The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

Device Description

The Capnostream™35 is a 4-inch color screen portable 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 microMediCO2 module provides the following inputs to the host monitor:

EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.

The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for AI/Machine Learning devices. Instead, it describes a medical device (Capnostream™35 Portable Respiratory Monitor) undergoing a 510(k) submission for substantial equivalence to predicate devices, focusing on regulatory compliance, safety, and general performance testing.

Therefore, many of the requested fields regarding AI/ML study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) cannot be extracted from this document.

However, I can extract information related to the device's general performance testing and intended use, which are analogous to acceptance criteria and their verification in a non-AI/ML context.

Here's an interpretation based on the provided text, focusing on the closest available information to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets as they would be for an AI model's precision or recall. Instead, the device's "performance" is considered in relation to meeting standards and demonstrating substantial equivalence to predicate devices.

Feature / Performance Aspect	Acceptance Criteria (Implied from Standards & Equivalence)	Reported Device Performance
Capnography	Must perform as predicate device K112368 (Capnostream20p)	The microMediCO2 module performs as in the predicate K112368.
Pulse Oximetry	Must perform as predicate device K130320 (Bedside Respiratory Patient Monitoring System)	The SpO2 module integrated performs as in the predicate K130320.
Safety	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12, IEC 60601-1-6.	Successfully undergone electrical safety testing according to specified IEC standards.
Environmental	Compliance with IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery, altitude use up to 15000 feet (4572m).	Successfully undergone environmental testing; device explicitly features these characteristics.
Electromagnetic	Compliance with IEC 60601-1-2.	Successfully undergone electromagnetic testing according to specified IEC standard.
Software	Must validate performance and substantial equivalence to predicate devices.	Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate devices.
Wireless Communication	Compliance with FDA guidance "Radio Frequency Wireless Technology in Medical Devices".	Wireless communication testing was conducted according to FDA guidance.
Hazard Analysis	Residual risks judged as acceptable.	Hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits.

2. Sample size used for the test set and the data provenance:

Not applicable for AI/ML device. The document describes non-clinical performance and safety testing against engineering standards and comparison to predicate devices, not AI model evaluation with specific test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This pertains to clinical data labeling for AI/ML, which is not described here.

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

Not applicable. This pertains to expert consensus for AI/ML ground truth, which is not described here.

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:

No such study was mentioned. This is not an AI-assisted device.

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

No standalone algorithm performance study was described in the context of AI/ML. The device itself is a standalone monitor, and its "performance" was evaluated through engineering tests and comparison to predicates.

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

Ground truth in this context typically refers to established engineering specifications, performance standards (e.g., ISO, IEC), and the known performance of the predicate devices. For instance, the accuracy of CO2 measurement would be validated against calibrated gas mixtures, and SpO2 against controlled hypoxia studies, which are the "ground truth" for those physiological parameters under specific test conditions. The document states "Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met."

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance testing and substantial equivalence assessment for product clearance. It involves:

Performance Testing: Conducted according to specific ISO standards (ISO 80601-2-55, ISO 80601-2-61) for the respective measurement parameters (capnography and pulse oximetry).
Electrical Safety Testing: Performed per IEC standards (IEC 60601-1, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12, IEC 60601-1-6).
Electromagnetic Compatibility (EMC) Testing: Performed per IEC 60601-1-2.
Environmental Testing: Verification of features like IP54 rating, shockproof status, sunlight readability, hot swap battery, and altitude capacity.
Software Testing: To validate performance and substantial equivalence.
Wireless Communication Testing: According to FDA guidance for wireless medical devices.
Hazard Analysis: Conducted in compliance with ISO 14971:2012 to assess and mitigate risks.

The overarching goal was to demonstrate that the Capnostream™35 Portable Respiratory Monitor has the "same intended use, technological characteristics and performance as its predicate devices" and that its functionality in new intended environments (out-of-hospital EMS) was verified through testing against relevant standards. The document concludes that "Testing did not raise any concerns when compared to its predicate devices therefore the subject device is substantially equivalent to its predicate devices."

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in black.

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

July 23, 2015

Oridion Medical 1987 Ltd Ms. Dalia Givony Regulatory Affairs Manager 7 Hamarpe Street Jerusalem, Israel 9777407

Re: K150272

Trade/Device Name: Capnostream™ 35 Portable Respiratory Monitor Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, DQA, MNR Dated: June 11, 2015 Received: June 16, 2015

Dear Ms. Givony:

This letter corrects our substantially equivalent letter of July 17, 2105.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Ms. Givony

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Traditional 510(k) Submission for Capnostream®35 Portable Respiratory Monitor

001 Statement Indications for Use

Capnostream™35 Portable Respiratory Monitor (This document is not confidential)

February 1, 2015

510(k) Number (if known)

Device Name: Capnostream™35 Portable Respiratory Monitor Indications for Use:

Intended Use

The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

Prescription Use _ X AND/OR AND/OR AND/OR (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

{3}------------------------------------------------

510K 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 15, 2015

SUBMITTER'S NAME AND ESTABLISHMENT ADDRESS:

Oridion Medical 1987 Ltd

7 Hamarpe St. P.O. Box 45025

Jerusalem, Israel 9777407

ESTABLISHMENT REGISTRATION NUMBER

8044004

CONTACT PERSON:

Dalia Givony, Regulatory Affairs Manager

Oridion Medical 1987 Ltd

7 Hamarpe St. P.O. Box 45025

Jerusalem, Israel 9777407

Telephone: +972-2-589 9235

FAX: +972-2-586-6680

{4}------------------------------------------------

DEVICE INFORMATION

Trade Name: Capnostream™35 Portable Respiratory Monitor; PM35MN

Common Name: Portable Respiratory Monitor

Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase

Regulation Number:

868.1400, Carbon Dioxide Analyzer (Classification CCK) Subsequent product codes: 870.2700 Pulse Oximeter (Classification DQA) 868.2375 Ventilatory Effort Recorder (Classification MNR)

PREDICATE DEVICE

Capnostream™35 is substantially equivalent to the following commercially available devices:

Manufacturer	Device	510(k) No.	Clearance Date
Primary predicate:Oridion Medical 1987Ltd.	Capnostream20pWith Smart A/hr &ODITM	K112368	July 19, 2012
Secondary predicate:Covidien, LLC	Bedside RespiratoryPatient MonitoringSystem WithRespiration RateSoftware	K130320	February 4, 2014

{5}------------------------------------------------

DEVICE DESCRIPTION

The microMediCO2 module provides the following inputs to the host monitor:

EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.

The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

INTENDED USE

{6}------------------------------------------------

The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for patients age 22 and up. The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

{7}------------------------------------------------

COMPARISON TO PREDICATE DEVICE

The Capnostream™35 is substantially equivalent to the following predicate devices:

Attribute	Primary PredicateDevice:	SecondaryPredicate Device:	Subject Device :
	Capnostream20pWith Smart A/hr &ODI (K112368)	Bedside RespiratoryPatient MonitoringSystem WithRespiration RateSoftware (K130320)	Capnostream™35Portable RespiratoryMonitor
Classification	II	II	II
Product Code	CCKDQAMNR	DQASubsequent code:BZQ	CCKSubsequent code:DQAMNR
Purpose andFunction	Continuous non-invasive monitoring ofexpired and inspiredCO2, EtCO2,respiration rate(provided from theCapnograph module),SpO2 and pulse rate	Continues non-invasive monitoringof SpO2, pulse rateand respiratory rate	Same as K112368(Respiration Rate isderived byCapnography)
Targetpopulation	Neonatal, pediatric,and adult patients.A/hr and ODIindication for use isfor adult patients age22 and up. IPI isintended for pediatricand adult patientsonly.	SpO2, Pulse Rate:Adult, pediatric, andneonatal patientsduring both nomotion and motionconditions, and forpatients who are wellor poorly perfused.Respiration Rate:adult patients whoare well perfusedduring no motion	Same as K112368.SpO2, Pulse Rate:same as K130320
		conditions
Where used	In hospitals, hospital-type facilities, intra-hospital transport andhome environments	SpO2, Pulse Rate: Inhospitals, hospital-type facilities, andduring intra hospitaltransport.Respiration Rate:hospitals andhospital-typefacilities.	In hospitals, hospital-type facilities, intra-hospital transport,out-of-hospitalEmergency MedicalService applicationsthat include groundand air transport.
FundamentalTechnology	NDIR (CO2)Spectrophotometryand Plethysmography	SpectrophotometryandPlethysmography	Same as K112368
PerformanceStandards	ISO 21647ISO 9919	EN 80601-2-61	ISO 80601-2-55ISO 80601-2-61
Main SafetyStandards	IEC/EN 60601-1IEC/EN 60601-1-2IEC 60601-1-8IEC 60601-2-49	EN 60601-1IEC 60601-1-2EN 60601-1-4EN 60601-1-8EN 60601-1-6	IEC 60601-1IEC 60601-1-2IEC 60601-1-8IEC 60601-2-49IEC 60601-1-12IEC 60601-1-6

{8}------------------------------------------------

{9}------------------------------------------------

TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS

The Capnostream™35 features the same technology (NDIR, Spectrophotometry and Plethysmography) as its primary predicate K112368 and the same performance characteristics as its predicates K112368 and K130320. The capnograph module (microMediCO2) integrated in the Capnostream™35 performs as in the predicate K112368 and the SpO2 module integrated in the Capnostream™35 performs as in the predicate K130320. The device was designed to support its use in out-of-hospital Emergency Medical Service applications for which it features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m).

PERFORMANCE TESTING

Non-clinical tests were performed to support the determination of substantial equivalence. Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met. The device has successfully undergone performance testing according to ISO 80601-2-55 and ISO 80601-2-61 as well as electrical safety, electromagnetic and environmental testing according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12 and IEC 60601-1-6. Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate devices.

Wireless communication testing was conducted according to FDA guidance document from Aug 13,2013- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff.

A hazard analysis was carried out on the Capnostream™35 monitor in compliance with ISO 14971:2012. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the device.

{10}------------------------------------------------

Substantial Equivalence

The Capnostream™35 has the same intended use, technological characteristics and performance as its predicate devices. Compared to its predicate devices, the Capnostream™35 is intended also for out-of-hospital Emergency Medical Service applications. Its functionality in its intended environments was verified.

The Capnostream™35 has successfully undergone performance, electrical safety, electromagnetic, environmental and wireless communication testing to ensure it complies with its performance testing requirements. Testing did not raise any concerns when compared to its predicate devices therefore the subject device is substantially equivalent to its predicate devices.

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).