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.

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.

AI/ML Overview

This document describes a medical device called SOOTHE-N-SEAL™ Canker Sore Relief, a liquid protectant for oral ulcers. The document focuses on the claim of substantial equivalence to predicate devices based on clinical performance data. However, it does not explicitly define "acceptance criteria" through numerical targets for the studies. Instead, the studies aim to demonstrate safety, effectiveness in pain reduction (immediate and long-term), and non-detrimental effect on ulcer healing, comparing the device to sham or predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria are not stated, the table below reflects what the studies aimed to demonstrate to show substantial equivalence and the reported outcomes:

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Device Safety	No significant adverse effects; safe application technique	No significant adverse effects; no significant concerns with application. No adverse effects on healing with repeated use.
Immediate Pain Reduction (Challenged)	Significant reduction compared to sham; equivalent to predicate.	Significantly reduces pain immediately after application compared to sham. Equivalent to Carrington® OraPatch™.
Long-Term Pain Reduction (Challenged)	Sustained pain reduction for several hours; better than predicate.	Nearly half of subjects reporting initial reduction continued to record pain reduction over four hours later, prior to second application. Better than Carrington® OraPatch™.
Ease of Use (Self-Application)	Subjects able to correctly self-apply.	All subjects in the multi-center study were able to place the protective film correctly in a single application on the first attempt (with labeled instructions). Considered effective and easy to use.
Effect on Ulcer Healing	Not detrimental to healing; may benefit healing.	May benefit ulcer healing and is not detrimental to healing when self-applied up to four times a day.
Total Pain (entire episode)	Not significantly different from control/predicate.	Not significantly different between SOOTHE-N-SEAL™ and other arms of the multi-center study.
Time to Total Pain Relief	Not significantly different from control/predicate.	Not significantly different between SOOTHE-N-SEAL™ and other arms of the multi-center study.

2. Sample Sizes and Data Provenance

Test Set 1 (Single-center study):
- Sample Size: 42 subjects.
- Data Provenance: Not explicitly stated, but "single-center study" suggests a localized study, likely within the country where the device was developed or intended to be marketed (implied US, given the FDA submission).
- Retrospective/Prospective: Prospective (subjects were randomized to treatment, pain assessments recorded during the study).
Test Set 2 (Multi-center clinical study):
- Sample Size: 155 subjects.
- Data Provenance: Not explicitly stated, but "multi-center" suggests multiple sites, likely within the US given the FDA submission.
- Retrospective/Prospective: Prospective (subjects randomized and observed over time).

3. Number of Experts and Qualifications for Ground Truth

The document states that subjects were "examined daily by the clinical investigator until ulcer healing." It does not specify the exact number of clinical investigators or their specific qualifications (e.g., medical doctors, nurses, etc.) beyond being a "clinical investigator." It also describes the investigator applying the device in the first study. No specific "experts" for establishing ground truth in the sense of independent review of data, like radiologists for imaging, are mentioned for this type of device.

4. Adjudication Method for the Test Set

The document implies that "clinical investigators" performed daily examinations. There is no mention of a formal adjudication method (like 2+1 or 3+1 consensus) for the assessments of pain or healing. Pain was self-reported by subjects (unchallenged pain) and measured by their response to an irritant (challenged pain). Healing was assessed by the clinical investigator.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context described. This type of study is more common for diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The described studies are clinical trials comparing the device to sham or predicate devices in terms of patient-reported outcomes and investigator assessment of healing.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (a liquid protectant) and not an algorithm or AI system. Therefore, a standalone performance study in the context of an algorithm's performance without human intervention is not relevant.

7. Type of Ground Truth Used

Clinical observation and patient-reported outcomes:
- Patient-reported pain: Subjects recorded "unchallenged, or ambient, pain" and "challenged pain" (in response to orange juice). They also recorded unchallenged pain four times daily in a study diary.
- Clinical Investigator assessment: Ulcer healing was assessed daily by the clinical investigator.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are clinical trials for product validation.

9. How Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this device.

Summary

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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 AdhesiveK933741, K964852 Carrington® OraPatch™

2. Device Description

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

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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

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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Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.