For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.

Device Description

OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.

AI/ML Overview

The provided 510(k) summary for K024180 (OraMagicRx™ Oral Wound Rinse) does not contain the detailed information typically associated with acceptance criteria and studies for device performance as an AI/ML-driven device or diagnostic. This submission is for a medical device (oral wound rinse) and relies on substantial equivalence to a predicate device, rather than a performance study with specific acceptance criteria in the way a diagnostic or AI algorithm would.

Therefore, many of the requested sections about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable or not present in this document.

However, I can extract the relevant information from the provided text, primarily around the basis for acceptance which is substantial equivalence.

Here's a breakdown based on the information available:

Acceptance Criteria and Study for OraMagicRx™ Oral Wound Rinse (K024180)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied by Substantial Equivalence)	Reported Device Performance/Comparison
Safety:
- Biocompatibility (absence of unacceptable irritation,	- Established by primary dermal irritation test (rabbits), sensitization test (guinea pigs), and in vitro cytotoxicity test.
sensitization, or cytotoxicity)
Effectiveness/Function:
- Similar composition to predicate device	- "OraMagicRx™ Oral Wound Rinse is similar in composition..."
- Identical in function to predicate device	- "...and identical in function..."
- Identical in intended use to predicate device	- "...and intended use, to Radiacare™ Oral Wound Rinse (Carrington Laboratories, Inc.) and other legally marketed hydrogel wound dressing products."
- Performs at least as well as legally marketed predicate devices	- "...performs at least as well as legally marketed predicate devices, such as Carrington's Radiacare™ Oral Wound Rinse."
Intended Use:
- For the management of mucositis/stomatitis, all types of oral	- "For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces."
wounds, aphthous ulcers/canker sores, and traumatic ulcers.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Radiacare™ Oral Wound Rinse, K964852) and biocompatibility testing. The submission does not describe a clinical performance study in the way a diagnostic product would.

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

Not applicable / Not provided for clinical performance. The submission relies on substantial equivalence rather than a clinical performance study with a test set of patient data.
Biocompatibility Testing: The sample sizes used for the biocompatibility tests (primary dermal irritation, sensitization, in vitro cytotoxicity) are not specified in the 510(k) summary (e.g., number of rabbits, guinea pigs, or specific cell lines). The data provenance for these specific tests is not stated regarding country of origin or whether they were retrospective/prospective, but these are typically prospective laboratory studies.

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

Not applicable. No clinical test set requiring expert ground truth establishment for diagnostic performance is described. The relevant "experts" would be those who conducted and interpreted the biocompatibility tests according to standard protocols.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication for diagnostic performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, to assess the impact of the AI on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an oral wound rinse, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For biocompatibility: The ground truth would be established by the observed biological responses according to standardized testing protocols (e.g., absence of irritation, sensitization, cytotoxicity).
For substantial equivalence: The "ground truth" is the established safety and effectiveness profile of the predicate device (Radiacare™ Oral Wound Rinse) as determined by its prior regulatory clearance.

8. The Sample Size for the Training Set

Not applicable. This device is a medical product (oral rinse), not an AI/ML algorithm requiring a training set.

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary

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K024180

510 (k) SUMMARY

MAR 1 4 2003

1. ADMINISTRATIVE

Submitter: MPM Medical, Inc. 2301 Crown Court Irving, Texas 75038 (982) 893-4060

Contact Person: Paul R. Miller

Date of Preparation: February 25, 2003

II. DEVICE NAME

Proprietary Name: OraMagicRx™ Oral Wound Rinse Common Name: Mucositis/Stomatitis Oral Rinse Classification Name: Dressing, Wound and Burn, Hydrogel w/ Drug and/or Biologic

PREDICATE DEVICE ==============================================================================================================================================================================

Radiacare™ Oral Wound Rinse (K964852 Carrington Laboratories, Inc.)

IV. DEVICE DESCRIPTION

INTENDED USE V.

For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.

The biocompatibility of this device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.

VI. COMPARISON TO PREDICATE DEVICE

OraMagicRx™ Oral Wound Rinse is similar in composition, and identical in function and intended use, to Radiacare™ Oral Wound Rinse (Carrington Laboratories, Inc.) and other legally marketed hydrogel wound dressing products.

Accordingly, MPM Medical concluded that OraMagicRx™ Oral Wound Rinse is safe and effective for its intended use, and performs at least as well as legally marketed predicate devices, such as Carrington's Radiacare™ Oral Wound Rinse

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Public Health Service

MAR 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MPM Medical, Incorporated C/O Mr. Richard Hamer Consultant Richard Hamer Associates, Incorporated 48910 Denton Road, # 38 Belleville, Michigan 48111

Re: K024180

Trade/Device Name: OraMagicRxTM Oral Wound Rinse Regulation Number: None Regulation Name: Mucositis/Stomatitis Oral Rinse Regulatory Class: Unclassified Product Code: MGQ Dated: December 17, 2002 Received: December 18, 2002

Dear Mr. Hamer:

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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 controls provisions of the Act. The general controls provisions of the Act include requirements 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 your device can be found 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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Page 2 - Mr. Hamer

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

KO24180

Device Name:

OraMagicRx™ Oral Wound Rinse

Indications for Use:

For the management of oral mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers such as those caused by ill-fitting braces or dentures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number	K024180

Prescription Use (Per 21 CFR 801.109)	X	OR	Over-the-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

N/A