Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm

K150518 · Dupaco, Inc. · JXL · Jun 29, 2015 · Neurology

Device Facts

• Record ID: K150518
• Device Name: Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
• Applicant: Dupaco, Inc.
• Product Code: JXL · Neurology
• Decision Date: Jun 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Combined oral airway, bite block, and tongue depressor; used by anesthesia providers in clinical settings. Device maintains patent airway in anesthetized patients while preventing dental occlusion and protecting oral structures. Available in 80mm (medium) and 90mm (large) sizes. Non-sterile, single-use device. Provides physical barrier between teeth to prevent damage during procedures like ECT or to protect endotracheal tubes from occlusion.

Clinical Evidence

Bench testing only. Performance testing included product compression testing and biocompatibility testing (cytotoxicity, irritation/intracutaneous reactivity, sensitization, and oral toxicity) per ISO 10993.

Technological Characteristics

Combination oral airway, bite block, and tongue depressor. Material: Pellethane. Sizes: 80 mm and 90 mm. Non-sterile. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for anesthetized patients requiring a patent airway and bite protection during Electroconvulsive Therapy (ECT) or to prevent occlusion of an endotracheal tube.

Regulatory Classification

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.

Predicate Devices

• Epiguard (K050188)
• Veni-A-Oral Protector (K992269)

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

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 [phone] or [phone] 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 [phone] or [phone] 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

| <span>510(k) Owner</span> | Dupaco Inc.<br>4144 Avenida de la Plata<br>Oceanside, CA 92056<br>TEL: [phone]<br>FAX: [phone] |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Greg Holland<br>Regulatory Consultant to Dupaco Inc.<br>Regulatory Specialists, Inc.<br>3722 Ave. Sausalito<br>Irvine, CA 92606<br>TEL: [phone]<br>FAX: [phone]<br>EMAIL: [e-mail] |
| 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)<br>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 Block<br>and Tongue Depressor | Epiguard (K050188) | Ventil-A (K992269) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The Airway with Bite<br>Block and Tongue<br>Depressor is a combined<br>oral airway and bite block<br>that will allow an<br>anesthesia provider to<br>establish a patent airway<br>in an anesthetized patient<br>while simultaneously<br>preventing occlusion of<br>the teeth. It is intended<br>for use during<br>Electroconvulsive therapy<br>(ECT) procedures or<br>whenever a bite block is<br>required to prevent<br>occlusion of an<br>endotracheal tube. | The EpiGuard is<br>intended for the<br>prevention of oral soft<br>tissue damage during<br>epileptic tonic-clonic<br>seizures proceeded by<br>an aura | The Somatics Ventil-A<br>oral protector is a<br>single-use oral<br>protector for use during<br>seizures induced by<br>electroconvulsive<br>therapy, spontaneous<br>seizures, and<br>circumstance requiring<br>protection of the teeth,<br>lips, tongue, and buccal<br>mucosa (e.g., during<br>cardioversion) |
| Product Code | JXL | JXL | JXL |
| Technical<br>Characteristics | Combination device with<br>airway, bite block and<br>tongue depressor | Combination device with<br>airway and bite block | Combination device<br>with airway and bite<br>block |
| Biocompatibility | Meets ISO 10993<br>requirements | 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.