(226 days)
Not Found
No
The summary describes standard physiological monitoring and calculation based on measured parameters, with no mention of AI or ML techniques.
No.
The device is strictly for measurement and monitoring of CO2 levels and related respiratory parameters; it does not provide any therapeutic intervention or treatment.
Yes
Explanation: The device provides "continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate" and "integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values." These measurements are used by clinicians to assess patient conditions, which is a diagnostic function.
No
The device description explicitly details hardware components like the NanoPod enclosure, NanoMediCO2 capnography module, interface board, and cradle, which are integral to its function of measuring CO2.
Based on the provided text, the Microstream™ CO2 NanoPod is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Microstream™ CO2 NanoPod Function: The Microstream™ CO2 NanoPod measures and monitors carbon dioxide (CO2) directly from the patient's respiration during the breathing cycle. It does not analyze specimens taken from the body.
- Method of Measurement: The device utilizes sampling lines to capture respiratory gases, which are then analyzed by the internal module. This is a direct measurement of a physiological process, not an analysis of a biological sample.
Therefore, the Microstream™ CO2 NanoPod falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide 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 Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters.
The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.
Contraindications:
The device is not to be used as an apnea monitor.
Product codes (comma separated list FDA assigned to the subject device)
CCK, BZQ
Device Description
The Microstream™ CO2 NanoPod is a finished medical device that when connected to a host monitor is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, including End-tidal CO2 (EtCO2), Fractional Concentration of Inspired CO2 (FiCO2), and CO2 based respiration rate, for adult, pediatric, and neonatal patients utilizing Microstream™CO2 or Microstream™ Advance CO2 sampling lines.
The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. The IPI measurement is intended for use in pediatric and adult patients only, and A/hr and ODI measurements are intended for age 22 and up. Both IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod to calculate these parameters.
The Microstream™ CO2 NanoPod encloses a NanoMediCO2 capnography module, which measures inspired/expired carbon dioxide and respiration rate. The NanoPod is powered by the host monitor on a DC supply.
The Microstream™ CO2 NanoPod system includes the following sub-systems:
- . NanoPod is the medical device enclosure that encloses the NanoMediCO2 module. The NanoPod has a connected active cable that has a LEMO connector end, which connects to a host monitoring system.
- . NanoMediCO2 capnography module is enclosed in the NanoPod. The NanoMediCO2 module measures inspired and expired carbon dioxide and respiration rate. The active cable is what provides bidirectional communication between the Host monitor and the NanoMediCO2 module enclosed inside the NanoPod.
- . Interface Board is enclosed inside NanoPod which consists of an LED exposed on the outside of the NanoPod to provide the functional status of the subject device to the user.
- l Cradle is a plastic holder used to connect the NanoPod with a GCX clamp or other mounting solution, which can then be used to mount the NanoPod on a pole or bedrail. There are no sharp edges on the Microstream™ CO2 NanoPod, which enables the medical device to be held in the hand at times when it is removed from its mounting cradle.
The Microstream™ and or Microstream™ Advance CO2 sampling lines can attach to the NanoPod CO2 port on the NanoPod enclosure. Microstream™ Capnography parameters are displayed the Microstream™ and or Microstream™ Advance CO2 sampling line is connected to the NanoPod CO2 Port and the Microstream™ CO2 NanoPod is connected via LEMO connector to a host monitoring system. Please note that the Microstream™ and Microstream™ Advance sampling lines have been cleared in their own respective 510K submissions.
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 (for EtCO2, FiCO2, and CO2-based respiration rate)
pediatric and adult patients only (for IPI)
age 22 and up (for A/hr and ODI)
Intended User / Care Setting
Professionally trained health care providers
In hospitals, 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 Microstream™ CO2 NanoPod 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 Microstream™ CO2 NanoPod and its substantial equivalence to the predicate device.
Animal Performance Testing: Not Applicable. No animal performance testing was required to demonstrate device safety and effectiveness.
Clinical Performance Testing: Not Applicable. No clinical performance testing was required to demonstrate device safety and effectiveness.
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
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).
0
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July 29, 2022
Covidien LLC Andrew Berkeland Senior Regulatory Affairs Specialist 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K213911
Trade/Device Name: Microstream CO2 NanoPod Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, BZQ Dated: June 27, 2022 Received: June 28, 2022
Dear Andrew Berkeland:
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
1
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 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/cdrh-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) K213911
Device Name Microstream™ CO2 NanoPod
Indications for Use (Describe)
The Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide 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 Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters.
The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.
Contraindications:
The device is not to be used as an apnea monitor.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Microstream™ CO2 NanoPod 510(k) Summary
This summary of 510(k) safety and effectiveness information for the Microstream™ CO2 NanoPod 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, IIc 6135 Gunbarrel Avenue Boulder, CO 80301
Date Prepared: December 14, 2021
Primary Contact Person:
Andrew Berkeland Senior Requlatory Affairs Specialist
Phone: (720) 501-7884 Email: andy.j.berkeland@medtronic.com
Secondary Contact Person:
Greeshma Kayala Senior Requlatory Affairs Manager
Phone: (303) 579-1718 Email: greeshma.kayala@medtronic.com
DEVICE
| Trade Name: | Microstream™ CO 2 NanoPod |
|---|---|
| Classification Name: | Capnography - NanoPod |
| Regulation: | 21 CFR 868.1400, 21 CRF 868.2377 |
| Regulatory Class: | Class II |
| Product Code: | CCK, BZQ |
| Review Panel: | Anesthesiology |
PREDICATE DEVICE
| Predicate Manufacturer: | Oridion Medical 1987 LTD |
|---|---|
| Predicate Trade Name: | CapnostreamTM35 Portable Respiratory Monitor |
| Predicate 510(k): | K150272 |
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DEVICE DESCRIPTION
The subject device of this premarket 510(k) notification is referred to as the Microstream™ CO2 NanoPod throughout this submission.
The Microstream™ CO2 NanoPod is a finished medical device that when connected to a host monitor is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, including End-tidal CO2 (EtCO2), Fractional Concentration of Inspired CO2 (FiCO2), and CO2 based respiration rate, for adult, pediatric, and neonatal patients utilizing Microstream™CO2 or Microstream™ Advance CO2 sampling lines.
The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. The IPI measurement is intended for use in pediatric and adult patients only, and A/hr and ODI measurements are intended for age 22 and up. Both IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod to calculate these parameters.
The Microstream™ CO2 NanoPod encloses a NanoMediCO2 capnography module, which measures inspired/expired carbon dioxide and respiration rate. The NanoPod is powered by the host monitor on a DC supply.
The Microstream™ CO2 NanoPod system includes the following sub-systems:
- . NanoPod is the medical device enclosure that encloses the NanoMediCO2 module. The NanoPod has a connected active cable that has a LEMO connector end, which connects to a host monitoring system.
- . NanoMediCO2 capnography module is enclosed in the NanoPod. The NanoMediCO2 module measures inspired and expired carbon dioxide and respiration rate. The active cable is what provides bidirectional communication between the Host monitor and the NanoMediCO2 module enclosed inside the NanoPod.
- . Interface Board is enclosed inside NanoPod which consists of an LED exposed on the outside of the NanoPod to provide the functional status of the subject device to the user.
- l Cradle is a plastic holder used to connect the NanoPod with a GCX clamp or other mounting solution, which can then be used to mount the NanoPod on a pole or bedrail. There are no sharp edges on the Microstream™ CO2 NanoPod, which enables the medical device to be held in the hand at times when it is removed from its mounting cradle.
The Microstream™ and or Microstream™ Advance CO2 sampling lines can attach to the NanoPod CO2 port on the NanoPod enclosure. Microstream™ Capnography parameters are displayed the Microstream™ and or Microstream™ Advance CO2 sampling line is connected to the NanoPod CO2 Port and the Microstream™ CO2 NanoPod is connected via LEMO connector to a host monitoring system. Please note that the Microstream™ and Microstream™ Advance sampling lines have been cleared in their own respective 510K submissions.
INTENDED USE / INDICATIONS FOR USE
The Microstream™CO2 NanoPod, when connected to the host monitor, is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the
5
respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ and Microstream™ Advance CO2 sampling lines.
The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod in order to calculate these parameters.
The Microstream™ CO2 NanoPod is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.
CONTRAINDICATIONS
The device is not to be used as an apnea monitor.
TECHNOLOGICAL CHARACTERISTICS
The main difference between the subject device and the predicate, is the fact that the Microstream™ CO2 NanoPod is an external single parameter, capnography module, designed to be connected to a host monitor. The predicate Capnostream™35 Portable Respiratory Monitor (K150272), is a standalone, dual parameter monitor, equipped with MicroMediCO2 capnography module (product code CCK) and a pulse oximetry module (product code DQA).
The subject device, the Microstream™ CO2 NanoPod, has the same intended population, principles of operation, and fundamental technology as the predicate device, the Capnostream™35 Portable Respiratory Monitor. The subject device is a derivative of the capnography module that is inside the predicate device with software and hardware modifications to enable the subject device to be used in conjunction with an Original Equipment Manufacturer (OEM) host monitor.
Based on the results of the verification and validation studies. Covidien has established that the subject device, the Microstream™ CO2 NanoPod, is substantially equivalent to the predicate device.
The following technological characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence.
| Characteristic | Subject Device | Predicate Device K150272 |
|---|---|---|
| Classification | II | II |
| Device Classification | ||
| Name | Carbon Dioxide Gas Analyzer | |
| and | ||
| Breathing Frequency Monitor | Carbon Dioxide Gas Analyzer | |
| and | ||
| Breathing Frequency Monitor | ||
| Product Code | CCK, | |
| BZQ | 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, |
Table 1. Comparison of Technological Characteristics
6
| Characteristic | Subject Device | Predicate Device K150272 |
|---|---|---|
| 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 | ||
| 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 |
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 Microstream™ CO2 NanoPod, is substantially equivalent to the predicate device, the Capnostream™35 (Portable Respiratory Monitor).
The functional features and the intended use and indications for use of the Microstream™ CO2 NanoPod are substantially equivalent to the predicate device.
The Microstream™ CO2 NanoPod 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 Microstream™ CO2 NanoPod and its substantial equivalence to the predicate device.
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A hazard analysis was carried out on the Microstream™ CO2 NanoPod in compliance with ISO 14971:2019. 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. No animal performance testing was required to demonstrate device safety and effectiveness.
Clinical Performance Testing
Not Applicable. No clinical performance testing was required to demonstrate device safety and effectiveness.
CONCLUSIONS
The subject device, Microstream™ CO2 NanoPod is equivalent in intended use, technological characteristics, and performance to the existing legally marketed device. Testing did not raise any issue of safety and effectiveness; therefore, the device is substantially equivalent to the predicate device with respect to safety, effectiveness, indications for use and intended use.