(90 days)
Not Found
No
The summary describes a wound dressing and its clinical performance, with no mention of AI, ML, or related technologies.
Yes
Explanation: The device is described as a "wound dressing designed for the management of oral mucositis/stomatitis," which are conditions that it aims to treat or alleviate. It also states that it was found to "reduce discomfort" and provide "relief of pain," indicating a therapeutic purpose.
No
This device is a wound dressing designed for the management of oral mucositis/stomatitis, which is a therapeutic function, not a diagnostic one.
No
The device is described as a "wound dressing" and "oral wound rinse," which are physical substances applied to the body, not software. The description focuses on the materials and intended use of a physical product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "wound dressing designed for the management of oral mucositis/stomatitis." This indicates a therapeutic or management function applied directly to the wound, not a diagnostic test performed on a sample from the body.
- Device Description: The description reinforces that it's a "wound dressing" and an "oral wound rinse." These are topical applications for treatment.
- Performance Studies: The clinical trials described focus on the device's ability to reduce discomfort and promote healing of oral ulcers and mucositis. These are outcomes related to treatment efficacy, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis.
Product codes
79 FRO
Device Description
RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The ingredients used in RadiaCare™ Oral Wound Rinse are the same as used in Carrasyn Oral Wound Dressing or are food-grade materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
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.
Summary of Performance Studies
The first clinical trial: Carrasyn Oral Wound Dressing was found to reduce discomfort and no adverse events were reported in association with its use.
The second clinical study: 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.
Pilot study with RadiaCare™ Oral Wound Rinse: 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.
Key Metrics
Not Found
Predicate Device(s)
Carrasyn® Oral Wound Dressing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the word "CARRINGTON" in all caps, with two horizontal lines above and below the word. Below the word is the alphanumeric string "KA64852" in a handwritten style. The text is black and the background is white.
510(k) SUMMARY RADIACARE™ ORAL WOUND RINSE
DATE PREPARED 1.
November 12, 1996
- 3
997
SUBMITTER 2.
Carrington Laboratories, Inc. 2001 Walnut Hill Lane Irving, TX 75038-4404
CONTACT 3.
Dennis R. Sparkman, Ph.D. Regulatory Affairs (972) 650-7346
DEVICE NAME 4.
RadiaCare™ Oral Wound Rinse
DEVICE CLASSIFICATION న్.
Surgical Wound Dressings have not been classified. [Proposed Class I (CFR 878.4060)]
Product Code: 79 FRO
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS 6.
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 ● (800) 527-5216 | |||
|---|---|---|---|
| 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 |
| (972) 518-1300 | (972) 717-5009 | (972) 518-1300 | Miami, Florida 33102-5216 |
| (972) 518-1020 Fax | (972) 717-0997 Fax | (972) 756-0108 Fax | 011-506-666-0100 |
1
510(k) SUMMARY RADIACARE™ ORAL WOUND RINSE PAGE 2
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.