Capnostream20pHiFi mode provides ameasurement ofexpired carbondioxide and detectsspontaneous breathsfor infant/neonatalpatients ventilatedusing high frequencyoscillatory ventilation(HFOV).
Targetpopulation	It is intended for use with neonatal, pediatric,and adult patients. The Smart A/hr and ODIindication for use is for adult patients aged22 and higher only.	Identical targetpopulation formonitoring. In additionHiFi mode is intendedfor infants andneonates only
Design	Equivalent to the Capnostream20 describedin K094012	same
PerformanceStandards	ISO 21647ISO 9919	same
SafetyStandards	IEC/EN 60601-1IEC/EN 60601-1-2IEC 60601-1-8ISO 14971EN 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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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.

Regulation Number and Section

§ 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).