(89 days)
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.
The provided text is a 510(k) summary for the OraMagic™ Plus Oral Wound Rinse, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a new, novel technology. Therefore, much of the requested information regarding acceptance criteria and performance studies is not typically present in a 510(k) summary for a device like this.
Here’s an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products." "the addition of 10% benzocaine to the original formulation does not raise any new biocompatibility issues," as the safety of topical benzocaine (up to 20%) is "well established through a long history of over-the-counter use." |
| Effectiveness | "OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products." "MPM Medical, Inc. concluded that OraMagic™Plus Oral Wound Rinse is safe and effective for its intended use and performs as least as well as legally marketed predicate devices, such as MPM Medical's OraMagicRx™ Oral Wound Rinse." |
Explanation: The acceptance criteria for this 510(k) revolve around establishing substantial equivalence to a predicate device (OraMagicRx™ Oral Wound Rinse) in terms of safety and effectiveness. The reported performance is an assertion that the new device is "similar" and "performs at least as well as" the predicate, based on its composition, function, intended use, and the known safety profile of its ingredients. No specific numerical thresholds or performance metrics are provided in the document for these criteria, beyond the general statement of equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The submission relies on a comparison to a predicate device and the known safety of its ingredients, rather than a new clinical study with a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there was no explicit clinical study with a test set requiring expert ground truth establishment mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there was no explicit clinical study with a test set mentioned in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not conducted. This device is a topical rinse, not an AI or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a topical rinse and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as a ground truth for a new study. The "ground truth" for the device's efficacy is implicitly derived from the established safety and efficacy of its predicate device and the long history of safe use of its active ingredient (benzocaine).
8. The sample size for the training set
This information is not applicable/not provided. There is no mention of a "training set" as this device is not an AI or machine learning product.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
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MAY 10 2005
510 (K) SUMMARY
I. ADMINISTRATIVE
Submitter: MPM Medical, Inc. 2301 Crown Court Irving, Texas 75038 (982) 893-4060
Contact Person: Paul R. Miller
Date of Preparation: February 3, 2006
II. DEVICE NAME
Proprietary Name: Oramagic™Plus Oral Wound Rinse
Common Name: Mucositis/Stomatitis Oral Rinse
Classification Name: Dressing, Wound and Bum, Hydrogel w/Drug and/or Biologic
III. PREDICATE DEVICE
OramagicRx™ Oral Wound Rinse KO24180 (MPM Medical, Inc.)
IV. DEVICE DESCRIPTION
OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.
V. INTENDED USE
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
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The biocompatibility of the predicate device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vivo cytotoxicity test. Since the safety of topical benzocaine (up to 20%) has been well established through a long history of over-the-counter use, the addition of 10% benzocaine to the original formulation does not raise any new biocompatibility issues.
VI. COMPARISON TO PREDICATE DEVICE
OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products.
Accordingly, MPM Medical, Inc. concluded that OraMagic™Plus Oral Wound Rinse is safe and effective for its intended use and performs as least as well as legally marketed predicate devices, such as MPM Medical's OraMagicRx™ Oral Wound Rinse.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its head and neck. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
MPM Medical, Incorporated C/O Mr. Richard A. Hamer Richard Hamer Associates, Incorporated 897 Chancery Court Monroe, Michigan 48161
Re: K060340
Trade/Device Name: OraMagic™ Plus Oral Wound Rinse Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MGO Dated: February 3, 2006 Received: February 15, 2006
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
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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Indications for Use
510(k) Number if known: 5060340
Device Name: OraMagic™ Plus Oral Wound Rinse
Indications for Use: For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Devaluation (ODE)
Susa Runge
Page 1 of 1
f Anesthesiology, General Hospital,
ion Control, Dental Devices
Number: K060386
N/A