ALOCLAIR™ ORAL SPRAY is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further imitation.
ALOCLAIR™ ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers.

Device Description

ALOCLAIR™ ORAL SPRAY is a viscous spray formulation, which is presented for over-thecounter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.

AI/ML Overview

This document is a 510(k) summary for the ALOCLAIR™ ORAL SPRAY. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a study that establishes acceptance criteria or reports detailed device performance against such criteria.

The document states:

"Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL SPRAY. All results are satisfactory."

This is a general statement and does not provide the specific details required to answer your request. Therefore, I cannot provide the requested information based on the input text.

The requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) is not present in the provided 510(k) summary.

Summary

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K042722

JAN I 3 2005

Attachment 7 510(k) Summary

September 30, 2004

1. Submission Applicant & Correspondent:

Name: Sinclair Pharmaceuticals, Ltd. Address: Borough Road Godalming Surrey GU7 2AB United Kingdom

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

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

3. Devices to Which New Device is Substantially Equivalent:

Sinclair Aloclair Oral Gel cleared in 510(k) K049050

Sinclair Aloclair Oral Rinse cleared in 510(k) K023155

4. Device Description:

5. Intended Use of the Device:

Aloclair™ Oral Spray is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further imitation.

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6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:

The ALOCLAIR™ ORAL SPRAY has the same intended/indications for use as the predicate Aloclair Oral Gel and Aloclair Rinse.

ProductName	Aloclair Spray	Aloclair Gel	Aloclair Rinse
Method ofUse	Pre-mixed	Pre-mixed	Pre-mixed
# 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	Management andrelief of pain, nonirritating, does notsting, safe ifswallowed
Area of Use	Oral Mucosa	Oral Mucosa	Oral Mucosa
Disease State	Aphthous UlcersStomatitis, Orallesions	Aphthous UlcersStomatitis, Orallesions	Aphthous UlcersStomatitis, Orallesions
Type ofProduct	Oral GelRinse/Mouthwash	Oral GelRinse/Mouthwash	OralRinse/Mouthwash
Presentation	Non Sterile	Non Sterile	Non Sterile

7. Tests and Conclusions:

Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL SPRAY. All results are satisfactory.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

JAN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042722

Trade/Device Name: ALOCLAIR™ ORAL SPRAY Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: September 29, 2004 Received: October 29, 2004

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 (301) 594-0115. 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/dsma/dsmamain.html

Sincerely yours,

Carls

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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Attachment 3
510(k) Number (if known)	K042722
Device Name	ALOCLAIR™ ORAL SPRAY
Indications for Use	ALOCLAIR™ ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers.

Prescription Use _ ______________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) Subpart C)

Over-The-Counter Use _ V (21 CFR 807

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Runne

(Civision Sign-Off) ് vision of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________ KA 2722

Regulation Number and Section

N/A