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, 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.

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.

AI/ML Overview

This 510(k) summary describes a device, the Capnostream®20p with Masimo MX1 SpO2 board, which is a combined capnograph/pulse oximeter monitor. The submission seeks to prove its substantial equivalence to predicate devices, particularly concerning the addition of three new parameters: SpCO, SpMet, and SpHb.

Based on the provided text, the device itself is a medical monitor, not an AI or algorithm-based diagnostic tool that would typically undergo studies to demonstrate performance against established acceptance criteria in the manner requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria for new functionality.

Therefore, many of the requested categories (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for training) are not applicable or explicitly mentioned in the provided regulatory submission for this type of medical device.

However, I can extract the relevant information regarding performance, a comparison to predicate devices, and the intended use.

Acceptance Criteria and Device Performance Study Summary

The submission does not present a study with specific acceptance criteria in the format of a diagnostic algorithm or AI performance evaluation. Instead, it asserts substantial equivalence to existing predicate devices based on design, intended use, and adherence to performance and safety standards. The "performance" in this context refers to the device's ability to accurately measure the stated physiological parameters in line with its predicate devices and relevant standards.

The primary document provided is a "Traditional 510(k) Submission," which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is typically achieved through engineering and verification/validation testing against standards, rather than large-scale clinical trials establishing new performance benchmarks.

1. A table of acceptance criteria and the reported device performance:

Since specific acceptance criteria for a new clinical performance study (like sensitivity/specificity targets) for this device are not presented, the table below reflects the comparison to predicate device characteristics and adherence to recognized standards, which serve as the "acceptance criteria" for a 510(k) submission of this nature.

Feature / Criteria	Acceptance (Predicate Device Equivalent)	Reported Device Performance (Capnostream20p with Masimo MX1 SpO2 board)
Indications for Use	The Capnostream®20p combined capnograph/pulse oximeter monitor is intended for continuous, non-invasive measurement and monitoring of carbon dioxide concentration, respiration rate, functional oxygen saturation (SpO2), and pulse rate. Intended for neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport, and home environments. It also includes an Integrated Pulmonary Index (IPI).	Identical, with the addition of continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb), measured by an SpCO/SpMet/SpHb sensor. All other indications for use, patient populations, and environments remain the same as the predicate. The device still provides IPI based on the four core parameters.
Target Population	It is intended for use with neonatal, pediatric, and adult patients.	Identical.
Design	Equivalent to the Capnostream20 (K094012).	Equivalent to the Capnostream20 described in K094012, with the addition of the Masimo MX1 SpO2 board enabling the measurement of SpCO, SpMet, and SpHb.
Performance Standards	ISO 21647, ISO 9919	Adherence to ISO 21647 and ISO 9919. The three new parameters (SpCO, SpMet, SpHb) "have been clinically validated by Masimo Corporation" (a separate predicate device, K080238).
Safety Standards	IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-8, UL 60601-1, ISO 14971, EN 980	Adherence to IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-8, ISO 14971, EN 980 (UL 60601-1 not explicitly listed for new device, but other safety standards are identical or similar). Hazard analysis was performed, concluding residual risks were acceptable.
Software Functional Equivalence	Software for predicate controls display of parameters and alarms.	Software testing was performed to validate the performance of the new monitor software and its substantial equivalence to the predicate device, including display of new parameters and alarms.
Clinical Validation of New Parameters	(Not applicable for predicate device as these parameters were not included)	The new parameters (SpCO, SpMet, SpHb) were originally clinically validated by Masimo Corporation for their predicate device (K080238). The current submission leverages this existing validation for the module integrated into the Capnostream20p.
Overall Safety & Effectiveness	Existing legally marketed predicate devices are safe and effective.	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. It is substantially equivalent to the predicate devices with respect to safety, effectiveness, and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document primarily references software testing and adherence to standards for the Capnostream20p device itself. No specific clinical test set sample sizes for the overall device's performance (beyond the existing Masimo validation for the SpCO/SpMet/SpHb module) are provided in this summary.
The data provenance for the clinical validation of SpCO, SpMet, and SpHb, if conducted by Masimo, is not detailed in this submission. It relies on the prior clearance (K080238) of the Masimo device.
The document does not specify whether any de novo clinical studies for this specific integrated device were prospective or retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the summary. For a 510(k) submission showing substantial equivalence for a monitoring device, ground truth established by experts in this manner is not typically required or presented unless new clinical performance (e.g., diagnostic accuracy) is being claimed for a novel algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided, as the submission does not detail a clinical study with expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical monitoring device, not an AI diagnostic algorithm, and no MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the typical sense for an AI algorithm. The device itself is a "standalone" monitor that provides continuous measurements. The "performance" is its intrinsic measurement accuracy against physical standards and clinical correlation, as established by the predicate devices. The new SpCO/SpMet/SpHb parameters are derived from the Masimo MX1 SpO2 board, which would have undergone its own standalone validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the core capnography and pulse oximetry functions, ground truth would typically be established through physical gas standards for CO2, and controlled blood gas analysis and controlled hypoxia/hyperoxia studies for SpO2, matched against invasive measurements, as per ISO standards.
For the added SpCO, SpMet, and SpHb parameters, the submission states these "have been clinically validated by Masimo Corporation." Such validation would typically involve co-oximetry blood sampling as the ground truth against the non-invasive measurements from the Masimo sensor.

8. The sample size for the training set:

This information is not applicable and not provided. The device does not appear to employ machine learning that would require a separate "training set" in the context of an AI algorithm.

9. How the ground truth for the training set was established:

Not applicable, as no training set for an AI algorithm is mentioned.

Summary

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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:

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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 1987Medical Ltd	Capnostream20	K094012	February 9, 2010
Masimo Corporation	Masimo Rainbow SETRadical 7 Pulse CO-Oximeter	K080238	May 12, 2008

DEVICE DESCRIPTION

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).

The microMediCO2 module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index).

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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

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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 MasimoMX1 SpO2 board, softwareversion 6.1.	Predicate Device:Capnostream BedsideMonitor with microMediCO2:K094012, software version5.6
Indications foruse	The Capnostream®20p combinedcapnograph/pulse oximeter monitorand its accessories are intended toprovide professionally trained healthcare providers with continuous, non-invasive measurement andmonitoring of carbon dioxideconcentration of the expired andinspired breath and respiration rate,and with continuous noninvasivemonitoring of functional oxygensaturation of arterial hemoglobin	The Capnostream®20pcombined capnograph/pulseoximeter monitor is intended toprovide professionally trainedhealth care providers withcontinuous, non-invasivemeasurement and monitoringof carbon dioxide concentrationof the expired and inspiredbreath and respiration rate, andwith continuous non-invasivemonitoring of functional oxygen

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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 IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

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Targetpopulation	Identical	It is intended for use withneonatal, pediatric, and adultpatients
Design	Equivalent to the Capnostream20described in K094012	See K094012.
Where Used	It is to be used by physicians,nurses and other trained health careproviders in critical care patientsettings, such as anesthesiology,intensive care medicine, neonatalintensive care and other health careareas.	It is to be used by physicians,nurses and other trained healthcare providers in critical carepatient settings, such asanesthesiology, intensive caremedicine, neonatal intensivecare and other health careareas.
PerformanceStandards	ISO 21647ISO 9919	ISO 21647ISO 9919
SafetyStandards	IEC/EN 60601-1IEC/EN 60601-1-2IEC 60601-1-8ISO 14971EN 980	IEC/EN 60601-1IEC/EN 60601-1-2IEC 60601-1-8UL 60601-1ISO 14971EN 980
Biocompatibility	There are no issues ofbiocompatibility for this device andno biocompatibility testing wasperformed.	There are no issues ofbiocompatibility for this deviceand no biocompatibility testingwas performed.
Sterility	This device does not requiresterilization	This device does not requiresterilization

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.

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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.

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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.

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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

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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.

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: __

Regulation Number and Section

§ 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).