RADIACARE ORAL WOUND RINSE

K964852 · Carrington Laboratories, Inc. · OLR · Mar 3, 1997 · SU

Device Facts

• Record ID: K964852
• Device Name: RADIACARE ORAL WOUND RINSE
• Applicant: Carrington Laboratories, Inc.
• Product Code: OLR · SU
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis.

Device Story

RadiaCare™ Oral Wound Rinse is a topical wound dressing for oral mucositis/stomatitis management. Device applied by patient to oral cavity; provides pain relief. Ingredients are food-grade or identical to predicate Carrasyn Oral Wound Dressing. Used in clinical settings or home care for patients undergoing cancer therapy. Output is physical coating of oral mucosa; reduces discomfort and pain associated with ulcerations. Benefits include symptomatic relief and safe use if swallowed.

Clinical Evidence

Two clinical trials on predicate Carrasyn Oral Wound Dressing: 1) Randomized, double-blind, active-controlled study (n=60) on aphthous ulcers showed reduced discomfort with no adverse events. 2) Open-label, uncontrolled study (n=30) showed significant discomfort reduction within 2 minutes. Pilot study (n=2) on RadiaCare™ in cancer patients with oral mucositis/stomatitis reported pain relief lasting ~2 hours.

Technological Characteristics

Oral wound dressing; ingredients identical to predicate or food-grade. No specific materials, dimensions, or sterilization methods provided.

Indications for Use

Indicated for the management of oral mucositis/stomatitis in patients experiencing pain due to radiotherapy to the head and neck or chemotherapy.

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

• Carrasyn Oral Wound Dressing (not specified)
• Carrington Wound Dressing (not specified)

Submission Summary (Full Text)

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CARRINGTON
K964852
510(k) SUMMARY
RADIACARE™ ORAL WOUND RINSE

1. DATE PREPARED
November 12, 1996
MAR - 3 1997

2. SUBMITTER
Carrington Laboratories, Inc.
2001 Walnut Hill Lane
Irving, TX 75038-4404

3. CONTACT
Dennis R. Sparkman, Ph.D.
Regulatory Affairs
[phone]

4. DEVICE NAME
RadiaCare™ Oral Wound Rinse

5. DEVICE CLASSIFICATION
Surgical Wound Dressings have not been classified.
[Proposed Class I (CFR 878.4060)]
Product Code: 79 FRO

6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS
RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The oral wound rinse is equivalent to the predicate device, Carrasyn® Oral Wound Dressing. Determination if substantial equivalence for this device was based on descriptive information about the design, materials and intended use of the device.

| Carrington Laboratories, Inc. | ● Post Office Box 168128 | ● Irving, TX 75016-8128 | ● [phone] |
| --- | --- | --- | --- |
| Corporate Office & Manufacturing: | Research & Development: | Distribution Center & Accounting: | Costa Rica |
| 2001 Walnut Hill Lane | 1300 E. Rochelle Boulevard | 1909 Hereford Drive | Suite SJO-2632 - Unit C-101 |
| Irving, Texas 75038 | Irving, Texas 75062 | Irving, Texas 75038 | 1601 N.W. 97th Avenue |
| [phone] | [phone] | [phone] | Miami, Florida 33102-5216 |
| [phone] Fax | [phone] Fax | [phone] Fax | 011-506-866-0100 |

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510(k) SUMMARY
RADIACARE™ ORAL WOUND RINSE
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The ingredients used in RadiaCare™ Oral Wound Rinse are the same as used in Carrasyn Oral Wound Dressing or are food-grade materials.

Two clinical trials have been conducted to date using Carrasyn Oral Wound Dressing. The first clinical trial was a randomized, double-blind, active-controlled study involved 60 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. The patients were randomly assigned to two groups where one group of 30 patients were treated with Carrasyn Oral Wound Dressing and one group of 30 patients treated with a control. The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the oral ulcers were healed. Carrasyn Oral Wound Dressing was found to reduce discomfort and no adverse events were reported in association with its use.

The second clinical study was an open-label, uncontrolled study involving 30 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. All patients were treated Carrasyn Oral Wound Dressing. The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the oral ulcers were healed. Carrasyn Oral Wound Dressing was found to significantly reduce discomfort within 2 minutes and no adverse events were reported in association with its use.

The above clinical studies demonstrate that Carrasyn Oral Wound Dressing is safe for oral use, relieves pain and has not been associated with any adverse events. It is also safe if swallowed. There were no safety concerns in either clinical study.

A pilot study used RadiaCare™ Oral Wound Rinse on two cancer patients with oral mucositis/stomatitis, a painful condition that results due to radiotherapy to the head and neck, and with some chemotherapeutic agents. Both reported relief of pain that lasted for approximately 2 hours.

Based on lack of any adverse events and on statistically and clinically significant reduction in discomfort associated with Carrasyn Oral Wound Dressing, this product is concluded to be a safe and effective agent in the management of oral mucositis/stomatitis and substantially equivalent to the predicate device, Carrington Wound Dressing.

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