(185 days)
Not Found
No
The document describes standard respiratory parameter measurement and calculation based on sensor data, with no mention of AI or ML techniques.
No
The device is described as a monitoring device that measures respiratory parameters and communicates them to a host device. It does not actively treat or intervene in the patient's condition.
No
The device monitors respiratory and ventilatory parameters and gas exchange parameters. While this information can be used by qualified medical personnel to diagnose, the device itself is described as a "monitoring" device and does not "diagnose" conditions.
No
The device description explicitly states that the modules include hardware components for measuring respiratory and ventilatory parameters, and the submission includes hardware testing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing substances like blood, urine, tissue, etc., outside of the body.
- Device Function: The CARESCAPE Respiratory Modules measure respiratory and ventilatory parameters directly from the patient's breath (a gas sample). This is a form of in vivo (within the living body) or ex vivo (outside the living body but directly from the patient) measurement, not the analysis of a specimen derived from the body in the traditional IVD sense.
- Intended Use: The intended use is for monitoring respiratory and ventilatory parameters of patients, not for analyzing bodily fluids or tissues for diagnostic purposes.
Therefore, while it's a medical device used for monitoring physiological parameters, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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, 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 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.
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 only.
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)
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.
The subject device 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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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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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.
2
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
3
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 Oy |
| Kuortaneenkatu 2 | |
| 00510 Helsinki | |
| FINLAND | |
| Primary Contact Person: | Joel Kent |
| Senior Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | Monica Morrison |
| Sr. Regulatory Affairs Director | |
| GE Healthcare | |
| E-mail: monica.morrison@ge.com |
Anna Pehrsson
Regulatory Affairs Leader
GE Healthcare
E-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 Phase
21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase
21 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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(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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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:
| Module
Characteristics | Predicate CARESCAPE
Respiratory Modules, E-sCO, E-
sCOV, E-sCOVX, E-sCAiO, E-
sCAiOV, E-sCAiOVX and
accessories (K183394) | Proposed CARESCAPE
Respiratory Modules, E-sCO,
E-sCOV, E-sCOVX, E-sCAiO,
E-sCAiOV, E-sCAiOVX, E-
sCAiOE, E-sCAiOVE and
accessories | Discussion of
Differences |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The CARESCAPE Respiratory
Modules (E-sCO, E-sCOV, E-
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
a gent 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 and E-
sCAiOVE) are indicated for use
with a host device for monitoring
respiratory parameters (CO2, O2,
N2O, anesthetic agents, anesthetic
a gent 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. | Equivalent
Editorial change to add
models E-sCAiOE and E-
sCAiOVE to the
indications for use
statement.
The change does not
significantly affect safety
and/or effectiveness. |
| | Physical Properties | | |
| Module size (H x
W 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 sampling
flow rate | $120 \pm 20$ ml/min | $120 \pm 20$ ml/min | Identical |
| Respiration
Rate:
Measurement
range | 4 to 100 breaths/min | 4 to 100 breaths/min | Identical |
| Respiration
Rate: Breath
detection | 1 vol% peak to peak change in CO2
level | 1 vol% peak to peak change in
CO2 level | Identical |
| | Measurements of CO2, N2O and anesthetic agent concentrations and identification of anesthetic agents | | |
| Measurement
principle | Non-dispersive Infrared sensor | Non-dispersive Infrared sensor | Identical |
| CO2
Measurement
range | 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 |
| N2O
Measurement
range | 0...100vol% | 0...100vol% | Identical |
| N2O Accuracy | $\pm$ (2 vol% + 2% of reading)
$\pm$ (2 vol%+8%of reading for
concentrations 85...100 vol% | $\pm$ (2 vol% + 2% of reading)
$\pm$ (2 vol%+8%of reading for
concentrations 85...100 vol% | Identical |
| Anesthetic
agents
measured | Halothane, Enflurane, Isoflurane,
Sevoflurane, Desfurane | Halothane, Enflurane, Isoflurane,
Sevoflurane, Desfurane | Identical |
| Anesthetic
agent
Measurement
ranges | 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 |
| Anesthetic
agents Accuracy | $\pm$ (0.15vol%+5%ofreading) | $\pm$ (0.15vol%+5%ofreading) | Identical |
| | Measurement of oxygen concentration | | |
| Measurement
principle | Differential paramagnetic
measurement | Differential paramagnetic
measurement | Identical |
| Measurement
range | 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 | | | |
| Measurement
principle | Pressure signals conducted to the
module from D-Lite or Pedi-Lite
airway adapters by a double lumen
tube | Pressure signals conducted to the
module from D-Lite or Pedi-Lite
airway adapters by a double
lumen tube | Identical |
| Airway
pressure
Measurement
range | -20...+100 cmH2O | -20...+100 cmH2O | Identical |
| Airway
Pressure
Accuracy | ±1 cmH2O | ±1 cmH2O | Identical |
| Airway Flow
Measurement
range | -100...+100 l/min. (adults)
-25...+25 l/min (pediatric) | -100...+100 l/min. (adults)
-25...+25 l/min (pediatric) | Identical |
| Tidal volume
Measurement
range | 150...2000 ml(adults)
5...300 ml (pediatric) | 150...2000 ml(adults)
5...300 ml (pediatric) | Identical |
| Tidal Volume
Accuracy | ±6% or 30 ml adult
±6% or 4 ml pediatric | ±6% or 30 ml adult
±6% or 4 ml pediatric | Identical |
| Minute volume
Measurement
range | 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 | | | |
| VO2
measurement
range | 20 to 1000 ml/min | 20 to 1000 ml/min | Identical |
| VO2
measurement
accuracy | With D-lite, D-lite+ and Pedi-lite:
±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65%)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85%)
With D-lite++
±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65% and
respiration rate≤30 breaths/min)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85% or
respiration rate> 30 breaths/min)
Not valid with O2+N2O mixtures. | With D-lite, D-lite+ and Pedi-lite:
±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65%)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85%)
With D-lite++
±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65% and
respiration rate≤30 breaths/min)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85% or
respiration rate> 30 breaths/min)
Not valid with O2+N2O mixtures. | Identical |
| VCO2
measurement
range | 20 to 1000 ml/min | 20 to 1000 ml/min | Identical |
| VCO2
measurement
accuracy | With D-lite, D-lite+ and Pedi-lite: | With D-lite, D-lite+ and Pedi-lite: | Identical |
| measurement accuracy | | | |
| | ±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65%)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85%)
With D-lite++
±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65% and
respiration rate≤30 breaths/min)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85% or
respiration rate>30 breaths/min)
Not valid with O2+N2O mixtures | ±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65%)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85%)
With D-lite++
±10% or ±10 ml, whichever is
greater (FiO2 ≤ 65% and
respiration rate≤30 breaths/min)
±15% or ±15 ml, whichever is
greater (FiO2: 65%...85% or
respiration rate>30 breaths/min)
Not valid with O2+N2O mixtures | Identical |
| Front panel connectors | | | |
| Gas sampling
line connector | The D-fend Pro water trap located
on the module front panel includes
a gas sampling line connector. | The D-fend Pro water trap located
on the module front panel
includes a gas sampling line
connector. | Identical |
| Gas exhaust line
connector | The module front panel includes a
gas exhaust connector for
connecting the gas exhaust line. | The module front panel includesa
gas exhaust connector for
connecting the gas exhaust line. | Identical |
| Spirometry
connectors | E-sCAiOV and E-sCAiOVX: Two
spirometry connectors for
connecting the spirometry tubes. | E-sCAiOV, E-sCAiOVX and E-
sCAiOVE: Two spirometry
connectors for connecting the
spirometry tubes. | Identical |
| Mechanical
interface for
connecting the
fresh gas
sampling line | Not available | The E-sCAiOE and E-sCAiOVE
module front panel includes a
fresh gas sample connector
utilized in some anesthesia
applications. | Equivalent
The fresh gas connector
is only utilized in some
anesthesia machine
applications. When the
fresh gas sample
connector is not in use,
the operation of E-
sCAiOE and E-sCAiOVE
is identical to E-sCAiO
and E-sCAiOV,
respectively. |
| Labeling | | | |
| Module Front
Panel Labeling | The labeling on the module front
panel 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-sCAIOVX
only, text "Spirometry")
Spirometry key labeling (Save
Loop
Change Loop)
BF type applied part (symbol IEC
60417-5333) | The labeling on the module front
panel 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-
SCAIOVX, E-SCAIOVE only,
text "Spirometry")
Spirometry key labeling (Save
Loop
Change Loop) (E-sCOV, E-
sCOVX, E-SCAIOV, E-
SCAIOVX, E-SCAIOVE only)
BF type applied part (symbol IEC
60417-5333)
The E-sCAIOE and E-sCAIOVE
modules include symbol "input"
ISO 7000-0794 next to the fresh
gas connector. | Equivalent
The E-sCAIOE and E-
SCAIOVE modules have
symbol ISO 7000-0794
next to the fresh gas
connector as required by
ISO 80601-2-55:2018
clause 201.7.2.101 e).
The addition does not
affect safety and/or
effectiveness of the
device. |
| Module user's
manual | The modules have a user's manual
that describes the usage, technical
specifications and safety of the
CARESCAPE Respiratory
Modules. | The modules have a user's manual
that describes the usage, technical
specifications and safety of the
CARESCAPE Respiratory
Modules.
The user's manual has been
revised to refer to the E-SCAIOE
and E-SCAIOVE modules in
various instances. Also an
explanation for the fresh gas
connector and a note indicating
only qualified service personnel is
authorized to remove the
protecting screw have been added.
In addition to the modifications
required due to the addition of the
E-SCAIOE and E-SCAIOVE
modules, other minor editorial
clarifications have been made. | Equivalent
The user's manual has
been updated to describe
the fresh gas connector
and to advise that only
qualified service
personnel is authorized to
interact with the
connector.
Other updates to the
user's manual are
considered minor
editorial updates.
This does not affect
safety and/or
effectiveness of the
device. |
9
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GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
10
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GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
11
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GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
12
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GE Healthcare Finland Oy Kuortaneenkatu 2 Fl-00510 Helsinki, Finland
13
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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
14
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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.