Sorbact Foam Gentle Border, Sorbact Superabsorbent

K153674 · Abigo Medical AB · FRO · Jul 1, 2016 · SU

Device Facts

• Record ID: K153674
• Device Name: Sorbact Foam Gentle Border, Sorbact Superabsorbent
• Applicant: Abigo Medical AB
• Product Code: FRO · SU
• Decision Date: Jul 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Sorbact® Foam Gentle Border is indicated for use in the management of moderately exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds. Sorbact® Superabsorbent is indicated for use in the management of heavily exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

Device Story

Sorbact® Absorbent Dressings consist of acetate fabric coated with dialkyl carbamoyl chloride (DACC) to provide hydrophobic microbe binding; combined with absorbent polyurethane foam or superabsorbent core to manage wound exudate; covered by semi-permeable polyurethane film or polypropylene non-woven; Sorbact® Foam Gentle Border includes silicone adhesive border for fixation. Dressings applied to wound surface by clinician; DACC coating binds hydrophobic microbes (e.g., S. aureus, P. aeruginosa, E. coli) to dressing; microbes removed upon dressing change; absorbent core retains exudate; semi-permeable film allows vapor/gas exchange while protecting skin from maceration. Intended for single use; sterile; provides physical barrier and microbial management to support wound healing.

Clinical Evidence

No clinical data submitted. Evidence consists of bench testing, including fluid handling, packaging, stability, and sterilization validation. Biocompatibility testing performed per ISO-10993, including cytotoxicity, irritation, and sensitization.

Technological Characteristics

Wound contact layer: DACC-coated acetate fabric. Exudate absorption: Polyurethane foam or polyacrylate superabsorbent particles. Backing: Polyurethane film or polypropylene non-woven. Fixation: Silicone adhesive border (Foam Gentle Border model). Sterilization: Ethylene Oxide (SAL 10-6). Biocompatible per ISO-10993. Single-use.

Indications for Use

Indicated for patients with moderately to heavily exuding partial to full thickness wounds, including chronic (venous, arterial, diabetic, pressure) ulcers, postoperative dehisced wounds, and traumatic wounds; applicable to clean, colonized, contaminated, or infected wounds.

Predicate Devices

• Cutimed® Sorbact® Wound Dressings (K143151)
• Sorbact® Wound Dressings (K063059)

Submission Summary (Full Text)

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

July 1, 2016

ABIGO Medical AB % Ms. Deborah Lavoi Grayeski Senior Project Manager M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, New York 10018

Re: K153674

Trade/Device Name: Sorbact Foam Gentle Border, Sorbact Superabsorbent Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2016 Received: June 6, 2016

Dear Ms. Grayeski:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

Radiological Health

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

Enclosure

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## Indications for Use

510(k) Number (if known) K153674

Device Name Sorbact® Absorbent Dressings (Sorbact® Foam Gentle Border, Sorbact® Superabsorbent )

### Indications for Use (Describe)

Rx.: Sorbact® Foam Gentle Border is inthe management of moderately exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## SECTION 5

## 510(k) Summary

| I.<br>SUBMITTER | |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | ABIGO Medical AB<br>Ekonomivägen 5<br>SE-436 33 Askim<br>Sweden<br>Phone: [phone]<br>Fax: [phone] |
| Correspondent Contact: | Deborah Lavoie Grayeski<br>M Squared Associates, Inc.<br>575 8th Avenue, Suite 1212<br>New York, NY 10018<br>USA<br>Office: 703-562-9800x250<br>Mobile: [phone], Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 18, 2015 |
| II.<br>DEVICE | |
| Trade Name: | Sorbact® Absorbent Dressings<br>(Sorbact® Foam Gentle Border, Sorbact® Superabsorbent ) |
| Common Name: | Wound Dressing |
| Regulatory Class: | Unclassified (Pre-amendment) |
| Review Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| III.<br>PREDICATE DEVICES | |
| K143151, Cutimed® Sorbact® Wound Dressings, BSN medical GmbH | |
| K063059, Sorbact® Wound Dressings, ABIGO Medical AB | |

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#### DEVICE DESCRIPTION IV.

Sorbact® Absorbent Dressings come in two models, Sorbact® Foam Gentle Border and Sorbact® Superabsorbent, for use with moderately or heavily exuding wounds, respectively. Both dressings come in multiple sizes, are sterile (EO), hydrophobic microbe binding, and for single use only. The dressings combine a Sorbact® wound contact layer with absorbent polyurethane foam or a superabsorbent core. The dressings are covered by a semi-permeable polyurethane film or polypropylene non-woven. A fixation border is made of silicone adhesive.

#### V. INDICATIONS FOR USE

Rx.: Sorbact® Foam Gentle Border is indicated for use in the management of moderately exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

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| Characteristic | Sorbact® Wound Dressings | Cutimed® Sorbact® Wound Dressings<br>K143151 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Sorbact® Foam Gentle Border is<br>indicated for use in the management<br>of moderately exuding partial to full<br>thickness wounds (including clean,<br>colonized, contaminated, or infected<br>wounds): chronic wounds (venous<br>and arterial ulcers, diabetic ulcers<br>and pressure ulcers), postoperative<br>dehisced wounds and traumatic<br>wounds.<br><br>Sorbact® Superabsorbent is indicated<br>for use in the management of heavily<br>exuding partial to full thickness<br>wounds (including clean, colonized,<br>contaminated, or infected wounds):<br>chronic wounds (venous and arterial<br>ulcers, diabetic ulcers and pressure<br>ulcers), postoperative dehisced<br>wounds and traumatic wounds. | Cutimed® Sorbact® Hydroactive is<br>indicated for use in the management of<br>low to moderate exuding partial to full<br>thickness wounds (including clean,<br>colonized, contaminated, or infected<br>wounds): chronic wounds (venous and<br>arterial ulcers, diabetic ulcers and<br>pressure ulcers), postoperative<br>dehisced wounds and traumatic<br>wounds.<br><br>Cutimed® Sorbact® Hydroactive B is<br>indicated for use in the management of<br>low to moderate exuding partial to full<br>thickness wounds (including clean,<br>colonized, contaminated, or infected<br>wounds): chronic wounds (venous and<br>arterial ulcers, diabetic ulcers and<br>pressure ulcers), postoperative<br>dehisced wounds and traumatic<br>wounds.<br><br>Cutimed® Siltec® Sorbact® is indicated<br>for use in the management of<br>moderately to heavily exuding partial to<br>full thickness wounds (including clean,<br>colonized, contaminated, or infected<br>wounds): chronic wounds (venous and<br>arterial ulcers, diabetic ulcers and<br>pressure ulcers), postoperative<br>dehisced wounds and traumatic<br>wounds. |
| Device Design | | |
| | The Sorbact® Absorbent Dressings<br>are designed with an acetate fabric<br>coated with DACC (Sorbact®) in<br>combination with an absorbent core,<br>which absorbs and retains wound<br>exudate. The dressings include a<br>semi-permeable polyurethane film to<br>allow vapor and oxygen to penetrate<br>or water-repellent polypropylene<br>non-woven. Sorbact® Foam Gentle<br>Border is also designed with a<br>silicone adhesive border for fixation. | The Cutimed® Sorbact® Wound<br>Dressings are designed with an acetate<br>fabric coated with DACC (Sorbact®) in<br>combination with an absorbent core,<br>which absorbs and locks exudate from<br>the wound, and a transparent semi-<br>permeable polyurethane film to allow<br>vapor and oxygen to penetrate the film.<br>It is also designed with an adhesive<br>layer for fixation (except the<br>Hydroactive dressing). |
| Wound Contact<br>Material | Sorbact® fabric (acetate fabric<br>coated with dialkyl carbamoyl<br>chloride, DACC) | Same |
| Exudate Absorption<br>Material | Polyurethane foam or polyacrylate<br>superabsorbent particles | Hydropolymer matrix or<br>superabsorbent polyurethane foam |
| Backing | Polyurethane film or polypropylene<br>non-woven | Polyurethane film |
| Self-adhesive Border | Yes<br>(for Sorbact® Foam Gentle Border) | Yes<br>(for Cutimed® Sorbact® Hydroactive B<br>and Cutimed® Siltec® Sorbact®) |
| Mechanism of<br>Action | Used for the management of clean,<br>colonized, contaminated, or infected<br>wounds; rapidly absorbs and locks<br>exudate within an absorbent core;<br>allows water vapor to evaporate<br>from the skin to the outside<br>protecting the skin from maceration | Used for the management of clean,<br>colonized, contaminated, or infected<br>wounds; rapidly absorbs and locks<br>exudate within an absorbent core;<br>allows water vapor and gases to<br>evaporate from the skin to the outside<br>protecting the skin from maceration |
| Sizes | Multiple sizes | Multiple sizes |
| Wear Time | Up to 4 days | Up to 4 days |
| Biocompatible | Yes | Yes |
| Sterilization | Ethylene Oxide (SAL 10-6) | Gamma irradiation (SAL 10-6) for<br>Cutimed® Sorbact® Hydroactive and<br>Cutimed® Sorbact® Hydroactive B;<br>Ethylene Oxide (SAL 10-6) for Cutimed®<br>Siltec Sorbact® |
| Single Use | Yes | Yes |
| Storage Conditions | Dry and away from sunlight.<br>For Sorbact® Superabsorbent: below<br>25°C | Dry, below 25°C |
| Shelf Life | 3 years (Sorbact® Superabsorbent)<br>5 years (Sorbact® Foam Gentle<br>Border | 3 years |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

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| Characteristic | Sorbact® Absorbent Dressings | Sorbact® Wound Dressings K063059 |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Other technological<br>characteristics:<br>Mechanism of action | Sorbact® can bind hydrophobic<br>microbes based on in vitro testing<br>of the following strains: S. aureus,<br>S. gordonii, P. aeruginosa, and<br>E. coli. When the dressing is<br>removed, microbes adhered to the<br>dressing will be removed. | Same |

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#### VII. PERFORMANCE DATA

To verify that the device design met its functional performance and safety requirements, representative samples of the device underwent testing.

## Bench testing

Performance verification testing (fluid handling tests, packaging tests) Stability testing Sterilization validation testing

## Biocompatibility testing

The biocompatibility evaluation of the devices was conducted in accordance with the FDA Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Testing was performed on representative samples of the devices and included the following tests:

- Cytotoxicity
- Irritation
- Sensitization ●

#### VIII. CONCLUSIONS

ABIGO Medical AB considers the Sorbact® Absorbent Dressings to be as safe, as effective, and performing as well as the predicate devices described above. This conclusion is based on the devices' similarities in intended use, design, mechanisms of action, technology, materials and performance.

Note: No clinical information has been submitted