TOPICAL APPLICATOR

K070596 · Sharn, Inc. · CCT · Jun 21, 2007 · Anesthesiology

Device Facts

• Record ID: K070596
• Device Name: TOPICAL APPLICATOR
• Applicant: Sharn, Inc.
• Product Code: CCT · Anesthesiology
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for atomizing topical anesthetics to the oropharynx and upper airway regions

Device Story

Topical applicator delivers topical anesthetic solutions to oropharynx, upper airway, nasal passages, or endotracheal tubes. Device consists of a syringe, flexible semi-rigid tube, and atomizer tip/nozzle. Clinician attaches syringe to tube; manual depression of piston generates fine particle spray mist. Used in hospitals and sub-acute settings. Device allows user-controlled dosage. Absence of internal malleable wire (found in some predicates) is compensated by K-resin tubing material, allowing clinician to shape tube for anatomical fit. Benefits include targeted delivery of anesthetic to specific sites while minimizing inhalation risk to alveolar regions due to larger particle size compared to nebulizers.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate using cascade impactor measured total dose, residual mass, simulated clinical dose percentage, particle size, and MMAD. Plume geometry evaluated via digital imaging and photographic grid measuring spray distance, velocity, and dispersion angle over time.

Technological Characteristics

Materials: Acetal/Delrin, K-resin, Polyethylene, Polyvinylchloride (PVC). Biocompatibility: ISO 10993-1. Sensing/Actuation: Manual piston syringe. Form factor: Flexible, semi-rigid tube with atomizer tip. Connectivity: None. Sterilization: Not stated (disposable).

Indications for Use

Indicated for atomizing topical anesthetics to the oropharynx and upper airway regions in individuals requiring topical anesthesia at the direction and discretion of a 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

• Wolfe Tory MADgic (K002255)
• Sherwood Monoject syringe (K852544)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "K070596" in a handwritten style. Below this, the words "Topical Applicator" are printed in a smaller, more formal font. The text appears to be part of a label or identifier, possibly related to a product or item.

#### Non-Confidential Summary of Safety and Effectiveness Page 1 of 2

25-May-07

| JUN 2 | 1 | 2007 |
|-------|---|------|
|-------|---|------|

Sharn, Inc. 4517 George Rd. # 200 Tel - 813-889-9614 Fax - 813-886-2701 Tampa, FL 33634 Official Contact: Bruce Tomlinson - President Proprietary or Trade Name: Topical applicator Common/Usual Name: Atomizer Classification Name: Laryngo-Tracheal topical applicator Classification Code: CCT - 21 CFR 868.5170 Device: Topical Applicator Predicate Devices: Wolfe Tory - MADgic - K002255 Sherwood Monoject syringe - K852544 Device Description: The Topical applicator incorporates a small tube with atomizing tip which can connect to a syringe and when placed in the patient's mouth or throat and / or inside an endotracheal tube or in the nasal passages it then delivers topical anesthetic solutions. Indications for Use: Intended for atomizing topical anesthetics to the oropharynx and upper airway regions Environment of Use: Hospitals, sub-acute settings where topical solutions are needed. Patient Population: Individuals requiring topical anesthetic at the direction and discretion of the clinician.

#### Differences Between Other Legally Marketed Predicate Devices

The Sharn Topical Applicator when compared in performance testing for particle size and plume geometry to the predicate, Wolfe Tory MADgic - K002255 was found to be substantially equivalent.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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K070596

Topical Applicator

# Non-Confidential Summary of Safety and Effectiveness
25-May-07

| Features | Predicate<br>Wolfe Tory MADgic K002255 | Proposed Device |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Intended for the application of<br>topical anesthetics to the<br>oropharynx and upper airway region | Intended for the application of topical<br>anesthetics to the oropharynx and<br>upper airway region |
| Types of medications used | Topical solutions, i.e.,<br>Topical anesthetics<br>Vasoconstrictors | Topical solutions, i.e.,<br>Topical anesthetics<br>Vasoconstrictors |
| Environment of Use /<br>Patient population | Not disclosed | Locations where topical anesthetics<br>solutions are used.<br>Individuals requiring topical<br>anesthetic at the direction and<br>discretion of the clinician. |
| Disposable, non-sterile | Yes | Yes |
| Components | Syringe<br>Flexible, malleable, semi-rigid tube<br>Atomizer tip / nozzle | Syringe (k852544)<br>Flexible, semi-rigid tube<br>Atomizer tip / nozzle |
| Places inserted | Nasal, Orotrachael | Nasal. Orotrachael |
| Dosage Amount | User controlled | User controlled |
| Delivery form | Fine particle spray mist | Fine particle spray mist |
| Spray generated by | Piston syringe | Piston syringe |
| Basic dimensions | Tip diameter - 0.157" OD<br>Tube length - 8.25" overall | Tip diameter - 0.31" OD (7.9 mm)<br>Tube length - 8.25" overall |
| Materials | Polycarbonate<br>Polyvinylchloride (PVC) | Acetal/ Delrin, K-resin<br>Polyethylene, Polyvinylchloride |
| Biocompatibility | Unknown | Tested to ISO 10993-1 |
| Performance testing | Comparative using Cascade impactor to measure the following listed<br>criteria | |
| Total Dose | 2.88 cc - Lidocaine | 2.75 cc - Lidocaine |
| Delivered max 3 cc | 2.87 cc - Saline | 2.78 cc - Saline |
| Residual Mass (cc) Ave. | 0.12 cc | 0.25 cc |
| Simulated Clinical Dose % | 94.7% - Lidocaine<br>95.0% - Saline | 92.3% - Lidocaine<br>94.0% - Saline |
| Particle Size | 470 um - Lidocaine<br>470 um - Saline | 835 um - Lidocaine<br>803 um - Saline |
| MMAD (um) | 1.87 um - Lidocaine<br>1.90 um - Saline | 1.93 um - Lidocaine<br>2.00 um - Saline |
| GSD (um) | Similar | Similar |
| Plume Geometry<br>Evaluated using digital<br>image and photographic grid<br>measuring spray distance,<br>velocity, dispersion angle all<br>vs. time | | |

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K070596

Topical Applicator

# Discussion and Table of the Comparison and Differences

. I

| Features | Predicate | Proposed Device |
|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Wolfe Tory MADgic K002255 | |
| Indications for use | Intended for the application of<br>topical anesthetics to the | Intended for the application of topical<br>anesthetics to the oropharynx and |
| | oropharynx and upper airway region | upper airway region |
| Types of medications used | Topical solutions, i.e.,<br>Topical anesthetics,<br>Vasoconstrictors | Topical solutions, i.e.,<br>Topical anesthetics<br>Vasoconstrictors |
| Environment of Use /<br>Patient population | Not disclosed | Locations where topical anesthetics<br>solutions are used.<br>Individuals requiring topical<br>anesthetic at the direction and<br>discretion of the clinician. |
| Disposable, non-sterile | Yes | Yes |
| Components | Syringe<br>Flexible, malleable, semi-rigid tube<br>Atomizer tip / nozzle | Syringe (k852544)<br>Flexible, semi-rigid tube<br>Atomizer tip / nozzle |
| Places inserted | Nasal, Orotrachael | Nasal, Orotrachael |
| Dosage Amount | User controlled | User controlled |
| Delivery form | Fine particle spray mist | Fine particle spray mist |
| Spray generated by | Piston syringe | Piston syringe |
| Device dead space (ml) | 0.12 ml device only | 0.13 ml device only |
| Basic dimensions | Tip diameter - 0.157" OD<br>Tube length - 8.25" overall | Tip diameter – 0.31" OD (7.9 mm)<br>Tube length - 8.25" overall |
| Materials | Polycarbonate<br>Polyvinylchloride (PVC) | Acetal / Delrin, K-resin<br>Polyethylene<br>Polyvinylchloride (PVC) |
| Biocompatibility | Unknown | Tested to ISO 10993-1 |
| Performance testing | Comparative using Cascade impactor to measure the following listed<br>criteria | |
| Total Dose | 2.88 cc - Lidocaine | 2.75 cc - Lidocaine |
| Delivered max 3 cc | 2.87 cc - Saline | 2.78 cc - Saline |
| Residual Mass (cc) Ave. | 0.12 cc | 0.25 cc |
| Simulated Clinical Dose % | 94.7% - Lidocaine<br>95.0% - Saline | 92.3% - Lidocaine<br>94.0% - Saline |
| Particle Size | 470 um - Lidocaine | 835 um - Lidocaine |
| MMAD (um) | 470 um - Saline | 803 um - Saline |
| GSD (um) | 1.87 um - Lidocaine<br>1.90 um - Saline | 1.93 um - Lidocaine<br>2.00 um - Saline |
| Plume Geometry | Similar see Section 18 | Similar see Section 18 |
| Evaluated using digital<br>image and photographic<br>grid measuring spray<br>distance, velocity,<br>dispersion angle all vs. time | | |

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Premarket Notification 510(k) Section 5 - 510(k) Summary

Topical Applicator

# Discussion:

# Particle Size:

While the difference represents a measurable difference, it would not be classified as "substantially different." The intent of the device is to deliver a topical medication to a specific sight in close proximity to the tip. Therefore bigger particles are important, otherwise the medication may be inhaled to another location that is not intended (alveolar). Both particle sizes of the respective devices are sufficiently large to insure this.

The simulated clinical dose for both devices were equal, and almost exactly equal to the "filled dose" minus the "residual", is further verification of this position (i.e., all medication was accounted for at the sight of delivery or remaining in the device. none was inhaled).

Therefore both devices equally performed their function and are "substantially equivalent."

### Tube malleable wire:

The proposed device does not include a malleable wire in the tubing as this is a patented feature. We believe that the intent of the malleable wire was to allow the tube to hold a curve or shape for insertion into the patient's throat. However this feature is not a requirement for any atomizer to be functional.

The lack of a malleable wire does not introduce or create any new safety or performance issues in fact one might consider our design as "safer" as the tube is less stiff. This is not a claim which is proposed to be used or demonstrated.

The use of K-resin for our tubing allows the clinician to bend the tube and for it to "hold" some curve or shape, anatomical, during the intended use.

Therefore there are no significant differences between the proposed device and the predicate.

It is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sharn, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court # 102 Bonita Springs, Florida 34134-2015

JUN 2 1 2007

Re: K070596

Trade/Device Name: Topical Applicator Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: II Product Code: CCT Dated: June 11, 2007 Received: June 12, 2007

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Dryden

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

Page 1 of 1

510(k) Number: K070596 Device Name: Topical applicator Indications for Use: Intended for atomizing topical anesthetics to the oropharynx and upper airway regions

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(k) Number: .................................................................................................................................................................

...

ാന Sign-Off) sion of Anesthesiology, General Hospital, i Control, Dental Devices

Ko70596

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