SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.

Device Description

SINCLAIR ORAL RINSE contains Delmopinol hydrochloride, an anti-plaque agent that presents a surface barrier preventing oral bacteria from adhering to and colonizing on tooth surfaces and forming dental plaque. SINCLAIR ORAL RINSE helps prevent the binding of bacteria to the tooth surfaces, thereby interfering with the primary steps of plaque formation.

AI/ML Overview

The provided text describes the 510(k) submission for Sinclair Oral Rinse, which is essentially an affirmation of its substantial equivalence to an already marketed device (Decapinol Oral Rinse). This type of submission is common for medical devices that are not "AI/ML-enabled" in the way that typically involves complex algorithms for diagnosis, prognosis, or image analysis.

Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone performance, and expert qualifications) are not applicable to this submission. The "device" in question is a chemical oral rinse, not a software or AI system.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present formal "acceptance criteria" in the way one would for an AI model's performance metrics (e.g., sensitivity, specificity, accuracy against a threshold). Instead, the acceptance criteria are met by demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (as demonstrated by argument)
Same Intended Use as predicate device	"SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate." This matches the predicate's indication.
Same Technological Characteristics as predicate device	"Sinclair Oral Rinse has the same technological characteristics as the predicate, in that each oral rinse is applied topically to the oral mucosa and gingiva, thus reducing the adherence of colonizing bacteria."
As Safe and Effective as predicate device	"Extensive in vitro and in vivo testing has documented the safety and efficacy of Sinclair Oral Rinse and documentation is enclosed." (A summary of results is noted to be in Attachment 5, which is not provided in the input text.)

2. Sample size used for the test set and the data provenance

Not Applicable: This is a chemical product, not an AI/ML device requiring a test set for algorithm performance. The "testing" mentioned refers to traditional clinical and in-vitro studies for drug/device safety and efficacy. No specific sample sizes for these studies are provided in the excerpt, nor is data provenance (country of origin, retrospective/prospective) for these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No ground truth in the context of AI model evaluation is being established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No test set in the context of AI model evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: The device is an oral rinse, not an AI assistance tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable: The device is an oral rinse, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable: No ground truth in the context of AI model evaluation is being established. The "ground truth" for the efficacy of the oral rinse would be actual clinical outcomes related to gingivitis prevention/reduction, likely measured through clinical assessments in human trials.

8. The sample size for the training set

Not Applicable: This is a chemical product, not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not Applicable: No training set.

Summary

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Confidential

Attachment 7

753166

17 17

510(k) Summary

Submission Applicant & Correspondent:

Sinclair Pharmaceuticals Limited Name: Address: Borough Road Godalming Surrey

GU7 2AB United Kingdom

Phone No .: 1 972 478 4380 Contact Person: Michael Killeen, Executive VP, North America

SINCLAIR ORAL RINSE 2. Name of Device:

Trade/Proprietary/Model Name: SINCLAIR ORAL RINSE Delmopinol hydrochloride Common or Usual Name: Classification Names:

1. Devices to Which New Device is Substantially Equivalent: Decapinol Oral Rinse 510(k) K041482
1. Device Description:

SINCLAIR ORAL RINSE helps prevent the binding of bacteria to the tooth surfaces, thereby interfering with the primary steps of plaque formation.

1. Intended Use of the Device:
  SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed.

SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.

1. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
  Sinclair Pharmaceuticals Ltd

510(k) for Sinclair Oral Rinse

Page 29 of 31

{1}------------------------------------------------

K053166

SINCLAIR ORAL RINSE is substantially equivalent to the following devices:

Decapinol Oral Rinse cleared in 510(k) K041482, which is an oral rinse indicated for the relief and Decapmor of gingivitis. Sinclair Oral Rinse has the same intended use (oral rinse) as the predicate device, as required by 510(k) regulations.

Sinclair Oral Rinse has the same technological characteristics as the predicate, in that each oral Shiciall Oral Kinschias the same toonline the oral mucosa and gingiva, thus reducing the adherence of colonizing bacteria.

Extensive in vitro and in vivo testing has documented the safety and efficacy of Sinclair Oral Rinse and documentation is enclosed.

In summary, the SINCLAIR ORAL RINSE described in this submission is, in our opinion, In summary, the becapinol Oral Rinse cleared in 510(k) K041482 by meeting the following standards set by FDA:

has the same intended use as the predicate device; and o
has the same technological characteristics as the predicate device; or o
and the sponsor demonstrates that the device is as safe and effective as the o legally marketed device.
1. Tests and Conclusions:

Functional and performance testing has been conducted to assess the safety and effectiveness of SINCLAIR ORAL RINSE. A summary of the results is attached in Attachment 5.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Mr. Michael Killeen Executive Vice President North America Sinclair Pharmaceuticals Limited Borough Road Godalming Surrey GU7 2AB UNITED KINGDOM

Re: K053166

Trade/Device Name: Sinclair Oral Rinse Regulation Number: 21 CFR 872.5580 Regulation Name: Oral Rinse Regulatory Class: II Product Code: NTO Dated: May 3, 2006 Received: May 8, 2006

Dear Mr. Killeen:

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. Killeen

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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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Confidential

K053166

Attachment 3

Indications for Use Statement

510(k) Number (if known)

Device Name

SINCLAIR ORAL RINSE

OTC labeling:

Indications for Use

SINCLAIR ORAL RINSE helps to prevent and reduce

gingivitis, when used as directed.

SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/ OR

Over-The Counter Use (21 CFR 807 Subpart C) __ V

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/ Albam 1 2 67-000

on of Anesthesiology, General Hospital, a Non Control, Dental Devices

Number: K053160

Sinclair Pharmaceuticals Ltd

510(k) for Sinclair Oral Rinse

Page 19 of 31

Regulation Number and Section

§ 872.5580 Oral rinse to reduce the adhesion of dental plaque.

(a)
Identification. The device is assigned the generic name oral rinse to reduce the adhesion of dental plaque and is identified as a device intended to reduce the presence of bacterial plaque on teeth and oral mucosal surfaces by physical means. The device type includes those devices that act by reducing the attachment and inhibiting the growth of bacterial plaque.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.