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. The ingredients used in RadiaCare™ Oral Wound Rinse are the same as used in Carrasyn Oral Wound Dressing or are food-grade materials.

AI/ML Overview

The provided document describes the RadiaCare™ Oral Wound Rinse and its substantial equivalence to the predicate device, Carrasyn® Oral Wound Dressing. The acceptance criteria and supporting studies are presented in relation to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from study outcomes)	Reported Device Performance (Carrasyn® Oral Wound Dressing)
Reduction in discomfort/pain from oral ulcers	Found to reduce discomfort (Study 1 & 2)
Safety for oral use	Safe for oral use (Study 1 & 2)
No adverse events during use	No adverse events reported (Study 1 & 2)
Safety if swallowed	Safe if swallowed (Conclusion based on Studies 1 & 2)

Note: The document explicitly states that the RadiaCare™ Oral Wound Rinse is equivalent to the predicate device, Carrasyn® Oral Wound Dressing, and its substantial equivalence is based on descriptive information about design, materials, and intended use. The performance data for RadiaCare™ itself is limited to a pilot study on two patients, which reported pain relief. The primary evidence for performance and safety relies on the studies conducted on the predicate device, Carrasyn® Oral Wound Dressing.

2. Sample Size Used for the Test Set and Data Provenance

The “test set” here refers to the subjects in the clinical trials for the predicate device, Carrasyn® Oral Wound Dressing.

Study 1 (Randomized, double-blind, active-controlled):
- Sample Size: 60 healthy volunteer patients.
- Breakdown: 30 patients treated with Carrasyn® Oral Wound Dressing, 30 patients treated with a control.
- Data Provenance: Not explicitly stated, but implied to be prospective clinical trials as subjects were treated and observed. No country of origin is mentioned.
Study 2 (Open-label, uncontrolled):
- Sample Size: 30 healthy volunteer patients.
- Data Provenance: Not explicitly stated, implied to be a prospective clinical trial. No country of origin is mentioned.

Pilot Study for RadiaCare™ Oral Wound Rinse:

Sample Size: 2 cancer patients with oral mucositis/stomatitis.
Data Provenance: Implied to be a prospective pilot study. No country of origin is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The studies described involve patient-reported outcomes (discomfort, adverse events), rather than expert assessment of primary endpoints like diagnosis or classification.

For discomfort, patients kept a diary.
For adverse events, patients completed an adverse report form.

Therefore, there were no external experts used to establish a "ground truth" in the traditional sense of a diagnostic or classification study. The ground truth for effectiveness was direct patient reporting of sensation (discomfort/pain relief).

4. Adjudication Method for the Test Set

The studies did not involve an adjudication panel for evaluating outcomes.

Patient discomfort was self-reported via a diary.
Adverse events were self-reported via an adverse report form.
Healing was observed, but the method of assessment (e.g., by a clinician, patient, or both) is not detailed beyond "treatment was continued until the oral ulcers were healed."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The studies were clinical trials comparing the device to a control (Study 1) or observing its effects (Study 2) directly on patients, focusing on patient-reported outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is an oral wound rinse, not an algorithm or AI-based system. Therefore, standalone performance (in the context of AI) is not relevant.

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoints (reduction in discomfort) was patient-reported outcomes. For safety, the ground truth was patient-reported adverse events and observation that "no adverse events were reported."

8. The Sample Size for the Training Set

This is not applicable as the studies described are clinical trials for a medical device (an oral wound rinse), not an AI algorithm that requires a training set. The term "training set" is relevant for machine learning models.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Summary

{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.

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.

00006

Regulation Number and Section

N/A