ProThelial™ & Orafate Sucralfate Malate 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, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.

Device Description

ProThelial™ & Orafate Sucralfate Paste is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. ProThelial™ & Orafate Sucralfate Paste may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucraffate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7.0.

AI/ML Overview

The provided 510(k) summary does not describe acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared active ingredients, polymerization mechanism, intended use, and similar technological characteristics.

Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment are not present in this document.

Here's a breakdown of what can be extracted and what is explicitly not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on substantial equivalence rather than meeting specific performance criteria demonstrated through a direct performance study with acceptance criteria. The "performance" is implicitly tied to being "as safe, as effective, and performs as well as the predicate devices."

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

This information is not provided. No specific test set or clinical study demonstrating performance metrics with a sample size is described. The submission relies on the established safety and efficacy of the active ingredient (sucralfate) in the predicate devices.

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

This information is not provided. There is no mention of a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided. As no test set with ground truth is described, there's no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done (or at least not described in this summary). The submission is not a comparative effectiveness study but a substantial equivalence claim.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a medical paste, not an AI algorithm.

7. The Type of Ground Truth Used

This information is not provided as no specific study requiring a defined ground truth for performance evaluation is described. The "ground truth" for the substantial equivalence claim is the established safety and efficacy profile of sucralfate as an active ingredient in similar products.

8. The Sample Size for the Training Set

Not applicable. This device is a medical paste, not a machine learning model, so there is no "training set."

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

Not applicable. This device is a medical paste, not a machine learning model, so there is no "training set" or ground truth for it.

Key Information from the Document Regarding "Proof"

The "proof" of the device's suitability for market, according to this 510(k) summary, rests entirely on the concept of substantial equivalence to already approved predicate devices.

Basis for Substantial Equivalence:
- Identical Active Ingredient: Sucralfate is identified as the "sole active ingredient" and "clinically effective component" in ProThelial™ & Orafate Sucralfate Malate Paste, and it is also the active ingredient in the predicate devices (K043587 Sucralfate HCl Topical Paste and K082856 Carapaste® Oral Wound Dressing).
- Similar Mechanism of Action: All devices require and facilitate the polymerization of sucralfate to form a protective film, and proper operation requires mucoadherence.
- Identical Intended Use: The indications for use are identical for the subject device and the predicate devices, covering a range of oral lesions and aiming to form a protective layer to relieve pain and irritation.
- Similar Technological Characteristics: The table comparing the devices highlights very similar patient groups, areas of use, product type (paste), and presentation (non-sterile).
- Non-Clinical Performance Data: The submission states that "The non-clinical performance data relied on in this submission for a determination of substantial equivalence is the identical nature of clinically effective component of this and the predicate devices." It also mentions "non-clinical tests involve those required by USP national standards to verify the presence sucralfate."
Conclusion: The manufacturer concludes that "ProThelial™ & Orafate are substantially equivalent to predicate devices K0435897 and K082856" based on these comparisons, asserting that the subject device is "as safe, as effective, and performs as well as the predicate devices."

In summary, this 510(k) summary does not present clinical study data with acceptance criteria for the new device. Instead, it argues that because the new device is fundamentally the same (in active ingredient, mechanism, and intended use) as already approved devices, it can be considered equally safe and effective without new, extensive performance studies.

Summary

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510(k) SUMMARY

ProThelial™ & Orafate Sucralfate Malate Paste

1. Submission Applicant & Correspondent

Submission Date: Revision Date:

Name: Address:

Phone No: Contact Person:

December 18, 2012 March 12, 2013 July 22, 2013 Mueller Medical International LLC 48a Moosup Valley Road Foster RI 02825 USA 401-397- 6203 Ricky W. McCullough MD

AUG 07 2013

2. Name of Device

Common or Usual Name: Trade/Proprietary/Model Name: Classification Name: Product Code: Classification:

Sucralfate Malate Paste ProThelial™ & Orafate Sucralfate Paste Dressing, Wound, Drug FRO Unclassified

3. Devices to Which New Device is Substantially Equivalent

ProThelial™ & Orafate Sucralfate Paste is a hydrogel wound dressing that is substantially equivalent to K043587 Sucralfate HCl Topical Paste and K082856 Carapaste® Oral Wound Dressing, Its substantial equivalence is based firstly on sucralfate being the active inqredient for each of the devices without which neither device would be operative as wound dressings.

Additionally, similar to its predicate devices, the present device requires the polymerization of sucralfate in order to function. Lastly both the present device and the predicate devices have the identical Indication of Use.

4. Device Description

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5. Intended Use of the Device

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

Product Name	ProThelial™ & Orafate	Sucralfate Topical Paste	Sucralfate HCl Topical Paste
Device Number	K123904	K082856	K043587
Patient Group	Pediatric & Adult	Pediatric & Adult	Pediatric & Adult
Method of Use	Pre-Mixed with Malic Acid& Calcium Carbonate	Pre-Mixed with HCI Acid	Mix with HCl at time of use
Administrationsper day	Application to mucosalwounds 2 -3 times daily	As Needed for Applicationto mucosal wounds	As Needed for Applicationto mucosal wounds
Claim	Management and relief ofpain, non irritating, safe ifswallowed	Management and relief ofpain, non irritating, doesnot sting, safe if swallowed	Management and relief ofpain, non irritating, doesnot sting, safe if swallowed
Area of Use	Oral Mucosa	Oral Mucosa	Oral Mucosa
Indication	Oral lesions of all typesincluding aphthous ulcer,stomatitis, mucositis,traumatic ulcers,abrasions, wounds fromoral surgeryTo form a protective layerover the mucosa byreversibly adhering to thesurface allowing relief ofpain and protection againstfurther irritation.	Oral lesions of all typesincluding aphthous ulcer,stomatitis, mucositis,traumatic ulcers,abrasions, wounds fromoral surgeryTo form a protective layerover the mucosa byreversibly adhering to thesurface allowing relief ofpain and protection againstfurther irritation.	Oral lesions of all typesincluding aphthous ulcer,stomatitis, mucositis,traumatic ulcers,abrasions, wounds fromoral surgeryTo form a protective layerover the mucosa byreversibly adhering to thesurface allowing relief ofpain and protection againstfurther irritation.
Type of Product	Paste	Paste	Paste
Presentation	Non Sterile	Non Sterile	Non Sterile

As seen in table below, there is no difference between the subject and predicates with respect to indications for use or technology.

ProThelial™ & Orafate Sucralfate Paste forms a protective layer over the oral mucosa, adhering to the mucosal surface, relieving pain and and irritation. The predicate devices, K082856 and K043587 use Hydrochloric acid, a strong acid, to effect polymerization of sucralfate.

Unlike predicate devices, the present device contains nine components each of which purposefully contribute to the operation of the device. Sucralfate is the sole active conveying protective cover for the oral mucosa. Malate and calcium carbonate facillate the polymerization of sucralfate in water. The water provide matrix for the polymerization of sucralfate and a vehicle to hold polymerized sucralfate in place when applied. Xanthan qum and calcium sulfate provide the paste consistency for

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the device. Sodium saccharin maintains agreeable palatability of the device while methyl and propyl parabens preserve a microbial-static condition for the paste during its shelf life.

7. Conclusions

Both the present device and predicate devices use sucralfate as the active component to achieve their clinical effect. Each of the devices requires the facilitated polymerization of sucralfate in order for the devices to function. Each of the devices requires direct application, transient contact with the patient and multiple administrations for their use. Proper operation of each of the devices requires mucoadherence of sucralfate.

The non-clinical performance data relied on in this submission for a determination of substantial equivalence is the identical nature of clinically effective component of this and the predicate devices. The clinically effective component is sucralfate USP, without which neither device would function. The non-clinical tests involve those required by USP national standards to verify the presence sucralfate. Sucralfate used in each of the devices is an a-D-glucopyranoside, ß-Dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex, molecular weight of 2,086.75 having the following structure:

Image /page/2/Picture/5 description: The image shows a chemical structure of a disaccharide. It consists of two monosaccharide units linked together by a glycosidic bond. The monosaccharide units are in a cyclic form, with multiple hydroxyl groups (-OR) attached to the carbon atoms.

[AI(OH), ] x [H2O]y (x=8 to 10 and v= 22 to 31)

R= SO AL(OH),

The physical wound covering properties of ProThelial™ & Orafate Sucralfate Paste would be expected to be at least as effective as those of the predicate devices.

No new biocompatibility or other safety issues are raised.

From the nonclinical tests discussed above the subject device is as safe, as effective, and performs as well as the predicate devices.

The manufacturer of record concludes from the comparison of clinically effective components of this device and the predicate devices that the current device, ProThelial™ & Orafate are substantially equivalent to predicate devices K0435897 and K082856.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ricky W. McCullough, MD Managing Director Mueller Medical International LLC 48a Moosup Valley Road Foster, Rhode Island 02825

August 7, 2013

Rc: K123904

Trade/Device Name: ProThelial" & Orafate "M Sucralfate Malate Paste Regulatory Class: Unclassified Product Code: FRO Dated: July 15, 2013 Received: July 17, 2013

Dear Dr. McCullough:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ricky W. McCullough, MD

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123904

Device Name: ProThelial TM & Orafate Sucralfate Malate Paste

Indications For Use:

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

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)

Jiyoung Dang -S

Page 1 of _1

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123904

Regulation Number and Section

N/A