Rx: 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 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 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.

AI/ML Overview

The provided text describes the Sorbact® Wound Dressing and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or detailed study results that prove the device meets specific acceptance criteria.

The document states:

"Sorbact® wound dressings have been shown in studies, including in vitro and clinical tests, to be safe and effective for their intended uses." (Page 4, Section V)

However, it lacks the specific data points needed to answer your questions within the context of acceptance criteria and proven performance. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting comprehensive study data with acceptance criteria.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text.

Here's a breakdown of what can be inferred from the provided text and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided. The document states that in vitro and clinical tests were conducted to show safety and effectiveness, but it does not specify any quantitative acceptance criteria (e.g., "bacterial reduction must be >X%") or the actual performance metrics achieved in those tests.

2. Sample Size Used for the Test Set and Data Provenance

Cannot be provided. The document mentions "clinical tests" but does not provide any details about the sample size (number of patients/wounds), study design, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Cannot be provided. The document does not describe the establishment of a ground truth for a test set, nor does it mention any expert involvement in such a process. This kind of detail is typically relevant for studies involving subjective assessments (e.g., image-based diagnostics) which is not the primary focus of a wound dressing's efficacy where clinical outcome is key.

4. Adjudication Method for the Test Set

Cannot be provided. As there's no mention of a test set with subjective assessments by experts, there's no description of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Cannot be provided. The document does not describe an MRMC study or any scenario where human readers would improve with or without AI assistance, as this device is a wound dressing, not an AI diagnostic tool.

6. Standalone Algorithm Performance

Cannot be provided. This question is irrelevant as the Sorbact® Wound Dressing is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Cannot be provided in detail. For a medical device like a wound dressing, the "ground truth" for demonstrating safety and effectiveness would typically be clinical outcomes (e.g., wound healing rates, reduction in infection, absence of adverse events), and potentially microbiological data for its antimicrobial claims. However, the document does not specify how this ground truth was established or measured in the "clinical tests."

8. Sample Size for the Training Set

Cannot be provided. This question is irrelevant as the Sorbact® Wound Dressing is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Cannot be provided. This question is irrelevant for the same reason as point 8.

Summary

{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:

Abigo Medical AB Ekonomivägen 5 S-436 33 Askim, Sweden 011-46-31-748-4950 Tel: 011-46-31-68-3951 Fax:

Emalee G. Murphy Kirkpatrick & Lockhart Preston Gates Ellis LLP 1601 K Street, NW Washington, DC 20006 202-778-9428 Tel: 202-778-9100 Fax: email: emalee.murphy@klgates.com

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:

{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.
RegulatoryStatus	Wound Dressing21 CFR 807.87Product Code FRO	K032986	K051542
Materials ofConstruction	A layer of sterilehydrophobic acetate orcotton fabric, plus theabsorbent dressing hasan absorption core ofnon-woven viscose. Thewound contact materialsare coated with a fattyester that gives Sorbact®a strong hydrophobic(water-repelling)property.	Collagen and silverlactate provided in asterile hydrated collagensheet.	A single layer ofTriosyn compositesterile dressingconsisting of anabsorbent polyester non-woven pad, a permeableadhesive, iodinated resinbeads, and a non-adherent high-densitypolyethylene mesh(HDPE).
Sterility	Yes	Yes	Yes
ComparableSizes and Forms	Yes	Yes	Yes
BiocompatibilityTesting	Yes	Yes	Yes
Intended Use	Rx: For the managementof moderate to heavilyexudating partial to fullthickness (clean,colonized, contaminatedor infected) wounds,including post-operativewounds, trauma wounds,shallow cavity wounds,fistulas, pressure ulcers,diabetic ulcers, andvenous ulcers.OTC: For the manage-ment of superficialwounds such as minorabrasions, cuts, pressure	Rx: For the managementof full and partialthickness woundsincluding pressure anddiabetic ulcers, mixedvascular etiology ulcers,venous ulcers, donor andgraft sites, abrasions andlacerations, traumaticwounds healing bysecondary intention,dehisced surgicalwounds, and first andsecond degree burns.	Rx: For use in partialand full thicknesswounds, includingpressure ulcers, venousulcers, diabetic ulcers,first-and-second degreeburns, donor sites andsurgical wounds. Maybe used over debridedand grafted partialthickness wounds.
		No	No
	sores and burns.
AntimicrobialEffect	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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

N/A