(274 days)
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.
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.
The provided text describes the 510(k) premarket notification for the UltraEzAir® (UEA1A) device, a laryngotracheal topical anesthesia applicator. It does not contain information about a study that would establish new acceptance criteria or describe a standalone algorithm performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing and comparison of technological characteristics.
Here’s a breakdown of the information as requested, largely based on what is available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable table for the device's main function (topical anesthesia application) in the context of a new efficacy study. Instead, substantial equivalence is claimed based on functional and performance bench testing demonstrating the device is "as safe and effective as the predicate device" and comparison of technological characteristics.
However, the document lists some technical specifications which could be considered performance characteristics or implicitly, "acceptance criteria" against which the device was tested.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate/Functional Testing) | Reported Device Performance (UltraEzAir®) |
|---|---|---|
| Intended Use | Application of topical anesthetic to oropharynx and upper airway region. | Applies topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using airflow. |
| Method of Operation | Similar to predicate device: application of topical anesthetic. | Delivery form is a fine mist using piezoelectric technology and air flow through an endoscope. Device does not come into direct contact with patient. |
| Typical Particle Size | Predicate: 30-100 microns | 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. |
| Rate of Anesthetic Delivery | Predicate: Unknown; Reference: Minimum nebulization rate of 0.25 mL/min | Variable between 0.062 and 0.077 mL/min |
| Flow Rate | Predicate: Unknown | 1.5 L/min |
| Biocompatibility | Per ISO 10993-1, and ISO 18562-1, 18562-2, 18562-3 | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity. Gas Pathway Testing (emissions of particulate matter and volatile organic compounds). |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2 | Testing to IEC 60601-1, IEC 60601-1-2 completed. |
| RFID Interference | Compliance with AIM 7351712 | Testing to AIM 7351712 completed. |
| Human Factors | Evaluation of reprocessing instructions | Reprocessing instructions for the reusable Base were evaluated. |
| Shelf Life (Tubing) | Predicate: 3 years | 2 years from date of manufacture. |
| Use Life (Base Unit) | Predicate: N/A; Reference: 3 Years | 3 years or 2,500 5-minute uses, whichever comes first. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "Animal and Clinical testing were not required for a determination of substantial equivalence of the UltraEzAir®." Therefore, there was no clinical "test set" in terms of patient data. The "test set" refers to samples used for bench testing (e.g., device units for flow rate, particle size, electrical safety testing, biocompatibility testing). The document does not specify the sample sizes for these bench tests, nor their provenance as they are laboratory tests, not data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There was no clinical ground truth established for a test set of patient data, as no animal or clinical testing was required for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical ground truth or human interpretation requiring an adjudication method.
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
Not applicable. This device is a topical anesthesia applicator, not an AI-powered diagnostic or interpretive device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument for drug delivery, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects, the "ground truth" was established by engineering and quality assurance standards and specifications. For instance, particle size was measured, flow rates were quantified, and biocompatibility was assessed against ISO standards. The effectiveness and safety are deemed "substantially equivalent" to the predicate device, implying that the predicate's established performance serves as the benchmark or "ground truth" for general device function.
8. The sample size for the training set
Not applicable. This document is for a medical device (hardware and single-use components) and does not describe an AI or software algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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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"
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(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.
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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
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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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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), TopicalAnesthesia | |
| Review Panel: | Anesthesiology | |
| Predicate Device: | Clearance: | K153470 dated August 19, 2016 |
| Trade/Device Name: | MADgic Laryngo-Tracheal Mucosal AtomizationDevice | |
| Manufacturer: | TELEFLEX MEDICAL | |
| Regulation Number: | 21 CFR 868.5170 |
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| Regulation Name: | Laryngotracheal topical anesthesia applicator | ||
|---|---|---|---|
| Regulation Class | Class II | ||
| Product Code: | CCT - Applicator (Laryngo-Tracheal), TopicalAnesthesia | ||
| 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 PredicateDevice | A - Wellestablishedmethods | B - Meets orexceeds expectedpredicateperformance | C - Unmitigateduse-related ordesign-relatedsafety issues | D - Associateddesign-relatedrecall |
|---|---|---|---|---|
| MADgic Laryngo-Tracheal MucosalAtomizationDevice | Used relevantmethods that werepublished in thepublic domain | History of safe use,established due toduration of deviceon the market | No knownunmitigated use-related or designrelated safetyissues | No design-related recallidentified |
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.
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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.
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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 atopical anesthesiaapplicator used toapply topical anestheticto a patient'soropharynx and upperairway region throughthe working channel ofa flexible nasallaryngoscope using airflow. The device isdesigned for andintended to be used byphysicians trained andexperienced in flexibleendoscopic techniquesfor elective outpatientprocedures such as:- Transnasalesophagoscopy- Fiberopticendoscopic evaluationof swallowing withsensory testing(FEES/ST)- Vocal fold injections- Laryngeal biopsies- Laryngeal massexcisions- Laser excisions- Stroboscopy Dynamicvoice assessment- Dynamic voiceassessment- Peritonsillar abscessdrainage | The MADgic™LaryngoTrachealMucosal AtomizationDevice is intended forthe application oftopical anesthetics tothe oropharynx andupper airway region. | The AireHealth™Nebulizer electronicvibrating meshnebulizer is designed tonebulize liquidmedications forinhalation by a patient.The AireHealth™Nebulizer may be usedin adults or children 5years of age and older.The AireHealth™Nebulizer is a portableNebulizer for use in andout of the homeenvironment.The AireHealth™Nebulizer is notintended as a lifesustaining or lifesupporting device. TheAireHealth™ Nebulizeris not intended for usewith Pentamidine. |
| Device | Subject Device | Predicate Device | Reference Device |
| The safety andeffectiveness of thisdevice for use in theperformance of topicalanesthesia of the lowerairways (below thelevel of the trachea)have not beenestablished. | |||
| Regulation Number | 21 CFR 868.5170 | 21 CFR 868.5170 | 21 CFR 868.5630 |
| Regulation Name | Laryngotracheal TopicalAnesthesia Applicator | Laryngotracheal TopicalAnesthesia Applicator | Nebulizer |
| Device Class | Class II | Class II | Class II |
| Product Code | CCT | CCT | CAF |
| Product Classification | Applicator (Laryngo-Tracheal), TopicalAnesthesia | Applicator (Laryngo-Tracheal), TopicalAnesthesia | Nebulizer (DirectPatient Interface) |
| Prescription Use | Yes | Yes | Yes |
| Intended Use | |||
| Method of Operation | Application of topicalanesthetic to apatient's oropharynxand upper airwayregion through theworking channel of theflexible nasallaryngoscope using airflow | Application of topicalanesthetics to theoropharynx and upperairway region | Nebulization of liquidmedications forinhalation by a patientthough the nasal ororal cavity |
| Environment of Use | Professional healthcaresetting | Professional healthcaresetting | In Home or Out ofHome Use |
| Patient Population | Adult patients requiringtopical anesthesia oforopharynx and upperairway region prior toendoscopicexamination | Patients requiringtopical anesthesiabefore intubation | Children 5 years of ageor older and adultsrequiring nebulizedliquid medication forinhalation |
| Intended Medications | 4% topical lidocainesolution | Topical anestheticsolution (including 4%topical lidocaine) | Liquid medication forinhalation |
| Dosage Amount | User Controlled –Maximum of 0.4 ml (16mg) of 4% topicallidocaine solution atHigh Mist Densitysetting during typical 5-minute delivery time | User Controlled –2.8 ml lidocaine from a3ml Syringe | Unknown |
| Device | Subject Device | Predicate Device | Reference Device |
| Device Features | |||
| Typical Particle Size | 70% of particles aregreater than 11.72microns and averageparticle size is 12microns. Particle sizerange is 0.54 to > 14.9microns.- | 30-100 microns | 2.0-6.0 microns |
| PiezoelectricTransducer OperatingFrequency | 1.66 MHz ± 50 kHz | N/A | 115kHz |
| Method of Operation | Previous SubmissionDelivery form is a finemist using piezoelectrictechnology and air flowthrough an endoscope.Device does not comeinto direct contact withpatient. | Delivery form is a finespray mist generatedby piston syringe.Device comes intodirect contact withpatient | Inhalation by a patient.Nebulizes liquidmedications usingvibrating meshnebulizer incorporatedwith a piezoelectrictransducer. |
| Visualization of TargetAnatomy | Flexible NasalLaryngoscope | Laryngoscope | N/A |
| Rate of AnestheticDelivery | Variable between 0.062and 0.077 mL/min | Unknown | Minimum nebulizationrate 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 ofmanufacture | Three (3) years fromdate of manufacture | N/A |
| Use Life of Unit | 3 years or 2,500 5-minute uses whichevercomes 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% RelativeHumidity | Unknown | 15 to 90% RelativeHumidity |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 |
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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 (< 24 hrs) with indirect gas pathway contact. The biocompatibility evaluation for the UltraEZAir device was conducted in accordance with the guidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation
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and Testing Within a Risk Management Process," The testing included the following:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
Per ISO 18562-1 "Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process", Gas Pathway Testing using the methods in ISO 18562-2 "Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter" and ISO 18562-3 "Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)" was completed as part of the biocompatibility testing.
Summary of Non-Clinical Functional and Performance Testing
Reprocessing instructions for the reusable Base were evaluated in the Human Factors testing.
Non-clinical bench performance testing was performed on the subject device including verification/validation testing to functional specifications, which demonstrated that the device is as safe and effective as the predicate device.
The following Functional and Performance Bench testing has been completed:
Testing to IEC 60601-1, IEC 60601-1-2 Testing to AIM 7351712 for RFID Interference Device Characterization for: Flow Rate, Delivery Rate, Particle Size, Back Pressure, Pressure Over Time, Air Flow Rate Over Time, and Filter Efficiency Human Factors Engineering per IEC 62366 Small Bore Connections Evaluation System Verification: Inspection and Non-Functional System Labeling Inspection Packaging/Shipping Validation
Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new
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questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the subject device.
Summary of Animal and Clinical Data
Animal and Clinical testing were not required for a determination of substantial equivalence of the UltraEzAir®.
1.8 Shelf Life
The useful life of the Base was determined to be 3 years after purchase or 2,500 5-minute uses, whichever comes first.
The shelf life of the non-sterile Mist Assembly and Delivery Lines were evaluated by AirKor® and it has been concluded that the Mist Assembly and Delivery Lines are not susceptible to degradation that would lead to functional failure. However, the shelf life of the Mist Assembly and Delivery Lines were determined to be two years from date of manufacture.
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1.9 Conclusion
AirKor® considers the UltraEzAir® to be substantially equivalent to the The MADgic Laryngo-Tracheal Mucosal Atomization Device. The information presented in the 510(k) supports that the UltraEzAir® is as safe, as effective, and performs as well as the predicate devices and is substantially equivalent to the identified predicate and reference devices in design rationale, methodology of use, and performance.
§ 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).