The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

Device Description

The CARESCAPE™ Respiratory Modules, E-sCO, E-sCOV, E-sCAiO and E-sCAiOV and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate) and ventilatory parameters (airway pressure, flow and breathing volumes) of hospital patients. Parameters measured by the CARESCAPE™ Respiratory Modules and accessories are CO2, N2O, O2, Anesthetic agents, Agent ID and Spirometry depending on the model used. The CARESCAPE™ Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPETM Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE™ Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE™ Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system. The CARESCAPE™ Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

AI/ML Overview

This 510(k) summary describes a device submission for the CARESCAPE™ Respiratory Modules, which are intended for monitoring respiratory and ventilatory parameters in adult, pediatric, and neonatal patients.

Based on the provided text, the device did not undergo clinical studies to support substantial equivalence. The submission relies on non-clinical testing and comparison to a predicate device. Therefore, a direct response to some of the requested points regarding acceptance criteria and a study demonstrating performance against those criteria cannot be fully provided from this document alone, as the document states that clinical studies were not required.

However, I can extract information related to the device's technical specifications, non-clinical evaluations, and safety considerations, which serve as the basis for its substantial equivalence determination.

Acceptance Criteria and Device Performance (Based on Non-Clinical Tests and Standards Compliance)

Since no clinical study demonstrating device performance against specific acceptance criteria is provided, the "acceptance criteria" here refer to compliance with voluntary standards and the predicate device's performance, as asserted by the manufacturer in the context of a 510(k) submission. The device's "performance" is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device and successful completion of non-clinical tests.

Table 1: Acceptance Criteria (Standards Compliance) and Reported Device Performance

Acceptance Criteria (Standards and Design Aspects)	Reported Device Performance (Summary)
Safety Standards:
IEC 60601-1:1988, A1:1991, A2:1995, Corr1:1995 (General Safety)	Designed and tested for compliance with this standard.
IEC 60601-1-2:2001, A1:2004 (Electromagnetic Compatibility)	Designed and tested for compliance with this standard.
IEC 60601-1-4:2000 Consol. Ed. 1.1 (Programmable Medical Systems)	Designed and tested for compliance with this standard.
IEC 60601-1-6:2006 (Usability)	Designed and tested for compliance with this standard.
EN1041:2008 (Information Supplied by Manufacturer)	Designed and tested for compliance with this standard.
ISO 21647:2009 (Respiratory Gas Monitors Specific Requirements)	Designed and tested for compliance, with noted non-compliances (see below)
IEC 62366:2007 (Usability Engineering)	Designed and tested for compliance with this standard.
Non-Clinical Test Outcomes:
Risk Analysis	Completed
Requirements Reviews	Completed
Design Reviews	Completed
Unit Level Testing (Module verification)	Completed
Integration Testing (System verification)	Completed
Final Acceptance Testing (Validation)	Completed
Performance Testing (Verification)	Completed
Safety Testing (Verification)	Completed
Equivalence to Predicate Device (K051092):
Fundamental Technology	Same as predicate devices.
Safety and Effectiveness	As safe and effective as predicate devices.

Note on ISO 21647:2009 Non-Compliances:
The document explicitly states non-compliance with several clauses of ISO 21647:2009 for certain older monitoring systems when used with the new modules. These pertain to:

Clause 49.101: RGM providing a medium priority alarm signal when power falls below minimum.
Clause 57.3 aa): Detachable power supply cord protection against accidental disconnection.
Clause 102: Compliance with all requirements of IEC 60601-1-8:2003 (alarm systems).
Clause 201.1.2: RGM providing a means to detect gas reading alarm conditions and alarm priority for unidentified anesthetic agents.
Clause 201.1.2: Alarm signals for mixtures of halogenated agents based on MAC levels.
Clause 201.8.3: Manufacturer-configured alarm preset for audio-paused or alarm-paused interval.

These non-compliances are acknowledged and apply to specific older monitor models (S/5 Anesthesia monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia Monitor, S/5 Compact Critical Care Monitor, CARESCAPE B650, CARESCAPE B850). The FDA's substantial equivalence determination implies these non-compliances were deemed acceptable in the context of the overall safety and effectiveness of the device as cleared.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- No specific sample size for a clinical test set is mentioned. The device did not require clinical studies. Non-clinical tests were performed, but details on sample sizes for these internal verification and validation activities (e.g., how many units tested, how many scenarios) are not provided in this summary.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by the manufacturer, GE Healthcare Finland Oy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with expert-established ground truth was used for this 510(k) submission. The ground truth for non-clinical performance and safety testing would be based on engineering specifications, reference measurement standards, and accepted validation methodologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test data requiring adjudication was involved in this submission.
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. This device is a respiratory gas monitor, not an AI software intended to assist human readers (e.g., in medical image interpretation). Therefore, an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for a "standalone" algorithmic performance study in the context of AI. The device itself performs measurements and calculates parameters. Its "standalone" performance is implicitly covered by the performance testing and compliance with standards. It is a measurement device, not an interpretative AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established by calibrated reference equipment, known physical quantities, and compliance with the specified requirements and standards.
The sample size for the training set:
- Not applicable. This device is a hardware and software system for physiological monitoring, not a machine learning or AI model trained on a specific dataset.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K123195

510(k) Summary

FEB 2 8 2013

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In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: October 10, 2012

Submitter: GE Healthcare Finland Oy,

Kuortaneenkatu 2, Helsinki, FI-00510 FINLAND

Primary Contact Person: Joel Kent Manager, Quality and regulatory Affairs GE Healthcare phone 781-449-8685 fax 781-433-1344

Secondary Contact Person:

Rauno Ruoho GE Healthcare Finland Oy phone +358-10-3943624

fax +358-9-272-6532

Device: Trade Name:

CARESCAPETM Respiratory Modules, E-sCO, E-sCOV, EsCAiO and E-sCAiOV and accessories

Common/Usual Name: Respiratory gas module

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Classification Names: 21 CFR 868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseousphase

21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-phase

21 CFR 868.1850 Spirometer. Monitoring (W/WO alarm)

21 CFR 868.2600 Monitor, Airway Pressure (Includes gauge and/or alarm)

21 CFR 868.1700 Analyzer, Gas. Nitrous-Oxide. Gaseous-phase (Anesthetic conc)

21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-phase (Anesthetic conc.)

21 CFR 868.1500 Analyzer, Gas. Halothane Gaseous-phase (Anesthetic conc.)

21 CFR 868.1500 Analyzer, Gas, Desflurane, Gaseous-phase (Anesthetic conc.)

21 CFR 868.1500 Analyzer, Gas, Isoflurane Gaseous-phase (Anesthetic conc.)

21 CFR 868.1500 Analyzer, Gas, Sevoflurane, Gaseous-phase (Anesthetic conc)

Product Code:

CCK, CCL, BZK, CAP, CBR, CBQ, CBS, NHO, NHO, NHP

Predicate Device(s):

K051092: Datex-Ohmeda S/5TM Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CaiOV, E-CaiOV, E-CaiO, E-COVX, E-COV, E-CO and accessories.

The CARESCAPE™ Respiratory Modules, E-sCO, E-sCOV, E-Device Description: sCAiO and E-sCAiOV and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate) and ventilatory parameters (airway pressure, flow and breathing volumes) of hospital patients.

Parameters measured by the CARESCAPE™ Respiratory Modules and accessories are CO2, N2O, O2, Anesthetic agents, Agent ID and Spirometry depending on the model used. The CARESCAPE™ Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPETM Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas

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concentrations. The CARESCAPE™ Respiratory Modules acquire the detected signals from the sensors of the modules. calculate the parameter values and communicate them to the host device. The CARESCAPE™ Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.

The CARESCAPETM Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-Intended Use: sCAiO, E-sCAiOV) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal . volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

The CARESCAPE™ Respiratory Modules is a modified version Technology: of the predicate Datex-Ohmeda S/5TM Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CaiOV, E-CaiOV, E-CaiO, E-COVX, E-COV, E-CO and accessories (K051092) with improved features and parameters.

The fundamental technology of the CARESCAPE™ Respiratory Modules is the same as the predicate devices.

The CARESCAPE™ Respiratory Modules is as safe and effective as the predicate devices.

Determination of Substantial Equivalence:

The CARESCAPE™ Respiratory Modules and its applications comply with voluntary standards as detailed below. The following quality assurance measures were applied to the development of the system:

Summary of Non-Clinical Tests:

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Risk Analvsis
Requirements Reviews
Design Reviews .
. Testing on unit level (Module verification)
. Integration testing (System verification)
Final acceptance testing (Validation) .
. Performance testing (Verification)
Safety testing (Verification)

The CARESCAPE™ Respiratory Modules were designed and tested for compliance to the following standards:

IEC 60601-1:1988, A1:1991, A2:1995, Corr1:1995, 1. Medical Electrical Equipment Part 1: General Requirements for Safety - Second Edition

IEC 60601-1-2:2001, A1:2004, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and

IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical 3. equipment - Part 1-4: General requirements for safety --Collateral standard: Programmable electrical medical systems, edition 1.1. (General)

IEC60601-1-6:2006, Medical electrical equipment - Part 4. General requirements for basic safety and essential 1-6: performance - collateral Standard: Usability

EN1041:2008, Information supplied by the manufacturer 5. of medical devices

ISO 21647:2009, Medical electrical 6. equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors

Except for the following clauses:

. Clause 49.101 The RGM shall provide at least a medium priority alarm signal when the power falls below the minimum value for normal operation.

This non-compliance is valid with following monitors: S/5 Anesthesia monitor (AM), S/5 Critical Care Monitor (CCM), S/5 Compact Anesthesia Monitor (CAM), S/5 Compact Critical Care Monitor (CCCM) and CARESCAPE B850.

Clause 57.3 aa) Any detachable power supply cord of an . RGM shall be protected against accidental disconnection at the appliance inlet.

This non-compliance is valid with following monitors: S/5

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Anesthesia monitor (AM), S/5 Critical Care Monitor (CCM), S/5 Compact Anesthesia Monitor (CAM), S/5 Compact Critical Care Monitor (CCCM).

. Clause 102 Compliance with all the requirements of IEC 60601-1-8:2003

This non-compliance is valid with following monitors: S/5 Anesthesia monitor (AM), S/5 Critical Care Monitor (CCM), S/5 Compact Anesthesia Monitor (CAM), S/5 Compact Critical Care Monitor (CCCM).

. Clause 201.1.2 For each respiratory gas that an RGM is designed to monitor, the RGM shall provide a means to detect each gas reading alarm condition, with its minimum priority. If the RGM is capable of detecting the presence of more than one halogenated anaesthetic agent within a gas mixture, but not of quantifying gas levels and displaying the gas readings, it shall generate at least a medium priority alarm signal in the presence of such a mixture.

Clause 201.1.2 If the RGM is capable of detecting, . quantifying and displaying a mixture of halogenated agents, the RGM shall

a) generate at least a low priority alarm signal whenever it detects a mixture of halogenated agents of less

than three MAC; and

b) generate at least a medium priority alarm signal whenever it detects a mixture of halogenated agents of equal to or greater than three MAC.

This non-compliance is valid with following monitors: S/5 Anesthesia monitor (AM), S/5 Critical Care Monitor (CCM), S/5 Compact Anesthesia Monitor (CAM), S/5 Compact Critical Care Monitor (CCCM).

. Clause 201.8.3 The manufacturer-configured alarm preset for the audio-paused or alarm-paused interval shall be no greater than 2 min.

This non-compliance is valid with following monitors: S/5 Anesthesia monitor (AM), S/5 Critical Care Monitor (CCM), S/5 Compact Anesthesia Monitor (CAM), S/5 Compact Critical Care Monitor (CCCM).

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IEC 62366:2007, Medical Devices - Application of 7. usability engineering to medical devices (General)

Summary of Clinical Tests:

The subject of this premarket submission, CARESCAPE™ Respiratory Modules did not require clinical studies to support substantial equivalence.

GE Healthcare considers the CARESCAPE™ Respiratory Conclusion: Modules, E-sCO, E-sCOV, E-sCAiO and E-sCAiOV and accessories to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

February 28, 2013

Mr. Rauno Ruoho GE Healthcare Finland Ov Kuortaneenkatu 2 Helsinki, Finland FIN-00510

Re: K123195

Trade/Device Name: CARESCAPETM Respiratory Modules, E-sCO E-sCOV E-sCAiO and E-sCAiOV and Accessories Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: January 24, 2013 Received: January 28, 2013

Dear Mr. Ruoho:

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 - Mr. Ruoho

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,

Image /page/7/Picture/6 description: The image shows the text "Kwame O. Ulmer for". The words are written in a simple, sans-serif font. The text is arranged horizontally, with "Kwame" on the left, followed by "O. Ulmer", and then "for" on the right. The letters in "Kwame O. Ulmer" are stylized with a lined pattern.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

· Enclosure

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123195 510(k) Number (if known):

Device Name: CARESCAPE™ Respiratory Modules, E-sCO E-sCOV E-sCAiO and E-sCAiOV and accessories

Indications for Use

Indications for use:

These modules are intended for use by qualified medical personnel only.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Lester W Schultheis Jr 2013.02.28 11:57:12 -05'00'

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

510(k) Number:

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).