Medicant Mucosal Atomizer
Device Facts
| Record ID | K172956 |
|---|---|
| Device Name | Medicant Mucosal Atomizer |
| Applicant | Medica Holdings, LLC |
| Product Code | CCT · Anesthesiology |
| Decision Date | Apr 6, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5170 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Medicant Mucosal Atomizer is intended for the application of topical anesthetics to the oropharynx and upper airway region.
Device Story
The Medicant Mucosal Atomizer is a manual, single-patient, disposable device used in hospitals and clinical settings to deliver topical anesthetic solutions. It consists of a 3 cc syringe, a nasal cone, and a flexible tube (4.5" or 8.5" lengths). The device is operated by a clinician to deliver a fine mist spray through the nasal passages or directly to the laryngo-tracheal region via placement inside an endotracheal tube. By atomizing the anesthetic, the device provides targeted topical analgesia to the oropharynx and upper airway, facilitating procedures requiring airway management or anesthesia.
Clinical Evidence
Bench testing only. Performance testing included aerosol characterization (total dose, MMAD, GSD), plume geometry (spray distance, velocity, dispersion angle), biocompatibility (cytotoxicity, sensitization, irritation), mechanical testing (drop test, bond tensile strength), and ISO 594-1 Luer performance. Aging and shelf-life performance were also evaluated.
Technological Characteristics
Manual, non-sterile, single-patient disposable applicator. Components include a 3 cc syringe, nasal cone, and flexible tubing. Atomization principle via nozzle tip. Materials are biocompatible (ISO 10993-1 compliant). Connectivity: None. Energy source: Manual (syringe-driven).
Indications for Use
Indicated for individuals requiring topical analgesia at the direction and discretion of the clinician.
Regulatory Classification
Identification
A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.
Predicate Devices
- MADgic Laryngo-Tracheal Mucosal Atomization Device (K153470)
Reference Devices
- Sharn Topical Applicator (K070596)
Submission Summary (Full Text)
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## 510(k) Summary
| Date Prepared: | 04-Apr-2018 |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Medica Holdings, LLC<br>5200 Meadows Rd Ste 150<br>Lake Oswego, OR 97035 | |
| Official Contact: | George Reed<br>President |
| Proprietary or Trade Name: | Medicant Mucosal Atomizer |
| Common/Usual Name: | Laryngotracheal topical anesthesia applicator |
| Classification Name: | 21CFR 868.5170<br>CCT - Applicator (Laryngo-Tracheal), Topical Anesthesia<br>Class 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,<br>directly to the laryngo-tracheal region via a wand-like configuration of<br>the device is placed inside an endotracheal tube for a directed spray.<br>The device is offered in 3 configurations, all supplied with a 3 cc<br>syringe. |
| 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 of<br>topical anesthetics to the oropharynx and upper airway region. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Individuals requiring topical analgesia at the direction and discretion of<br>the clinician. |
| Environments of Use: | Hospitals and clinical settings where topical anesthethic solutions are<br>needed. |
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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 Mucosal<br>Atomization Device<br>K153470 | Sharn Topical Applicator<br>K070596 |
| Indicated Use | The Medicant Mucosal Atomizer is<br>intended for the application of<br>topical anesthetics to the oropharynx<br>and upper airway region | The MADgicTM Laryngo-Tracheal<br>Mucosal Atomization Device is<br>intended for the application of topical<br>anesthetics to the oropharynx and<br>upper airway region | Intended for atomizing topical<br>anesthetics to the<br>oropharynx and upper airway regions |
| Patient Population | Individuals requiring topical<br>anesthetics at the direction and<br>discretion of the clinician. | Individuals requiring topical<br>anesthetics at the direction and<br>discretion of the clinician. | Individuals requiring topical<br>anesthetics at the direction and<br>discretion of the clinician. |
| Environment of Use | Hospitals and clinical settings where<br>topical anesthetic solutions are<br>needed. | Hospitals and clinical settings where<br>topical anesthetic solutions are<br>needed. | Hospitals and clinical settings where<br>topical anesthetic solutions are<br>needed. |
| Rx | Yes | Yes | Yes |
| Design | Single Patient<br>Disposable, Non-sterile | Single Patient<br>Disposable, Non-sterile | Single Patient<br>Disposable, Non-sterile |
| Components | Syringe<br>Flexible tube - 4.5" and 8.5"<br>Atomizer tip / nozzle<br>Nasal cone | Syringe<br>Flexible tube - 4.5" and 8.5"<br>Atomizer tip / nozzle<br>Nasal cone | Syringe<br>Flexible tube<br>Atomizer tip / nozzle |
| Places inserted | Nasal<br>Orotracheal | Nasal<br>Orotracheal | Nasal<br>Orotracheal |
| Total Dose Delivered | 2.9 ml saline<br>2.8 ml lidocaine | 2.8 ml saline<br>2.8 ml lidocaine | unknown |
| From a 3 ml syringe | | | |
| Particle Size MMAD (μm) | 18.8 μm saline<br>18.7 μm lidocaine | 18.7 μm saline<br>18.7 μm lidocaine | unknown |
| Plume Geometry | Similar | Similar | unknown |
| Biocompatibility | Cytotoxicity<br>Sensitization<br>Intracutaneous | Cytotoxicity<br>Sensitization<br>Intracutaneous | 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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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
