PROCTIGARD

K140558 · Access Pharmaceuticals, Inc. · PHN · Jul 16, 2014 · GU

Device Facts

• Record ID: K140558
• Device Name: PROCTIGARD
• Applicant: Access Pharmaceuticals, Inc.
• Product Code: PHN · GU
• Decision Date: Jul 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

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

Device Story

ProctiGard™ is a viscous, mucoadhesive liquid hydrogel supplied in single-use enema bottles. Designed for symptomatic management of rectal mucositis. Applied via enema bottle applicator to form a protective coating over rectal mucosa. Formulation consists of film-forming polymers, pharmaceutical aids, and preservatives. Identical in composition and mode of action to predicate MuGard® (K062795), which targets oral mucosa. Provides physical barrier to protect rectal tissue. Used in clinical or home settings as prescribed.

Clinical Evidence

Bench testing only. Safety established through biocompatibility testing per ISO 10993, including in vitro cytotoxicity, sensitization testing in guinea pigs, and mucosal irritation testing in rabbits.

Technological Characteristics

Viscous liquid hydrogel; mixture of film-forming polymers, pharmaceutical aids, and preservatives. Delivered via single-use enema bottle. Biocompatibility verified per ISO 10993 standards.

Indications for Use

Indicated for symptomatic management of rectal mucositis in patients requiring such treatment.

Regulatory Classification

Identification

Mucoadhesive application for the protective coating of the rectal mucosa.

Predicate Devices

• MuGard® Mucoadhesive Oral Wound Dressing (K062795)

Submission Summary (Full Text)

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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 Floor<br>New York, NY 10019 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |
| E. | Contact Person: | Jeffrey B. Davis<br>President & CEO<br>[e-mail] |

#### 5.2 Device Identification

| A. | Device Trade Name: | ProctiGard™ |
|----|----------------------|------------------------------------------------------------------------|
| B. | Common Name: | Protective coating, mucoadhesive application, for<br>the 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

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.

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 [phone] or [phone] 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)

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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