Sucralfate HCI Topical Paste 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. This 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 lesions associated with oral surgery.

Device Description

Sucralfate HCI Topical Paste "10 is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. This compounding process is intended for execution by a pharmacist, dentist, physician, podiatrist, veterinarian, other licensed prescriber or supervised staff trained to handle HCl 1.0N. The amorphous hydrogel paste formed by this reaction is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or inconsistently present.

Sucralfate is reacted with HC1 1.0N in a ratio of approximately of 5 - 8 mL HCl per 5 gram sucralfate. Increased proportions of HCl produce thinner pastes. When reacted with hydrochloric acid sucralfate forms an amorphous hydrous gel that binds reversibly to wounds. Although reacted with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.8. The sucralfate paste formed by this reaction may be administered directly to an accessible wound to provide an adherent physical covering of the wound bed.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Sucralfate HCl Topical Paste." The 510(k) submission process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, i.e., substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require clinical trials to establish device performance against specific acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial designed to establish efficacy and safety for a novel device. Instead, the "study" described is a comparison of technological characteristics and safety profiles to predicate devices to demonstrate substantial equivalence.

Based on the provided text, here's a breakdown of the requested information, noting that much of it is not applicable to a 510(k) substantial equivalence determination:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided document is a 510(k) premarket notification for "Sucralfate HCl Topical Paste." The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove efficacy against pre-defined acceptance criteria through a standalone clinical trial in the way a Premarket Approval (PMA) application would. Therefore, the "acceptance criteria" here refer to the FDA's criteria for substantial equivalence, and the "study" is the comparison made by the applicant to predicate devices.

The document asserts substantial equivalence based on:

Technological Characteristics: The device forms a protective layer over the oral mucosa, adhering to the surface to protect against irritation and relieve pain, similar to predicate devices.
Safety and Effectiveness: Multiple clinical studies (not detailed in this document but likely historical literature or studies on sucralfate) are cited to demonstrate that the safety and effectiveness of topical sucralfate are at least equivalent to the identified predicate devices.
Biocompatibility/Safety: The long history of safe use of sucralfate in oral doses (up to 4 grams daily) is cited, noting no new adverse reactions with topical application, thus raising no new biocompatibility or other safety issues.

Conclusion stated in the 510(k): "The physical properties of the prepared sucralfate polymer would be expected to be at least as effective as those of the predicate devices. Since the safety of sucralfate taken orally as a drug in doses up to 4 gram daily has been well established, no new biocompatibility or other safety issues are raised."

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence to Predicate Devices)	Reported Device Performance (as presented in 510(k))
Function: Forms a protective layer over oral mucosa.	Sucralfate HCl Topical Paste™ forms a protective layer over the oral mucosa by adhering to the mucosal surface.
Mechanism of Action: Adheres to mucosal surface, protects against irritation, relieves pain.	Device operates by adhering to the mucosal surface, allowing it to protect against further irritation and relieve pain.
Safety Profile: No new adverse reactions or biocompatibility issues compared to predicate devices or established sucralfate use.	"No new adverse reactions reported after use of sucralfate applied topically, no new biocompatibility or other safety issues are raised."
Effectiveness: At least equivalent to predicate devices for intended uses.	"Multiple clinical studies demonstrate that the safety and effectiveness of topical sucralfate is at least equivalent to that of the identified predicate devices in those uses."
Intended Use: Similar to predicate devices (management of various mouth lesions).	Device is intended for "management of mouth lesions of all types including aphthous ulcer, stomatitis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery."

Sample size used for the test set and the data provenance
- The document mentions "Multiple clinical studies" as evidence for safety and effectiveness but does not provide details on the sample sizes or data provenance (e.g., country of origin, retrospective or prospective nature) of these studies. This type of detail is typically not required for a 510(k) if the evidence refers to previously published literature or established clinical use of the active ingredient (sucralfate).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. For a 510(k) submission based on substantial equivalence to existing devices and literature review, there isn't a "test set" in the sense of a new study requiring expert ground truth establishment for a novel diagnostic device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no new clinical test set requiring expert adjudication is described in the document.
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
- Not applicable. This device is a topical paste, not an AI-powered diagnostic or imaging device, so MRMC studies or AI assistance are irrelevant to its evaluation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a topical paste, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the claims of safety and effectiveness appears to be existing clinical literature and historical safety data regarding sucralfate, both oral and topical applications, rather than a newly established ground truth from a specific study cited within this 510(k). The document relies on the "long history of safe use of sucralfate in oral doses" and "multiple clinical studies" (assumed to be readily available public information) as the basis for its claims.
The sample size for the training set
- Not applicable. This device did not involve a "training set" in the context of machine learning or AI development.
How the ground truth for the training set was established
- Not applicable for the same reason as above.

Summary

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

K043587\u20442

510K Summary Sucralfate HCl Topical Paste™

FEB 3 2006

Submission Applicant & Correspondent 1.

Submission Date	December 17, 2004
Name:	Patrick D. McGrath, Ph.D.
Address:	1471 Greystone DriveGurnee, IL 60031
Phone No:	(847)-543-4138
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:Katen Paste™ Kit

Katen Paste Sucralfate Paste Kit TM

Dressing, Wound & Burn, Hydrogel w/Drug or Biologic Classification Name:

Product Code: MGQ FRO

Classification: Unclassified

Devices to Which New Device is Substantially Equivalent 3.

Gelclair Concentrated Oral Gel K013056 Salicept Oral Patch K012126

Device Description 4.

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

Image /page/1/Picture/0 description: The image shows a handwritten string of characters that appears to be a code or identifier. The string is "K043587" with a fraction "2/2" written as a subscript. The characters are written in a simple, slightly irregular style, suggesting they were written quickly or without precise attention to uniformity.

5. Intended Use of the Device

Sucralfate HCI Topical Paste™ 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, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.

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

Sucralfate HCI Topical Paste™ 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. Multiple clinical studies demonstrate that the safety and effectiveness of topical sucralfate is at least equivalent to that of the identified predicate devices in those uses. In view of the long history of safe use of sucralfate in oral doses up to 4 grams daily and with no new adverse reactions reported after use of sucralfate applied topically, no new biocompatibility or other safety issues are raised.

7. Conclusions

The physical properties of the prepared sucralfate polymer would be expected to be at least as effective as those of the predicate devices. Since the safety of sucralfate taken orally as a drug in doses up to 4 gram daily has been well established, 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 and Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3

2006

Patrick D. McGrath, Ph.D. 1471 Greystone Drive Gurnee, Illinois 60031

Re: K043587

Trade/Device Name: Sucralfate HC1 Topical Paste Regulatory Class: Unclassified Product Code: FRO Dated: January 7, 2006 Received: January 10, 2006

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, 1)rug, 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 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.

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

Page 2 - Dr. McGrath

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-9115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jarbace freem

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

Enclosure

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

K043587

Indications for Use

510(k) Number (if known):

Device Name: Sucralfate HCI Topical Paste

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Barbara Buchner

Page 1 of

(Division Division of General, Restorative, and Neurological De rices

510(k) Number K043587

Regulation Number and Section

N/A