(79 days)
RexaStom™ Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces.
RexaStom Oral Ease is a dry, wafer or matrix type material, similar to coarse blotting paper. For mucositis, it is supplied in a 2.5-cm curcular format, packaged in a vacuumsealed, foil packet. Its ingredients are either food grade or generally regarded as safe and therefore the wafer material is safe when swallowed. RexaStom is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and provides temporary management of pain associated with various types of injuries to the mouth.
RexaStom's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contour of the wound, and protects the wound from contamination and irritation by forming a temporary protective barrier that is similar to the natural mucosa.
This document describes a 510(k) summary for a medical device called RexaStom™ Oral Ease. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable or not available in the provided text.
The document discusses the device's intended use, technological characteristics, and composition in comparison to existing predicate devices (Gelclair Concentrated Oral Gel and Aloclair Oral Rinse). The core argument is one of "substantial equivalence," meaning that the new device is as safe and effective as existing legally marketed devices.
Key points from the document regarding the device and its assessment:
- Acceptance Criteria and Reported Performance: No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, or effect sizes) are mentioned. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices in terms of indications, composition, safety, and effectiveness.
- Study Type: This is not a study designed to evaluate performance against specific metrics but rather a submission to demonstrate substantial equivalence.
- Ground Truth: The concept of "ground truth" as typically used in AI/diagnostic studies does not apply here. The "truth" is established by showing similarity to legally marketed devices.
- Sample Size: No patient or data sample sizes are mentioned for a performance study. The document states, "Testing with more subjects may require addition of flavoring and possibly sweetener, which we assume will not require further approval," implying that if any testing with subjects occurred, it was for sensory aspects rather than clinical efficacy.
- Experts and Adjudication: Not applicable, as there's no clinical trial or diagnostic performance evaluation described that would require expert adjudication.
- MRMC or Standalone Studies: Not applicable.
- Training Set: Not applicable as this is not an AI/algorithm-based device requiring training data.
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NOV 21 2008
RexaDerm, Inc.
3156 Doolittle Drive ♦ Northbrook, Illinois 60062♦ 847-562-0146
Conceller and and the consisted on the proposition of the proposition of the least of the least of
August 19, 2008
510(k) SUMMARY
-
- Submission Owner and Correspondent:
- a. RexaDerm, Inc.
- b. Address: 3156 Doolittle Drive Northbrook, Illinois 60062
- c. Phone: 847-562-0146
- d. Fax: 847-562-0146
- Contact Person: e. Clyde R. Goodheart, MD, President
| 2. Name of Device: | RexaStom™ Oral Ease |
|---|---|
| Trade name: | RexaStom Oral Ease |
| Common or usual name: | Dressing, Wound and Burn, Hydrogel w/Drug or Biologic |
| Classification names: | Dressing, Wound and Burn, Hydrogel w/Drug or Biologic |
-
- Device Description:
RexaStom Oral Ease is a dry, wafer or matrix type material, similar to coarse blotting paper. For mucositis, it is supplied in a 2.5-cm curcular format, packaged in a vacuumsealed, foil packet. Its ingredients are either food grade or generally regarded as safe and therefore the wafer material is safe when swallowed. RexaStom is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and provides temporary management of pain associated with various types of injuries to the mouth.
- Device Description:
RexaStom's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contour of the wound, and protects the wound from contamination and irritation by forming a temporary protective barrier that is similar to the natural mucosa.
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5. Intended Use of the Device
The indications for RexaStom are the same as for the predicate devices:
RexaStom"" Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces.
- Technological Characteristics of the Device Compared to Predicate Devices:
RexaStom, like the predicate devices cited in this 510(k), adheres to the wound surface, conforms to the contours of the wound, and provides temporary management of pain by forming a protective barrier over the wound, similar to undamaged natural mucosa. All these barriers manage pain by protecting the wound from contamination and irritation. They all slowly dissolve in the mouth, and all are safe if swallowed. Thus, the indication for use and the mode of action of this device are identical to those of predicate devices. We have found that the coating behavior of RexaStom in the mouth is the same as that for Gelclair, one of the predicate devices.
RexaStom is equivalent in composition to that of the cited predicate devices, except that because it is freeze-dried, glycerin is added to decrease brittleness, and preservatives have been omitted from its formulation. Further, because it is freeze-dried, it is light and easy to handle, and easier to use in public settings, because no mixing is needed. Because of this feature, we believe patients will be more likely to use the product for temporary relief of pain to make it easier for them to eat.
RexaStom contains five ingredients, all of which are food grade or approved by FDA for internal use, and generally regarded as safe. These ingredients are also in Gelclair, perhaps the closest predicate device. As it is now formulated, RexaStom omits flavoring, and is tasteless. Testing with more subjects may require addition of flavoring and possibly sweetener, which we assume will not require further approval.
Conclusion: RexaStom Oral Ease is substantially equivalent to the predicate devices in its indications and composition, and in its safety and effectiveness. Because the formulation of RexaStom is similar to, but more simple than, the predicate devices, the criteria for substantial equivalence have been met.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clyde R. Goodheart, M.D. President RexaDerm, Incorporated 3156 Doolittle Drive Northbrook, Illinois 60062
Re: K082553
Trade/Device Name: RexaStom™ oral Ease Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MGQ Dated: August 29, 2008 Received: September 3, 2008
Dear Dr. Goodheart:
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.
NOV 21 2008
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 - Dr. Goodheart
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 on quirements of the Act or any Federal statutes and regulations administered by other Federal squarens. 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 Scction 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Quares
Chiu S. Lin, Ph. D
Division 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): Not known.
Device Name: RexaStom™ Oral Ease
Indications For Use:
RexaStom™ Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces,
Note that the indications for RexaStom are the same as for the predicate devices.
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 Evaluation (ODE)
Susan Rushe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: FC82583
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