The Capnostream20 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 Capnostream20 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 Capnostream20 bedside monitor is a two parameter monitor consisting of a CO2 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a SPECIAL 510(k) submission, indicating that the device (Capnostream20 with microMediCO2 CO2 module) is being submitted for substantial equivalence to a previously cleared predicate device (Capnostream20 with miniMediCO2 CO2 module). In such submissions, the primary "study" is often a demonstration of equivalence to the predicate device, rather than a de novo clinical trial with novel acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device's established performance and meeting relevant regulatory standards. The device performance is generally stated as being equivalent to or meeting the same standards as the predicate.

Attribute	Acceptance Criteria (based on Predicate/Standards)	Reported Device Performance (Capnostream20 with microMediCO2 CO2 module)
Indications for Use	Identical to the predicate device (continuous, non-invasive measurement and monitoring of CO2 concentration, respiration rate, SpO2, and pulse rate for neonatal, pediatric, and adult patients in various medical environments; integrated pulmonary index (IPI) as an adjunct).	Identical to the indications for use in the predicate device.
Target Population	Neonatal, pediatric, and adult patients.	Neonatal, pediatric, and adult patients.
Design	Equivalent to the Capnostream20 described in K082268, with the microMediCO2 CO2 module having enhanced processing and memory and being smaller. Functional features and intended use must be substantially equivalent.	Identical to the Capnostream20 described in K082268 with the exception of the introduction of the micromediCO2 CO2 module. Functional features and intended use are substantially equivalent.
Where Used	Identical to the predicate device (by trained healthcare providers in critical care settings like anesthesiology, intensive care, NICU, etc.).	Identical to the predicate device (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	Compliance with ISO 21647 (Respiratory gas monitors) and ISO 9919 (Pulse oximeter equipment - Particular requirements for basic safety and essential performance). The new module provides the same inputs (FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI, continuous CO2 numeric and waveform).	ISO 21647, ISO 9919. The module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index), and continuous CO2 numeric and waveform. (Implies compliance).
Safety Standards	Compliance with IEC/EN 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance), IEC/EN 60601-1-2 (Electromagnetic compatibility), IEC 60601-1-8 (Alarm systems - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems), UL 60601-1, and ISO 14971 (Medical devices - Application of risk management to medical devices). Hazard analysis concluded residual risks were acceptable.	IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-8, UL 60601-1, ISO 14971. Hazard analysis confirmed acceptable residual risks. Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed.
Biocompatibility	No biocompatibility issues and no testing required, similar to the predicate.	No issues of biocompatibility, no testing done.
Sterility	Not requiring sterilization and marked non-sterile, similar to the predicate.	Does not require sterilization and is shipped marked non-sterile.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not provide a specific sample size for a "test set" in the context of clinical data for the new microMediCO2 CO2 module. The submission focuses on design and performance verification/validation against existing predicate standards, rather than new clinical trials with patient data. The "test set" here refers to engineering and bench testing to demonstrate compliance with standards and equivalence.
Data Provenance: Not applicable in the context of clinical patient data. The provenance of the validation data would be from Oridion's internal testing and compliance activities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified or applicable in the context of expert-adjudicated ground truth for a clinical dataset. The "ground truth" for this engineering-focused submission is derived from established international standards (ISO, IEC, UL) and a comparison to the predicate device's performance. Performance testing would likely involve engineers and technicians.
Qualifications of Experts: Not specified, as it's not a clinical study requiring expert adjudication of patient cases.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This submission doesn't describe a clinical study requiring adjudication of expert interpretations. The verification and validation activities would follow standard engineering and quality assurance protocols, where measurements are compared against specifications and standards, not through expert consensus on medical findings.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done, and it is not relevant to this submission. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not explicitly termed "standalone algorithm performance" as it would be for AI. However, the document states: "Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed." This indicates that the microMediCO2 CO2 module's performance was evaluated independently before integration into the Capnostream20 monitor. This is essentially demonstrating the technical performance of the module itself.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device, in terms of its performance, is based on:
- Reference measurements/standards: For CO2 and SpO2 accuracy, this would involve comparing the device's readings against highly accurate reference instruments or calibrated gas mixtures as dictated by ISO standards (ISO 21647, ISO 9919).
- Predicate device's performance: The fundamental "ground truth" for this 510(k) is that the new module performs equivalently to the previously cleared predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physiological monitor, not a machine learning model that requires a "training set" in the AI sense. Its calibration and operational parameters are determined through engineering design and testing, not by learning from a dataset.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" in this context.

Summary

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SPECIAL-510(k) Submission for CAPNOSTREAM20 two parameter bedside monitor with microMediCO2 CO2 module 510(k) Summary of Safety and Effectiveness 1094012

7. 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)

MAY 1 2 2010

: "!

DATE THIS SUMMARY WAS PREPARED

December 15th, 2009

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: 857-919-2923 Fax: +972-2-586-6680 Email: rachel.weissbrod@oridion.com

DEVICE INFORMATION

Trade Name: Capnostream20 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: D001115.

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SPECIAL-510(k) Submission for CAPNOSTREAM20 two parameter bedside monitor with microMediCO2 CO2 module 510(k) Summary of Safety and Effectiveness

PREDICATE DEVICE

Capnostream20 with the microMediCO2 CO2 board is substantially equivalent to the following commercially available device:

Manufacturer	Device	510(k)No.	Clearance Date
Oridion 1987 Medical Ltd	Capnostream20	K082268	February 9th, 2009

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) .

Each module is controlled by dedicated software that is an integral part of the respective module.

INTENDED USE

The Capnostream20 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 (SpQ₂) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospital type facilities, intra-hospital transport and home environments.

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SPECIAL-510(k) Submission for CAPNOSTREAM20 two parameter bedside monitor with microMediCO2 CO2 module 510(k) Summary of Safety and Effectiveness o ratient'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 DEVICE

The Capnostream20 with the micromediCO2 CO2 module is substantially equivalent to the predicate Capnostream20 with the minimediCO2 CO2 module.

The new device meets the safety and performance standards met by the predicate device.

The functional features and the intended use of the Capnostream20 with the new CO2 module are substantially equivalent to the predicate device. No significant changes were made to the monitor hardware or software specifications to support the integration of the new module. Slight mechanical changes were made to the monitor to accommodate the smaller dimensions of the new module. The micromediCO2 module is smaller in size than the miniMediCO2 module, in order to facilitate integration inside other OEM monitors, and provides enhanced processing and memory capacity, to support software applications for future development. The module provides the following inputs to the host monitor:

FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index), and continuous CO2 numeric and waveform.

The micromediCO2 includes a smaller lamp, a new solenoid, broader use of molded parts to improve production quality, increased processing power, reduced power consumption and improved flow regulation.

The module software provides full backward compatibility with the miniMedicO2 and supports RS232 or USB communication with the host monitor.

A hazard analysis was carried out on the module and on the Capnostream20 monitor with the new module. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system. Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed.

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. '

Attribute	Capnostream20 BedsideMonitor withmicroMediCO2CO2 module	Predicate Device- Capnostream20Bedside Monitor K082268
Indications foruse	The indications for use are identical tothe indications for use in the predicatedevice	The Capnostream20 combinedcapnograph/pulse oximeter monitor is intendedto provide professionally trained health careproviders the continuous, non invasivemeasurement and monitoring of carbondioxide concentration of the expired andinspired breath and respiration rate, and forthe continuous non-invasive monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2 and pulse rate). It isintended for use with neonatal, pediatric andadult patients in hospitals, hospital typefacilities, intra hospital transport and homeenvironments.
Targetpopulation	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 Capnostream20described in K082268 with theexception of the introduction of themicromediCO2 CO2 module	See K082268
Where Used	It is to be used by physicians, nursesand 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 andother trained health care providers in criticalcare patient settings, such as anesthesiology,intensive care medicine, neonatal intensivecare and other health care areas.
PerformanceStandards	ISO 21647ISO 9919	ISO 21647ISO 9919
SafetyStandards	IEC/EN 60601-1IEC/EN 60601-1-2IEC 60601-1-8UL 60601-1ISO 14971	IEC/EN 60601-1IEC/EN 60601-1-2IEC 60601-1-8UL 60601-1ISO 14971
Biocompatibility	There are no issues ofbiocompatibility for this device and nobiocompatibility testing was done.	There are no issues of biocompatibility for thisdevice and no biocompatibility testing wasdone.
Sterility	This device does not requiresterilization and is shipped markednon-sterile.	This device does not require sterilization and isshipped marked non-sterile.

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SPECIAL-510(k) Submission for CAPNOSTREAM20 two parameter bedside monitor with microMediCO2 CO2 module 510(k) Summary of Safety and Effectiveness

CONCLUSION

Capnostream20 with the micromediCO2 CO2 module 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.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

MAY 12 2010

Ms. Rachel Weissbrod Director of Regulatory Affairs Oridion Capnography, Incorporated 160 Gould Street Needham, Massachusetts 02494

Re: K094012

Trade/Device Name: Capnostream20 with Micromedico2 Module Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: April 13, 2010 Received: April 15, 2010

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. Rachel 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 (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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh 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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SPECIAL-510(k) Submission for CAPNOSTREAM20 two parameter bedside monitor with microMediCO2 CO2 module Statement of Indications for Use

6. Statement of Indications for Use

TWO PARAMETER CAPNOSTREAM MONITOR (This document is not confidential) Indications for Use

December 15th, 2009

Ko94012 510(k) Number (if known)

Device Name: Capnostream 20

Indications for Use:

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

Prescription Use X (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)

L. Schull

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K094012

Page 9

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).