(650 days)
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.
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.
The provided text describes the 510(k) premarket notification for the Endure ETCO2/O2 Nasal Cannula (K213767). It indicates that the device is substantially equivalent to a legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The document focuses on demonstrating this equivalence, rather than setting and proving acceptance criteria in the traditional sense of a clinical trial for a new therapeutic or diagnostic device.
However, based on the information provided, we can infer the "acceptance criteria" through the comparative performance testing and the "study" that proves the device meets (or is equivalent to) those criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Endure ETCO2/O2 Nasal Cannula performs similarly or identically to the predicate device (Oridion K010024) in key functional areas.
| Feature/Test | Acceptance Criteria (Implied: Similar/Identical to Predicate K010024) | Reported Device Performance (Endure ETCO2/O2 Nasal Cannula K213767) |
|---|---|---|
| Indication for Use | To sample exhaled gas via nasal cannula and simultaneously provide supplemental Oxygen near the nose and mouth for inhalation | 1) To deliver supplemental Oxygen to patients and 2) to obtain CO2 sampling of exhaled air |
| Environment of Use | Hospitals, sub-acute, pre-hospital settings | Hospitals, sub-acute, pre-hospital 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 |
| Duration of Use | Single patient use - Disposable, Less than 24 hours | Single patient use - Disposable, Less than 24 hours |
| Single Patient Use | Yes | Yes |
| Dispensing | Only on prescription or as ordered by a medical provider. | Only as per the order of a physician or medical provider. |
| Basic Components | Nasal cannula, Oxygen tubing, Gas sampling line | Nasal Cannula, Oxygen tubing, Gas sampling line |
| Patient Interface | Nasal cannula | Nasal Cannula |
| 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 |
| Material | Flexible PVC | Flexible PVC |
| Sampling Tube Specifications | ID-0.06" / OD-0.1" / Length -2" (for predicate) | ID-0.08" / OD-0.1" / Length -2" |
| Biocompatibility | ISO 10993-1 compliant (Cytotoxicity, Sensitization, Intracutaneous Irritation) | ISO 10993-1 compliant (Cytotoxicity, Sensitization, Intracutaneous Irritation) |
| Gas Pathway Test | Compliance with ISO 18562 | Compliance with ISO 18562 |
| CO2 Sampling/ETCO2 levels | Similar performance to predicate device | Found to be similar between the predicate device and the proposed device. |
| O2 Flow Rates | Similar performance to predicate device (at 2, 4, and 6 LPM) | Found to be similar between the predicate device and the proposed device. |
| Physical Measurements | Similar to predicate device | Found to be similar between the predicate device and the proposed one. |
| Luer Fitting | Similar and leak-free to predicate device | Found to be similar and leak-free. |
| Shelf Life | 5 years | 3 years (with supporting aging studies) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The performance testing appears to be primarily laboratory-based comparisons between the proposed device and the predicate.
- Test Set Sample Size: Not explicitly stated for performance tests. The comparison of physical measurements, CO2 sampling, and O2 flow rates implies a limited number of devices were tested against each other.
- Data Provenance: Not applicable in the context of patient data for the performance comparison. The tests were likely conducted in a controlled lab environment. The document states "Age testing done with cannulas manufactured in 2019" which suggests a retrospective analysis of previously manufactured devices for aging studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert clinical assessment for ground truth. The performance testing involves objective measurements (e.g., CO2 levels, O2 flow, physical dimensions) and adherence to standards (e.g., ISO 10993, ISO 18562).
4. Adjudication Method for the Test Set
Not applicable. There is no clinical imaging or diagnostic interpretation involved that would require an adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical accessory for delivering oxygen and sampling CO2, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: Compliance with international standard ISO 10993-1 and ISO 18562. This represents established biological safety standards.
- For Performance Testing (CO2, O2, Physical): Comparison against the performance of the legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The predicate device's performance established the "ground truth" or benchmark for equivalence.
- For Age Testing/Shelf Life: Laboratory-based aging studies where the performance of aged devices is compared to new devices (and found equivalent to "cannulas manufactured in 2022").
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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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
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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
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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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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:
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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.
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| Table of comparisonFeatures | Predicate Device ORIDIONK010024 | Endure ETCO2/O2 Nasal CannulaK213767 | Equivalence |
|---|---|---|---|
| Indication for use | To sample exhaled gas via nasalcannula and simultaneously providesupplemental Oxygen near the noseand mouth for inhalation | Endure ETCO2/O2 Nasal Cannula has twofunctions1) It is intended to deliver supplementalOxygen to patients and2) to obtain CO2 sampling of exhaled air | Indication use is exactly the sameforboth pridcate device and Endurecannula. Both devices sample CO2 fromexahled air and deliver Oxygen at thesame time. |
| Environment of use | Hospitals, sub-acute, pre-hospitalsettings | Hospitals, sub-acute, pre-hospital settings | Substantially equivalent: Both devicesare used in hospital, prehospital andsubacute settings. |
| Intended Population | Adults and Pediatrics - Patientrequiring supplemental oxygen and /or sampling of expired gases | Adults and Pediatrics - Patient requiringsupplemental oxygen and / or sampling ofexpired gases | Substantially equivalent: Both devicesare in adults and pediatrics. |
| Duration of use | Single patient use - DisposableLess than 24 hours | Single patient use - DisposableLess than 24 hours | Substantially equivalent: Both predicateand proposed devices are for single uselasting less than 24 hours. |
| Single Patient Use | Yes | Yes | Identical: Both predicate and proposeddevices are for single use. |
| Dispensing | Only on prescription or as ordered bya medical provider. | Only as per the order of a physician ormedical provider. | Substantially equivalent: Dispensing isallowed only as per the order of aphysician or medical provider. |
| Basic Component | Nasal cannula, Oxygen tubingGas sampling line | Nasal Cannula, Oxygen tubingGas sampling line | Identical: Basic components are thesame for both predicate device andproposed device |
| Patient Interface | Nasal cannula | Nasal Cannula | Patient interface is the same for bothpredicate device and proposed device |
| Design | Split / channeled nasal cannula,sampling in one and Oxygen delivery inthe other | Split / channeled nasal cannula withsampling in one and Oxygen delivery in theother | Substabtially Equivalent: Split /channeled nasal cannula with samplingin one and Oxygen deliver in the other |
| Material | Flexible PVC | Flexible PVC | Identical: Material is the same for bothproposed device and predicate device |
| Sampling tube specifications | Not providedID-0.06" / OD-0.1"Length -2" | ID-0.08" / OD-0.1"Length -2" | Identical: We have made measurementsof the predicate device and compared itto the proposed one. |
| BiocomaptibilityCytotoxicitySkin SensitivitySkin Irritation | ISO 10993-1 | ISO 10993-1 | Identical test results for cytotoxicity,skin senitivity and skin irritation |
| Performance TestingLuer FittingTensile strengthEnd tidal CO2 measurement | Performance TestingLuer FittingTensile strengthEnd tidal CO2 measurement | Equivalent. | |
| Age Testing | Not provided | Yes | Age testing done with cannulasmanufactured in 2019 and found to beequivalent to cannulas manufactured in2022. Such information is not availablefor the predicate device. |
| Shelf Life | 5 years | 3 years ( Aging studied are only available toverify 3 years of shelf life) | Different. Although they have adifference in shelf life, both of themhave the same intended use, principle ofoperation, performancecharacteristics and scientifictechnology. So the difference is unlikelyto raise any new safety oreffectiveness |
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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.
§ 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).