Endure ETCO2/02 Nasal Cannula

K213767 · Endure Industries, Inc. · CCK · Sep 12, 2023 · Anesthesiology

Device Facts

• Record ID: K213767
• Device Name: Endure ETCO2/02 Nasal Cannula
• Applicant: Endure Industries, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Sep 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Device is a split-lumen nasal cannula for simultaneous supplemental oxygen delivery and exhaled gas sampling. Used in hospitals, surgery centers, and acute care settings; operated by clinicians. Oxygen delivered through one nasal prong; CO2 sampled from the other for capnography monitoring. Device connects to external gas analyzer/capnograph via Luer fitting. Provides real-time respiratory monitoring and oxygenation support. Benefits include non-invasive patient monitoring and respiratory support in acute care environments.

Clinical Evidence

Bench testing only. Comparative testing performed against predicate device including CO2 sampling accuracy, ETCO2 levels, O2 flow rates (2, 4, 6 LPM), physical measurements, and Luer fitting leak testing. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous irritation) conducted per ISO 10993-1. Gas pathway testing conducted per ISO 18562.

Technological Characteristics

Flexible medical grade PVC tubing; split/channeled nasal cannula design; 7-foot length; 22mm x 6mm adaptor; Luer connectors. Single-use, non-sterile. Biocompatibility per ISO 10993-1; gas pathway testing per ISO 18562.

Indications for Use

Indicated for patients >12 years of age requiring supplemental oxygen and/or CO2 monitoring.

Regulatory Classification

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.

Predicate Devices

• Oridion Nasal CO2/O2 Cannula (K010024)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

- 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.

| 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.

- 2. Proprietary or Trade Name: Endure ETCO2/02 Nasal Cannula
Common/Usual Name: Analyzer, gas, carbon-dioxide, gaseous phase (accessories)

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

- 3. 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

#### 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 comparison<br>Features | Predicate Device ORIDION<br>K010024 | Endure ETCO2/O2 Nasal Cannula<br>K213767 | Equivalence |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | To sample exhaled gas via nasal<br>cannula and simultaneously provide<br>supplemental Oxygen near the nose<br>and mouth for inhalation | Endure ETCO2/O2 Nasal Cannula has two<br>functions<br>1) It is intended to deliver supplemental<br>Oxygen to patients and<br>2) to obtain CO2 sampling of exhaled air | Indication use is exactly the same<br>forboth pridcate device and Endure<br>cannula. Both devices sample CO2 from<br>exahled air and deliver Oxygen at the<br>same time. |
| Environment of use | Hospitals, sub-acute, pre-hospital<br>settings | Hospitals, sub-acute, pre-hospital settings | Substantially equivalent: Both devices<br>are used in hospital, prehospital and<br>subacute settings. |
| Intended Population | Adults and Pediatrics - Patient<br>requiring supplemental oxygen and /<br>or sampling of expired gases | Adults and Pediatrics - Patient requiring<br>supplemental oxygen and / or sampling of<br>expired gases | Substantially equivalent: Both devices<br>are in adults and pediatrics. |
| Duration of use | Single patient use - Disposable<br>Less than 24 hours | Single patient use - Disposable<br>Less than 24 hours | Substantially equivalent: Both predicate<br>and proposed devices are for single use<br>lasting less than 24 hours. |
| Single Patient Use | Yes | Yes | Identical: Both predicate and proposed<br>devices are for single use. |
| Dispensing | Only on prescription or as ordered by<br>a medical provider. | Only as per the order of a physician or<br>medical provider. | Substantially equivalent: Dispensing is<br>allowed only as per the order of a<br>physician or medical provider. |
| Basic Component | Nasal cannula, Oxygen tubing<br>Gas sampling line | Nasal Cannula, Oxygen tubing<br>Gas sampling line | Identical: Basic components are the<br>same for both predicate device and<br>proposed device |
| Patient Interface | Nasal cannula | Nasal Cannula | Patient interface is the same for both<br>predicate device and proposed device |
| Design | Split / channeled nasal cannula,<br>sampling in one and Oxygen delivery in<br>the other | Split / channeled nasal cannula with<br>sampling in one and Oxygen delivery in the<br>other | Substabtially Equivalent: Split /<br>channeled nasal cannula with sampling<br>in one and Oxygen deliver in the other |
| Material | Flexible PVC | Flexible PVC | Identical: Material is the same for both<br>proposed device and predicate device |
| Sampling tube specifications | Not provided<br>ID-0.06" / OD-0.1"<br>Length -2" | ID-0.08" / OD-0.1"<br>Length -2" | Identical: We have made measurements<br>of the predicate device and compared it<br>to the proposed one. |
| Biocomaptibility<br>Cytotoxicity<br>Skin Sensitivity<br>Skin Irritation | ISO 10993-1 | ISO 10993-1 | Identical test results for cytotoxicity,<br>skin senitivity and skin irritation |
| Performance Testing<br>Luer Fitting<br>Tensile strength<br>End tidal CO2 measurement | | Performance Testing<br>Luer Fitting<br>Tensile strength<br>End tidal CO2 measurement | Equivalent. |
| Age Testing | Not provided | Yes | Age testing done with cannulas<br>manufactured in 2019 and found to be<br>equivalent to cannulas manufactured in<br>2022. Such information is not available<br>for the predicate device. |
| Shelf Life | 5 years | 3 years ( Aging studied are only available to<br>verify 3 years of shelf life) | Different. Although they have a<br>difference in shelf life, both of them<br>have the same intended use, principle of<br>operation, performance<br>characteristics and scientific<br>technology. So the difference is unlikely<br>to raise any new safety or<br>effectiveness |

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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

- 8. 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.

- 9. 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.