OC-FLEX Flexible IntraOral Cannula

K161250 · Venture Therapeutics, Inc. · CCK · Mar 17, 2017 · Anesthesiology

Device Facts

• Record ID: K161250
• Device Name: OC-FLEX Flexible IntraOral Cannula
• Applicant: Venture Therapeutics, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OC-FLEX® Flexible IntraOral Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.

Device Story

OC-FLEX is a disposable, non-sterile, single-patient-use intraoral cannula; delivers supplemental oxygen and samples exhaled gas (EtCO2) simultaneously. Device features dual-lumen PVC tubing; one lumen for gas delivery, one for sampling. Includes integrated flexible wire for customizable positioning within oral cavity; end cap contains 3-micron hydrophobic filter to prevent moisture/fluid transfer to monitoring equipment. Used in hospital, sub-acute, and pre-hospital settings; operated by clinicians. Input: medical-grade oxygen source and patient exhaled breath. Output: oxygen delivered to oral cavity; exhaled gas routed to external capnograph. Healthcare providers use capnograph output to monitor patient ventilatory rate and oxygenation status. Flexible design allows use in patients where nasal cannulas are unsuitable, potentially improving monitoring accuracy and patient comfort.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing using a Harvard Respiratory pump and mannequin head. Testing compared EtCO2 measurement accuracy of subject device vs. predicate across 36 combinations of respiratory rates (8, 16, 25 bpm), tidal volumes (750, 600, 300 ml), and oxygen flow rates (0-6 L/min). Results showed subject device had equal or less variance from true EtCO2 values compared to predicate within 95% confidence intervals.

Technological Characteristics

Materials: Phthalate-free PVC, non-latex. Design: Dual-lumen tubing with integrated flexible positioning wire and 3-micron hydrophobic filter end cap. Connectivity: Standard luer connectors for gas monitor interface. Manufacturing: Injection molding and extrusion. Non-sterile, single-use. No software, electronics, or energy source.

Indications for Use

Indicated for adult patients requiring supplemental oxygen therapy and exhaled gas monitoring (EtCO2) to determine ventilatory rate, particularly those where nasal cannulas are contraindicated or ineffective (e.g., mouth-breathers, deviated septum, facial reconstructive surgery).

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

• Hudson RCI® Softech® Bi-Flo® Cannula (K961150)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

Venture Therapeutics, Inc. Marilyn Friedly Director, Regulatory Affairs 6525 Doubletree Avenue Columbus. Ohio 43229

Re: K161250

Trade/Device Name: OC-FLEX Flexible Intraoral Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: February 13, 2017 Received: February 16, 2017

Dear Marilyn Friedly:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161250

Device Name OC-FLEX® Flexible IntraOral Cannula

#### Indications for Use (Describe)

The OC-FLEX® Flexible IntraOral Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.

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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FORM FDA 3881 (8/14)

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## 510(k) SUMMARY

## A. Submitter

Venture Therapeutics. Inc. 10739 Johnstown Road New Albany, OH, 43054 Telephone: [phone]

#### B. Contact Person

Marilyn A. Friedly Director, Regulatory Affairs mfriedly @ venturetherapeutics.com

## C. Date Prepared

March 17, 2017

## D. Device Name

| Proprietary Name: | OC-FLEX®<br>Flexible IntraOral Cannula |
|----------------------|------------------------------------------------------|
| Common Name: | Oxygen Delivery / Carbon Dioxide<br>Sampling Cannula |
| Classification Name: | Carbon Dioxide Gas Analyzer<br>(accessories) |
| Regulatory | Class II per 21 CFR 868.1400 |
| Product Code | CCK |

#### E. Predicate Device

Hudson RCI® Softech® Bi-Flo® Cannula (K961150)

#### F. Device Description

The OC-FLEX® Flexible IntraOral Cannula is a disposable, non-sterile, single use device that is intended to provide a means for sampling exhaled gases from a patient (i.e., end-tidal CO2) with the option to simultaneously or independently deliver supplemental gas therapy (i.e., O2).

The device design consists of dual, conjoined PVC tubing united by an end cap providing two separate gas pathways. One portion of the tubing is dedicated to supplying gas from a gas source to the patient as required by the prescribed therapy. The other portion of the tubing is dedicated to the sampling of exhaled gas from the patient to a gas analyzer (i.e., a capnograph) for end-tidal CO2 monitoring. The design of the OC-FLEX® Flexible IntraOral Cannula incorporates a flexible wire located inside a separate, dedicated lumen in the gas supply tubing in conjunction with an end cap comprised of a filter. The flexible wire feature of the cannula is isolated from the delivery gas as well as the exhaled gas in a dedicated lumen within the gas supply tubing. This allows

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Image /page/4/Picture/0 description: The image shows the logo for Venture Therapeutics. The word "Venture" is written in a cursive font and is placed above a green line. The word "Therapeutics" is written in a smaller font and is placed below the green line.

customizable positioning of the cannula for delivery and sampling of gas. This design is engineered to provide the practitioner flexibility and mobility during the procedure. The end cap minimizes occlusion during sampling of exhaled gas and segregates the gas sampling from the supplied gas for therapy to the patient. This design feature allows the delivery of the prescribed gas (i.e., oxygen) to the oral cavity. The end cap design features a 3-micron hydrophobic filter, which prevents the transfer of water vapor or other body fluid from the patient down to the monitoring line and into the gas sampling equipment.

The OC-FLEX® Flexible IntraOral Cannula is a single patient device, designed for use by one patient over a single course of treatment. The device is available with either a male luer connector or female luer connector. The device is supplied in a sealed poly bag in a non-sterile state and is not to be sterilized.

| ELEMENT | OC-FLEX® Flexible IntraOral Cannula |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The OC-FLEX® Flexible IntraOral Cannula is an adjunct to<br>oxygen therapy with its primary function being that of delivering<br>low flow oxygen to a patient while providing a means to sample<br>expired gas. It is intended for use in patients requiring oxygen<br>therapy to improve blood oxygen levels while monitoring expired<br>gas to determine ventilatory rate. |
| Environment of Use | Hospital, sub-acute and pre-hospital settings |
| Patient Population | Adult patient requiring exhaled gas monitoring and/or<br>supplemental oxygen |
| Oxygen | Oxygen is provided to the patient via the oral cannula connecting<br>the oxygen source to the patient |
| Gas Sampling | The gas sampling line is intended to interface with the patient via<br>the oral cannula and a standard luer connector to the gas monitor |
| Product Labeling | O2 / CO2 Oral Cannula |
| Single use or reusable | Single use |
| Shelf life | 2 years |

## G. Intended Use

#### H. Description of Substantial Equivalence

The components found in the OC-FLEX® Flexible IntraOral Cannula have been used in legally marketed devices. Substantial equivalence was determined based on the prior use of components in legally marketed devices in conjunction with extensive biocompatibility data. Substantial equivalence of effectiveness was determined utilizing comparative bench studies of the OC-FLEX® Flexible IntraOral Cannula and predicate device.

The OC-FLEX® Flexible IntraOral Cannula has been designed with a slight difference from the predicate device in the location of the delivery of gas and the sampling of the exhaled breath. The predicate device delivers gas and samples the exhaled breath via the nasal passage and the OC-FLEX® Flexible IntraOral Cannula delivers gas and samples the exhaled breath via the oral

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cavity. In addition to typical O2 delivery and end-tidal CO2 for the majority of patients, the location difference allows for monitoring the exhaled breath for specific types of patients (e.g. the mouth-breathing patient, the patient with a deviated septum, or the patient receiving a facial reconstructive procedure that impedes the use of a nasal cannula). Effectiveness of the device suitably compares to that of the predicate as demonstrated in bench testing.

The OC-FLEX® Flexible IntraOral Cannula incorporates a flexible wire located inside a separate, dedicated lumen in the gas supply tubing in conjunction with an end cap comprised of a filter. The flexible wire feature of the cannula is isolated from the delivery gas as well as the exhaled gas in a dedicated lumen within the gas supply tubing. This allows variable positioning of the cannula for delivery and sampling of gas. To verify the biocompatibility of the materials used in the manufacturing of the OC-FLEX® Flexible IntraOral Cannula, extensive biocompatibility testing was conducted. The testing demonstrated that the materials used have no cytotoxic effect. The testing also confirmed that the materials used are non-irritants and do not have sensitization effects.

The following common characteristics further summarize substantial equivalence:

- The OC-FLEX® Flexible IntraOral Cannula has the same intended use as the predicate ● device.
- Both the OC-FLEX® Flexible IntraOral Cannula and the predicate device are single . patient use devices.
- Both the OC-FLEX® Flexible IntraOral Cannula and the predicate device are supplied . non sterile in individually packaged poly bags.
- . Both the OC-FLEX® Flexible IntraOral Cannula and the predicate device utilize the same main design technology: the use of PVC tubing for the delivery of therapy gas and the transport of sampling exhaled gas.
- . Neither the OC-FLEX® Flexible IntraOral Cannula nor the predicate device is a lifesupporting or life-sustaining device.
- Neither the OC-FLEX® Flexible IntraOral Cannula nor the predicate device use software ● or are mechanically or electronically driven.
- Both the OC-FLEX® Flexible IntraOral Cannula and the predicate device utilize the same manufacturing process for their components: injection molding and extruded plastic.
- Both the OC-FLEX® Flexible IntraOral Cannula and the predicate device utilize a similar . primary material: PVC tubing (the OC-FLEX® Flexible IntraOral Cannula uses DEHPfree PVC).
- Both the OC-FLEX® Flexible IntraOral Cannula and the predicate device utilize male and . female luer connectors.

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Image /page/6/Figure/0 description: The image shows the logo for Venture Therapeutics. The word "Venture" is written in a stylized blue font, with a green line underneath it. Below the line, the word "Therapeutics" is written in a smaller, similar blue font.

| ELEMENT | OC-FLEX® FLEXIBLE<br>INTRAORAL CANNULA-<br>New Device | HUDSON RCI<br>SOFTECH BI-FLO | PERFORMANCE<br>TESTING |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K161250 | K961150 | N/A |
| Intended Use | This device is an adjunct to<br>oxygen therapy with its<br>primary function being that of<br>delivering low flow oxygen to<br>a patient while providing a<br>means to sample expired gas.<br>It is intended for use in<br>patients requiring oxygen<br>therapy to improve blood<br>oxygen levels while<br>monitoring expired gas to<br>determine ventilatory rate. | Same | N/A |
| Prescription | Yes | Yes | N/A |
| Environment of<br>Use | Hospital, sub-acute and pre-<br>hospital setting | Same | N/A |
| Technological<br>characteristic | Provide a means to deliver<br>exhaled end-tidal CO2 to a<br>capnograph via tubing from<br>the oral cavity<br>Provide means to deliver<br>continuous medical grade O2<br>as required via tubing to the<br>oral cavity | Provide a means to deliver<br>exhaled end-tidal CO2 to a<br>capnograph via tubing from<br>nasal prong<br>Provide means to deliver<br>continuous medical grade O2<br>as required via tubing to nasal<br>prong | EtCO2 Performance<br>Testing with<br>Simultaneous<br>Oxygen Delivery<br>EtCO2 Performance<br>Testing with<br>Simultaneous<br>Oxygen Delivery |
| Design | Cannula made of dual,<br>conjoined tubing connected<br>with an end cap:<br><br>One portion of tubing is for<br>the sampling of end-tidal CO2<br><br>One portion of tubing is for<br>the delivery of the oxygen to<br>the patient<br><br>Isolated flexible wire for<br>cannula positioning<br><br>3-micron hydrophobic filter | Cannula made of dual,<br>conjoined tubing connected to<br>end piece made of two nasal<br>prongs:<br><br>One portion of tubing is for<br>the sampling of end-tidal CO2<br><br>One portion of tubing is for<br>the delivery of the oxygen to<br>the patient<br><br>No flexible wire<br><br>No filter | Biocompatibility<br>Testing:<br>Cytotoxicity<br>Sensitization;<br>Intracutaneous<br>Irritation<br><br>Volatile Organic<br>Compound (VOC)<br>Testing<br><br>Particulate Matter<br>Testing |
| Material of<br>construction | PVC (Phthalate free)<br>Not made with natural rubber<br>latex | PVC<br>Not made with natural rubber<br>latex | N/A |
| ELEMENT | OC-FLEX® FLEXIBLE<br>INTRAORAL CANNULA-<br>New Device | HUDSON RCI<br>SOFTECH BI-FLO | PERFORMANCE<br>TESTING |
| Energy used or<br>delivered | Not Applicable | Not Applicable | N/A |
| Manufacturing<br>Process | Injection molding,<br>Extrusion and assembly | Injection molding; Extrusion<br>and assembly | N/A |
| Performance | Comparison end-tidal CO2<br>results at various settings | Equivalent | EtCO2 Performance<br>Testing with<br>Simultaneous<br>Oxygen Delivery |
| Labeling | Oxygen delivery and carbon<br>dioxide sampling cannula | Same | N/A |

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## I. Non-Clinical Performance Data

The substantial equivalence of the OC-FLEX® Flexible IntraOral Cannula has been demonstrated via biocompatibility testing, volatile organic compound (VOC) and particulate matter testing, and comparative performance bench testing, respectively.

#### Biocompatibility Testing

To confirm the suitability of the materials used in the manufacture of the cannula, biocompatibility studies were performed as per ISO 10993 "Biological evaluation of medical device." These studies included the following tests:

- Cytotoxicity ●
- . Sensitization
- . Intracutaneous Irritation

The OC-FLEX® Flexible IntraOral Cannula has successfully completed the ISO 10993 testing for biocompatibility with no incidence of cytotoxicity, sensitization or intracutaneous irritation.

#### Volatile Organic Compound (VOC) and Particulate Matter Testing

To evaluate the safety of the dry gas pathway of the OC-FLEX® Flexible IntraOral Cannula, volatile organic compound (VOC) and particulate matter testing were performed.

The OC-FLEX® Flexible IntraOral Cannula was evaluated for VOC's using EPA methodology. Results of the VOC testing were compared against health protective toxicological values to determine the margin of safety based on patient population. All compounds identified by this testing have demonstrated levels within available recommended limits.

The OC-FLEX® Flexible IntraOral Cannula was assessed using NIOSH methodology for the determination of respirable particulate matter. Results were compared to safety values for particulate matter exposure to the patient. Particulate matter results have demonstrated levels below the recommended limits.

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Image /page/8/Picture/0 description: The image shows the logo for Venture Therapeutics. The word "Venture" is written in a cursive font and is above a green line. The word "Therapeutics" is written in a smaller, non-cursive font and is below the green line.

## Performance Testing

To address any potential impact of design difference between the OC-FLEX® Flexible IntraOral Cannula and the predicate device, additional testing was performed. To demonstrate the effectiveness of the design, a comparative bench test was conducted on the OC-FLEX® Flexible IntraOral Cannula against the predicate device. The results demonstrated that the OC-FLEX® Flexible IntraOral Cannula varied less or equal to the true values when compared to the predicate device, thereby supporting the effectiveness of the device.

| Study Attribute | Description |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Subject | The OC-FLEX® Flexible IntraOral Cannula was tested alongside the predicate device (Hudson RCI Softech Bi-Flo Cannula) |
| Objective | To measure the end-tidal CO2 values utilizing an oxygen-delivering cannula under simulated patient conditions |
| Acceptance Criteria | End-tidal CO2 values shall not be statistically different (or vary less from the true end-tidal CO2 values) than the predicate device. |
| Apparatus | Harvard Respiratory pump and mannequin head to simulate patient head. Cannula connected to oxygen supply line, CO2 sensing line and CO2 detector (capnograph) |
| Simulated<br>Respiratory Setting | Respiratory rate : 8, 16, 25 bpm<br>Tidal Volume: 750, 600, 300 ml<br>I:E ratio (All Conditions): 1:1 (inspiration: expiration)<br>End-Tidal Concentration: 5% |
| Oxygen Delivery<br>Setting | Source flow of 0, 1, 3, and 6 liters per minute for each setting was used. The system was allowed at least 3 minutes of oxygen delivery to equilibrate prior to sampling CO2. |
| Measurement | Each test was sampled three times at each combination of settings for a total of 36 tests (3 samples x 3 respiratory settings x 4 oxygen flow rates). |
| Results | The end-tidal CO2 values for the OC-FLEX® Flexible IntraOral Cannula were not statistically different, or varied less from the true end-tidal CO2 values, than the predicate product.<br>A comparison of variances of the end-tidal CO2 measurements from the actual values for the two devices indicates that the OC-FLEX® Flexible IntraOral Cannula has the least variance from true value when compared to the predicate device, within 95% confidence intervals. |
| Discussion | The OC-FLEX® Flexible IntraOral Cannula met the predetermined acceptance criteria of the test.<br>Both the OC-FLEX® Flexible IntraOral Cannula and predicate device are intended to provide means for sampling ETCO2 with the option to deliver supplemental O2 therapy to patients.<br>This performance test demonstrated that the OC-FLEX® Flexible IntraOral Cannula performs equally to, or better than, the predicate device in accurately capturing end-tidal CO2, thereby supporting the substantial equivalence of the OC-FLEX® Flexible IntraOral Cannula to the predicate product. |

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# J. Clinical Performance Data

No clinical studies were conducted on this device.

## K. Conclusion

The device data and test results demonstrate the OC-FLEX® Flexible IntraOral is substantially equivalent to the predicate device.