ALOCLAIR ORAL GEL

K040950 · Sinclair Pharmaceuticals, Ltd. · OLR · Jun 21, 2004 · SU

Device Facts

• Record ID: K040950
• Device Name: ALOCLAIR ORAL GEL
• Applicant: Sinclair Pharmaceuticals, Ltd.
• Product Code: OLR · SU
• Decision Date: Jun 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

SINCLAIR ALOCLAIR™ ORAL GEL 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 irritation.

Device Story

Aloclair Oral Gel is a viscous, pre-mixed hydrogel for over-the-counter use. Applied topically to the oral mucosa, the gel forms a protective film over lesions. This physical barrier covers the affected area to provide rapid pain relief and prevent further irritation from external contact. It is intended for use by patients experiencing oral discomfort from various lesions or mechanical trauma. The device is non-sterile and safe if swallowed.

Clinical Evidence

Bench testing only. Extensive functional and performance testing were conducted to assess safety and effectiveness; all results were satisfactory.

Technological Characteristics

Viscous hydrogel formulation; non-sterile; pre-mixed; intended for topical application to oral mucosa. No electronic, software, or energy-based components.

Indications for Use

Indicated for pain relief in patients with mouth lesions, including aphthous stomatitis, aphthous ulcers, minor lesions, chafing, traumatic ulcers, and abrasions from braces or ill-fitting dentures.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

• Sinclair Aloclair Oral Rinse (K023155)
• Sinclair Gelclair Concentrated Oral Gel (K013056)

Submission Summary (Full Text)

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K040950

JUN 2 1 2004

## Attachment 7 510(k) Summary

April 9, 2004

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

Borough Road Godalming Surrey GU7 2AB United Kingdom

972 939 2442 Phone No .: Michael Killeen Contact Person:

| 2. Name of Device: | ALOCLAIR ™ ORAL GEL |
|-------------------------------|--------------------------------------------------------|
| Trade/Proprietary/Model Name: | ALOCLAIR™ ORAL GEL |
| Common or Usual Name: | Dressing, Wound & Burn, Hydrogel w/Drug or<br>Biologic |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug or<br>Biologic |

3. Devices to Which New Device is Substantially Equivalent:

Sinclair Aloclair Oral Rinse cleared in 510(k) K023155

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

- 4. Device Description:
ALOCLAIR™ ORAL GEL is a viscous gel 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.

5. Intended Use of the Device:

Aloclair™ Oral Gel 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 irritation.

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Image /page/1/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K040950". The characters are written in a simple, slightly slanted style, with varying stroke thicknesses. The image has a clean, white background, which makes the characters stand out.

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

The Aloclair™ ORAL GEL has the same intended/indications for use as the prodicate The ALOCEAIR - ORAL GEE The Cell and AloeCeuticals (Carrington Lab) OraRinse™

| Product<br>Name | Aloclair Gel | Aloclair Rinse | Gelclair |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Method of<br>Use | Pre-mixed | Pre-mixed | Mix with water |
| # of<br>applications<br>per day | Take as needed | Take as needed | Take as needed |
| Claim | Management and<br>relief of pain, non<br>irritating, does not<br>sting, safe if<br>swallowed | Management and<br>relief of pain, non<br>irritating, does not<br>sting, safe if<br>swallowed | Management and<br>relief of pain, non<br>irritating, does not<br>sting, safe if<br>swallowed |
| Area of Use | Oral Mucosa | Oral Mucosa | Oral Mucosa |
| Disease State | Aphthous Ulcers<br>Stomatitis, Oral<br>lesions | Aphthous Ulcers<br>Stomatitis, Oral<br>lesions | Oral<br>Mucositis/Stomatitis<br>s, Oral lesions |
| Type of<br>Product | Oral Gel<br>Rinse/Mouthwash | Oral Rinse/Mouthwash | Oral Rinse<br>Concentrate for<br>dilution |
| 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 GEL. All results are satisfactory.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2004

Mr. Michael Killeen Executive Director Sinclair Pharmaceuticals, Limited 2340 Trinity Mills, Suite 300 Carrollton, Texas 75006

Re: K040950

Trade/Device Name: Sinclair Aloclair™ Oral Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: April 3, 2004 Received: April 28, 2004

Dear Mr. Killeen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became ================================================================================================================================================= referenced above and have decemblics are) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, on to de viees mat nave oost (Act) that do not require approval of a premarket the Federal Pood, Drug, und Ocomens , therefore, market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Fet. "The girling 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 If your device is classified (see ass 10) ional controls. Existing major regulations affecting ( (FMA), It may of subject to sach adalaf Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements 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 Please be advised that FDA s issualled of a bases and on the sther Foderal eggenies mean that FDA nas made a decernmance and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal of the Act of ally rederal statues and registements, including, but not limited to: registration You must comply with an the Fec 3 require.com (21 CFR Part 801); good manufacturing practices in the Archives and and listing (21 CFR Fall 807), laboling (21 OFF CF 2017) (21 CFR Part 820); and if requirements as set forth in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your lection 5 10(k) I his letter will anow you to begin marketing your device of your device to a premarket notification. The PDF milling or cassification 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), a If you desire specific advice to: your do at [phone]. Also, please note the regulation please contact the Other or Ochiphan promarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general international and Consumer Assistance at its toll-free Division of Online [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Charles

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 | Indications for Use |
|--------------|---------------------|
|--------------|---------------------|

| 510(k) Number (if known) | K040950 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SINCLAIR ALOCLAIR™ ORAL GEL |
| Indications for Use | SINCLAIR ALOCLAIR™ ORAL GEL 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 irritation. |

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

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

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED and the same of the same of the same of the same of the same of the same and the same and the seat and the search and the search and the search and the comments of the commen

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | 12040950 |
|----------------|----------|
|----------------|----------|

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