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K Number
K964852
Device Name
RADIACARE ORAL WOUND RINSE
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1997-03-03

(90 days)

Product Code
OLR
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K201389
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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 ulcersFound to reduce discomfort (Study 1 & 2)
Safety for oral useSafe for oral use (Study 1 & 2)
No adverse events during useNo adverse events reported (Study 1 & 2)
Safety if swallowedSafe 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.

N/A