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 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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OC-FLEX® Flexible IntraOral Cannula, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Attribute	Acceptance Criteria	Reported Device Performance
End-tidal CO2 values	End-tidal CO2 values shall not be statistically different (or vary less from the true end-tidal CO2 values) than the predicate device.	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. 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.

The OC-FLEX® Flexible IntraOral Cannula also underwent other non-clinical testing with the following results:

Biocompatibility Testing: Successfully completed ISO 10993 testing (Cytotoxicity, Sensitization, Intracutaneous Irritation) with no incidence of cytotoxicity, sensitization, or intracutaneous irritation.
Volatile Organic Compound (VOC) Testing: All identified compounds demonstrated levels within available recommended limits (using EPA methodology).
Particulate Matter Testing: Particulate matter results demonstrated levels below recommended limits (using NIOSH methodology).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The performance test involved a total of 36 tests. This was derived from (3 samples x 3 respiratory settings x 4 oxygen flow rates). Specifically, for each combination of respiratory setting (8, 16, 25 bpm) and oxygen flow rate (0, 1, 3, 6 LPM), three measurements were taken.
Data Provenance: This was a bench study using a Harvard Respiratory pump and a mannequin head. Therefore, the data is synthetic/simulated and not from human subjects or a specific country of origin in the traditional sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts or their qualifications for establishing the "true end-tidal CO2 values" for the bench testing. The "true end-tidal CO2 values" are implied to be the controlled input values of 5% end-tidal concentration set on the simulation apparatus.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. The results were based on direct measurement and statistical comparison to the predetermined "true" end-tidal CO2 values.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This was a bench study comparing the device's performance against a predicate device and controlled "true" values. There were no human readers involved in interpreting the results from the device in a clinical context.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance study was done. The described performance testing is a standalone evaluation of the device's ability to accurately measure end-tidal CO2 under various simulated conditions, without human intervention in the measurement process itself, other than setting up the experiment.

7. Type of Ground Truth Used

The ground truth used was controlled, simulated values (e.g., 5% end-tidal concentration) set on a Harvard Respiratory pump and mannequin head apparatus. This represents an ideal, known "true" value in a controlled environment.

8. Sample Size for the Training Set

The document does not mention a training set. This device is a physical medical device (cannula) and its performance was evaluated through physical bench testing, not through machine learning or AI models that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

As there was no training set, this information is not applicable.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Page 1 of 1

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510(k) SUMMARY

A. Submitter

Venture Therapeutics. Inc. 10739 Johnstown Road New Albany, OH, 43054 Telephone: 614-430-3300

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®Flexible IntraOral Cannula
Common Name:	Oxygen Delivery / Carbon DioxideSampling Cannula
Classification Name:	Carbon Dioxide Gas Analyzer(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

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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.

ELEMENT	OC-FLEX® Flexible IntraOral Cannula
Indications for use	The OC-FLEX® Flexible IntraOral Cannula is an adjunct tooxygen therapy with its primary function being that of deliveringlow flow oxygen to a patient while providing a means to sampleexpired gas. It is intended for use in patients requiring oxygentherapy to improve blood oxygen levels while monitoring expiredgas to determine ventilatory rate.
Environment of Use	Hospital, sub-acute and pre-hospital settings
Patient Population	Adult patient requiring exhaled gas monitoring and/orsupplemental oxygen
Oxygen	Oxygen is provided to the patient via the oral cannula connectingthe oxygen source to the patient
Gas Sampling	The gas sampling line is intended to interface with the patient viathe 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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ELEMENT	OC-FLEX® FLEXIBLEINTRAORAL CANNULA-New Device	HUDSON RCISOFTECH BI-FLO	PERFORMANCETESTING
510k	K161250	K961150	N/A
Intended Use	This device is an adjunct tooxygen therapy with itsprimary function being that ofdelivering low flow oxygen toa patient while providing ameans to sample expired gas.It is intended for use inpatients requiring oxygentherapy to improve bloodoxygen levels whilemonitoring expired gas todetermine ventilatory rate.	Same	N/A
Prescription	Yes	Yes	N/A
Environment ofUse	Hospital, sub-acute and pre-hospital setting	Same	N/A
Technologicalcharacteristic	Provide a means to deliverexhaled end-tidal CO2 to acapnograph via tubing fromthe oral cavityProvide means to delivercontinuous medical grade O2as required via tubing to theoral cavity	Provide a means to deliverexhaled end-tidal CO2 to acapnograph via tubing fromnasal prongProvide means to delivercontinuous medical grade O2as required via tubing to nasalprong	EtCO2 PerformanceTesting withSimultaneousOxygen DeliveryEtCO2 PerformanceTesting withSimultaneousOxygen Delivery
Design	Cannula made of dual,conjoined tubing connectedwith an end cap:One portion of tubing is forthe sampling of end-tidal CO2One portion of tubing is forthe delivery of the oxygen tothe patientIsolated flexible wire forcannula positioning3-micron hydrophobic filter	Cannula made of dual,conjoined tubing connected toend piece made of two nasalprongs:One portion of tubing is forthe sampling of end-tidal CO2One portion of tubing is forthe delivery of the oxygen tothe patientNo flexible wireNo filter	BiocompatibilityTesting:CytotoxicitySensitization;IntracutaneousIrritationVolatile OrganicCompound (VOC)TestingParticulate MatterTesting
Material ofconstruction	PVC (Phthalate free)Not made with natural rubberlatex	PVCNot made with natural rubberlatex	N/A
ELEMENT	OC-FLEX® FLEXIBLEINTRAORAL CANNULA-New Device	HUDSON RCISOFTECH BI-FLO	PERFORMANCETESTING
Energy used ordelivered	Not Applicable	Not Applicable	N/A
ManufacturingProcess	Injection molding,Extrusion and assembly	Injection molding; Extrusionand assembly	N/A
Performance	Comparison end-tidal CO2results at various settings	Equivalent	EtCO2 PerformanceTesting withSimultaneousOxygen Delivery
Labeling	Oxygen delivery and carbondioxide 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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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)
SimulatedRespiratory Setting	Respiratory rate : 8, 16, 25 bpmTidal Volume: 750, 600, 300 mlI:E ratio (All Conditions): 1:1 (inspiration: expiration)End-Tidal Concentration: 5%
Oxygen DeliverySetting	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.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.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.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.

Regulation Number and Section

§ 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).