CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lessions associated with oral surgery.

Device Description

CARAPASTE ® Oral Wound Dressing, Sucralfate HCl Topical Paste, is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or is inconsistently present. CARAPASTE ® Oral Wound Dressing may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.5.

AI/ML Overview

The provided document is a 510(k) summary for the CARAPASTE® Oral Wound Dressing, K082856. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring the submission of new clinical or performance data to establish safety and effectiveness.

Therefore, the document does not contain information regarding a study that proves the device meets specific acceptance criteria based on its own performance. Instead, it asserts substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" are generally that the new device has substantially equivalent technological characteristics and intended use to a predicate device, and does not raise new questions of safety or effectiveness. Direct performance metrics are typically not required unless there are significant technological differences or new indications for use.

Acceptance Criteria	Reported Device Performance
Not specified directly in the document, as this is a 510(k) submission based on substantial equivalence. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness.	CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa, adheres to the mucosal surface, and relieves pain and promotes wound healing of mouth lesions. (This is a description of its mechanism and intended effects, not quantitative performance data against specific criteria.)

2. Sample size used for the test set and the data provenance

This information is not applicable/not provided as this 510(k) submission does not include primary clinical studies with a test set. The submission relies on demonstrating substantial equivalence to a predicate device (Sucralfate HCl Topical Paste K043587) rather than presenting new performance data from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided. There is no mention of a test set with ground truth established by experts in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There is no mention of a test set requiring adjudication in this 510(k) summary.

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

This information is not applicable/not provided. The device is an oral wound dressing and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable/not provided. The device is a physical wound dressing and does not involve algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. The 510(k) summary does not describe a study that established a "ground truth" for the device's performance, as it relies on substantial equivalence.

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 is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided. There is no mention of a training set or ground truth establishment in this 510(k) summary.

Summary

{0}------------------------------------------------

510K Summary CARAPASTE® Oral Wound Dressing K082856

Submission Applicant & Correspondent 1.

Submission Date	September 25, 2008
Name:	McGrath Pharmaceuticals, Inc.
Address:	683 Center Street Unit C
Phone No:	Grayslake, IL 60030(847)-548-7860
Contact Person	Patrick D. McGrath, Ph.D.
2. Name of Device
Common or Usual Name:	Sucralfate HCl Topical Paste
Trade/Proprietary/Model Name:		The following Trade Names will be used
	CARAPASTE® Oral Wound Dressing
Classification Name:	Dressing, Wound, Drug
Product Code:	FRO
Classification:	Unclassified

Devices to Which New Device is Substantially Equivalent 3.

Sucralfate HCl Topical Paste K043587

4. Device Description

ട. Intended Use of the Device

{1}------------------------------------------------

6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices

CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa, adheres to the mucosal surface and relieves pain and promotes wound healing of mouth lesions.

7. Conclusions

The physical wound covering properties of CARAPASTE® Oral Wound Dressing would be expected to be at least as effective as those of the predicate devices. No new biocompatibility or other safety issues are raised.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

McGrath Pharmaceuticals, Inc. % Patrick D. McGrath Ph.D. President and Founder 683 Center Street, Unit C Grayslake, Illinois 60030

Re: K082856

Trade/Device Name: CARAPASTE® Oral Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 25, 2008 Received: September 29, 2008

Dear Dr. McGrath:

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.

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 eestronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -- Patrick D. McGrath Ph.D.

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 1egally 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.

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:___CARAPASTE® Oral Wound Dressing

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ronden for nxm

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K082856

Regulation Number and Section

N/A