OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding) and to attract water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.

Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.

Device Description

Sorbact® gel Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms.

AI/ML Overview

The provided 510(k) summary for the Sorbact® Gel Wound Dressing (K100591) does not contain information about a study proving the device meets specific acceptance criteria in the manner typically described for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). Instead, the summary focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested elements for a detailed study description are not applicable or cannot be extracted from this document. However, I can provide the available information based on the content.

Here's an analysis of the "acceptance criteria" and the "study" as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating that the new device, Sorbact® gel, performs equivalently to the predicate device, Sorbact® Wound Dressing, in its ability to bind hydrophobic microorganisms, and also passes standard biocompatibility tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Microbial Binding Ability (Hydrophobic Microbes/Germs)	"Results of the test were identical for both devices." (Sorbact gel vs. original Sorbact wound dressing)
Biocompatibility - Skin Sensitization	"Sorbact gel passed all tests."
Biocompatibility - Cytotoxicity	"Sorbact gel passed all tests."
Biocompatibility - Skin Irritation	"Sorbact gel passed all tests."
Technological Characteristics (with hydrogel addition)	Allows effective management of low exuding dry wounds and creates a moist wound healing environment. (This is a design modification, not a performance metric for comparison)
Intended Use	"Sorbact gel has identical... intended use as the original Sorbact wound dressing."
Overall Predicate Equivalence Conclusion (FDA)	The FDA determined the device is substantially equivalent (for the indications for use stated).

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

Sample Size: Not specified for the comparative microbial binding test. For biocompatibility, the number of samples/subjects is not mentioned, but these are typically standardized in vitro or in vivo tests.
Data Provenance: Not specified. Standard biocompatibility tests follow international guidelines (e.g., ISO 10993). The microbial binding test is a comparative test performed by the manufacturer. Whether it involved human data, animal data, or in vitro models, or its geographic origin, is not stated.

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

Not applicable. This study does not involve establishing ground truth from expert readings for image analysis or diagnostic performance, as it is a wound dressing. The "ground truth" for microbial binding is the performance of the predicate device. For biocompatibility, it's adherence to established safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method, as it's not a reader study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is not an MRMC study. It is a comparison of a modified medical device to its predicate.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this is not an AI/ML device. The performance claimed is for the device's inherent physical and chemical properties (microbial binding, biocompatibility), not an algorithm.

7. The Type of Ground Truth Used

Comparative Performance: For microbial binding, the "ground truth" was established by the performance of the legally marketed predicate device, Sorbact® Wound Dressing, in the identical test ("Results of the test were identical for both devices.").
Safety Standards: For biocompatibility (Skin Sensitization, Cytotoxicity, Skin Irritation), the ground truth is implicitly defined by the pass/fail criteria of recognized international standards (e.g., ISO 10993 series for biological evaluation of medical devices).

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set in the context of AI/ML.

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

Not applicable. This device does not use a training set in the context of AI/ML.

In summary, this 510(k) pertains to a wound dressing and demonstrates substantial equivalence through direct comparison of a specific performance characteristic (microbial binding) and adherence to general safety standards (biocompatibility). It does not involve complex clinical studies or AI/ML performance evaluations typically associated with the detailed questions on acceptance criteria for diagnostic devices.

Summary

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11 100591 10f Z

JAN 2 4 2011

	JAN 24 20
510(k) owner:	Abigo Medical ABEkonomivagen 5Askim, Sweden+46 31 748 4971
ContactInformation:	C. G. Bundy Associates, Inc.435 Rice Creek Terrace NEFridley, MN 55432 USAPhone: 763-574-1976Fax: 763-571-2437
Date ofsummary:	February 26, 2010, Revised November 30, 2010
Device Name:	Proprietary Name: Sorbact® gelCommon/Classification Name: Wound Dressing
ClassificationRegulation:	Unclassified, Class II medical device
ProductCode:	FRO
PredicateDeviceldentification:	Sorbact® Wound Dressing, K063059
DeviceDescription:	Sorbact gel Wound Dressings are sterile bandages that attract and capturewater-repelling (hydrophobic) microorganisms.
Intended Use:	OTC: Sorbact Gel Wound Dressing is intended for use in the management ofminor wounds (dry to low exuding) and to attract water repelling germs. Thedressing may be used on minor scrapes, cuts, sores and burns.
	Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry tolow exuding partial to full thickness wounds (including clean, colonized,contaminated or infected wounds). The dressing is indicated for post-operativewounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers,diabetic ulcers, and venous ulcers.

DL
1/24/11

510(k) Summary

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K100591

2 of 2

Technological characteristics, comparison to predicate device:

Sorbact® Wound Dressings are sterile bandages that attract water-repelling (hydrophobic) microorganisms. The dressings are coated with DACC (dialky) carbamoyl chloride), a hydrophobic (water-repelling) fatty ester acid that atracts and reduces the overall concentration of hydrophobic microbes in a wound each time the dressing is changed. The original Sorbact Wound Dressing has been modified by the addition of a hydrogel. The hydrogel addition allows effective management of low exuding dry wounds and creates a moist wound healing environment.

The Sorbact® gel was compared against the original Sorbact wound dressing regarding the ability to bind hydrophobic microbes and water repelling germs. Results of the test were identical for both devices.

Sorbact gel was tested for biocompatibility and the following tests were conducted:

Skin Sensitization Cytotoxicity Skin Irritation

Sorbact gel passed all tests.

Conclusion: The Sorbact gel has identical features, performance and intended use as the original Sorbact wound dressing. Results of comparative performance testing against the predicate device show that Sorbact® gel is substantially equivalent to devices on the market (cleared by the 510(k) process).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 a caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Abigo Medical, AB % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 435 Rice Creek Terrace Fridley, Minnesota 55432

Re: K100591

Regulatory Class: Unclassified Product Code: FRO Dated: January 11, 2011 Received: January 19, 2011

Dear Ms. Bundy:

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

JAN 2 4 2011

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Page 2 - Ms. Constance G. Bundy

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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Bo Dm

N. Molkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K100591

Device Name: Sorbact® Gel Wound Dressing

Indications for Use:

OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding). The dressing may be used on minor scrapes, cuts, sores and burns.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kaneberkni

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100571

Regulation Number and Section

N/A