The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during Electroconvulsive Therapy (ECT) procedures or whenever a bite block is required to prevent occlusion of an endotracheal tube.

Device Description

The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during ECT procedures and whenever a bite block is required to prevent occlusion of an endotracheal tube.

The Airway with Bite Block and Tongue Depressor is available in two sizes, Medium - 80 mm and Large - 90 mm.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Airway with Bite Block and Tongue Depressor." It focuses on establishing substantial equivalence to existing predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for AI/ML-based medical devices or comparative effectiveness studies with human readers.

Instead, the document primarily describes the device, its intended use, and a comparison with predicate devices based on technological characteristics and non-clinical performance tests (biocompatibility and compression testing). The "study" mentioned is a set of non-clinical performance tests.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies for AI performance is not available in this regulatory submission.

Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Product compression strength	Not explicitly stated as "acceptance criteria" but "Product compression testing" was conducted. Results are not detailed beyond "found to have similar technological characteristics and to be equivalent" to predicates.
Biocompatibility (to ISO 10993)	Meets ISO 10993 requirements (Cytotoxicity, Irritation or Intracutaneous Reactivity, Sensitization, Oral Toxicity).

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

Sample Size: Not specified for any of the non-clinical performance tests.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described as non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contract lab.

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

Not applicable as this is a physical device and the "ground truth" for non-clinical performance tests like compression or biocompatibility is determined by standardized test methods, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

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 comparative effectiveness study was not done. The device is a physical medical device, not an AI/ML diagnostic tool meant to assist human readers.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For biocompatibility, the ground truth or reference standard is conformity to the requirements of ISO 10993 through specific chemical and biological assays.
For product compression testing, the ground truth would be the physical properties (e.g., force, displacement) measured according to the test method.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary

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

June 29, 2015

Dupaco. Inc. c/o Mr. Greg Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606

Re: K150518

Trade/Device Name: Airway with Bite Block and Tongue Depressor Regulation Number: 21 CFR 882.5070 Regulation Name: Bite Block Regulatory Class: II Product Code: JXL, CAE Dated: March 30, 2015 Received: March 31, 2015

Dear Mr. Holland:

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.

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Page 2 - Mr. Holland

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 device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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) K150518

Device Name

Airway with Bite Block and Tongue Depressor

Indications for Use (Describe)

The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent arway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during Electroconvulsive Therapy (ECT) procedures or whenever a bite block is required to prevent occlusion of an endotracheal tube.

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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5. 510(k) Summary or 510(k) Statement

510(k) Owner	Dupaco Inc.4144 Avenida de la PlataOceanside, CA 92056TEL: 800.546.4550FAX: 760.758.1465
Contact person	Greg HollandRegulatory Consultant to Dupaco Inc.Regulatory Specialists, Inc.3722 Ave. SausalitoIrvine, CA 92606TEL: 949.262-0411FAX: 949.552.2821EMAIL: greg@regulatoryspecialists.com
Date summary was prepared	June 29, 2015
Name of device	Airway with Bite Block and Tongue Depressor
Common Name	Oral Airway and Bite Block
Classification Name	Bite Block
Regulation	882.5070
Product Code	JXL, CAE
Predicates	Epiguard (K050188)Veni-A-Oral Protector (K992269)

510(k) SUMMARY

Description

The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during ECT procedures and whenever a bite block is required to prevent occlusion of an endotracheal tube.

The Airway with Bite Block and Tongue Depressor is available in two sizes, Medium - 80 mm and Large - 90 mm.

Intended Use

The Airway with Bite Block and Tongue Depressor is intended for use as an oral airway and bite block.

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Indications for Use

The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during Electroconvulsive therapy (ECT) procedures or whenever a bite block is required to prevent occlusion of an endotracheal tube.

Technological Characteristics

The predicate and the Airway with Bite Block and Tonque Depressor were compared in the following areas and found to have similar technological characteristics and to be equivalent:

The following non-clinical performance tests were conducted:

Product compression testing Biocompatibility to ISO 10993 Cytotoxicity Irritation or Intracutaneous Reactivity Sensitization Oral Toxicity

	Airway with Bite Blockand Tongue Depressor	Epiguard (K050188)	Ventil-A (K992269)
Indications foruse	The Airway with BiteBlock and TongueDepressor is a combinedoral airway and bite blockthat will allow ananesthesia provider toestablish a patent airwayin an anesthetized patientwhile simultaneouslypreventing occlusion ofthe teeth. It is intendedfor use duringElectroconvulsive therapy(ECT) procedures orwhenever a bite block isrequired to preventocclusion of anendotracheal tube.	The EpiGuard isintended for theprevention of oral softtissue damage duringepileptic tonic-clonicseizures proceeded byan aura	The Somatics Ventil-Aoral protector is asingle-use oralprotector for use duringseizures induced byelectroconvulsivetherapy, spontaneousseizures, andcircumstance requiringprotection of the teeth,lips, tongue, and buccalmucosa (e.g., duringcardioversion)
Product Code	JXL	JXL	JXL
TechnicalCharacteristics	Combination device withairway, bite block andtongue depressor	Combination device withairway and bite block	Combination devicewith airway and biteblock
Biocompatibility	Meets ISO 10993requirements	Not known	Not known
Materials	Pellethane	Silicone	Not known
Sterility	Non Sterile	Non Sterile	Not known

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the Airway with Bite Block and Tongue Depressor is substantially equivalent to the predicates as an oral airway and bite block.

Regulation Number and Section

§ 882.5070 Bite block.

(a)
Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.(b)
Classification. Class II (performance standards).