(160 days)
No
The document does not mention AI, ML, or related concepts, and the device description focuses on hardware and standard signal processing for CO2 measurement.
No
This device is for continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during respiration, serving as a diagnostic and monitoring tool rather than providing direct therapeutic intervention.
Yes
The device is described as providing "continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate." This act of measuring and monitoring physiological parameters for the purpose of assessing a patient's condition falls under the definition of a diagnostic device.
No
The device description clearly outlines hardware components, including a "NanoPod" module and an "Active cable module," which are responsible for physical measurements and communication. While software is mentioned as being tested, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle". This is a measurement taken directly from the patient's breath, not from a sample of bodily fluid or tissue that is tested in vitro (outside the body).
- Device Description: The description details a module that connects to a host monitor and uses sampling lines to measure CO2 from the patient's respiration. This aligns with a respiratory monitoring device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in a laboratory setting.
Therefore, the CARESCAPE™* CO2 - Microstream™ parameter is a patient monitoring device used for respiratory assessment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines.
The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.
Product codes
CCK
Device Description
The GE CARESCAPE™* CO2 -Microstream™ parameter is a module utilizing Microstream™ Capnography technology designed for use with specific GE Host monitors (CARESCAPE™* ONE. CARESCAPE™* B450 [K213234]. CARESCAPE™* B650 [K213181]. or CARESCAPE™* B850 [K213336]).
The GE CARESCAPE™* CO2 -Microstream™ parameter comprised of two main sub-systems:
- Microstream™ NanoMediCO2 is a Capnography module in its plastic enclosure called . the NanoPod, responsible for measuring the inspired carbon dioxide and respiration rate of adults, pediatric patients, and neonatal patients,
- . U-MCO2-active cable module in its enclosure (called "Active cable" or "Bridge" or "Common block") responsible for enabling the bidirectional communication between the Host monitor and the NanoMediCo2 module, using the specific GE communication protocol (Taq-Length-Data). The Active Cable also acts as a power supply to the NanoPod, transferring power from the host to the pod and provides the user with an indication of the Pod's functional status.
The NanoPod mates on one side with the Microstream™ Advance Filter Lines. On the other side the NanoPod attaches to GE patient monitoring system via the U-MCO2- active cable, allowing them to display the Microstream™ Capnography parameters.
The U-MCO2 active cable module, is connected to an interface board located inside the active device (NanoPod), while on the other side of the U-MCO2 active cable, there is a proprietary GE (Amphenol) connector, designed to connect solely with GE Healthcare monitors. The NanoPod is activated by Microstream™ Advance Filter Lines that are connected through the blue door located on the upper side of the NanoPod.
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
professionally trained health care providers
In hospital-type facilities, during intra-hospital transport between and within areas of care.
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 Performance Testing: The CARESCAPE™* CO2 - Microstream™ parameter has successfully undergone performance, safety, electromagnetic and environmental testing to ensure compliance with expected performance standards. Software testing was performed to validate the performance of the CARESCAPE™* CO2 -Microstream™ parameter and its substantial equivalence to the predicate device. A hazard analysis was carried out on the CARESCAPE™* CO2 - Microstream™ parameter in compliance with ISO 14971:2012. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the device.
Animal Performance Testing: Not applicable. Animal performance testing was not necessary to show substantial equivalence.
Clinical Performance Testing: Not applicable. Clinical evidence was not necessary to show substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Covidien Ilc Inna Reznikov Regulatory Affairs Specialist 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K213518
Trade/Device Name: CARESCAPE CO2 Microstream parameter Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 7, 2022 Received: March 9, 2022
Dear Inna Reznikov:
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/cfpmn/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.
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
1
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 531-542 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-continuing-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).
Sincerely,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K213518
Device Name
CARESCAPE™* CO2 - Microstream™ parameter
Indications for Use (Describe)
The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines.
The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.
| 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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3
CARESCAPE™* CO2 - Microstream™ parameter
510(k) Summary
The of 510(k) summary for the CARESCAPE™* CO2 - Microstream™ parameter is submitted in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with the requirements of 21 CFR §807.92.
SUBMITTER INFORMATION
Submitted By:
Covidien, Ilc 6135 Gunbarrel Avenue Boulder, CO 80301
Date Prepared: October 31, 2021
Contact Person:
Inna Reznikov Regulatory Affairs Specialist Phone: +972-546406768 Email: Inna.reznikov@medtronic.com
DEVICE
| Trade Name: | CARESCAPE™* CO2 - Microstream™ parameter |
|---|---|
| Common Name: | Capnography - NanoPod |
| Classification Regulation: | 21 CFR 868.1400 |
| Classification Name: | Carbon Dioxide Gas Analyzer |
| Regulatory Class: | Class II |
| Product Code: | CCK |
| Review Panel: | Anesthesiology |
PREDICATE DEVICE
| Predicate Manufacturer: | Oridion Medical 1987 LTD |
|---|---|
| Predicate Trade Name: | Capnostream TM 35 Portable Respiratory Monitor |
| Predicate 510(k): | K150272 |
Covidien IIc
4
DEVICE DESCRIPTION
The GE CARESCAPE™* CO2 -Microstream™ parameter is a module utilizing Microstream™ Capnography technology designed for use with specific GE Host monitors (CARESCAPE™* ONE. CARESCAPE™* B450 [K213234]. CARESCAPE™* B650 [K213181]. or CARESCAPE™* B850 [K213336]).
The GE CARESCAPE™* CO2 -Microstream™ parameter comprised of two main sub-systems:
- Microstream™ NanoMediCO2 is a Capnography module in its plastic enclosure called . the NanoPod, responsible for measuring the inspired carbon dioxide and respiration rate of adults, pediatric patients, and neonatal patients,
- . U-MCO2-active cable module in its enclosure (called "Active cable" or "Bridge" or "Common block") responsible for enabling the bidirectional communication between the Host monitor and the NanoMediCo2 module, using the specific GE communication protocol (Taq-Length-Data). The Active Cable also acts as a power supply to the NanoPod, transferring power from the host to the pod and provides the user with an indication of the Pod's functional status.
The NanoPod mates on one side with the Microstream™ Advance Filter Lines. On the other side the NanoPod attaches to GE patient monitoring system via the U-MCO2- active cable, allowing them to display the Microstream™ Capnography parameters.
The U-MCO2 active cable module, is connected to an interface board located inside the active device (NanoPod), while on the other side of the U-MCO2 active cable, there is a proprietary GE (Amphenol) connector, designed to connect solely with GE Healthcare monitors. The NanoPod is activated by Microstream™ Advance Filter Lines that are connected through the blue door located on the upper side of the NanoPod.
INDICATIONS FOR USE
The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.
Note (this statement is not part of the Indications for use): The indications for use of the subject device are a subset of (narrower than and encompassed by) the predicate device's indications and therefore fall within the same indications for use as that of the predicate. Thus, the indications for use statement of subject device are substantially equivalent to the indications for use of the predicate.
PRINCIPLE OF OPERATION
The NanoMediCO2, similarly to the MicroMediCO2 in the predicate Capnostream™35 Portable Respiratory Monitor (cleared by K150272), is an electrical board that is responsible for measuring the CO2 level by using non-dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO2 during every breath, the amount of CO2 present at the end of exhalation (etCO2), and the Respiratory Rate. Infrared spectroscopy is used to measure the
Covidien IIc
5
concentration of molecules that absorb infrared light. Because the absorption is proportional to the concentration of the absorbing molecule, the concentration can be determined by comparing its absorption to that of a known standard, ISO 80601-2-55. Once inside the Microstream™ CO2 sensor, the gas sample goes through a micro-sample cell (15 microliters). This extremely small volume is quickly flushed, allowing for fast rise time and accurate CO2 readings, even at high respiration rates.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The main difference between the subject of this submission to the predicate, is that the CARESCAPE™* CO2 -Microstream™ parameter is an external single parameter, capnography module (CCK), designed to be connected to the GE host Monitor, while the predicate Capnostream™35 Portable Respiratory Monitor, is a standalone, dual parameter monitor, equipped with MicroMediCO2 capnography module (CCK) and a Nellcore pulse oximetry module (DQA).
The subject device, the CARESCAPE™* CO2 - Microstream™ parameter, has the same intended population, principle of operation, and fundamental technology as the capnography portion in the predicate device, the Capnostream™35 Portable Respiratory Monitor (K150272). The subject device is a derivative of the capnography module inside the predicate device with software and hardware modifications performed to enable the subject device to be used in conjunction with specific host monitors of GE (CARESCAPE™* ONE, CARESCAPE™* B450, CARESCAPE™* B650, or CARESCAPE™* B850
The verification and validation tests enable the use of the CARESCAPE™* CO2 -Microstream™ parameter for use with specific hostmonitors of GE (CARESCAPE™* ONE with software version 3.2, CARESCAPE™* B450, CARESCAPE™* B650, or CARESCAPE™* B850 with software version 3.2.). The subject device is intended to be used with the same Microstream™ Advance Filter Lines that are commercially available for use with the predicate device.
Based on the results of the verification and validation studies (including system verification), Covidien has established that the subject device, the CARESCAPE™* CO2 - Microstream™ parameter, is substantially equivalent to the predicate device.
The following technological characteristics were compared between the subject device and predicate device to demonstrate substantial equivalence in Table 1 below:
| Characteristic | Subject Device | Predicate Device K150272 |
|---|---|---|
| Classification | II | II |
| Device Classification | ||
| Name | Carbon Dioxide Gas Analyzer | Carbon Dioxide Gas Analyzer |
| Product Code | CCK | CCK |
| DQA | ||
| MNR | ||
| Purpose and Function | Continuous non-invasive | |
| monitoring of expired and | ||
| inspired CO2, EtCO2, | Continuous non-invasive | |
| monitoring of expired and | ||
| inspired CO2, EtCO2, | ||
| capnography derived | ||
| respiration rate | capnography derived respiration | |
| rate, SpO2 and pulse rate | ||
| Energy Source | Powered by the host monitor | Power supply operating on AC |
| (90-264VAC), 47 to 63 Hz); | ||
| alternatively, on a rechargeable | ||
| internal lithium-ion battery or on | ||
| a removable lithium-ion battery. | ||
| Target population | Adult, pediatric, and neonatal | |
| patients | Adult, pediatric, and neonatal | |
| patients | ||
| Intended user | Professionally trained health | |
| care providers | Professionally trained health | |
| care providers | ||
| Where used | In hospitals, hospital-type | |
| facilities, during intra-hospital | ||
| transport between and within | ||
| areas of care. | In hospitals, hospital-type | |
| facilities, intra-hospital transport, | ||
| out-of-hospital Emergency | ||
| Medical Service applications | ||
| that include ground and air | ||
| transport. | ||
| Fundamental | ||
| Technology | Non-dispersive infrared (NDIR) | |
| (CO2) Spectroscopy | ||
| and Plethysmography | Non-dispersive infrared (NDIR) | |
| (CO2) Spectroscopy | ||
| and Plethysmography | ||
| Performance Standards | ISO 80601-2-55 | ISO 80601-2-55 |
| ISO 80601-2-61 | ||
| External Materials | Polyurethane | |
| Silicon | ||
| Copolyester | Polyurethane | |
| Silicon | ||
| Polyester | ||
| Polyetherimide | ||
| Polycarbonate | ||
| TPE | ||
| Main Safety Standards | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-1-6 | ||
| IEC 80601-2-49 (section | ||
| 202.8.102, Figure 202.104) | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-49 | ||
| IEC 60601-1-12 | ||
| IEC 60601-1-6 | ||
| IEC 60601-1-8 |
Table 1. Comparison of Technological Characteristics
6
MATERIALS
Each part of the product is made of a material that suits its functionality, the materials of the parts in the two products, the subject device, and the predicate, are not necessarily the same but are made up of identical material families, like plastics, metals, elastomers and others. Please refer to Table 1 for the external material comparison.
WHEN THE DEVICE IS USED AS INTENDED THERE IS NO DIRECT PATIENT CONTACT. External materials in the subject device comply to Biocompatibility standard ISO 10993.
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PERFORMANCE DATA
The following performance data were provided to support the substantial equivalence determination with the predicate device.
Bench Performance Testing
The subject device, the CARESCAPE™* CO2 - Microstream™ parameter, is substantially equivalent to the predicate device, the Capnostream™35 (Portable Respiratory Monitor).
The functional features and the indications for use of the CARESCAPE™* CO2 - Microstream™ parameter are substantially equivalent to the predicate device.
The CARESCAPE™* CO2 - Microstream™ parameter has successfully undergone performance, safety, electromagnetic and environmental testing to ensure compliance with expected performance standards.
Software testing was performed to validate the performance of the CARESCAPE™* CO2 -Microstream™ parameter and its substantial equivalence to the predicate device.
A hazard analysis was carried out on the CARESCAPE™* CO2 - Microstream™ parameter in compliance with ISO 14971:2012. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the device.
Animal Performance Testing
Not applicable. Animal performance testing was not necessary to show substantial equivalence.
Clinical Performance Testing
Not applicable. Clinical evidence was not necessary to show substantial equivalence.
CONCLUSION
The subject device, CARESCAPE™* CO2 - Microstream™ parameter is similar in intended use, principle of operation, materials, technological characteristics and performance to the existing legally marketed device. The subject device, CARESCAPE™* CO2 - Microstream™ parameter, software and hardware modifications were made to maintain the intended performance of the subject device and to enable interface with specific GE Host monitors (CARESCAPE™* ONE, CARESCAPE™* B450 [K213234], CARESCAPE™* B650 [K213181], or CARESCAPE™* B850 [K213336]).
From the evidence presented in this Premarket Notification, the subject device can be considered substantially equivalent to the predicate device.