(119 days)
Not Found
No
The 510(k) summary describes a physical medical device (oral airway and bite block) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are focused on physical properties and biocompatibility.
No
The device is described as an airway and bite block used to establish a patent airway and prevent teeth occlusion, which are supportive functions during medical procedures, rather than actively treating a disease or condition.
No
The device is described as an oral airway and bite block, used to establish and maintain a patent airway and prevent tooth occlusion. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly describes a physical medical device (oral airway and bite block) available in different sizes, and the performance studies involve physical testing (compression testing) and biocompatibility, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Airway with Bite Block and Tongue Depressor is a physical device inserted into the mouth to maintain an open airway and prevent biting. It does not analyze any biological samples.
- Intended Use: The intended use is to establish and maintain a patent airway and prevent teeth occlusion, which are mechanical functions, not diagnostic ones.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXL, CAE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesia provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were conducted:
Product compression testing
Biocompatibility to ISO 10993
Cytotoxicity
Irritation or Intracutaneous Reactivity
Sensitization
Oral Toxicity
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Epiguard (K050188), Veni-A-Oral Protector (K992269)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5. 510(k) Summary or 510(k) Statement
| 510(k) Owner | Dupaco Inc.
4144 Avenida de la Plata
Oceanside, CA 92056
TEL: 800.546.4550
FAX: 760.758.1465 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Greg Holland
Regulatory Consultant to Dupaco Inc.
Regulatory Specialists, Inc.
3722 Ave. Sausalito
Irvine, CA 92606
TEL: 949.262-0411
FAX: 949.552.2821
EMAIL: 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.
4
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
and Tongue Depressor | Epiguard (K050188) | Ventil-A (K992269) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The EpiGuard is
intended for the
prevention of oral soft
tissue damage during
epileptic tonic-clonic
seizures proceeded by
an aura | The Somatics Ventil-A
oral protector is a
single-use oral
protector for use during
seizures induced by
electroconvulsive
therapy, spontaneous
seizures, and
circumstance requiring
protection of the teeth,
lips, tongue, and buccal
mucosa (e.g., during
cardioversion) |
| Product Code | JXL | JXL | JXL |
| Technical
Characteristics | Combination device with
airway, bite block and
tongue depressor | Combination device with
airway and bite block | Combination device
with airway and bite
block |
| Biocompatibility | Meets ISO 10993
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.