GELCLAIR CONCENTRATED ORAL GEL

K013056 · Sinclair Pharmaceuticals, Ltd. · OLR · Dec 21, 2001 · SU

Device Facts

• Record ID: K013056
• Device Name: GELCLAIR CONCENTRATED ORAL GEL
• Applicant: Sinclair Pharmaceuticals, Ltd.
• Product Code: OLR · SU
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Sinclair Gelclair® CONCENTRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or disease. Also indicated also for diffuse aphthous ulcers.

Device Story

Gelclair is a viscous oral gel concentrate supplied in 15ml sachets; intended for dilution with 40ml of water. Upon oral administration, the mixture adheres to the oral mucosa to form a protective physical barrier. This mechanical action soothes lesions and manages pain. Used in clinical or home settings; patient-applied. Benefits include pain relief and protection of oral tissues without stinging or irritation. Safe if swallowed.

Clinical Evidence

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

Technological Characteristics

Viscous hydrogel concentrate. Ingredients: Purified water, propylene glycol, polyvinylpyrrolidone, sodium hyaluronate, potassium sorbate, sodium benzoate, hydroxyethylcellulose, PEG-40 hydrogenated castor oil, disodium edetate, benzalkonium chloride, flavor, saccharin sodium, glycyrrhetinic acid. Non-sterile. Mechanical barrier principle.

Indications for Use

Indicated for patients experiencing oral pain due to oral mucositis/stomatitis (chemotherapy/radiotherapy induced), oral surgery irritation, traumatic ulcers (braces/dentures), or disease, and diffuse aphthous ulcers.

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

• Carrington Laboratories Radiacare™ Oral Wound Rinse

Submission Summary (Full Text)

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Attachment 7

K013054

## 510(k) Summary

September 1, 2001

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

Godalming Surrey GU7 2AB United Kingdom

Phone No.: [phone] Denise Swift, Director of Regulatory Affairs Contact Person:

| 2. Name of Device: | Gelclair® CONCENTRATED ORAL GEL |
|-------------------------------|--------------------------------------------------------|
| Trade/Proprietary/Model Name: | Gelclair® CONCENTRATED 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:

Carrington Laboratories Radiacare™ Oral Wound Rinse.

## 4. Device Description:

Sinclair Pharmaceuticals, Ltd. Gelclair® CONCENTRATED ORAL GEL is a viscous gel formulation, which is presented in a sachet of 15ml for mixing with 40ml of water. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.

5. Intended Use of the Device:

Sinclair Gelclair® ConcentRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated also for diffuse aphthous ulcers.

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- 6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The Gelclair® Concentrated Oral GEL has the same intended/indications for use as the predicate Carrington Laboratories Radiacare™ Oral Wound Rinse.

| Product Name | Sinclair<br>Pharmaceuticals<br>Gelclair® | Carrington Labs<br>RadiaCareTM |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Purified Water,<br>Propylene Glycol,<br>Polyvinylpyrrolidone,<br>Sodium Hyaluronate,<br>Potassium Sorbate,<br>Sodium Benzoate,<br>Hydroxyethylcellulose,<br>PEG-40 Hydrogenated<br>Castor Oil, Disodium<br>Edetate, Benzalkonium<br>Chloride, Flavor,<br>Saccharin Sodium,<br>Glycyrrhetinic Acid | Acemannan hydrogel,<br>Aspartame, Flavor,<br>Fructose, Maltodextrin,<br>Polyvinylpyrrolidone,<br>Potassium Sorbate,<br>Sodium Benzoate |
| Method of Use | Mix with water | Mix with water |
| Number of<br>applications per day | Take as needed | Take as needed |
| Claim | Management and relief<br>of pain, does not sting,<br>nonirritating, safe if<br>swallowed | Management and relief<br>of pain, does not sting,<br>nonirritating, safe if<br>swallowed |
| Area of Use | Oral Mucosa | Oral Mucosa |
| Disease State | Oral<br>Mucositis/Stomatitis/Oral<br>Lesions | Oral<br>Mucositis/Stomatitis/Oral<br>Lesions |
| Type of Product | Concentrate for dilution | Concentrate for dilution |
| Presentation | Non Sterile | Non Sterile |

## 7. Tests and Conclusions:

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

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sinclair Pharmaceuticals, Incorporated Ms. Priscilla Cox Director, RA/QA Otterbrook Engineering 1 Alder Brook Chinley, High Peak, UNITED KINGDOM

DEC 21 2001

Re: K013056

Trade/Device Name: Gelclair Concentrated Oral Gel Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MGQ Dated: December 10, 2001 Received: December 11, 2001

Dear Ms. Cox:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinona, or to arrives 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 approvisions of the Act. The general controls provisions of the Act include contrements 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 (1 wr ), it hay ob easyed 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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Patricia Ciccerite/for

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

Enclosure

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| Attachment 3 | Indications for Use Statement |
|--------------|-------------------------------|
|--------------|-------------------------------|

| 510(k) Number (if known) | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sinclair Gelclair® CONCENTRATED ORAL GEL |
| Indications for Use | Sinclair Gelclair® CONCENTRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or disease. Also indicated also for diffuse aphthous ulcers. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

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Over-The Counter Use

Petina Lucent for Guesse

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________