MADgic Laryngo-Tracheal Mucosal Atomization Device

K153470 · Teleflex Medical · CCT · Aug 19, 2016 · Anesthesiology

Device Facts

• Record ID: K153470
• Device Name: MADgic Laryngo-Tracheal Mucosal Atomization Device
• Applicant: Teleflex Medical
• Product Code: CCT · Anesthesiology
• Decision Date: Aug 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5170
• Device Class: Class 2

Intended Use

The MADgic Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.

Device Story

Device is a disposable, non-sterile manual atomizer used in hospitals and sub-acute facilities by physicians. It consists of a syringe, luer lock adapter, semirigid tubular extension, and atomizer tip. Clinician draws topical anesthetic into syringe, attaches to device, and positions tubing in patient's oropharynx or upper airway. Compressing syringe plunger forces fluid through tubular extension into atomizer tip; tip spins fluid to create a fine particle spray (30-100 microns) distributed onto mucosal surfaces (mouth, pharynx, hypopharynx, epiglottis, vocal cords, larynx, trachea). Direct visualization via laryngoscope guides application. Device facilitates topical anesthesia prior to intubation, potentially improving patient comfort and procedure success.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included visual inspection, flow rate validation, leak testing, hydrostatic pressure testing (300 psi), atomization function, and tensile strength (>= 6.0 lb). Biocompatibility testing (cytotoxicity, sensitization, irritation) met ISO 10993-1 requirements.

Technological Characteristics

Manual, non-sterile, disposable atomizer. Materials: PVC (tubing), Polyvinyl Chloride (luer adapter), 302 Stainless Steel (wire), Polycarbonate (spray tip), K-Resin (tip insert), Polypropylene (syringe). Dimensions: 4.8mm tip diameter; 4.9-8.9 inch applicator length. Particle size: 30-100 microns. Conical fittings per ISO 540-2:1998; syringes per ISO 7886-1:1993.

Indications for Use

Indicated for patients requiring topical anesthetic before intubation.

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 (K002255)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2016

Teleflex Medical Kristen Bisanz Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, NC 27560

Re: K153470

Trade/Device Name: MADgic™ Laryngo-Tracheal Mucosal Atomization Device Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: Class II Product Code: CCT Dated: July 22, 2016 Received: July 25, 2015

Dear Kristen Bisanz:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, James J. Lee -S

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

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# Indications for Use

510(k) Number (if known) K153470

#### Device Name

MADgic Laryngo-Tracheal Mucosal Atomization Device

Indications for Use (Describe)

The MADgic Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.

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

### MADgicTM Laryngo-Tracheal Mucosal Atomization Device

#### Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: [phone].433.4996 Fax:

#### Contact Person

Kristen Bisanz Regulatory Affairs Specialist

#### Date Prepared

December 01, 2015

#### Device Name

| Trade Name: | MADgic™ Laryngo-Tracheal Mucosal Atomization<br>Device |
|-----------------------|--------------------------------------------------------|
| Classification Name: | Applicator, Laryngo-Tracheal, Topical Anesthesia |
| Product Code: | CCT |
| Regulation Number: | 868.5170 |
| Classification: | II |
| Classification Panel: | Anesthesiology |

#### Predicate Device

This submission demonstrates substantial equivalence to the predicate device MADgic™ Laryngo-Tracheal Mucosal Atomization Device which was cleared in submission K002255.

#### Device Description

The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable nonsterile device that converts a solution of topical anesthetic into a fine particle spray for application to mucosal surfaces. The device consists of an atomizer tip, a semirigid tubular extension, a standard luer lock adapter and a syringe. The clinician draws up the desired volume of topical anesthetic into the syringe, attaches it to the luer lock fitting of the atomizer, and manipulates the tubing extensions into the desired position. As the syringe plunger is compressed, the anesthetic is forced into the tubular extension and out of the atomizer tip. The tip takes the pressurized fluid column and begins spinning it, allowing the fluid to exit the small hole at the end in a

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cone shaped spray. The anesthetic mist is gently distributed onto the mucosal surface in front of this tip. Topical anesthesia application can begin in the mouth and pharynx, and then proceed to the hypopharynx, epiglottis and vocal cords, larynx and trachea via direct visualization using a laryngoscope.

#### Indications for Use

The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.

#### Patient Population

This device is for patients requiring topical anesthetic before intubation.

#### Environments of use

The environments of use are hospitals and sub-acute facilities as directed by a physician.

#### Contraindications

There are no contraindications for this device.

#### Substantial Equivalence

The proposed device is substantially equivalent to the predicate device:

| Predicate Device | Manufacturer | 510(k) Number | Date Cleared | System Dead Space | MAD600/600OS = 0.25mL<br>MAD700-730/730OS =<br>0.19mL<br>MAD720 = 0.13mL | MAD600/600OS<br>= 0.24mL<br>MAD700-730/730OS<br>= 0.18mL<br>MAD720 = 0.12mL | Equivalent |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------|
| MADgic™ Laryngo-Tracheal<br>Mucosal Atomization Device | Wolfe Tory<br>Medical | K002255 | September<br>19, 2000 | Tip Diameter | 0.19 inches (4.8mm) | 0.19 inches (4.8mm) | Identical |
| | Predicate<br>K002255<br>MADgicTM Laryngo-<br>Tracheal Mucosal<br>Atomization Device | Proposed MADgicTM<br>Laryngo-Tracheal<br>Atomization Device | Equivalence | Applicator Length | MAD600/600OS<br>= 8.5 inches (21.6cm)<br>MAD720/730/730OS<br>= 4.5 inches (11.4cm) | MAD600/600OS<br>= 8.9 inches (22.6cm)<br>MAD720/730/730OS<br>= 4.9 inches (12.4cm) | Equivalent |
| Classification Name | Applicator, Laryngo-<br>Tracheal, Topical Anesthesia | Applicator, Laryngo-<br>Tracheal, Topical Anesthesia | Identical | Sterilization | Non-Sterile | Non-Sterile | Identical |
| Device Name | MADgic™ Laryngo-<br>Tracheal Mucosal<br>Atomization Device | MADgic™ Laryngo-<br>Tracheal Mucosal<br>Atomization Device | Identical | Packaging | Packaged individually in<br>polyethylene pouches with<br>twenty-five (25) devices<br>per inner carton, four (4)<br>cartons per case (for a total<br>of 100 devices) | Packaged individually in<br>polyethylene pouches with<br>twenty-five (25) devices<br>per inner carton, four (4)<br> | Identical |
| Common Name | Atomizer | Atomizer | Identical | Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
| Product Code | 73CCT | 73CCT | Identical | Dosage Amount | User Controlled | User Controlled | Identical |
| Classification | Class II | Class II | Identical | Material for Tubing | Alpha Gary 2222R-90 | Colorite Polymers<br>Unichem, 9088-015, Clear,<br>DEHP-Free PVC | Equivalent |
| Regulation Number | 868.5170 | 868.5170 | Identical | Material for Luer<br>Adaptor | Polycarbonate | Polyvinyl Chloride 2014 G-<br>010 | Equivalent |
| Indications for Use | The MADgic™ Laryngo-<br>Tracheal Mucosal<br>Atomization Device is<br>intended for the application<br>of topical anesthetics to the<br>oropharynx and upper<br>airway region. | The MADgic™ Laryngo-<br>Tracheal Mucosal<br>Atomization Device is<br>intended for the application<br>of topical anesthetics to the<br>oropharynx and upper airway<br>region. | Identical | Material for Wire | 302 Stainless Steel | 302 Stainless Steel | Identical |
| Prescription | Yes | Yes | Identical | Material for Spray<br>Tip | Dow Calibre 2081-15,<br>Polycarbonate | Dow Calibre 2081-15,<br>Polycarbonate | Identical |
| Environment of Use | Hospitals, Sub-acute<br>facilities, and emergency<br>medical services | Hospitals, Sub-acute<br>facilities, and emergency<br>medical services | Identical | Material for Spray<br>Tip Insert | Chevron K-Resin, KR03 | Chevron K-Resin, KR03 | Identical |
| Patient Population | Patients requiring topical<br>anesthesia before intubation | Patients requiring topical<br>anesthesia before intubation | Identical | Material for Syringe | Polypropylene and Non-<br>Latex Rubber | Polypropylene and Non-<br>Latex Rubber | Identical |
| Contraindications | None | None | Identical | Material for<br>Adhesive | Cyclohexanone | Cyclohexanone | Identical |
| Shelf Life | Three (3) years from date<br>of manufacture | Three (3) years from date<br>of manufacture | Identical | Material for Foil<br>Hot Stamp | Not present | 100% Virgin, high clarity<br>polyethylene film | Equivalent |
| Typical Particle Size | 30-100 microns | 30-100 microns | Identical | | | | |

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# Comparison to Predicate Device

The proposed device has the same indications for use, operating principles, classification, function, and general design as the predicate device. Biocompatibility testing and performance testing have been performed on the proposed device in order to establish substantial equivalence to the predicate device. The proposed changes to the device do not impact the safety or effectiveness of the MADgic™ Laryngo-Tracheal Mucosal Atomization Device.

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# Materials

All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.

| Test | Acceptance Criteria | Results |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Cytotoxicity - L929<br>MEM Elution Assay | The test article will meet the requirements of the test if it<br>obtains a Grade of 0,1,or 2 (not more than 50% of the cells<br>are round, devoid of intracytoplasmic granules, and no<br>extensive cell lysis) | Acceptable |
| Sensitization -<br>Kligman<br>Maximization Assay | The test article will be considered a non-irritant if the<br>difference between the test article mean score and the<br>vehicle control mean score is 1.0 or less. | Acceptable |
| Irritation -<br>Intracutaneous<br>Injection Assay | The test article will meet the requirements of the test if it<br>receives a Grade of 1, 0 or less using the Kligman scoring<br>system. | Acceptable |

# Performance Data

Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs.

| Test | Test Objective | Acceptance Criteria | Results |
|-------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Visual Inspection | To visually inspect the<br>device for defects of<br>components or assembly | Visually observe for:<br>- Proper assembly and presence of all<br>components<br>- No cracks in the tip and luer<br>- No short shots in the molded<br>components<br>- The presence of solvent around<br>circumference of bonding surface<br>covering a minimum of one third of<br>the total area<br>- No gaps between the insert post and<br>tubing | Pass |
| Flow Test | To validate the flow rate<br>of the device | The flow rate should be greater than<br>or equal to 225 sccm and less than or<br>equal to 700 sccm. | Pass |
| Leak Test | To validate the leak<br>value of the device | The leak value should be less than or<br>equal to 0.05psi. | Pass |
| Hydrostatic Test | To validate the effect of<br>hydrostatic pressure on<br>the device | The device must remain assembled<br>after being subjected to a minimum<br>300psi hydrostatic pressure. | Pass |

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| Atomization Test<br>Post Hydrostatic | To validate the<br>atomization function of<br>the device | Upon atomization there can be no<br>streaming, no excessive dripping, or<br>occlusions. | Pass |
|--------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------|------|
| Tensile | To validate the tensile<br>strength of the device | The tensile strength should be greater<br>than or equal to 6.0 lb. | Pass |

The testing below summarizes the specification verification.

| Test | Specification | Acceptance Criteria |
|----------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------|
| Typical Particle Size | 30-100 microns | N/A. Specification Study. |
| System Dead Space | MAD600/600OS = 0.24mL<br>MAD700-730/730OS = 0.18mL<br>MAD720 = 0.12mL | N/A. Specification Study. |
| Tip Diameter | 0.19 inches (4.8 mm) | N/A. Specification Study. |
| Applicator Length | MAD600/6000S/700 =<br>8.9 inches<br>MAD720/730/730OS =<br>4.9 inches | N/A. Specification Study. |
| Conical Fittings with<br>6% Taper | Clauses 4.1-4.1 of ISO 540-2:1998 | Certificate of Conformance<br>from the Supplier |
| Sterile Hypodermic<br>Syringes of Single Use | ISO 7886-1:1993 | Certificate of Conformance<br>from the Supplier |

### Conclusion

Based on the performance and comparative test results, the proposed MADgic™ Laryngo-Tracheal Mucosal Atomization Device is substantially equivalent to the predicate device cleared to market in K002255. The modifications made to the MADgic™ Laryngo-Tracheal Mucosal Atomization Device do not introduce any new issues of safety and effectiveness.