(185 days)
The CARESCAPE Respiratory Modules, (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) 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 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 E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE 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), 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 signals detected by the module sensors, 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 devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.
This 510(k) introduces two new module models in the CARESCAPE Respiratory Modules family: E-sCAiOE and E-sCAiOVE. These new module models include added hardware compared to the modules cleared in K183394. The operation, measured parameters and performance specifications of the E-sCAiOE and E-sCAiOVE is identical to E-sCAiO and E-sCAiOV when used with the current module host devices cleared in the USA. The added modules E-sCAiOE and E-sCAiOVE have the same software as CARESCAPE Respiratory Modules cleared in K183394.
The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE Respiratory Modules. This document describes the device and its claimed substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or a study involving human readers or expert ground truth adjudication for image analysis. Therefore, based on the provided text, I cannot answer the questions related to AI/ML device acceptance criteria and study details.
The document focuses on:
- Device Description: Respiratory modules that measure various parameters like CO2, O2, N2O, anesthetic agents, and ventilatory parameters.
- Predicate Device: K183394 CARESCAPE Respiratory Modules.
- Key Change: Introduction of two new module models (E-sCAiOE and E-sCAiOVE) with added hardware (fresh gas sample connector) but identical operation, measured parameters, and performance specifications when used with current host devices.
- Non-Clinical Tests: Bench testing related to software, hardware, and performance, including compliance with various IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-55). Biocompatibility and environmental testing were also conducted. Software was considered "Major" level of concern.
- Clinical Tests: The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
Therefore, I cannot extract the following information that would be relevant to an AI/ML device study:
- Table of acceptance criteria and reported device performance for an AI/ML model.
- Sample size for a test set or data provenance for AI/ML validation.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size of AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth used (expert consensus, pathology, outcome data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to traditional medical device clearance, not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
November 9, 2021
GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, Helsinki FI-00510 Finland
Re: K211171
Trade/Device Name: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories 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
Dear Joel Kent:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 21, 2021. Specifically, FDA is updating this SE Letter as an administrative correction to your Indications for Use form.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Todd Courtney, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (301) 796-6371, todd.courtney@fda.hhs.gov.
Sincerely,
Todd D. Courtney -S
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 21, 2021
GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, Helsinki FI-00510 Finland
Re: K211171
Trade/Device Name: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories 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: September 23, 2021 Received: September 27, 2021
Dear Joel Kent:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continung-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv. Todd D. Courtney -ર Todd Courtnev Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211171
Device Name
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOVE and accessories
Indications for Use (Describe)
The CARESCAPE Respiratory Modules, (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) 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 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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1):
| Date: | October 21, 2021 |
|---|---|
| Owner/Submitter: | GE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFINLAND |
| Primary Contact Person: | Joel KentSenior Regulatory Affairs ManagerGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com |
| Secondary Contact Person: | Monica MorrisonSr. Regulatory Affairs DirectorGE HealthcareE-mail: monica.morrison@ge.comAnna PehrssonRegulatory Affairs LeaderGE HealthcareE-mail: anna.pehrsson@ge.com |
| Device names (807.92(a)(2)): | |
| Trade Name: | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-SCAIOVE and accessories |
| Common/Usual Name: | Respiratory gas module and accessories |
| Classification Names: | 21 CFR 868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous Phase21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase21 CFR 868.1850 Spirometer, Monitoring (W/WO Alarm) |
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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 Concentration)
21 CFR 868.1620 Analyzer, Gas, Halothane Gaseous-Phase (Anesthetic Conc.)
21 CFR 868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
21 CFR 868.1500 Analyzer, Gas, Isoflurane Gaseous-Phase (Anesthetic Concentration)
21 CFR 868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Primary Product Code CCK
Subsequent Product Code: CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP
Predicate Device(s) K183394 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, (807.92(a)(3): E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
Device Description The CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-(807.92(a)(4)): sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, EsCAiOVE 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), 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 Page 2 of 11
510(k) SUMMARY K211171
Page 2 of 11
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Image /page/6/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable.
(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 signals detected by the module sensors, 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 devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.
This 510(k) introduces two new module models in the CARESCAPE Respiratory Modules family: E-sCAiOE and EsCAiOVE. These new module models include added hardware compared to the modules cleared in K183394. The operation, measured parameters and performance specifications of the EsCAiOE and E-sCAiOVE is identical to E-sCAiO and EsCAiOV when used with the current module host devices cleared in the USA. The added modules E-sCAiOE and EsCAiOVE have the same software as CARESCAPE Respiratory Modules cleared in K183394.
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Image /page/7/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. Decorative flourishes surround the circle, adding to the logo's classic and recognizable design. The logo is simple, yet elegant.
The indications for use are edited to include the added modules. There are no other changes to the indications for use.
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-Intended Use: (807.92(a)(5): sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, EsCAiOVE) 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 within the limits of respiration rates and tidal volumes to en sure specified measurement accuracy.
These modules are intended for use by qualified medical personnel only.
Technology (807.92(a)(6)): The fundamental scientific technology of the CARESCAPE Respiratory Modules and accessories is the same as in the predicate devices (K183394). There are no changes to the measured parameters or calculations done by the host devices.
A summary of the main changes compared to the predicate device is listed below.
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Product Comparison versus Predicate Main Features:
| ModuleCharacteristics | Predicate CARESCAPERespiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX andaccessories (K183394) | Proposed CARESCAPERespiratory Modules, E-sCO,E-sCOV, E-sCOVX, E-sCAiO,E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE andaccessories | Discussion ofDifferences |
|---|---|---|---|
| Indications foruse | The CARESCAPE RespiratoryModules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX) are indicated for usewith a host device for monitoringrespiratory parameters (CO2, O2,N2O, anesthetic agents, anesthetica gent identification, andrespiratory rate) and ventilatoryparameters (airway pressure, flowand volume) of adult, pediatric,and neonatal patients and gasexchange parameters (VCO2,VO2) of adult and pediatricpatients.When monitoring neonatal or otherpatients that have high respirationrate or low tidal volume thesemodules shall be used within thelimits of respiration rates and tidalvolumes to ensure specifiedmeasurement accuracy.These modules are intended foruse by qualified medical personnelonly. | The CARESCAPE RespiratoryModules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,E-sCAiOVX, E-sCAiOE and E-sCAiOVE) are indicated for usewith a host device for monitoringrespiratory parameters (CO2, O2,N2O, anesthetic agents, anesthetica gent identification, andrespiratory rate) and ventilatoryparameters (airway pressure, flowand volume) of adult, pediatric,and neonatal patients and gasexchange parameters (VCO2,VO2) of adult and pediatricpatients.When monitoring neonatal orother patients that have highrespiration rate or low tidalvolume these modules shall beused within the limits ofrespiration rates and tidal volumesto ensure specified measurementaccuracy.These modules are intended foruse by qualified medicalpersonnel only. | EquivalentEditorial change to addmodels E-sCAiOE and E-sCAiOVE to theindications for usestatement.The change does notsignificantly affect safetyand/or effectiveness. |
| Physical Properties | |||
| Module size (H xW x D) | 112 x 37 x 205 mm(4.4 x 1.5 x 8.7 in) | 112 x 37 x 205 mm(4.4 x 1.5 x 8.7 in) | Identical |
| Module weight | 0.7 kg (1.5 lb) | 0.7 kg (1.5 lb) | Identical |
| Parameter specifications | |||
| Gas samplingflow rate | $120 \pm 20$ ml/min | $120 \pm 20$ ml/min | Identical |
| RespirationRate:Measurementrange | 4 to 100 breaths/min | 4 to 100 breaths/min | Identical |
| RespirationRate: Breathdetection | 1 vol% peak to peak change in CO2level | 1 vol% peak to peak change inCO2 level | Identical |
| Measurements of CO2, N2O and anesthetic agent concentrations and identification of anesthetic agents | |||
| Measurementprinciple | Non-dispersive Infrared sensor | Non-dispersive Infrared sensor | Identical |
| CO2Measurementrange | 0 to 15 vol%(0 to 15 kPa)(0 to 113 mmHg) | 0 to 15 vol%(0 to 15 kPa)(0 to 113 mmHg) | Identical |
| CO2 Accuracy | $\pm$ (0.2vol%+2% of reading) | $\pm$ (0.2vol%+2% of reading) | Identical |
| N2OMeasurementrange | 0...100vol% | 0...100vol% | Identical |
| N2O Accuracy | $\pm$ (2 vol% + 2% of reading)$\pm$ (2 vol%+8%of reading forconcentrations 85...100 vol% | $\pm$ (2 vol% + 2% of reading)$\pm$ (2 vol%+8%of reading forconcentrations 85...100 vol% | Identical |
| Anestheticagentsmeasured | Halothane, Enflurane, Isoflurane,Sevoflurane, Desfurane | Halothane, Enflurane, Isoflurane,Sevoflurane, Desfurane | Identical |
| AnestheticagentMeasurementranges | Hal, Enf, Iso: 0 to 6 vol%Sev: 0 to 8 vol%Des: 0 to 20 vol% | Hal, Enf, Iso: 0 to 6 vol%Sev: 0 to 8 vol%Des: 0 to 20 vol% | Identical |
| Anestheticagents Accuracy | $\pm$ (0.15vol%+5%ofreading) | $\pm$ (0.15vol%+5%ofreading) | Identical |
| Measurement of oxygen concentration | |||
| Measurementprinciple | Differential paramagneticmeasurement | Differential paramagneticmeasurement | Identical |
| Measurementrange | 0 to 100 vol% | 0 to 100 vol% | Identical |
| Accuracy | $\pm$ (1 vol%+2% of reading) | $\pm$ (1 vol%+2% of reading) | Identical |
| Spirometry measurements | |||
| Measurementprinciple | Pressure signals conducted to themodule from D-Lite or Pedi-Liteairway adapters by a double lumentube | Pressure signals conducted to themodule from D-Lite or Pedi-Liteairway adapters by a doublelumen tube | Identical |
| AirwaypressureMeasurementrange | -20...+100 cmH2O | -20...+100 cmH2O | Identical |
| AirwayPressureAccuracy | ±1 cmH2O | ±1 cmH2O | Identical |
| Airway FlowMeasurementrange | -100...+100 l/min. (adults)-25...+25 l/min (pediatric) | -100...+100 l/min. (adults)-25...+25 l/min (pediatric) | Identical |
| Tidal volumeMeasurementrange | 150...2000 ml(adults)5...300 ml (pediatric) | 150...2000 ml(adults)5...300 ml (pediatric) | Identical |
| Tidal VolumeAccuracy | ±6% or 30 ml adult±6% or 4 ml pediatric | ±6% or 30 ml adult±6% or 4 ml pediatric | Identical |
| Minute volumeMeasurementrange | 2...20 l/min. (adults)0.1...5 l/min. (pediatric) | 2...20 l/min. (adults)0.1...5 l/min. (pediatric) | Identical |
| Gas Exchange measurements | |||
| VO2measurementrange | 20 to 1000 ml/min | 20 to 1000 ml/min | Identical |
| VO2measurementaccuracy | With D-lite, D-lite+ and Pedi-lite:±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65%)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85%)With D-lite++±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65% andrespiration rate≤30 breaths/min)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85% orrespiration rate> 30 breaths/min)Not valid with O2+N2O mixtures. | With D-lite, D-lite+ and Pedi-lite:±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65%)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85%)With D-lite++±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65% andrespiration rate≤30 breaths/min)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85% orrespiration rate> 30 breaths/min)Not valid with O2+N2O mixtures. | Identical |
| VCO2measurementrange | 20 to 1000 ml/min | 20 to 1000 ml/min | Identical |
| VCO2measurementaccuracy | With D-lite, D-lite+ and Pedi-lite: | With D-lite, D-lite+ and Pedi-lite: | Identical |
| measurement accuracy | |||
| ±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65%)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85%)With D-lite++±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65% andrespiration rate≤30 breaths/min)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85% orrespiration rate>30 breaths/min)Not valid with O2+N2O mixtures | ±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65%)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85%)With D-lite++±10% or ±10 ml, whichever isgreater (FiO2 ≤ 65% andrespiration rate≤30 breaths/min)±15% or ±15 ml, whichever isgreater (FiO2: 65%...85% orrespiration rate>30 breaths/min)Not valid with O2+N2O mixtures | Identical | |
| Front panel connectors | |||
| Gas samplingline connector | The D-fend Pro water trap locatedon the module front panel includesa gas sampling line connector. | The D-fend Pro water trap locatedon the module front panelincludes a gas sampling lineconnector. | Identical |
| Gas exhaust lineconnector | The module front panel includes agas exhaust connector forconnecting the gas exhaust line. | The module front panel includesagas exhaust connector forconnecting the gas exhaust line. | Identical |
| Spirometryconnectors | E-sCAiOV and E-sCAiOVX: Twospirometry connectors forconnecting the spirometry tubes. | E-sCAiOV, E-sCAiOVX and E-sCAiOVE: Two spirometryconnectors for connecting thespirometry tubes. | Identical |
| Mechanicalinterface forconnecting thefresh gassampling line | Not available | The E-sCAiOE and E-sCAiOVEmodule front panel includes afresh gas sample connectorutilized in some anesthesiaapplications. | EquivalentThe fresh gas connectoris only utilized in someanesthesia machineapplications. When thefresh gas sampleconnector is not in use,the operation of E-sCAiOE and E-sCAiOVEis identical to E-sCAiOand E-sCAiOV,respectively. |
| Labeling | |||
| Module FrontPanel Labeling | The labeling on the module frontpanel includes the following items:Module type (eg. E-sCO)Gas input (symbol ISO 7000-0794)Gas exhaust (symbol ISO 7000-0795)Spirometry inputs (E-sCOV, E-sCOVX, E-sCAIOV, E-sCAIOVXonly, text "Spirometry")Spirometry key labeling (SaveLoopChange Loop)BF type applied part (symbol IEC60417-5333) | The labeling on the module frontpanel includes the followingitems:Module type (eg. E-sCO)Gas input (symbol ISO 7000-0794)Gas exhaust (symbol ISO 7000-0795)Spirometry inputs (E-sCOV, E-sCOVX, E-SCAIOV, E-SCAIOVX, E-SCAIOVE only,text "Spirometry")Spirometry key labeling (SaveLoopChange Loop) (E-sCOV, E-sCOVX, E-SCAIOV, E-SCAIOVX, E-SCAIOVE only)BF type applied part (symbol IEC60417-5333)The E-sCAIOE and E-sCAIOVEmodules include symbol "input"ISO 7000-0794 next to the freshgas connector. | EquivalentThe E-sCAIOE and E-SCAIOVE modules havesymbol ISO 7000-0794next to the fresh gasconnector as required byISO 80601-2-55:2018clause 201.7.2.101 e).The addition does notaffect safety and/oreffectiveness of thedevice. |
| Module user'smanual | The modules have a user's manualthat describes the usage, technicalspecifications and safety of theCARESCAPE RespiratoryModules. | The modules have a user's manualthat describes the usage, technicalspecifications and safety of theCARESCAPE RespiratoryModules.The user's manual has beenrevised to refer to the E-SCAIOEand E-SCAIOVE modules invarious instances. Also anexplanation for the fresh gasconnector and a note indicatingonly qualified service personnel isauthorized to remove theprotecting screw have been added.In addition to the modificationsrequired due to the addition of theE-SCAIOE and E-SCAIOVEmodules, other minor editorialclarifications have been made. | EquivalentThe user's manual hasbeen updated to describethe fresh gas connectorand to advise that onlyqualified servicepersonnel is authorized tointeract with theconnector.Other updates to theuser's manual areconsidered minoreditorial updates.This does not affectsafety and/oreffectiveness of thedevice. |
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GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
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GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
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Image /page/11/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized with curved lines, and the circle has decorative swirls around it.
GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
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Image /page/12/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" intertwined in the center. The circle is surrounded by a decorative border of stylized swirls.
GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
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Summary of Non-Clinical Tests:
Determination of Substantial Equivalence (807.92(b)(1))
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE Respiratory Modules, demonstrating the design meets the specifications.
Biocompatibility testing related to System level Volatile Organic Compounds (VOC) and particulate matter testing has been executed to cover biocompatibility for the new materials in the dry gas path.
Hardware testing of the modules included gas accuracy verification, gas module pneumatics verification and leakage verification. In addition, functionality with a host device during the Fresh Gas Sample Check has been verified.
Testing compliance of the device with the applicable standards was completed as follows:
- IEC 60601-1:2012 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014: Medical electrical equipment Part . 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-2-49:2011: Medical electrical equipment Part 2-49: Particular requirements for the safety essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55: 2011: Medical electrical equipment Part . 2-55: Particular requirements for the basic safety and
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essential performance of respiratory gas monitors
Environmental testing was successfully completed per the safety and particular standard above as well as ISTA 2A:2011.
Software testing included software design, development, verification, validation and traceability. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered "Major" level of concern, the same as the
Clinical (807.92(b)(2)): Summary of Clinical Tests:
The subject of this premarket submission, the CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories did not require clinical studies to support substantial equivalence.
- Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, EsCAiOVX, E-sCAiOE, E-sCAiOVE and accessories to be as safe, as effective, and performance is substantially equivalent to the predicate device.
§ 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).