ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.

AI/ML Overview

This 510(k) premarket notification is for ProctiGard™, a device indicated for the symptomatic management of rectal mucositis. The submission asserts substantial equivalence to a predicate device, MuGard® Mucoadhesive Oral Wound Dressing (K062795).

Here is an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Primary Acceptance Criterion for Substantial Equivalence: Device formulation is identical to a legally marketed predicate device, ensuring similar safety and efficacy profile.	ProctiGard™'s liquid hydrogel formulation is identical to that of MuGard® Mucoadhesive Oral Wound Rinse (K062795). Both devices utilize a mixture of film-forming polymers, pharmaceutical aids, and preservatives.
Biocompatibility: Meet ISO 10993 standards for in vitro cytotoxicity, sensitization, and mucosal irritation.	Safety has been established through biocompatibility testing of the hydrogel liquid according to ISO 10993, including in vitro cytotoxicity tests, sensitization testing in guinea pigs, and mucosal irritation testing in rabbits.
Mode of Action: Achieve a protective layer over the relevant mucosa.	The mode of action of ProctiGard™ is achieved in an identical manner to MuGard® (i.e., formation of a protective layer over the mucosa), but specifically over the rectal mucosa.
Intended Use: Symptomatic management of mucositis.	ProctiGard™ is indicated for the symptomatic management of rectal mucositis, similar in function to MuGard®'s indication for oral mucositis.
Material Composition: Identical to predicate device.	The composition of the liquid hydrogel of ProctiGard™ is identical to that of MuGard®.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not describe a clinical "test set" or a clinical study involving human subjects for ProctiGard™. The device's substantial equivalence is primarily based on the identical composition and analogous mode of action to its predicate device, MuGard®, along with preclinical biocompatibility testing. The data provenance for the biocompatibility tests (guinea pigs, rabbits) is not specified geographically or as retrospective/prospective.

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

Not applicable. No clinical test set involving human subjects requiring expert ground truth establishment is described in this submission.

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

Not applicable. No clinical test set is described.

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

Not applicable. ProctiGard™ is a medical device (a protective coating), not an AI diagnostic tool.

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

Not applicable. ProctiGard™ is a medical device, not an AI algorithm.

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

The "ground truth" for the device's claims of safety and effectiveness relies on:

Identity of Formulation: The chemical and physical composition of ProctiGard™ is stated to be identical to the legally marketed predicate device, MuGard®.
Biocompatibility Standards: Compliance with ISO 10993 standards (in vitro cytotoxicity, sensitization, mucosal irritation in animal models) serves as the "ground truth" for safety.
Analogous Mode of Action: The understanding that a protective layer over mucosa provides symptomatic relief, which was established for the predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The basis for approval is substantial equivalence to a predicate, supported by preclinical biocompatibility testing and identical formulation.

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

Not applicable. No training set is described.

Summary

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JUL 16 2014 2140558

510(K) SUMMARY

5.1 Submitter Information

A.	Company Name:	Access Pharmaceuticals, Inc.
B.	Company Address:	1325 Avenue of the Americas, 27th FloorNew York, NY 10019
C.	Company Phone:	(212) 786-6205
D.	Company Facsimile:	(212) 786-6210
E.	Contact Person:	Jeffrey B. DavisPresident & CEOjeff.davis@accesspharma.com

5.2 Device Identification

A.	Device Trade Name:	ProctiGard™
B.	Common Name:	Protective coating, mucoadhesive application, forthe rectal mucosa
C.	Classification Name:	Unclassified
D.	Device Class:	Unclassified
E.	Device Code:	PHN
F.	Advisory Panel:	Gastroenterology-urology

Identification of Predicate Devices 5.3

The liquid hydrogel formulation of ProctiGard™ is identical to that of MuGard®, and therefore ProctiGard™ is substantially equivalent to the following predicate device:

MuGard® . Mucoadhesive Oral Wound Dressing manufactured by Access Pharmaceuticals, Inc. and cleared for commercial distribution under 510(k) K062795.

5.4 Device Description

CONFIDENTIAL

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ર્ડ Indications for Use

ProctiGard™ is indicated for the symptomatic management of rectal mucositis.

Comparison to Predicate Devices 5.6

The liquid hydrogel formulation of ProctiGard™ is identical to that of MuGard® Mucoadhesive Oral Wound Rinse (Access Pharmaceuticals, Inc.) and similar to other legally marketed hydrogel wound dressing products. ProctiGard™ is designed for the rectal mucosa while MuGard targets the oral mucosa. MuGard® is provided in an 8 fluid ounce bottle while ProctiGard™ is provided in a single use enema bottle.

The mode of action of ProctiGard™ is achieved in an identical manner to that of MuGard® Mucoadhesive Oral Wound Rinse, i.e., through the formation of a protective layer over the mucosa (over the rectal mucosa rather than the oral mucosa).

The composition of the liquid hydrogel of ProctiGard™ is identical to that of MuGard® Mucoadhesive Oral Wound Rinse, i.e., a mixture of film-forming polymers, pharmaceutical aids, and preservatives.

The safety of ProctiGard™ has been established through biocompatibility testing of the hydrogel liquid according to ISO 10993, i.e., in vitro cytotoxicity tests, sensitization testing in guinea pigs and mucosal irritation testing in rabbits.

On the basis of this information, Access Pharmaceuticals concluded that ProctiGard™ is safe and effective for its intended use and performs equivalently to the identified legally marketed predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

July 16, 2014

Access Pharmaceuticals, Inc. Jeffrey B. Davis President & CEO 1325 Avenue of the Americas, 27th Floor New York, NY 10019

Re: K140558 Trade/Device Name: ProctiGardTM Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: PHN Dated: June 12, 2014 Received: June 13, 2014

Dear Jeffrey B. Davis,

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.

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Page 2 - Jeffrey B. Davis

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

Benjamin R Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

K140558 510(k) Number:

ProctiGard™ Device Name:

Indications for Use:

ProctiGard™ is indicated for the symptomatic management of rectal mucositis.

Type of Use (Select one or both, as applicable):

Prescription Use X (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)

Benjamin R. Fisher -S 2014.07.16 09:12:05 -04'00'

CONFIDENTIAL

Regulation Number and Section

N/A