The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT pump and its accessories.

Device Description

The Avance® Foam Abdominal Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Abdominal Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.

The Avance® Foam Abdominal Dressing Kit is together with the Avance® Pump and it's accessories is a complete negative pressure system for managing open abdomens. This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The Avance® Foam Abdominal Dressing Kit consists of the following components:

Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines.

Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.

Avance® Film with Safetac® Technology 20x40 cm in size, is a flexible, transparent film dressing consisting of a thin polyurethane film coated with a soft silicone adhesive. The soft silicone layer adheres gently to dry peri-wound skin, but not to a moist wound surface. The soft silicone layer is covered with a polvethylene release film. It is applied over the wound filler and surrounding skin with the intension to fixate the wound filler and create an airtight seal.

A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.

AI/ML Overview

The provided document describes the Avance® Foam Abdominal Dressing Kit, a negative pressure wound therapy device, and its acceptance criteria and performance data.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Predetermined Acceptance Criteria	Reported Device Performance
Functional Performance	Vacuum Level	Within chosen levels	Met: "The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior."
	Fluid Transport (Function)	Efficient transport without blockage	Met: "The fluid was efficiently transported from the wound model without blockage or problems."
Material Properties	Drapability	Established criteria	Met: "all test articles were successfully subjected to the testing criteria for drapability. The predetermined acceptance criteria were met."
	Tear Strength	Established criteria	Met: "all test articles were successfully subjected to the testing criteria for tear strength. The predetermined acceptance criteria were met."
	Tensile Strength	Established criteria	Met: "all test articles were successfully subjected to the testing criteria for tensile strength. The predetermined acceptance criteria were met."
	Fluid Transport (Material)	Established criteria	Met: "all test articles were successfully subjected to the testing criteria for fluid transport. The predetermined acceptance criteria were met."
Biocompatibility	Organ Contact Layer:
	- Cytotoxicity	Pass/Met	Met
	- Sensitization	Pass/Met	Met
	- Irritation/Intracutaneous Reactivity	Pass/Met	Met
	- Acute Systemic Toxicity	Pass/Met	Met
	- Subchronic Toxicity	Pass/Met	Met
	- Genotoxicity	Pass/Met	Met
	- Implantation	Pass/Met	Met
	Foam:
	- Cytotoxicity	Pass/Met	Pass
	- Sensitization	Pass/Met	Pass
	- Irritation/Intracutaneous Reactivity	Pass/Met	Met
	Transparent Film:
	- Cytotoxicity	Pass/Met	Pass
	- Sensitization	Pass/Met	Pass
	- Irritation/Intracutaneous Reactivity	Pass/Met	Met
	Transfer Pad:
	- Cytotoxicity	Pass/Met	Pass
	- Sensitization	Pass/Met	Pass
	- Irritation/Intracutaneous Reactivity	Pass/Met	Met

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the functional and material property tests (e.g., how many kits were tested for vacuum level, drapability, etc.). It refers to "all test articles," implying a defined, but unquantified, test set.

For biocompatibility testing, the sample size or number of biological units tested for each component is not specified.

The data provenance is not explicitly mentioned as retrospective or prospective, nor are country of origin details provided. However, the tests are laboratory-based performance and biocompatibility assessments, not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the presented data. The acceptance criteria for this medical device are based on objective, quantifiable engineering and biological tests (e.g., vacuum levels, fluid transport rates, material strength, biocompatibility assays) and not on expert interpretation of observational data. Therefore, there's no "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication method for the test set

This question is not applicable to the presented data. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers or evaluators make subjective assessments that require consensus, such as interpreting medical images or clinical outcomes. The tests described are objective, laboratory-based physical and chemical assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device in question is a negative pressure wound therapy dressing kit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI's effect on human reader performance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to its evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional and material performance tests, the "ground truth" is established by the defined specifications and engineering standards for the device's operation. For example, a specific vacuum level range or a minimum tear strength might be the "ground truth" against which the device's performance is measured.

For biocompatibility, the "ground truth" is established by ISO 10993 standards and the biological responses observed in the in vitro and in vivo tests.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this device.

Summary

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APR 1 4 2014 K130852

、

510(k) SUMMARY

This 510(k) summary of safety and efficacy information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Date Prepared:	March 20, 2013
Submitter:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Angela L. Bunn, RACDirector, Regulatory Affairs of the AmericasTel: 678-250-7930Fax: 678-250-7981e-mail: angela.bunn@molnlycke.com
Trade/Proprietary Name:	Avance® Foam Abdominal Dressing Kits
Common Name:	NPWT Dressing Kits
Classification Name:	Powered Suction Pump and Surgical Mesh
Predicate Device Name(s):	Avance® Foam Dressing Kits (K122132)RENASYS™ AB Abdominal Dressing Kit(K112784)

Description of Device:

The Avance® Foam Abdominal Dressing Kit consists of the following components:

Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines.

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Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.

A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.

Intended Use/Indication for Use:

Performance Data:

The kit was tested in conjunction with the pump and the performance results were as follows:

. The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior.
. The fluid was efficiently transported from the wound model without blockage or problems.

The Avance® Foam Abdominal Dressing Kit was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

These tests were comprised of:

Drapability - Testing showed that all test articles were successfully subjected to the testing criteria for drapability. The predetermined acceptance criteria were met. Tear Strength- Testing showed that all test articles were successfully subjected to the testing criteria for tear strength. The predetermined acceptance criteria were met.

Tensile Strength- Testing showed that all test articles were successfully subjected to the testing criteria for tensile strength. The predetermined acceptance criteria were met.

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Fluid Transport- Testing showed that all test articles were successfully subjected to the testing criteria for fluid transport. The predetermined acceptance criteria were met.

Biocompatibility:

. /

This table includes the testing criteria required as well as the test outcomes for the components within the Avance® Foam Abdominal Dressing Kit.

Avance® Foam Abdominal Dressing Kit ComponentsBiological Assessment Requirements for Testing based on ISO 10993
Component	ToxicologicalEvaluation under ISO10993 for ProductCategorization	Testing Outcome
Organ Contact Layer	Cytotoxicity Sensitization Irritation/IntracutaneousReactivity Acute Systemic Toxicity Subchronic Toxicity Genotoxicity Implantation	Met Met Met Met Met Met Met
Foam	Cytotoxicity Sensitization Irritation/IntracutaneousReactivity	Pass Pass Met
Transparent Film	Cytotoxicity Sensitization Irritation/IntracutaneousReactivity	Pass Pass Met
Transfer Pad	Cytotoxicity Sensitization Irritation/IntracutaneousReactivity	Pass Pass Met

Clinical Testing:

No clinical data was required.

Product Comparison to Predicate(s)

All of the kit components with the exception of the Organ Contact Layer have been cleared for use as a NPWT dressing kit under K122132. The components used in this abdominal dressing kit (with the exception of the Organ Contact Layer) are identical to those in material and function of the components cleared under K122132. The only difference in any one of those components is the size and shape of the foam.

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The Avance® Foam Abdominal Dressing Kit has the same indication for use as the RENASYS™ AB Abdominal Dressing Kit (KI12784) and the same types of kit components.

Conclusion:

Based on the information presented in this submission, it can be concluded that the Avance® Foam Abdominal Dressing Kit is substantially equivalent to the current Avance® Foam Dressing Kits (K122132) and the RENASY'S™ AB Abdominal Dressing Kit (K112784) predicate(s) with respect to intended use, materials, design, and technological characteristics.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 14, 2014

Molylcke Health Care US, LLC Ms. Angela L. Bunn. RAC Director, Regulatory Affairs of the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K130852

Trade/Device Name: Avance® Form Abdominal Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXJ, OMP Dated: February 24, 2014 Received: February 25, 2014

Dear Ms. Bunn:

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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Page 2 - Ms. Angela L. Bunn, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Krause -S

for

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K130852

Device Name: Avance® Foam Abdominal Dressing Kit

Indications For Use:

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyoung Dang -S

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Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.