SORBACT WOUND DRESSING

K063059 · Abigo Medical AB · FRO · Apr 19, 2007 · SU

Device Facts

• Record ID: K063059
• Device Name: SORBACT WOUND DRESSING
• Applicant: Abigo Medical AB
• Product Code: FRO · SU
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Sorbact® Wound Dressings are intended for use in the management of moderate to heavily exudating partial to full thickness wounds (including clean, colonized, contaminated or infected wounds) and to bind hydrophobic microbes The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers. OTC: Sorbact® Wound Dressings are intended for use in the management of draining minor wounds and to attract and bind water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.

Device Story

Sorbact® Wound Dressing is a sterile bandage designed to manage wound exudate and reduce microbial load. The dressing consists of acetate or cotton fabric coated with DACC (dialkyl carbamoyl chloride), a hydrophobic fatty ester acid. Principle of operation: the hydrophobic coating physically attracts and binds water-repelling (hydrophobic) microorganisms to the dressing fibers; microbes are then removed from the wound bed during dressing changes. Available in various forms including adsorbent dressings, compresses, ribbon gauze, and swabs. Used in clinical or home settings by healthcare providers or patients. By reducing the concentration of hydrophobic microbes, the device assists in wound management and healing. No active antimicrobial agents are released; the mechanism is purely physical adsorption.

Clinical Evidence

Safety and effectiveness supported by in vitro and clinical tests. No specific metrics or sample sizes provided in the summary document.

Technological Characteristics

Sterile hydrophobic acetate or cotton fabric; absorbent dressings include non-woven viscose core. Coated with DACC (dialkyl carbamoyl chloride) fatty ester. Physical adsorption mechanism for antimicrobial effect. Biocompatible materials. Sterilized.

Indications for Use

Indicated for management of moderate to heavily exudating partial to full thickness wounds (post-operative, trauma, shallow cavity, fistulas, pressure/diabetic/venous ulcers) and minor wounds (scrapes, cuts, sores, burns) in patients requiring wound care; binds hydrophobic microbes.

Predicate Devices

• ColActiveAG Antimicrobial Gel Sheet Dressing (K052696)
• Triosyn T40 Antimicrobial Wound Dressing (K051542)

Submission Summary (Full Text)

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

K063059 page 1/4

## 510(k) NOTIFICATION SUMMARY

### General Information I.

| Submission Applicant and Correspondent: | APR 1 9 2000 |
|-----------------------------------------|--------------|
|-----------------------------------------|--------------|

Name: Address:

US Agent and

Correspondent:

A.

Abigo Medical AB Ekonomivägen 5 S-436 33 Askim, Sweden 011-46-31-748-4950 Tel: [phone] Fax:

Emalee G. Murphy Kirkpatrick & Lockhart Preston Gates Ellis LLP 1601 K Street, NW Washington, DC 20006 202-778-9428 Tel: [phone] Fax: email: [e-mail]

- Wound Dressing B. Name of Device Trade Name: Sorbact® Wound Dressing Common Name:
### C. Regulatory Information:

Classification: Product Codes: Panel: Performance Standard:

Device Est. Reg .:

Nonabsorbable Gauze, Surgical Sponge & Wound and Burn Dressing for External Use

Unclassified FRO General and Plastic Surgery No performance standard is applicable at this time. TBA

Sorbact® dressings are CE certified as Class IIb medical devices (for use principally with wounds that have breached the dermis and can only heal by secondary intent).

### Devices to Which the New Device is Substantially Equivalent: D.

ColActiveAG Antimicrobial Gel Sheet Dressing (K052696) Triosyn T40 Antimicrobial Wound Dressing (K051542)

#### II. Device Description:

Sorbact Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms. The dressings are coated with DACC (dialky) carbamoyl chloride), a hydrophobic (water-repelling) fatty ester acid that binds to and reduces the

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

K063059 page 2/4

overall concentration of hydrophobic microbes in a wound each time the dressing is changed. Available Sorbact products include adsorbent dressings, compresses, ribbon gauze tamponades, round swabs and surgical dressings.

#### III. Indications for Use

- Sorbact® Wound Dressings are intended for use in the management of moderate Rx: to heavily exudating partial to full thickness wounds (including clean, colonized, contaminated or infected wounds) and to bind hydrophobic microbes The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
- OTC: Sorbact® Wound Dressings are intended for use in the management of draining minor wounds and to attract and bind water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.

## Summary of Technical Characteristics of the Device Compared to the Predicate IV. Devices

The Sorbact® wound dressings are substantially equivalent to FDA-cleared antimicrobial wound dressings ColActiveAG Antimicrobial Gel Sheet Dressing (K052696) and Triosyn T40 Antimicrobial Wound Dressing (K051542).

All three dressings consist of well-known bandage materials: Sorbact® uses sterile hydrophobic acetate or cotton fabric, plus the absorption dressing has an absorption core of non-woven viscose. Colactive AG uses a sterile hydrated collagen sheet; Triosyn T40 uses a layer of absorbent non-woven polyester with a non-adherent high-density polyethylene mesh (HDPE).

All three dressings are indicated for the management of full and partial thickness wounds including various types of ulcers (pressure, diabetic, venous ulcers), abrasions and lacerations, traumatic wounds, and surgical wounds.

All three dressings indicated for prescription use, are sterile, and claim an antimicrobial activity. Sorbact® acts by adsorption to remove bacteria from a wound, while Colactive AG and Triosyn T40 include an antimicrobial active substance as part of the device.

The difference in the mechanisms of antimicrobial action does not affect the substantial equivalence of Sorbact® dressings.

{2}------------------------------------------------

K063059 Page 3/4

# Substantial Equivalence Comparison Chart:

.

| Product Name | Sorbact® | ColactiveAG | Triosyn T40 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Abigo Medical AB | Covalon Technolgies Ltd. | Triosyn Corp. |
| Regulatory<br>Status | Wound Dressing<br>21 CFR 807.87<br>Product Code FRO | K032986 | K051542 |
| Materials of<br>Construction | A layer of sterile<br>hydrophobic acetate or<br>cotton fabric, plus the<br>absorbent dressing has<br>an absorption core of<br>non-woven viscose. The<br>wound contact materials<br>are coated with a fatty<br>ester that gives Sorbact®<br>a strong hydrophobic<br>(water-repelling)<br>property. | Collagen and silver<br>lactate provided in a<br>sterile hydrated collagen<br>sheet. | A single layer of<br>Triosyn composite<br>sterile dressing<br>consisting of an<br>absorbent polyester non-<br>woven pad, a permeable<br>adhesive, iodinated resin<br>beads, and a non-<br>adherent high-density<br>polyethylene mesh<br>(HDPE). |
| Sterility | Yes | Yes | Yes |
| Comparable<br>Sizes and Forms | Yes | Yes | Yes |
| Biocompatibility<br>Testing | Yes | Yes | Yes |
| Intended Use | Rx: For the management<br>of moderate to heavily<br>exudating partial to full<br>thickness (clean,<br>colonized, contaminated<br>or infected) wounds,<br>including post-operative<br>wounds, trauma wounds,<br>shallow cavity wounds,<br>fistulas, pressure ulcers,<br>diabetic ulcers, and<br>venous ulcers.<br><br>OTC: For the manage-<br>ment of superficial<br>wounds such as minor<br>abrasions, cuts, pressure | Rx: For the management<br>of full and partial<br>thickness wounds<br>including pressure and<br>diabetic ulcers, mixed<br>vascular etiology ulcers,<br>venous ulcers, donor and<br>graft sites, abrasions and<br>lacerations, traumatic<br>wounds healing by<br>secondary intention,<br>dehisced surgical<br>wounds, and first and<br>second degree burns. | Rx: For use in partial<br>and full thickness<br>wounds, including<br>pressure ulcers, venous<br>ulcers, diabetic ulcers,<br>first-and-second degree<br>burns, donor sites and<br>surgical wounds. May<br>be used over debrided<br>and grafted partial<br>thickness wounds. |
| | | No | No |
| | sores and burns. | | |
| Antimicrobial<br>Effect | Yes | Yes | Yes |

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

K063059 page 4/4

## V. Tests and Conclusions

Sorbact® wound dressings have been shown in studies, including in vitro and clinical tests, to be safe and effective for their intended uses.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

JUN 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abigo Medical SA % Kirkpatrick & Lockhart Preston Gates Ellis, LLP Ms. Emalee G. Murphy 1601 K Street Northwest Washington, District of Columbia 20006-1600

Re: K063059 Trade/Device Name: Sorbact® Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 22, 2007 Received: March 23, 2007

Dear Ms. Murphy:

This letter corrects our substantially equivalent letter of April 19, 2007.

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 (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 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.

{5}------------------------------------------------

Page 2 - Ms. Emalee G. Murphy

This letter will allow you to continue 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely Nours.

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

Enclosure

{6}------------------------------------------------

## Indications for Use

510(k) Number (if known): TBA

Sorbact® Wound Dressing Device Name:

Indications For Use:

- Sorbact® Wound Dressings are intended for use in the management of moderate to Rx: heavily exudating partial to full thickness wounds (including clean, colonized, neating entitions or infected wounds) and to bind hydrophobic microbes. The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ x Prescription Use (Part 21 CFR 801 Subpart D) (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) Page 1 of

OOR

Sign-(Division al, Restorative, Division of Gener Division rological Devices

**510(k) Number!**

{7}------------------------------------------------

## Indications for Use

510(k) Number (if known): K063059

Device Name: Sorbact® Wound Dressings

Indications For Use:

Sorbact® Wound Dressings are intended for over-the-counter use in the management of draining minor wounds and to attract and bind water repelling germs. The dressings may be used on minor scrapes, cuts, sores and burns

**Division Sign-Off**

ivision Sign-Off) Division of General, Rostorative, and Neurological Devices

**510(k) Number** K022055

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

3