SOOTHE-N-SEAL CANKER SORE RELIEF

K991923 · Closure Medical Corp. · MZW · Sep 2, 1999 · Dental

Device Facts

• Record ID: K991923
• Device Name: SOOTHE-N-SEAL CANKER SORE RELIEF
• Applicant: Closure Medical Corp.
• Product Code: MZW · Dental
• Decision Date: Sep 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

Device Story

SOOTHE-N-SEAL™ is a liquid protectant composed of 2-octyl cyanoacrylate (>99%) with polymerization inhibitors. Packaged in multi-use dropper bottles with polyurethane foam-tipped applicators. Used by patients in an over-the-counter (OTC) setting. Upon application to oral tissue, the liquid polymerizes within ~5 seconds to form a thin, flexible, protective film. The film acts as a physical barrier against irritants, providing immediate and long-lasting pain relief. The film remains adhered until natural tissue sloughing or mechanical displacement occurs. Patients self-apply up to four times daily. Clinical studies demonstrate immediate pain reduction comparable to predicate devices and superior long-term pain reduction (over 4 hours) compared to the Carrington® OraPatch™.

Clinical Evidence

Two clinical studies conducted. Study 1: 42 subjects, randomized, investigator-applied. Study 2: 155 subjects, multi-center, randomized, self-applied (4x/day) vs. Carrington® OraPatch™ and negative control (water). Primary endpoints: pain reduction (challenged/unchallenged) and ulcer healing. Results: 76% of subjects reported immediate pain reduction; 4-hour pain reduction was superior to OraPatch™. No significant adverse effects on healing or safety observed. Bench testing confirmed polymerization time and film characteristics.

Technological Characteristics

Composition: 2-octyl cyanoacrylate (>99%) with polymerization inhibitors. Form: Clear, colorless, free-flowing liquid. Delivery: Multi-use HDPE dropper bottle with polyurethane foam-tipped applicators. Mechanism: In-situ polymerization upon contact with oral tissue to form a protective film. Adhesion: High strength and flexibility. Sterilization: Non-sterile.

Indications for Use

Indicated for patients suffering from pain associated with canker sores, mouth sores, and traumatic ulcers (e.g., caused by braces).

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Octyldent® Dental Adhesive (K902078, K980159)
• Carrington® OraPatch™ (K933741, K964852)

Submission Summary (Full Text)

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#### 510(k) SUMMARY SEP 2 1999 SOOTHE-N-SEAL™ Canker Sore Relief

## 1. Device Name

| Trade Name: | SOOTHE-N-SEAL™ Canker Sore Relief |
|----------------------|---------------------------------------------------------------------------------------|
| Common Name: | Liquid Protectant for Canker Sore Pain Relief |
| Classification Name: | unclassified |
| Predicate Devices: | K902078, K980159 Octyldent® Dental Adhesive<br>K933741, K964852 Carrington® OraPatch™ |

# 2. Device Description

SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-sterile, clear, colorless, free-flowing liquid protectant packaged in high-density polyethylene multipleuse, controlled dropper bottles. The device package contains one gram of liquid protectant and 10 double-ended applicator swabs in a transparent polyethylene terephthalate tray with cardboard display label. Each end of the swab handle consists of a polyurethane foam sponge tip, one end rounded for drying the ulcer area and one end pointed for device application.

SOOTHE-N-SEAL™ Canker Sore Relief is composed of 2-octyl cyanoacrylate (>99%) with small amounts of polymerization inhibitors added to enhance shelf life. The chemical characteristics of 2-octyl cyanoacrylate are provided below.

| Chemical name: | 2-octyl cyanoacrylate |
|----------------------------|-----------------------|
| CAS registry number: | 133978-15-1 |
| Molecular formula: | C12H19NO2 |
| Molecular weight (g/mole): | 209 |
| Structural formula: | |

Image /page/0/Figure/9 description: This image shows the chemical structure of a molecule. The molecule contains a chain of carbon atoms with a double bond at one end and a nitrile group (CN) attached to one of the carbon atoms. There is also an ester group (COO) connecting the chain to another alkyl group with a methyl branch and a chain of five methylene units (CH2)5, ending with a methyl group (CH3).

## 3. Intended Use

SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides immediate and long lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

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# 4. Summary of Technological Characteristics

When applied on tissue surfaces of the mouth, the liquid formulation polymerizes to form a thin, protective film, typically within five seconds. Once polymerized, the applied layer of 2-octyl cyanoacrylate has a high degree of adhesion strength and flexibility. The polymer film is crenated and has a slightly rough feel in the mouth. The film remains adhered to the tissue surface until the underlying tissue to which it is bonded is spontaneously sloughed through natural re-epithelialization or until mechanically displaced.

## 5. Summary of Clinical Performance Data

The safety and effectiveness of SOOTHE-N-SEAL™ Canker Sore Relief in the management of oral ulcers has been demonstrated through two clinical studies. The first study was a singlecenter study of 42 subjects who were randomized to treatment with one of two device formulations or to sham treatment using saline. In this study, the device was applied by the clinical investigator twice on the day of enrollment, then once a day for the next three days, for a total of five applications. The second clinical study was a multi-center clinical study of 155 subjects who were randomized to receive either SOOTHE-N-SEAL™ Canker Sore Relief, a predicate device (the Carrington® OraPatch™), or a negative control (water). In this study, the device was self-applied by the study subjects four times a day according to labeled directions until the resolution of ulcer pain.

During the enrollment visit, subjects in both studies recorded unchallenged, or ambient, pain and challenged pain in response to holding an irritant, orange juice, in contact with the oral ulcer. These pain assessments were performed to measure the pain reduction provided by a single device application. Subjects in both studies also recorded unchallenged pain four times daily in a study diary and were examined daily by the clinical investigator until ulcer healing.

#### 5.1 Device Safety

Results of the clinical evaluation of SOOTHE-N-SEAL™ Canker Sore Relief show the device may be safely used for the management of oral ulcers. No significant adverse effects are associated with use of SOOTHE-N-SEAL™ Canker Sore Relief and no significant concerns are associated with the application technique to successfully apply a protective film in a single application. There is also no evidence from the multi-center study that use of the device up to four times daily has any adverse effects on healing or resolution of ulcer pain.

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## 5.2 Pain Reduction

Outcomes of both clinical studies show that one application of SOOTHE-N-SEAL™ Canker Sore Relief significantly reduces pain immediately after application as measured by a standardized challenge when compared to sham treatment. All subjects randomized to SOOTHE-N-SEAL™ Canker Sore Relief in the multi-center study were able to place the protective film correctly in a single application on the first attempt. This indicates that the device is effective in its ability to be used by the subject to create a protective barrier over the ulcer when the subject is provided with the labeled instructions. Results show that this immediate pain reduction is equal to that achieved by the predicate device, the Carrington® OraPatch™.

Long term pain reduction was also demonstrated after one application of SOOTHE-N-SEAL™ Canker Sore Relief in the multi-center study. Of the subjects in this group initially reporting a reduction in challenged pain (76%), nearly half continued to record a reduction in pain over four hours later, prior to the second application of the device. This was better than the performance of the predicate device, the Carrington® OraPatch™, which performed more closely to sham in this analysis.

The total pain experienced over the ulcer episode and the time to total relief of ulcer pain were not significantly different between subjects randomized to SOOTHE-N-SEAL™ Canker Sore Relief and those randomized to the other arms of the multi-center study.

# 5.3 Ulcer Healing

The results of the two clinical studies performed for SOOTHE-N-SEAL Canker Sore Relief indicate that use of the device may benefit ulcer healing and is not detrimental to healing when self-applied by the subject up to four times a day.

## 5.4 Conclusions Regarding Clinical Performance Data

Clinical studies verify that SOOTHE-N-SEAL™ Canker Sore Relief, when used in an overthe-counter environment, performs safely and as intended to reduce the pain of oral ulcers. Clinical study users considered the product to be effective and easy to use compared to other canker sore products currently available. Overall results show that SOOTHE-N-SEAL™ Canker Sore Relief is safe and appropriate for consumer use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1999

Mr. W. Thomas Stephens Manager, Regulatory Affairs Closure Medical, Corporation 5250 Greens Dairy Road Raleigh, North Carolina 27616

Re : K991923 Soothe-N-Seal™ Canker Sore Relief Trade Name: Requlatory Class: II Product Code: MZW Dated: June 4, 1999 Received: June 7, 1999

Dear Mr. Stephens:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਕਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Stephens

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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K991923 SOOTHE-N-SEAL™ Canker Sore Relief

# STATEMENT OF INDICATIONS FOR USE

Device Name: SOOTHE-N-SEAL™ Canker Sore Relief

Indications For Use:

SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

CLOSURE Medical Corporation

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