The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is indicated for oral/tracheal intubation for anesthesia, airway management and removal of accumulated subglottic secretions. It is indicated for singlepatient, single-use only.

Device Description

The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with preloaded stylet is a disposable, sterile, single-patient, single use device. The NeVap ASSET is packaged individually and supplied sterile with a standard 15mm connector and preloaded stylet. The NeVap ASSET is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation line with pilot balloon using a standard 10cc syringe (air only) through a one-way check valve. For evacuation of subglottic secretions, a separate (yellow) suction line, with male fitting, connects to standard hospital vacuum receptacles. Once properly intubated, subglottic secretions are evacuated through the suction appendage just superior to the cuff. To facilitate proper positioning, the suction appendage and lumen line marker are radiopaque.

AI/ML Overview

The provided text refers to a medical device, the NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet, and its demonstration of substantial equivalence to a predicate device. However, it does not contain the detailed results of a study that would include acceptance criteria and specific device performance metrics in the format requested, such as sensitivity, specificity, or AUC for an AI-powered device.

The document primarily focuses on bench testing, biocompatibility testing, sterilization validation, and a human factors/usability study to demonstrate that the device performs as intended and is substantially equivalent to its predicate.

Therefore, many of the requested categories for an AI device study (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this particular document.

Here's a summary of the information that can be extracted or inferred from the provided text, recognizing the limitations of the input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the NeVap ASSET met all predetermined acceptance criteria as specified by applicable standards, FDA guidance, and test protocols. However, it does not provide a table with these specific criteria or the quantitative "reported device performance" against them. It only lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance (Summary)
Performance Bench Testing (ISO 5361:2016, ISO 5356-1:2015)	Conformance to standards demonstrated, performance verified as substantially equivalent to predicate device for intended use.
Biocompatibility Testing (ISO 10993-1:2009 & FDA guidance)	Cytotoxicity, Implantation, Sensitization, Irritation/Intracutaneous reactivity, Material Mediated Pyrogenicity, Chemical Characterization (Extractable & Leachable), Toxicological Risk Assessment all passed, demonstrating safety.
Sterilization (Ethylene Oxide)	Validation conducted.
Human Factors/Usability (IEC 62366-1:2015)	Found to be in conformance with the standard.
Risk Analysis (ISO 14971)	Possible hazards systematically identified and evaluated, mitigated to acceptable risk levels.
Suction-T Component Tests:	Met performance requirements for intended use. Specific tests included: Suction Patency Test, Fluid Recovery Rates determination, Suction-T Pull Test (Shear and Tensile Force), Isolated Suction-T Material Pull Test.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided for an AI output. The studies described are for a physical medical device. Bench tests involve samples of the device itself, but not a "test set" of data in the AI sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. This information is relevant for studies involving human interpretation or clinical evaluation, particularly for AI ground truth. For this physical device, "ground truth" would be established by physical measurements and adherence to engineering standards.

4. Adjudication method for the test set:

Not applicable / Not provided. This is specific to studies involving expert review and often used in AI performance evaluation.

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:

No, an MRMC study was NOT done. The document explicitly states: "Clinical Testing was not conducted. Clinical evidence was not necessary to show substantial equivalence." This type of study would be relevant for an AI-assisted diagnostic tool, not for this physical endotracheal tube.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical instrument, not an algorithm, so a "standalone" AI performance study is irrelevant.

7. The type of ground truth used:

For the physical device, "ground truth" is established through physical measurements against engineering standards and specifications, biocompatibility test results, and validation of manufacturing processes.

8. The sample size for the training set:

Not applicable / Not provided. The device is not an AI algorithm.

9. How the ground truth for the training set was established:

Not applicable. The device is not an AI algorithm.

Summary

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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 the FDA logo, which 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.

February 16, 2018

NeVap, Inc. % Janet Kwiatkowski President MAE Consulting Group, LLC 119 North Road Deerfield, New Hampshire 03037

Re: K172208

Trade/Device Name: NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: January 17, 2018 Received: January 18, 2018

Dear Janet Kwiatkowski:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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) K172208

Device Name

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet

Indications for Use (Describe)

Ne Vap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is indicated for oral/tracheal intubation for anesthesia, airway management and removal of accumulated subglottic secretions. It is indicated for singlepatient, single-use only.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5- 510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary for the use of the NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with preloaded stylet.

5.1.Applicant:
NeVap, Inc. 975 Dionne Way San Jose, California ਰੇਵਾ 33
5.2.Sponsor Contact Person: Brenton Hanlon President NeVap, Inc. 975 Dionne Way San Jose, CA- 95133 Phone: +1(602) 421 1100 Email: brentonhanlon@hotmail.com
5.3. Regulatory Correspondent/ 510(k) Submission Contact:

Janet Kwiatkowski MAE Consulting Group, LLC 119 North Road, Deerfield, NH 03037 Phone: +1(603)340-7079 Email: Janetk@maegroups.com

5.4.Date Prepared: February 16, 2018

5.5. Device Information:

Proprietary Name: NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet

Endotracheal Tube

Panel: Anesthesiology Regulatory Number: 21 CFR 868.5730 Regulation Name: Tube, Tracheal (W/Wo Connector)

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Product Code:	BTR
Device Class:	Class II

5.6. Predicate Device:
. TaperGuard Evac™ Endotracheal Tubes (K090352)

5.7.Device Description:

5.8. Indication for Use:

The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with preloaded stylet is indicated for oral/tracheal intubation for anesthesia, airway management and removal of accumulated subglottic secretions. It is indicated for single-patient, single-use only.

5.9.Comparison of Technological Characteristics:

The NeVap Aspire Subglottic Suction Endotracheal Tube is substantially equivalent in intended use, design, performance and principles of operation to the predicate device. Both are polyvinylchloride tubes with a polyvinylchloride inflatable cuff and a suction lumen. Both incorporate a suction valve with integrated rinse port to aid in removing secretions that accumulate in the subglottic space. Both are provided with an additional preloaded stylet. The differences between the NeVap Aspire Subglottic Suction Endotracheal tube and the predicate device raise no different issues of safety and effectiveness. The NeVap Aspire Subglottic Suction Endotracheal Tube with Preloaded Stylet and the predicate device consist of the same fundamental technology and are sterilized with acceptable methods. Below is a comparison table that summarizes the technological characteristics of the subject and predicate endotracheal tubes.

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ComparativeCharacteristics	Proposed Device:NeVap Aspire Subglottic SuctionEndotracheal Tube with PreloadedStylet	Predicate Device:TaperGuard Evac™ EndotrachealTubes
510(k) Number	N/A	K090352
Indication for Use	The NeVap ASSET is indicated fororal/tracheal intubation for anesthesia,airway management and removal ofaccumulated subglottic secretions. It isindicated for single-patient, single-useonly.	The TaperGuard Evac™ Endotrachealtube is indicated for airwaymanagement by oral/nasal intubationof the trachea, and for evacuation ordrainage of the subglottic space.
Anatomical site	The NeVap ASSET is placed inside thepatient's tracheal airway via oralintubation.	The TaperGuard Evac Endotrachealtube is a device inserted into apatient's trachea via the nose ormouth to maintain an open airway.
Materials
Endotracheal Tube/Main Tube	Polyvinyl Chloride Compound withRadiopaque marker	Same
Pilot Balloon	PVC Pilot Balloon	Same
Inflation tube/tail	PVC	Same
Cuff Balloon	PVC with a cylindrical shape	PVC with a tapered shape
Male Suction LumenConnector	PVC	Same
Design
Preloaded Stylet	Yes	Yes
Descriptive Size (ID)	6.0, 6.5, 7.0, 7.5, 8.0, 8.5 (mm)	TaperGuard Evac™ Endotracheal Tube- Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5,9.0mm)
Magill Curve	Yes	Same
Murphy eye	Yes	Same
15mm Connector	Yes	Same
Radiopaque Line	Yes	Same
Suction port forremoval ofsecretions thataccumulate abovethe cuff balloon	Radial Multiport Suction T• The multiport Suction-T componentis located above the cuff andextends in a semi-circular manneraround the external surface of theendotracheal tube to facilitateevacuation of secretionsaccumulating above the cuff.	Single Suction Port• The single suction port is locatedabove the cuff with an evacuationlumen to facilitate evacuation ofsecretions accumulating above thecuff.
ComparativeCharacteristics	Proposed Device:NeVap Aspire Subglottic SuctionEndotracheal Tube with PreloadedStylet	Predicate Device:TaperGuard Evac™ EndotrachealTubes
Do the devices havethe sametechnologicalcharacteristics?	As compared above, the intended use is the same. This device specifies the device for single use. The indications for use statements are nearly identical for the two devices except that the predicate device can be inserted in the patient's trachea through oral and nasal intubation, whereas the proposed device can be inserted only through oral intubation. The proposed device specifies the device for single use, in compliance to the recognized labeling standards. Although worded differently, the indications for use identify the similar Intended use i.e., both devices are used for airway management and removal of accumulated subglottic secretions above the endotracheal cuff. The proposed device meets the performance functional tests specification and biocompatibility test requirements. Additionally, the potential hazards and use-related issues associated with the proposed device have been adequately mitigated in the risk analysis and device user interface has been adequately demonstrated in Human Factors/Usability study. Please see summary of testing for the proposed device in the section 5.10 below. All the test reports have been provided in this 510(k). The test results support the conclusion that the differences in the indication for use statement is not critical and does not affect the safety and effectiveness of the device when used as labeled in accordance with 21 CFR 807.92(a)(5).
	There exist a minor difference between the design and materials A risk analysis has been established for the Suction-T component in accordance with ISO 14971. The potential hazards including tissue damage, dislodgement, and device material failure have been identified and mitigated to acceptable risk levels. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. Please see summary of testing for Suction-T in the section below. Biocompatibility and performance testing were conducted, and the results demonstrate substantial equivalence.

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5.10. Summary of Testing

To ensure that the device design and construction are suitable for the intended use, the NeVap ASSET with Preloaded Stylet has been evaluated in the following tests:

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. Performance Bench testing has been conducted to verify that the performance of the proposed NeVap ASSET with Preloaded Stylet is substantially equivalent to the predicate device, and that the NeVap ASSET with preloaded stylet will perform as intended. Bench-top testing was conducted to assure conformance to the following standards:
- o ISO 5361:2016- Anaesthetic And Respiratory Equipment Tracheal Tubes and Connectors
- o ISO 5356-1:2015- Anaesthetic and Respiratory Equipment -- Conical connectors -- Part 1: Cones and sockets
The following Biocompatibility testing was performed in accordance with ISO 10993-. 1:2009 and FDA guidance on Use of International Standard ISO 10993-1
- Cytotoxicity o
- Implantation O
- Sensitization o
- Irritation / Intracutaneous reactivity O
- Material Mediated Pyrogenicity O
- Chemical Characterization- Extractable and Leachable o
- o Toxicological Risk Assessment
. Sterilization by ethylene oxide has been validated for NeVap ASSET with preloaded stylet.
. A Human Factors / Usability Study was conducted and the NeVap ASSET with preloaded stylet was found to be in conformance with the IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices
Clinical Testing was not conducted. Clinical evidence was not necessary to show substantial equivalence
A risk analysis according to ISO standard "14971 Medical Devices Application of risk . management to medical devices" was carried out for the NeVap ASSET with preloaded stylet. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode and Effect Analysis" technique.
. The following bench testing was conducted to support the performance of the Suction-T component of NeVap ASSET with preloaded stylet. The test results demonstrated that the device meets the performance requirements for its intended use:
- o Suction Patency Test
- Fluid Recovery Rates determination o
- Suction-T Pull Test (Shear and Tensile Force) O
- Isolated Suction-T Material Pull Test O

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5.11. Conclusion:

The NeVap ASSET with Preloaded Stylet met all predetermined acceptance criteria as specified by the applicable standards, FDA guidance documents and test protocols. Therefore, the NeVap ASSET with preloaded stylet is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).