SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.

Device Description

ALOCLAIR™ ORAL RINSE is a viscous gel formulation, which is presented for over-thecounter use premixed in containers of various sizes with plastic measuring cup. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.

AI/ML Overview

The provided text describes the submission for a medical device (ALOCLAIR™ ORAL RINSE) for 510(k) clearance. The document focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in the provided text. The document states that "Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory," but it does not elaborate on what these tests entailed, what the acceptance criteria were, or what the reported device performance was.

Based on the provided information, I can only provide the following:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
(Not specified in the document)	"All results are satisfactory." (No specific performance metrics or thresholds are provided.)

2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any information regarding a "test set" in the context of a clinical study or the sample size used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention any expert involvement in establishing ground truth for a test set. This type of information is typically part of a clinical trial, which is not detailed here.

4. Adjudication Method for the Test Set:
No information is provided regarding an adjudication method, as no test set requiring ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The submission is focused on demonstrating substantial equivalence to predicate devices, not on comparing performance with human readers, or the effect of AI assistance.

6. Standalone (Algorithm Only) Performance:
This product is an oral rinse, not an algorithm or AI-based device. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. Type of Ground Truth Used:
No specific type of ground truth is mentioned, as the document states that functional and performance testing was conducted, but does not specify the nature of these tests or how results were validated against a "ground truth."

8. Sample Size for the Training Set:
This is an oral rinse, not an AI or machine learning device that requires a training set.

9. How Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/machine learning device.

Summary of Device and Basis for Clearance:

The ALOCLAIR™ ORAL RINSE is a viscous gel formulation intended for over-the-counter use to provide rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions.

The basis for the 510(k) clearance is substantial equivalence to two predicate devices:

Sinclair Gelclair Concentrated Oral Gel (K013056)
AloeCeuticals (Carrington Lab) OraRinse (K983182)

The submission highlights that ALOCLAIR™ ORAL RINSE has the "same intended/indications for use" as these predicate devices. A comparison table (Section 6) details the technological characteristics, showing similarities in claims, area of use, disease state, and presentation (non-sterile), with minor differences in method of use (pre-mixed vs. mix with water) and product type (oral rinse/mouthwash vs. concentrate for dilution).

The document states that "Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory." However, it does not provide specific details about these tests, the acceptance criteria, or the actual performance results in a quantifiable manner. The FDA's letter (Section 2, 3) confirms the determination of substantial equivalence, allowing the device to be marketed.

Summary

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K023/55

NOV 2 5 2002

Attachment 7 510(k) Summary

September 20, 2002

Submission Applicant & Correspondent: Sinclair Pharmaceuticals, Ltd. Name: Address:

Borough Road Godalming Surrev GU7 2AB United Kingdom

Phone No .: +44 (0) 1483 428 611 Denise Swift, Director of Regulatory Affairs Contact Person:

2. Name of Device:	ALOCLAIR™ ORAL RINSE
Trade/Proprietary/Model Name:	ALOCLAIR™ ORAL RINSE
Common or Usual Name:	Dressing, Wound & Burn, Hydrogel w/Drug orBiologic
Classification Names:	Dressing, Wound & Burn, Hydrogel w/Drug orBiologic

Devices to Which New Device is Substantially Equivalent:

Sinclair Gelclair Concentrated Oral Gel cleared in 510(k) K013056

AloeCeuticals (Carrington Lab) OraRinse cleared in 510(k) K983182

Device Description:

Intended Use of the Device:

SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.

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1. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
  The ALOCLAIR™ ORAL RINSE has the same intended/indications for use as the predicate Sinclair Gelclair™ Concentrated Oral Gel and AloeCeuticals (Carrington Lab) OraRinse™

ProductName	Aloclair	Gelclair	OraRinse
Method ofUse	Pre-mixed	Mix with water	Mix with water
# ofapplicationsper day	Take as needed	Take as needed	Take as needed
Claim	Management andrelief of pain, nonirritating, does notsting, safe ifswallowed	Management andrelief of pain, nonirritating, does notsting, safe ifswallowed	Rapid relief frompain, pleasanttaste, does notsting, safe ifswallowed
Area of Use	Oral Mucosa	Oral Mucosa	Oral Mucosa
Disease State	Aphthous Ulcers,Canker Sores, Orallesions	OralMucositis/Stomatitis,Oral lesions	Apthous Ulcersand Canker Sores,Oral lesions
Type ofProduct	OralRinse/Mouthwash	Oral RinseConcentrate fordilution	Oral RinseConcentrate fordilution
Presentation	Non Sterile	Non Sterile	Non Sterile

7. Tests and Conclusions:

: : Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Denise Swift Director, Regulatory Affairs Sinclair Pharmaceuticals Limited Borough Road, Godalming, Surrey, GU 7 2AB UNITED KINGDOM

Re: K023155

Trade/Device Name: Sinclair Aloclair™ Oral Rinse Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel Wound Dressing and Burn Dressing Regulatory Class: Unclassified Product Code: MGO Dated: September 20, 2002 Received: September 23, 2002

Dear Ms. Swift:

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 - Ms. Swift

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 (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.

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613 . 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy/A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 3	Indications for Use Statement
510(k) Number(if known)	K023155
Device Name	SINCLAIR ALOCLAIR™ ORAL RINSE
Indications for Use	SINCLAIR ALOCLAIR™ ORAL with Aloe Vera extract,adheres to the mucosal surface and provides rapid painrelief from aphthous ulcers, canker sores, and minororal lesions, including ulcers caused by braces and ill

fitting dentures.

PLEASE DO NOT WRITE BELOW/THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K023185

Prescription Use (per 21 CFR 801.109)	OR	Over-The Counter Use	✓
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Sinclair Pharmaceuticals, Ltd 510(k) Submission for Aloclair™ Oral Rinse

CONFIDENTIAL

Regulation Number and Section

N/A