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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Capnostream 20 with Integrated Pulmonary Index (IPI) software. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a comprehensive clinical trial publication.

Based on the provided document, here's an attempt to extract the requested information. It's important to note that many specific details about how the acceptance criteria were met (like sample sizes for specific tests, expert qualifications, or detailed ground truth establishment methods) are not explicitly stated in this type of summary document. The document primarily focuses on asserting that these studies were performed and that the device met the requirements.

Acceptance Criteria and Device Performance for Capnostream 20 with Integrated Pulmonary Index (IPI)

The Capnostream 20 with IPI is primarily compared to its predicate device, the Capnostream 20 (miniMediCO2 software version 2.31), to demonstrate substantial equivalence. The acceptance criteria are implicitly those of safety and performance equivalent to the predicate device, with specific attention to the new IPI functionality.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Equivalent to the predicate device, raising no new potential safety risks.	"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." "A hazard analysis was carried out... concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system."
Software Validation	New software performs as intended and is substantially equivalent to the predicate device's software.	"Software testing was performed to validate the performance of the new software and its substantial equivalence to the predicate device."
Clinical Performance (IPI)	IPI meets user requirements; identifies all instances requiring clinical intervention and alerts practitioners to changes in pulmonary status, and is an effective adjunct to vital sign monitoring (not a replacement). Not for use in children < 1 year.	"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 IPI is an adjunct to, and is not intended to replace, vital sign monitoring." "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."
Intended Use	Meets the same intended use as the predicate device, with the addition of the IPI functionality as a single index of ventilatory status for adults and pediatric patients.	"The functional features and the intended use of Capnostream 20 with IPI are substantially equivalent to the predicate device." (Indications for use explicitly state the added IPI functionality and target population).
Hazard Analysis	Residual risks are acceptable when weighed against benefits.	"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."
Design	Identical to predicate device except for specified software changes.	"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."

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

Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "software testing" and "clinical evaluation" but does not give specific numbers for test cases, patients, or data points.
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. "Clinical evaluation" implies human subject data, but details are missing.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The document refers to the IPI being intended for "professionally trained health care providers" and that the clinical evaluation was performed "to ensure that the modified device meets user requirements" and identified "instances in which clinical intervention was required." This implies clinical experts were involved, but their specific roles, number, or qualifications are not detailed.

4. Adjudication Method

Adjudication Method: Not explicitly stated.

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

MRMC Study: Not explicitly stated. The document mentions a "clinical evaluation" and a "safety and effectiveness evaluation" that demonstrated the IPI's ability to alert clinicians and identify intervention needs. However, it does not describe a comparative study measuring human reader improvement with or without AI assistance. The IPI is presented as an adjunct to vital sign monitoring.

6. Standalone (Algorithm Only) Performance

Standalone Performance: The description of the clinical evaluation implies that the IPI (an algorithmically derived value) was evaluated for its ability to identify intervention needs and alert practitioners. While not explicitly called "standalone performance," the IPI itself is an algorithm-generated index displayed on the monitor. The evaluation of this index's clinical utility could be considered a form of standalone performance assessment in the context of its intended use as an alert system.

7. Type of Ground Truth Used

Type of Ground Truth: The "safety and effectiveness evaluation" aimed "to demonstrate that the IPI identified all instances in which clinical intervention was required and alerted the practitioner to these changes." This suggests that the ground truth was based on clinical assessment and the need for intervention as determined by medical observation (likely expert consensus or established clinical protocols, though not specified).

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. (This document is a 510(k) summary for a device iteration, not a detailed algorithm development paper. Information on training data for the IPI algorithm would likely be in internal development documents, not typically disclosed in this summary.)

9. How Ground Truth for Training Set was Established

Ground Truth Establishment for Training Set: Not explicitly stated. Given the IPI is an "Integrated Pulmonary Index" based on four physiological parameters (end tidal CO2, respiration rate, SpO2, and pulse rate) to represent "ventilatory status" and trigger alerts for "changes in the patient's pulmonary status," its development likely involved expert knowledge and potentially retrospective data analysis to correlate these parameters with specific clinical states or interventions. However, the document does not provide these details.

Summary

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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

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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

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) .

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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.

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

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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 Monitorwith MiniMediCO2 EtCO2 modulewith IPI software (version 2.51)	Predicate Device- Capnostream20 Bedside Monitor K072295
Indications foruse	The indications for use are identical to theindications for use in the predicate devicewith the addition of the following:The Capnostream 20 monitor providesthe clinician with an integrated pulmonaryindex (IPI). The IPI is based on fourparameters provided by the monitor: endtidal carbon dioxide, respiration rate,	The Capnostream 20 combinedcapnograph/pulse oximeter monitor isintended to provide professionallytrained health care providers thecontinuous, non invasivemeasurement and monitoring ofcarbon dioxide concentration of theexpired and inspired breath andrespiration rate, and for the continuousnon-invasive monitoring of functionaloxygen saturation of arterialhemoglobin (SpO2 and pulse rate). It is
	oxygen saturation and heart rate. The IPIis a single index of an adult or pediatricpatient's ventilatory status displayed on ascale of 1 - 10, where 10 indicatesoptimal pulmonary status. IPI monitoringdisplays a single value that representsthe patient's pulmonary parameters andalerts clinicians to changes in thepatient's pulmonary status.The IPI is an adjunct to, and is not	intended for use with neonatal,pediatric and adult patients inhospitals, hospital type facilities, intrahospital transport and homeenvironments.
Targetpopulation	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 20described in K072295 with the exceptionof the software changes in both theEtCO2 module and host monitordescribed in this submission	See K072295
Where Used	It is to be used by physicians, nurses andother trained health care providers incritical care patient settings, such asanesthesiology, intensive care medicine.neonatal intensive care and other healthcare areas	It is to be used by physicians, nursesand other trained health care providersin critical care patient settings, such asanesthesiology, intensive caremedicine, neonatal Intensive care andother health care areas
PerformanceStandards	ISO 21647ISO 9919	ISO 21647ISO 9919
SafetyStandards	IEC/EN 60601-1IEC/EN 60601-1-2(2001)IEC 60601-1-8UL 60601-1ISO 14971	IEC/EN 60601-1IEC/EN 60601-1-2(2001)IEC 60601-1-8UL 60601-1ISO 14971
Biocompatibility	There are no issues of biocompatibility forthis device and no biocompatibility testingwas done.	There are no issues of biocompatibilityfor this device and no biocompatibilitytesting was done.
Sterility	This device does not require sterilizationand is shipped marked non-sterile.	This device does not requiresterilization and is shipped markednon-sterile.

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. .

and the state of the state of the states of the states and

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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.

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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.

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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); 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

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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 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:

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).