(192 days)
No
The device description and performance studies focus on mechanical and aerosol delivery characteristics, with no mention of AI or ML terms or functionalities.
No
The device is used to apply topical anesthetics, which are drugs, not to directly treat a disease or condition itself. It's a delivery system for a therapeutic agent, but not a therapeutic device in its own right.
No
The device is described as an atomizer for applying topical anesthetics, indicating a therapeutic or procedural function rather than diagnosis.
No
The device description clearly outlines a physical device with a wand-like configuration, syringe, and different configurations, indicating it is a hardware device for delivering a solution. The performance studies also focus on physical characteristics like aerosol performance, particle size, and mechanical testing.
Based on the provided information, the Medicant Mucosal Atomizer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medicant Mucosal Atomizer is a device used to deliver a substance (topical anesthetics) to a specific anatomical site (oropharynx and upper airway region). It is a delivery system, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for the "application of topical anesthetics," which is a therapeutic or procedural application, not a diagnostic one.
- Device Description: The description focuses on the mechanism of delivery (atomization, wand configuration, syringe) and its use within an endotracheal tube, all related to drug delivery.
- Performance Studies: The performance studies listed are related to the physical characteristics and delivery capabilities of the device (aerosol performance, particle size, spray characteristics, biocompatibility, mechanical testing), not the accuracy or performance of a diagnostic test.
Therefore, the Medicant Mucosal Atomizer is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medicant Mucosal Atomizer is intended for the application of topical anesthetics to the oropharynx and upper airway region.
Product codes
CCT
Device Description
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.
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
Not Found
Intended User / Care Setting
Hospitals and clinical settings where topical anesthetic solutions are needed.
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
Non-clinical performance testing included:
- Aerosol Performance and Comparison Lidocaine and saline
- Total Dose
- Particle Size (MMAD microns)
- Geometric Standard Deviation (GSD)
- Plume Geometry - Lidocaine and saline
- Spray Distance
- Velocity
- Dispersion Angle
- Biocompatibility
- Aging / Shelf-life post-aging performance
- Mechanical drop test, bond tensile strength
- ISO 594-1 Luer performance
Key Metrics
Not Found
Predicate Device(s)
K153470 - MADgic Laryngo-Tracheal Mucosal Atomization Device
Reference Device(s)
K070596 - Sharn Topical Applicator
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
| Date Prepared: | 04-Apr-2018 |
|---|---|
| Medica Holdings, LLC | |
| 5200 Meadows Rd Ste 150 | |
| Lake Oswego, OR 97035 | |
| Official Contact: | George Reed |
| President | |
| Proprietary or Trade Name: | Medicant Mucosal Atomizer |
| Common/Usual Name: | Laryngotracheal topical anesthesia applicator |
| Classification Name: | 21CFR 868.5170 |
| CCT - Applicator (Laryngo-Tracheal), Topical Anesthesia | |
| 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, |
| 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. |
| 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
topical anesthetics to the oropharynx and upper airway region. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Individuals requiring topical analgesia at the direction and discretion of
the clinician. |
| Environments of Use: | Hospitals and clinical settings where topical anesthethic solutions are
needed. |
1
510(k) Summary
Comparison to the predicate device
| Device Comparison | Proposed Device | Primary Predicate | Reference Device |
|---|---|---|---|
| Medicant Mucosal Atomizer | MADgic Laryngo-Tracheal Mucosal | ||
| Atomization Device | |||
| K153470 | Sharn Topical Applicator | ||
| K070596 | |||
| Indicated Use | The Medicant Mucosal Atomizer is | ||
| intended for the application of | |||
| topical anesthetics to the oropharynx | |||
| and upper airway region | The MADgicTM Laryngo-Tracheal | ||
| Mucosal Atomization Device is | |||
| intended for the application of topical | |||
| anesthetics to the oropharynx and | |||
| upper airway region | Intended for atomizing topical | ||
| anesthetics to the | |||
| oropharynx and upper airway regions | |||
| Patient Population | Individuals requiring topical | ||
| anesthetics at the direction and | |||
| discretion of the clinician. | Individuals requiring topical | ||
| anesthetics at the direction and | |||
| discretion of the clinician. | 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. | Hospitals and clinical settings where | ||
| topical anesthetic solutions are | |||
| needed. | |||
| Rx | Yes | Yes | Yes |
| Design | Single Patient | ||
| Disposable, Non-sterile | 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 | Syringe | ||
| Flexible tube | |||
| Atomizer tip / nozzle | |||
| Places inserted | Nasal | ||
| Orotracheal | Nasal | ||
| Orotracheal | Nasal | ||
| Orotracheal | |||
| Total Dose Delivered | 2.9 ml saline | ||
| 2.8 ml lidocaine | 2.8 ml saline | ||
| 2.8 ml lidocaine | unknown | ||
| From a 3 ml syringe | |||
| Particle Size MMAD (μm) | 18.8 μm saline | ||
| 18.7 μm lidocaine | 18.7 μm saline | ||
| 18.7 μm lidocaine | unknown | ||
| Plume Geometry | Similar | Similar | unknown |
| Biocompatibility | Cytotoxicity | ||
| Sensitization | |||
| Intracutaneous | Cytotoxicity | ||
| Sensitization | |||
| Intracutaneous | Tested to ISO 10993-1 | ||
| Delivery form | Fine mist spray | Fine mist spray | Fine mist spray |
2
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
3
- Surface Contact, Mucosa
510(k) Summary Page 4 of 4 04-Apr-2018
- . Duration of Use - limited (