ABSOCLEAR

K130553 · Pharmaplast S.A.E. · FRO · Jul 3, 2013 · SU

Device Facts

• Record ID: K130553
• Device Name: ABSOCLEAR
• Applicant: Pharmaplast S.A.E.
• Product Code: FRO · SU
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Sterile, single-use dressings for management of pressure ulcers, 155 and 200 degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.

Device Story

AbsoClear is a sterile, single-use transparent synthetic wound dressing composed of absorbent acrylic polymers on a polyurethane film backing. Designed for use by healthcare professionals and consumers in clinical or home settings, the dressing maintains a moist wound environment to facilitate healing while absorbing exudate. Its transparency allows for visual monitoring of the wound site without requiring dressing removal. The device acts as a physical barrier against liquids and contaminants while permitting gas exchange (oxygen and water vapor). It is applied directly to the wound surface to protect the site and support the healing process.

Clinical Evidence

No clinical data. Bench testing only. Testing included absorption capacity, sterility, package seal strength, seal integrity, coat weight, peel adhesion, and moisture vapor transmission rate (MVTR). Biocompatibility testing per ISO 10993-1:2009 included cytotoxicity, sensitization, and intracutaneous reactivity. All acceptance criteria were met.

Technological Characteristics

Materials: Polyurethane film backing, synthetic acrylate adhesive. Principle: Occlusive dressing, moisture vapor transmission, exudate absorption. Form factor: Flat, sterile, single-use. Sterilization: Gamma irradiation (ISO 11137, SAL 10^-6). Biocompatibility: ISO 10993-1:2009 compliant.

Indications for Use

Indicated for management of pressure ulcers, 1st and 2nd degree burns, skin tears, abrasions, irritated skin, surgical incisions, and graft donor sites in patients requiring wound protection.

Predicate Devices

• 3M Tegaderm™ Transparent Film Dressing (K973063)

Submission Summary (Full Text)

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K|30553

Image /page/0/Picture/1 description: The image shows the logo for "Pharmaplast". The logo consists of a stylized letter "P" inside of a circle, followed by the word "Pharmaplast" in a bold, sans-serif font. Below the text is a thick, black line that tapers to a point on the right side.

3 2013 JUL

510(k) Summary

This summary of information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

510(k) owner's name: Pharmaplast S.A.E. Address: Amria Free Zone, 23512, Alexandria, Egypt Phone and fax numbers: [phone], Fax [phone] Contact person: Mamdouh Atteia Summary Date: 27 September 2012

Pharmaplast S.A.E. 510[k]

AbsoClear®

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Trade or proprietary name of the device: AbsoClear®

Classification Name: Dressings, Wound and Burn, Occlusive (no drug or biologic)

Product Code: FRO

Classification: Unclassified; 510[k] required

Legally marketed device to which equivalence is claimed: 3M Tegaderm™ Transparent Film Dressing; K973063

Device Description

The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.

#### Intended Use

Sterile, single-use dressings for management of pressure ulcers, 155 and 200 degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.

Comparison to predicate device

Summary Comparison Table of New Device to Predicate Device

| Parameter | Device | Predicate Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AbsoClear Gel<br>AbsoClear Gel Comfort | Tegaderm Transparent Film<br>Dressing |
| Manufacturer | Pharmaplast S.A.E. | 3M |
| 510[k] # | K130553 | K811291, K812678, K852750,<br>K901845, K932422, and K973036 |
| Class | Unclassified | Same |
| 21 CFR<br>number/category | NA | Same |
| Code | FRO; unclassified | Same |
| Product Type | Dressings, Wound and<br>Burn, Occlusive | Same |
| Description | Transparent,<br>nonresorbable, sterile<br>dressing | Same |
| Parameter | Device | Predicate Device |
| Intended Use | For management of<br>pressure ulcers, 1st and<br>2nd degree bums, skin<br>tears, abrasions, or<br>irritated skin and surgical<br>incisions and graft donor<br>sites. | To cover and protect catheter<br>sites and wounds, to maintain a<br>moist environment for wound<br>healing or to facilitate autolytic<br> |
| Style | Flat; adhesive edge on<br>some models | Flat; adhesive edge |
| Components | Polyurethane film<br>backing laminated with a<br>synthetic acrylate<br>dressing | Same |
| Additive | No drug or biologic agent | Same |
| End User | Healthcare professionals<br>and consumers | Same |
| Frequency of<br>Use | Single-use only | Same |
| Mode of Action | Provides a barrier to<br>liquids and<br>contaminants, supports a<br>moist wound<br>environment, and allows<br>the exchange of gases<br>such as oxygen and<br>water vapor | Same |
| Sterility | SAL 10e-6; gamma<br>irradiation: ISO 11137 | Same |

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# Bench Testing

All acceptance criteria for the following were met in GLP testing of each lot of . AbsoClear product: absorption capacity, sterility, package seal strength and seal integrity. For products that include adhesive borders, routine acceptance testing includes coat weight, peel adhesion, and MVTR.

AbsoClear®

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# Sterilization

The gamma sterilization process was validated per ISO 11137 to a Sterility Assurance Level of 10°. Bioburden and pyrogenicity testing were done as part of this process and all acceptance criteria were met.

## Shelf-life

Testing was done per multiple standards on the following to ensure that the product and packaging met all specifications after storage at 40°C for twelve months plus real time stability at 25°C for three years: peel adhesion; moisture vapor transmission rate; absorption capacity; sterility; packaging seal strength; packaging seal integrity. Shelf-life of the product is validated to three years.

#### Biocompatibility

Per ISO 10993-1:2009, AbsoClear is categorized as surface-contacting device that comes in contact with breached or compromised surfaces and has a possible exposure time of >24 hr. but not to exceed 30 days. According to this categorization the following biocompatibility tests were performed with the finished packaged, sterilized product: cytotoxicity [ISO 10993-5]; sensitization [ISO 10993-10]; and intracutaneous reactivity [ISO 10993-10]. Tests were done by an accredited testing laboratory and the product met all acceptance criteria.

#### Clinical Studies

All materials used in these products have been in use for these indications for many years. Therefore, non-clinical data on the pharmacodynamics, pharmacokinetics as well as on the toxicity of the substance are available. Additional clinical testing was not required.

### Device Comparison Statement

The Pharmaplast S.A.E. AbsoClear product line is biocompatible and has similar technological characteristics and materials as a previously cleared device and therefore raises no new no new issues of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Pharmaplast S.A.E. % Biotechnology Transfer, LLC Ms. Cynthia Pritchard 1016 Tobiano Lane Raleigh, North Carolina 27614

Re: K130553

Trade/Device Name: AbsoClear Regulatory Class: Unclassified Product Code: FRO Dated: April 27, 2013 Received: May 22, 2013

Dear Ms. Pritchard:

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

# July 3, 2013

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Page 2 - Ms. Cynthia Pritchard

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 yours,

# Mark N. Melkerson -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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Document Mail Center WO66-G609 Center for Devices and Radiological Health U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

#### Indications for Use

510(k) Number (if known): K130553

Device Name: AbsoClear Gel and AbsoClear Gel Comfort

Indications for Use:

Sterile, single-use dressings for management of pressure ulcers, 131 and 200 degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-the-Counter Use (Part 21 CFR 807 Subpart C)

# Jiyoung Dang -S

and

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130553

Pharmaplast S.A.E. 510[k]

AbsoClear®

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