(165 days)
Not Found
No
The document describes standard respiratory and ventilatory parameter measurement and calculation based on sensor data, without mentioning any AI or ML techniques for data processing, analysis, or decision-making. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is indicated for monitoring respiratory and ventilatory parameters, not for providing therapy.
No
The device monitors respiratory and ventilatory parameters, but it doesn't provide a diagnosis or interpretation of those parameters to identify a disease or condition. The monitoring data is sent to a host device for further analysis and alarm management.
No
The device description explicitly states that the CARESCAPE Respiratory Modules are "single-width plug-in parameter modules" and 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." This indicates the presence of physical hardware components for gas sampling and measurement, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring respiratory parameters... and ventilatory parameters... and gas exchange parameters... of adult, pediatric and neonatal patients." This describes a device used for monitoring physiological parameters directly from the patient's breath, not for testing samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description reinforces this by explaining that the device "measure respiratory parameters... ventilatory parameters... and gas exchange parameters... of hospital patients." It also mentions a "diverting type" system where "a small continuous flow of gas is sampled from the patient's breath." This further confirms that it's analyzing gas directly from the patient's respiratory system.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Performing tests in a laboratory setting
- Providing diagnostic information based on the analysis of samples
The device is a patient monitoring device that measures physiological parameters related to respiration and gas exchange.
N/A
Intended Use / Indications for Use
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric 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.
Product codes (comma separated list FDA assigned to the subject device)
CCK, CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP
Device Description
The CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, 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), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric and neonatal patients.
Intended User / Care Setting
Qualified medical personnel / Hospital patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive non-clinical testing was performed to establish equivalence of the CARESCAPE Respiratory substantial Modules and its applications. Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the module and its applications are substantially equivalent to the predicate devices.
The subject of this premarket submission, CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
GE Healthcare Finland Oy Mari Salmenkaita Regulatory Affairs Leader Kuortaneenkatu 2 FI-00510 Helsinki Finland
Re: K150245
Trade/Device Name: Carescape Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, EsCAiO, E-sCAiOV, E-sCAiOVX Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP Dated: June 16, 2015 Received: June 17, 2015
Dear Ms. Salmenkaita:
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
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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. 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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Indications for Use
510(k) Number (if known) K150245
Device Name
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
Indications for Use (Describe)
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo, which is a circular emblem with the stylized letters 'g' and 'e' intertwined in the center. The letters are in a cursive font and are surrounded by a dark background. The outer edge of the circle is adorned with decorative, teardrop-shaped elements, adding a touch of elegance to the design.
GE Healthcare Finland Oy Kuortaneenkatu 2, P.O. Box 900 FI-00031 GE
Finland
T: +358 10 39411 F: +358 9 1463310
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 17, 2015 |
|---|---|
| Submitter: | GE Healthcare Finland Oy, |
| Kuortaneenkatu 2, Helsinki, | |
| FI-00510 FINLAND | |
| Primary Contact Person: | Mari Salmenkaita |
| Regulatory Affairs Leader | |
| GE Healthcare Finland Oy | |
| phone (+358) 10-394-2122 | |
| fax (+358) 9-272-6532 | |
| email mari.salmenkaita@ge.com | |
| Secondary Contact Person: | Rauno Ruoho |
| Regulatory Affairs Manager | |
| GE Healthcare Finland Oy | |
| phone (+358) 10-394 3624 | |
| fax (+358) 9-272-6532 | |
| email rauno.ruoho@ge.com | |
| Device names: |
| Trade Name: CARESCAPE 101 Respiratory Modules, E-sCO, E-sCOV, E- |
|---|
| sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX |
Common/Usual Name: Respiratory gas module
4
| Classification Names: | 21 CFR 868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-phase |
|---|---|
| 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 868.1730 Computer, Oxygen-uptake | |
| 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, BZL, CBQ, CBS, NHO, NHQ, NHP |
| Predicate Device(s): | K123195: CARESCAPET™ Respiratory Modules, E-sCO, E-sCOV, E-sCAiO and E-sCAIOV and accessories |
K051092: Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CaiOV, E-CaiO, E-CaiO, E-COVX, E-COV, E-CO and accessories.
5
- The CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-Device Description: sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, 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), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE 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.
- The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-Intended Use: sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX) 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 and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.
When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used
6
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.
- Technology: The modified CARESCAPE Respiratory Modules add models EsCOVX, E-sCAiOVX with the gas exchange calculation to existing predicate device CARESCAPE Respiratory Modules with current software version 1. The gas exchange algorithm is currently available on the predicate device Datex-Ohmeda S/5 Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-COVX (K051092), this 510(k) implements this feature into CARESCAPE Respiratory Modules, E-sCO, EsCOV, E-sCAiO and E-sCAiOV family (K123195). The implemented parameters are oxygen consumption (VO2) and carbon dioxide production (VCO2). The developed software is version 2.
The fundamental technology of the CARESCAPE Respiratory Modules E-sCO. E-sCOV. E-sCOVX, E-sCAiO. E-sCAiO. E-sCAiOV, EsCAiOVX is the same as in the predicate devices.
The CARESCAPE Respiratory Modules E-sCO, E-sCOV, EsCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX is as safe and effective as the predicate devices.
| Determination of | Sub |
|---|---|
| Substantial Equivalence: |
mmary of Non-Clinical Tests
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:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation) ●
- Performance testing (Verification)
- Standard compliance testing (Verification) ●
Extensive non-clinical testing was performed to establish equivalence of the CARESCAPE Respiratory substantial Modules and its applications. Verification and validation testing was performed according to predetermined acceptance criteria,
7
which concluded that the module and its applications are substantially equivalent to the predicate devices.
The CARESCAPE Respiratory Modules were designed and tested for compliance to the following standards:
-
- IEC 60601-1:1988, A1:1991, A2:1995, Corr1:1995, electrical Medical 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 tests -Edition 2.0
-
- IEC 60601-1-2:2007, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- IEC 60601-1-4:1996 + A1:1999, Medical Electrical Equipment - Part 1-4: General Requirements for Safety -Collateral Standard: Programmable Electrical Medical Systems
-
- IEC 62304:2006, Medical device software Software lifecycle processes
-
- IEC 60601-1-6:2006, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability - Edition 2.0
-
- IEC 60601-1-6:2010, Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
- IEC 62366:2007, Medical Devices Application of usability engineering to medical devices
-
- ISO 21647:2004 + C1:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
-
- EN1041:2008, Information supplied by the manufacturer of medical devices
Summary of Clinical Tests:
The subject of this premarket submission, CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX did not require clinical studies to support substantial equivalence.
GE Healthcare considers the CARESCAPE Respiratory Modules Conclusion:
8
E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).