(650 days)
Not Found
No
The description focuses on the physical design and function of a nasal cannula for oxygen delivery and CO2 sampling, with no mention of AI or ML technologies.
Yes
The device is intended to deliver supplemental oxygen to patients, which is a therapeutic function.
Yes
The device obtains CO2 sampling of exhaled air, and the device description explicitly states it samples CO2 from exhaled air to a capnograph. Measuring CO2 levels for monitoring is a diagnostic function, indicating the patient's respiratory status.
No
The device description clearly states it is a physical nasal cannula and exhaled gas sampling device, which are hardware components.
Based on the provided information, the Endure ETCO2/O2 Nasal Cannula is likely considered an IVD (In Vitro Diagnostic) device, or at least has a component that falls under the IVD definition.
Here's why:
- Function 2: "to obtain CO2 sampling of exhaled air" This function involves collecting a biological sample (exhaled air) for analysis.
- Device Description: "sampling of CO2 from exhaled air to a capnograph." This explicitly states that the collected sample is sent to a capnograph for analysis. Capnography is a method of monitoring the concentration or partial pressure of carbon dioxide (CO2) in the respiratory gases. While the cannula itself doesn't perform the analysis, it is the critical component for collecting the sample that is then analyzed by the capnograph.
How it fits the IVD definition:
IVD devices are defined as reagents, instruments, and systems intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of disease or for the assessment of health.
In this case:
- Specimen: Exhaled air containing CO2.
- Collection: The nasal cannula is the device used to collect this specimen.
- Examination: The capnograph performs the examination of the CO2 levels in the collected specimen.
- Purpose: Monitoring CO2 levels in exhaled air is used for monitoring the patient's respiratory status, which is crucial for diagnosis, monitoring, and treatment in the described care settings.
Important Considerations:
- The cannula itself is not the analytical instrument. The capnograph is the analytical instrument. However, the cannula is an essential part of the "system" for obtaining the diagnostic information.
- Regulatory classification can be complex. While the sampling function points towards IVD, the oxygen delivery function is not an IVD function. Regulatory bodies like the FDA might classify the device based on its primary intended use or as a combination product with both medical device and IVD components.
Conclusion:
While the Endure ETCO2/O2 Nasal Cannula also has a non-IVD function (oxygen delivery), its explicit function of sampling exhaled air for CO2 analysis by a capnograph strongly suggests that it is either classified as an IVD device itself (as a specimen collection device for IVD purposes) or is a component of an IVD system. Therefore, it is highly likely to be considered an IVD device, at least in part.
N/A
Intended Use / Indications for Use
Endure ETCO2/O2 Nasal Cannula has two functions
-
- It is intended to deliver supplemental Oxygen to patients and
- to obtain CO2 sampling of exhaled air
Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.
Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.
Product codes
CCK, CAT
Device Description
Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.
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
Patients above 12 years of age.
Intended User / Care Setting
Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.
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)
Comparative CO2 sampling and ETCO2 level testing were done and was found to be similar between the predicate device and the proposed device. O2 flow rates were also compared at 2,4 and 6 LPM flow and were found to be similar. Physical measurements were also done and were found to be similar between the predicate device and the proposed one. Luer fitting was also compared and found to be similar and leak-free.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010024 Oridion Nasal CO2/O2 Cannula
Reference Device(s)
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
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 & Human Services logo. To the right of that 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.
September 12, 2023
Manoj Kumar Consultant/Part Time Executive 45 N Fulton St Homer, New York 13077
Re: K213767
Trade/Device Name: Endure ETCO2/02 Nasal Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CAT Dated: January 8, 2023 Received: January 17, 2023
Dear Manoj Kumar:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Bradley Q. Quinn -S
Bradley Quinn 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213767
Device Name Endure ETCO2/02 Nasal Cannula
Indications for Use (Describe)
Endure ETCO2/O2 Nasal Cannula has two functions
-
- It is intended to deliver supplemental Oxygen to patients and
- to obtain CO2 sampling of exhaled air
Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.
Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.
| 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
K213767
SUMMARY ("510(k) Summary" as required by section 807.92(c).)
1. Submitters Information:
Company Name: Endure Industries Inc
Company Address: 45 N Fulton St
Homer, NY 13077
Contact Person: Manoj Kumar, Physician Consultant.
-
- Proprietary or Trade Name: Endure ETCO2/02 Nasal Cannula
Common/Usual Name: Analyzer, gas, carbon-dioxide, gaseous phase (accessories)
- Proprietary or Trade Name: Endure ETCO2/02 Nasal Cannula
Classification Name: Analyzer, gas, carbon-dioxide, gaseous phase (accessories)
Product Code: CCK - CFR 868.1400
Device Class: Class II
Additional Product Code: CAT Cannula, Oxygen Nasal
-
- Predicate Device Identification: This pre-market notification will demonstrate that Endure Industries CO2/Oxygen sampling cannula is substantially equivalent to the predicate device listed below
K010024 Oridion Nasal CO2/O2 Cannula
- Predicate Device Identification: This pre-market notification will demonstrate that Endure Industries CO2/Oxygen sampling cannula is substantially equivalent to the predicate device listed below
4. Device description:
Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.
5. Indications for Use:
4
Endure ETCO2/O2 Nasal Cannula has two functions 1) It is intended to deliver supplemental Oxygen to patients and 2) To obtain CO2 sampling of exhaled air
Environment of use:
The device is intended to be used in hospitals, surgery centers and other acute care centers..
Patient population:
Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.
6. Technological characteristics of the device compared to the predicate device:
The technological features of the predicate and proposed devices are found to be the similar as shown in the table below. The following features are discussed here:
Design: The cannula is divided to separate the CO2 sampling part from the O2 delivery area. The length of the tubing is 7 feet for both predicate and proposed devices. Both adult and pediatric types have the same length. Male or Female Luer connectors are present on both types. The length of the adaptor is 22mm x 6 mm for both devices.
Material: Both adult and pediatric tubing are made of flexible medical grade PVC as in the predicate device.
Sterilization: The device is marketed as single-use and non-sterile. This is the same for the predicate device.
Packaging configuration: The product is individually packaged in heat sealed poly bag with instructions of use and other information inserted inside as a label. 10 units are in a shipping carton.
5
| Table of comparison
Features | Predicate Device ORIDION
K010024 | Endure ETCO2/O2 Nasal Cannula
K213767 | Equivalence |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | To sample exhaled gas via nasal
cannula and simultaneously provide
supplemental Oxygen near the nose
and mouth for inhalation | Endure ETCO2/O2 Nasal Cannula has two
functions
- It is intended to deliver supplemental
Oxygen to patients and - to obtain CO2 sampling of exhaled air | Indication use is exactly the same
forboth pridcate device and Endure
cannula. Both devices sample CO2 from
exahled air and deliver Oxygen at the
same time. |
| Environment of use | Hospitals, sub-acute, pre-hospital
settings | Hospitals, sub-acute, pre-hospital settings | Substantially equivalent: Both devices
are used in hospital, prehospital and
subacute settings. |
| Intended Population | Adults and Pediatrics - Patient
requiring supplemental oxygen and /
or sampling of expired gases | Adults and Pediatrics - Patient requiring
supplemental oxygen and / or sampling of
expired gases | Substantially equivalent: Both devices
are in adults and pediatrics. |
| Duration of use | Single patient use - Disposable
Less than 24 hours | Single patient use - Disposable
Less than 24 hours | Substantially equivalent: Both predicate
and proposed devices are for single use
lasting less than 24 hours. |
| Single Patient Use | Yes | Yes | Identical: Both predicate and proposed
devices are for single use. |
| Dispensing | Only on prescription or as ordered by
a medical provider. | Only as per the order of a physician or
medical provider. | Substantially equivalent: Dispensing is
allowed only as per the order of a
physician or medical provider. |
| Basic Component | Nasal cannula, Oxygen tubing
Gas sampling line | Nasal Cannula, Oxygen tubing
Gas sampling line | Identical: Basic components are the
same for both predicate device and
proposed device |
| Patient Interface | Nasal cannula | Nasal Cannula | Patient interface is the same for both
predicate device and proposed device |
| Design | Split / channeled nasal cannula,
sampling in one and Oxygen delivery in
the other | Split / channeled nasal cannula with
sampling in one and Oxygen delivery in the
other | Substabtially Equivalent: Split /
channeled nasal cannula with sampling
in one and Oxygen deliver in the other |
| Material | Flexible PVC | Flexible PVC | Identical: Material is the same for both
proposed device and predicate device |
| Sampling tube specifications | Not provided
ID-0.06" / OD-0.1"
Length -2" | ID-0.08" / OD-0.1"
Length -2" | Identical: We have made measurements
of the predicate device and compared it
to the proposed one. |
| Biocomaptibility
Cytotoxicity
Skin Sensitivity
Skin Irritation | ISO 10993-1 | ISO 10993-1 | Identical test results for cytotoxicity,
skin senitivity and skin irritation |
| Performance Testing
Luer Fitting
Tensile strength
End tidal CO2 measurement | | Performance Testing
Luer Fitting
Tensile strength
End tidal CO2 measurement | Equivalent. |
| Age Testing | Not provided | Yes | Age testing done with cannulas
manufactured in 2019 and found to be
equivalent to cannulas manufactured in
- Such information is not available
for the predicate device. |
| Shelf Life | 5 years | 3 years ( Aging studied are only available to
verify 3 years of shelf life) | Different. Although they have a
difference in shelf life, both of them
have the same intended use, principle of
operation, performance
characteristics and scientific
technology. So the difference is unlikely
to raise any new safety or
effectiveness |
6
7. Biocompatibility
We have done ISO 10993 testing on the component materials of the proposed devices. The nasal cannula part of the device is considered as in contact with the patient. Therefore the following tests are necessary. This was done by an accredited laboratory.
- Cytotoxicity
- . Sensitization
- Intracutaneous Irritation
The test results confirm that the material used are safe to use and does not pose any risks.
Gas pathway test conducted in accordance with ISO 18562
-
- Summary for performance testing
Comparative CO2 sampling and ETCO2 level testing were done and was found to be similar between the predicate device and the proposed device. O2 flow rates were also compared at 2,4 and 6 LPM flow and were found to be similar. Physical measurements were also done and were found to be similar between the predicate device and the proposed one. Luer fitting was also compared and found to be similar and leak-free.
- Summary for performance testing
-
- Conclusions: Endure Industries Inc. has demonstrated through various testing that the proposed device and predicate device can be found to be substantially equivalent. In addition, biocompatibility testing confirms the safety of the devices with regard to patient contact.