(274 days)
No
The description focuses on the mechanical and electrical function of the device for delivering topical anesthetic and does not mention any AI/ML components or capabilities.
Yes.
The device is used to apply topical anesthetic to a patient's oropharynx and upper airway region, which is a treatment to numb an area for a medical procedure.
No
The device is used to apply topical anesthesia, which is a treatment, not a diagnostic procedure.
No
The device description explicitly states it is an "electrically driven device" and consists of a reusable Base, Mist Assembly, and Delivery Line, which are all hardware components.
Based on the provided information, the UltraEzAir® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to apply topical anesthetic to a patient's oropharynx and upper airway. This is a therapeutic/procedural application, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as an applicator for nebulized lidocaine solution. It's a delivery system for a drug, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
The device is clearly intended for a medical procedure (topical anesthesia for endoscopy) and not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The UltraEzAir® is a topical anesthesia applicator used to apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures.
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
Product codes (comma separated list FDA assigned to the subject device)
CCT
Device Description
The UltraEzAir® is a prescription medical device intended for application of nebulized 4% topical lidocaine solution to the oropharynx and upper airway region of patients. The subject device is an electrically driven device. The subject device is intended to be used only in an outpatient clinical facility or office for anesthetic procedures by a healthcare professional who is trained by Airkor® on its use.
The UltraEzAir® is intended to be used on adult patients, weighing at least 80 lbs. requiring topical anesthesia of oropharynx and upper airway region prior to endoscopic examination in an outpatient clinical facility or office.
The UltraEzAir® consists of a reusable Base, a single-use non-sterile Mist Assembly placed on the Base, and a single-use nonsterile Delivery Line connected to the Mist Assembly. The Delivery Line is then connected to the working channel of an Olympus or Pentax flexible nasal laryngoscope and the lidocaine mist is applied using the distal end of the attached laryngoscope to adjacent target tissue. The application process is visualized using the attached laryngoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oropharynx and upper airway region
Indicated Patient Age Range
Adult patients, weighing at least 80 lbs.
Intended User / Care Setting
Physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures.
Outpatient clinical facility or office.
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)
Summary of Biocompatibility Testing:
The UltraEZAir is considered to be an externally communicating device with tissue contact for a limited duration (
§ 868.5170 Laryngotracheal topical anesthesia applicator.
(a)
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.(b)
Classification. Class II (performance standards).
0
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 16, 2024
% Eric Bannon Vice President of Regulatory and Clinical Affairs AlvaMed, Inc. 1116 Great Plain Avenue, Suite 1 Needham, Massachusetts 02495
Re: K240114
Trade/Device Name: UltraEzAir® (UEA1A) Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: Class II Product Code: CCT Dated: September 13, 2024 Received: September 13, 2024
Dear Eric Bannon:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240114
Device Name
UltraEzAir® (UEA1A)
Indications for Use (Describe)
The UltraEzAir® is a topical anesthesia apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures.
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
1.1 Name and Address of Submitter
DUALAMS, Inc., dba AIRKOR® 7139 Azalea Lane Dallas, Texas 75081 John Reid President Phone: +1 (972) 327 3345 johnfreid@airkor.com
1.2 Correspondent/Primary Contact Person
Eric Bannon Vice President of Regulatory and Clinical Affairs AlvaMed, Inc. ebannon@alvamed.com Phone: +1 (781) 710-8243 Fax: +1 (617) 249-0955
1.3 Submission Information
Date Summary Prepared:
October 16, 2024
| Subject Device: | Trade/Device Name: | UltraEzAir® |
|---|---|---|
| Manufacturer: | Airkor® | |
| Common Name: | Laryngotracheal topical anesthesia applicator | |
| Regulation Number: | 21 CFR 868.5170 | |
| Regulation Name: | Laryngotracheal topical anesthesia applicator | |
| Regulation Class | Class II | |
| Product Code: | CCT - Applicator (Laryngo-Tracheal), Topical | |
| Anesthesia | ||
| Review Panel: | Anesthesiology | |
| Predicate Device: | Clearance: | K153470 dated August 19, 2016 |
| Trade/Device Name: | MADgic Laryngo-Tracheal Mucosal Atomization | |
| Device | ||
| Manufacturer: | TELEFLEX MEDICAL | |
| Regulation Number: | 21 CFR 868.5170 |
5
| Regulation Name: | Laryngotracheal topical anesthesia applicator | ||
|---|---|---|---|
| Regulation Class | Class II | ||
| Product Code: | CCT - Applicator (Laryngo-Tracheal), Topical | ||
| Anesthesia | |||
| Reference Device: Clearance: | K201167 dated December 3, 2020 | ||
| Trade/Device Name: | AireHealthTM Nebulizer | ||
| Manufacturer: | AireHealth Inc. | ||
| Regulation Number: | 21 CFR 868.5630 | ||
| Regulation Name: | Nebulizer | ||
| Regulation Class | Class II | ||
| Product Code: | CAF Nebulizer (Direct Patient Interface) |
Valid Predicate Discussion
MADgic Laryngo-Tracheal Mucosal Atomization Device was selected as the valid predicate device used to support the 510(k) submission because it was cleared using well-established methods. The predicate device meets the expected predicate performance due to its duration of use. After conducting a search on the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR), MedSun Reports Database, Medical Device Safety & Availability (Biologics) and Recall Database websites it was found that there are no known unmitigated use-related or design safety issues and the predicate device has not been subject to a design-related recall.
| Valid Predicate
Device | A - Well
established
methods | B - Meets or
exceeds expected
predicate
performance | C - Unmitigated
use-related or
design-related
safety issues | D - Associated
design-related
recall |
|--------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------|
| MADgic Laryngo-
Tracheal Mucosal
Atomization
Device | Used relevant
methods that were
published in the
public domain | History of safe use,
established due to
duration of device
on the market | No known
unmitigated use-
related or design
related safety
issues | No design-
related recall
identified |
1.4 Device Description
The UltraEzAir® is a prescription medical device intended for application of nebulized 4% topical lidocaine solution to the oropharynx and upper airway region of patients. The subject device is an electrically driven device. The subject device is intended to be used only in an outpatient clinical facility or office for anesthetic procedures by a healthcare professional who is trained by Airkor® on its use.
6
The UltraEzAir® is intended to be used on adult patients, weighing at least 80 lbs. requiring topical anesthesia of oropharynx and upper airway region prior to endoscopic examination in an outpatient clinical facility or office.
The UltraEzAir® consists of a reusable Base, a single-use non-sterile Mist Assembly placed on the Base, and a single-use nonsterile Delivery Line connected to the Mist Assembly. The Delivery Line is then connected to the working channel of an Olympus or Pentax flexible nasal laryngoscope and the lidocaine mist is applied using the distal end of the attached laryngoscope to adjacent target tissue. The application process is visualized using the attached laryngoscope.
1.5 Indications for Use
The UltraEzAir® is a topical anesthesia applicator used to apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures.
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
1.6 Summary of Technological Characteristics
The principle of operation is the same as the primary predicate device: the subject device is a topical anesthetic applicator. Both devices use tubing for the anesthetic solution to the same mucosal membrane target region. For both the subject and the predicate devices, anesthetic solution is sprayed on the intended patient anatomy. The subject device mist of lidocaine solution is generated in the Mist Assembly, using piezoelectric nebulizer technology. The built-in air pump of the UltraEzAir® pushes the lidocaine mist out of the Mist Assembly, to be applied to the target. Users have three lidocaine mist delivery rates to choose from. The UltraEzAir® is equipped with a safety timer, which stops the generation of mist at 9 minutes of continuous use, and a temperature sensor and indicator, which also stops operation to prevent thermal damage to the internal components.
The following table provides an overview of general technological characteristics in comparison to the predicate and reference devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device. Biocompatibility evaluation testing, reprocessing method evaluation, and performance testing have been performed on the subject device in order to establish substantial equivalence to the predicate devices.
7
Substantial Equivalence Comparison Table
| Device | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Trade Name | UltraEzAir | MADgic™ | AireHealth™ Nebulizer |
| K Number | K240114 | K153470 | K201167 |
| Regulatory | |||
| Indication for Use | The UltraEzAir® is a | ||
| topical anesthesia | |||
| applicator used to | |||
| apply topical anesthetic | |||
| to a patient's | |||
| oropharynx and upper | |||
| airway region through | |||
| the working channel of | |||
| a flexible nasal | |||
| laryngoscope using air | |||
| flow. The device is | |||
| designed for and | |||
| intended to be used by | |||
| physicians trained and | |||
| experienced in flexible | |||
| endoscopic techniques | |||
| for elective outpatient | |||
| procedures such as: |
- Transnasal
esophagoscopy - Fiberoptic
endoscopic evaluation
of swallowing with
sensory testing
(FEES/ST) - Vocal fold injections
- Laryngeal biopsies
- Laryngeal mass
excisions - Laser excisions
- Stroboscopy Dynamic
voice assessment - Dynamic voice
assessment - Peritonsillar abscess
drainage | The MADgic™
LaryngoTracheal
Mucosal Atomization
Device is intended for
the application of
topical anesthetics to
the oropharynx and
upper airway region. | The AireHealth™
Nebulizer electronic
vibrating mesh
nebulizer is designed to
nebulize liquid
medications for
inhalation by a patient.
The AireHealth™
Nebulizer may be used
in adults or children 5
years of age and older.
The AireHealth™
Nebulizer is a portable
Nebulizer for use in and
out of the home
environment.
The AireHealth™
Nebulizer is not
intended as a life
sustaining or life
supporting device. The
AireHealth™ Nebulizer
is not intended for use
with Pentamidine. |
| Device | Subject Device | Predicate Device | Reference Device |
| | The safety and
effectiveness of this
device for use in the
performance of topical
anesthesia of the lower
airways (below the
level of the trachea)
have not been
established. | | |
| Regulation Number | 21 CFR 868.5170 | 21 CFR 868.5170 | 21 CFR 868.5630 |
| Regulation Name | Laryngotracheal Topical
Anesthesia Applicator | Laryngotracheal Topical
Anesthesia Applicator | Nebulizer |
| Device Class | Class II | Class II | Class II |
| Product Code | CCT | CCT | CAF |
| Product Classification | Applicator (Laryngo-
Tracheal), Topical
Anesthesia | Applicator (Laryngo-
Tracheal), Topical
Anesthesia | Nebulizer (Direct
Patient Interface) |
| Prescription Use | Yes | Yes | Yes |
| Intended Use | | | |
| Method of Operation | Application of topical
anesthetic to a
patient's oropharynx
and upper airway
region through the
working channel of the
flexible nasal
laryngoscope using air
flow | Application of topical
anesthetics to the
oropharynx and upper
airway region | Nebulization of liquid
medications for
inhalation by a patient
though the nasal or
oral cavity |
| Environment of Use | Professional healthcare
setting | Professional healthcare
setting | In Home or Out of
Home Use |
| Patient Population | Adult patients requiring
topical anesthesia of
oropharynx and upper
airway region prior to
endoscopic
examination | Patients requiring
topical anesthesia
before intubation | Children 5 years of age
or older and adults
requiring nebulized
liquid medication for
inhalation |
| Intended Medications | 4% topical lidocaine
solution | Topical anesthetic
solution (including 4%
topical lidocaine) | Liquid medication for
inhalation |
| Dosage Amount | User Controlled –
Maximum of 0.4 ml (16
mg) of 4% topical
lidocaine solution at
High Mist Density
setting during typical 5-
minute delivery time | User Controlled –
2.8 ml lidocaine from a
3ml Syringe | Unknown |
| Device | Subject Device | Predicate Device | Reference Device |
| Device Features | | | |
| Typical Particle Size | 70% of particles are
greater than 11.72
microns and average
particle size is 12
microns. Particle size
range is 0.54 to > 14.9
microns.- | 30-100 microns | 2.0-6.0 microns |
| Piezoelectric
Transducer Operating
Frequency | 1.66 MHz ± 50 kHz | N/A | 115kHz |
| Method of Operation | Previous Submission
Delivery form is a fine
mist using piezoelectric
technology and air flow
through an endoscope.
Device does not come
into direct contact with
patient. | Delivery form is a fine
spray mist generated
by piston syringe.
Device comes into
direct contact with
patient | Inhalation by a patient.
Nebulizes liquid
medications using
vibrating mesh
nebulizer incorporated
with a piezoelectric
transducer. |
| Visualization of Target
Anatomy | Flexible Nasal
Laryngoscope | Laryngoscope | N/A |
| Rate of Anesthetic
Delivery | Variable between 0.062
and 0.077 mL/min | Unknown | Minimum nebulization
rate of 0.25 mL/min |
| Flow Rate | 1.5 L/min | Unknown | Unknown |
| Hardware | | | |
| Sterilization | Non-sterile; Single use | Non-sterile; Single use | N/A |
| Shelf Life of Tubing | 2 years from date of
manufacture | Three (3) years from
date of manufacture | N/A |
| Use Life of Unit | 3 years or 2,500 5-
minute uses whichever
comes first | N/A | 3 Years |
| Energy Source | External | Manual | Internal |
| Operating Temperature | 15 to 30 °C | Unknown | 5 to 38 °C |
| Operating Humidity | 30 to 75% Relative
Humidity | Unknown | 15 to 90% Relative
Humidity |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 |
8
9
1.7 Performance Testing Summary
Summary of Biocompatibility Testing:
The UltraEZAir is considered to be an externally communicating device with tissue contact for a limited duration (