ALOCLAIR ORAL RINSE

K023155 · Sinclair Pharmaceuticals, Ltd. · OLR · Nov 25, 2002 · SU

Device Facts

• Record ID: K023155
• Device Name: ALOCLAIR ORAL RINSE
• Applicant: Sinclair Pharmaceuticals, Ltd.
• Product Code: OLR · SU
• Decision Date: Nov 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

Aloclair Oral Rinse is a viscous gel formulation containing Aloe Vera extract; intended for over-the-counter use. Device functions by adhering to oral mucosal surfaces to form a protective layer. Used by patients to manage and provide rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions. Administered as a rinse; premixed in containers with a measuring cup. No complex processing or clinical decision-making support involved; provides physical barrier for symptomatic relief.

Clinical Evidence

Bench testing only. Functional and performance testing conducted to assess safety and effectiveness; results reported as satisfactory.

Technological Characteristics

Viscous gel formulation containing Aloe Vera extract. Non-sterile. Oral rinse/mouthwash form factor. Pre-mixed for direct use. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients suffering from aphthous ulcers, canker sores, and minor oral lesions, including those caused by braces or ill-fitting dentures, to provide rapid pain relief.

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

Submission Summary (Full Text)

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K023/55

NOV 2 5 2002

# Attachment 7 510(k) Summary

September 20, 2002

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

> Borough Road Godalming Surrev GU7 2AB United Kingdom

Phone No .: [phone] 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 or<br>Biologic |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug or<br>Biologic |

3. 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

4. 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.

5. 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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- 6. 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™

| Product<br>Name | Aloclair | Gelclair | OraRinse |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Method of<br>Use | Pre-mixed | Mix with water | 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 | Rapid relief from<br>pain, pleasant<br>taste, does not<br>sting, safe if<br>swallowed |
| Area of Use | Oral Mucosa | Oral Mucosa | Oral Mucosa |
| Disease State | Aphthous Ulcers,<br>Canker Sores, Oral<br>lesions | Oral<br>Mucositis/Stomatitis,<br>Oral lesions | Apthous Ulcers<br>and Canker Sores,<br>Oral lesions |
| Type of<br>Product | Oral<br>Rinse/Mouthwash | Oral Rinse<br>Concentrate for<br>dilution | Oral Rinse<br>Concentrate for<br>dilution |
| 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

1. 1. 1. 1.

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 [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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<br>(if known) | K023155 |
| Device Name | SINCLAIR ALOCLAIR™ ORAL RINSE |
| Indications for Use | SINCLAIR ALOCLAIR™ ORAL with Aloe Vera extract,<br>adheres to the mucosal surface and provides rapid pain<br>relief from aphthous ulcers, canker sores, and minor<br>oral lesions, including ulcers caused by braces and ill |

fitting dentures.

.

: 上一篇: 上一篇:

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 | <div>✓</div> |
|---------------------------------------|----|----------------------|--------------|
|---------------------------------------|----|----------------------|--------------|

Sinclair Pharmaceuticals, Ltd 510(k) Submission for Aloclair™ Oral Rinse

CONFIDENTIAL

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