The proposed device delivers the solution through the nasal passages, directly to the laryngo-tracheal region via a wand-like configuration of the device is placed inside an endotracheal tube for a directed spray. The device is offered in 3 configurations, all supplied with a 3 cc syringe.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study details for the Medicant Mucosal Atomizer, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for Medicant Mucosal Atomizer

The 510(k) summary for the Medicant Mucosal Atomizer does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it demonstrates substantial equivalence to a predicate device (MADgic Laryngo-Tracheal Mucosal Atomization Device, K153470) by comparing key performance characteristics. The acceptance criteria can be inferred from the reported performance of the predicate device, which the new device aims to match or be similar to.

Therefore, the table below presents the performance comparisons that serve as the de facto acceptance criteria for demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Predicate Device Performance - K153470)	Reported Device Performance (Medicant Mucosal Atomizer)
Total Dose Delivered (from a 3ml syringe)	2.8 ml saline	2.9 ml saline
	2.8 ml lidocaine	2.8 ml lidocaine
Particle Size MMAD (μm)	18.7 μm saline	18.8 μm saline
	18.7 μm lidocaine	18.7 μm lidocaine
Plume Geometry	Similar	Similar
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous (passed/non-toxic for predicate)	Cytotoxicity, Sensitization, Irritation, Particulate Material, Toxicology Risk Assessment (tested, found non-cytotoxic, non-sensitizers, non-irritant)
Delivery form	Fine mist spray	Fine mist spray
Indications for Use	Application of topical anesthetics to the oropharynx and upper airway region	Application of topical anesthetics to the oropharynx and upper airway region
Patient Population	Individuals requiring topical anesthetics at the direction and discretion of the clinician. (Initially narrowed for predicate, but reference device K070596 used for broader comparison)	Individuals requiring topical anesthetics at the direction and discretion of the clinician.
Environment of Use	Hospitals and clinical settings where topical anesthetic solutions are needed.	Hospitals and clinical settings where topical anesthetic solutions are needed.
Rx	Yes	Yes
Design	Single Patient, Disposable, Non-sterile	Single Patient, Disposable, Non-sterile
Components	Syringe, Flexible tube (4.5" and 8.5"), Atomizer tip/nozzle, Nasal cone	Syringe, Flexible tube (4.5" and 8.5"), Atomizer tip/nozzle, Nasal cone
Places Inserted	Nasal, Orotracheal	Nasal, Orotracheal

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical trials or AI algorithm validation. The performance data presented (e.g., total dose, particle size, plume geometry) are likely derived from laboratory bench testing focused on the physical characteristics of the device.

Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for particle size).
Data Provenance: This is not a clinical study. The data provenance is from non-clinical performance testing conducted on the device itself. Given that it's a 510(k) submission, this testing would have been conducted by the manufacturer, Medica Holdings, LLC. The country of origin for the data is not specified but is implicitly where Medica Holdings conducts its R&D and testing. This is a prospective set of tests designed to evaluate the new device against established benchmarks (the predicate).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable. The device is a medical applicator, not an AI or diagnostic device that requires expert-established ground truth from images or other complex data. The "ground truth" for its performance characteristics (e.g., particle size, dose delivery) is established through established laboratory measurement techniques and instrumentation.

4. Adjudication Method for the Test Set

This question is not applicable. As there is no "test set" requiring expert judgment or interpretation (like in imaging studies), no adjudication method was used or needed. Performance is measured objectively through physical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This type of study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is compared. The Medicant Mucosal Atomizer is a physical medical device (an applicator for topical anesthetics), not a diagnostic or AI-powered system, so an MRMC study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question is relevant for AI algorithms. The Medicant Mucosal Atomizer is a physical device, and therefore, no "algorithm only" performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is based on objective physical measurements using scientific equipment and standardized test methods (e.g., particle size analyzers, flow meters for dose delivery). For biocompatibility, the ground truth is established by adherence to recognized standards like ISO 10993 (implied by the testing types: Cytotoxicity, Sensitization, Irritation).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is not an AI algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this device.

Summary

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510(k) Summary

Date Prepared:	04-Apr-2018
Medica Holdings, LLC5200 Meadows Rd Ste 150Lake Oswego, OR 97035
Official Contact:	George ReedPresident
Proprietary or Trade Name:	Medicant Mucosal Atomizer
Common/Usual Name:	Laryngotracheal topical anesthesia applicator
Classification Name:	21CFR 868.5170CCT - Applicator (Laryngo-Tracheal), Topical AnesthesiaClass II
Predicate Device:	K153470 - MADgic Laryngo-Tracheal Mucosal Atomization Device
Reference Device:	K070596 - Sharn Topical Applicator
Device Description:	The proposed device delivers the solution through the nasal passages,directly to the laryngo-tracheal region via a wand-like configuration ofthe device is placed inside an endotracheal tube for a directed spray.The device is offered in 3 configurations, all supplied with a 3 ccsyringe.

Description	With a 3 cc syringe
Nasal cone which is 1.65" long	X
4.5" long tube	X
8.5" long tube	X

Indications for Use:	The Medicant Mucosal Atomizer is intended for the application oftopical anesthetics to the oropharynx and upper airway region.
Patient Population:	Individuals requiring topical analgesia at the direction and discretion ofthe clinician.
Environments of Use:	Hospitals and clinical settings where topical anesthethic solutions areneeded.

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510(k) Summary

Comparison to the predicate device

Device Comparison	Proposed Device	Primary Predicate	Reference Device
	Medicant Mucosal Atomizer	MADgic Laryngo-Tracheal MucosalAtomization DeviceK153470	Sharn Topical ApplicatorK070596
Indicated Use	The Medicant Mucosal Atomizer isintended for the application oftopical anesthetics to the oropharynxand upper airway region	The MADgicTM Laryngo-TrachealMucosal Atomization Device isintended for the application of topicalanesthetics to the oropharynx andupper airway region	Intended for atomizing topicalanesthetics to theoropharynx and upper airway regions
Patient Population	Individuals requiring topicalanesthetics at the direction anddiscretion of the clinician.	Individuals requiring topicalanesthetics at the direction anddiscretion of the clinician.	Individuals requiring topicalanesthetics at the direction anddiscretion of the clinician.
Environment of Use	Hospitals and clinical settings wheretopical anesthetic solutions areneeded.	Hospitals and clinical settings wheretopical anesthetic solutions areneeded.	Hospitals and clinical settings wheretopical anesthetic solutions areneeded.
Rx	Yes	Yes	Yes
Design	Single PatientDisposable, Non-sterile	Single PatientDisposable, Non-sterile	Single PatientDisposable, Non-sterile
Components	SyringeFlexible tube - 4.5" and 8.5"Atomizer tip / nozzleNasal cone	SyringeFlexible tube - 4.5" and 8.5"Atomizer tip / nozzleNasal cone	SyringeFlexible tubeAtomizer tip / nozzle
Places inserted	NasalOrotracheal	NasalOrotracheal	NasalOrotracheal
Total Dose Delivered	2.9 ml saline2.8 ml lidocaine	2.8 ml saline2.8 ml lidocaine	unknown
From a 3 ml syringe
Particle Size MMAD (μm)	18.8 μm saline18.7 μm lidocaine	18.7 μm saline18.7 μm lidocaine	unknown
Plume Geometry	Similar	Similar	unknown
Biocompatibility	CytotoxicitySensitizationIntracutaneous	CytotoxicitySensitizationIntracutaneous	Tested to ISO 10993-1
Delivery form	Fine mist spray	Fine mist spray	Fine mist spray

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510(k) Summary Page 3 of 4 04-Apr-2018

The Medicant Mucosal Atomizer is viewed as substantially equivalent to the predicate device because:

Indications for Use - The indications for use are similar between both devices. Discussion - The indications for use are identical for the proposed device and the predicate - MADgic Laryngo-Tracheal Mucosal Atomization Device - K153470.

Patient Population - The patient population for the proposed device and predicate device are different. The predicate narrowed the patient population to patients requiring intubation. However, we have included a reference device - Sharn Topical Applicator - K070596 - which has a similar patient population to the Medicant Mucosal Atomizer.

Discussion - The difference is patient population between the proposed device and the predicate -MADgic Laryngo-Tracheal Mucosal Atomization Device - K153470 - does not raise different questions of safety and effectiveness. The reference device - Sharn Topical Applicator - K070596 - has similar indications for use, patient population, and environment of use.

Environment of Use - The indications for use are similar between both devices. Discussion - The environment of use are similar for the proposed device and the predicate -MADgic Laryngo-Tracheal Mucosal Atomization Device - K153470.

Technology - The Medicant Mucosal Atomizer delivers the solution through the nasal passages, directly to the laryngo-tracheal region via a wand-like configuration or the device is placed inside an endotracheal tube for a directed spray. The delivery form results in a fine mist spray.

Discussion - The technology is similar for the proposed device as compared to the predicate - MADgic Laryngo-Tracheal Mucosal Atomization Device - K153470.

Non-Clinical Performance Testing Summary -

Non-clinical performance testing included:

Aerosol Performance and Comparison Lidocaine and saline ●
- Total Dose o
- Particle Size (MMAD microns) o
- Geometric Standard Deviation (GSD) O
Plume Geometry - lidocaine and saline
- o Spray Distance
- Velocity O
- Dispersion Angle o
Biocompatibility
Aging / Shelf-life post-aging performance ●
Mechanical drop test, bond tensile strength ●
ISO 594-1 Luer performance .

Biocompatibility of Materials -

The components in patient contact are characterized as similar for the proposed device and the predicate, which is:

. Externally Communicating, Tissue and

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Surface Contact, Mucosa

510(k) Summary Page 4 of 4 04-Apr-2018

. Duration of Use - limited (< 24 hours)
. Cytotoxicity, Sensitization, Irritation, Particulate Material, and Toxicology Risk Assessment

Discussion -

The type of materials as well as the type and duration of patient contact is similar for the proposed and predicate device. Testing of the materials in patient contact were found to be non-cytotoxic, nonsensitizers, and a non-irritant.

Substantial Equivalence Conclusion:

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device did not raise different questions of safety or effectiveness for the intended use when compared with the predicate and can be considered as substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 6, 2018

Medica Holdings, LLC Paul Dryden Consultant 5200 Meadows Rd Ste 150 Lake Oswego, Oregon 97035

Re: K172956

Trade/Device Name: Medicant Mucosal Atomizer Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: Class II Product Code: CCT Dated: March 2, 2018 Received: March 6, 2018

Dear Paul Dryden:

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.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 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).