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 Max NPWT pump and its accessories.

Device Description

The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.

AI/ML Overview

This document describes a 510(k) premarket notification for the Avance Abdominal Dressing Kit. It is not an AI/ML device, and therefore does not contain information about acceptance criteria for AI/ML performance, study details for AI/ML models, or ground truth establishment.

Based on the provided text, here's what can be extracted regarding the device's assessment:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility (ISO 10993-1)	Met criteria for intended use
Ability to transport fluid away from wound	Performed as intended in test setup; all predefined acceptance criteria were met. (`Subject Avance Abdominal Dressing Kit performed as intended in the test setup, and all predefined acceptance criteria were met.`)

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

Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" but does not quantify the number of tests or samples.
Data Provenance: Not applicable. This is bench testing, not patient data from a specific country or collected retrospectively/prospectively.

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

Not applicable. The "ground truth" here refers to pre-defined engineering and biocompatibility standards, not expert interpretations of medical data.

4. Adjudication method for the test set

Not applicable. Performance was assessed against pre-defined technical criteria.

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

Not applicable. This is not an AI/ML device; therefore, no MRMC study with human readers and AI assistance was conducted or discussed.

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

Not applicable. This is not an AI/ML device. The "standalone" performance relates to the dressing kit's physical and functional properties, evaluated during bench testing.

7. The type of ground truth used

Engineering and Biocompatibility Standards: The ground truth for this device's performance evaluation were established engineering specifications for fluid transport and ISO 10993-1 standards for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. No training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is based on established medical device standards and engineering principles.

Summary relevant to the prompt:

This document describes a medical device undergoing 510(k) clearance, which is a process to demonstrate substantial equivalence to a legally marketed predicate device. The evaluation focuses on the device's physical and functional properties, as well as its biocompatibility. It is not an AI/ML device, hence most of the questions related to AI/ML specific criteria (like training/test sets, expert adjudication, MRMC studies, etc.) are not applicable. The studies mentioned are "non-clinical testing" focusing on ISO standards and bench testing for fluid transport.

Summary

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Public Health Service

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

November 17, 2016

Molnlycke Health Care Us, LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K161939

Trade/Device Name: Avance Abdominal Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Mesh, Surgical, Non-Absorbable, Large Abdominal Regulatory Class: Class II Product Codes: OXJ, OMP Dated: October 14, 2016 Received: October 17, 2016

Dear Megan Bevill:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 (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" (21 CFR 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, Jennifer R.

Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K161939

Device Name Avance Abdominal Dressing Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

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510(k) SUMMARY

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

Date Prepared:	November 16, 2016
Applicant:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877
Official Correspondent:	Megan BevillManager, Regulatory AffairsTel: 470-375-0049Fax: 678-245-7746email: megan.bevill@molnlycke.com
Trade/Proprietary Names:	Avance Abdominal Dressing Kit
Common Name:	NPWT Dressing Kit
Regulation Name:	Surgical Mesh
Device Class:	Class II
Regulation Number:	21 CFR 878.3300
Product Code:	OXJ, OMP
Predicate Device Information:Reference Device Information:	Avance Abdominal Dressing Kit (K130852)Avance Foam Dressing Kits (K141847)

Reason for 510(k) Submission:

This premarket notification has been prepared to obtain clearance for the following line addition to Mölnlycke's Avance Negative Pressure Wound Therapy (NPWT) System: Avance Abdominal Dressing Kit.

Description of Device:

Indication for Use:

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Technological Characteristics:

Feature	Avance Abdominal Dressing Kit	Avance Abdominal Dressing Kit
510(k) clearance	Subject device	K130852
Manufacturer	Mölnlycke Health Care	Mölnlycke Health Care
Common name	NPWT Dressing Kit	NPWT Dressing Kit
Regulation	21 CFR 878.3300	21 CFR 878.3300
Class name	Mesh, Surgical, Non-Absorbable, Large AbdominalWall Defects	Mesh, Surgical, Non-Absorbable, Large AbdominalWall Defects
Class	II	II
Product code	OXJ, OMP	OXJ, OMP
Functionality within NPWT system	The Avance Abdominal Dressing Kit contains allcomponents necessary to dress an abdominalwound in preparation for administering NPWT.	The Avance Abdominal Dressing Kit contains allcomponents necessary to dress an abdominalwound in preparation for administering NPWT.
Indication for use	The Avance Foam Abdominal Dressing Kit isindicated for temporary bridging of abdominal wallopenings where primary closure is not possibleand/or repeat abdominal entries may be required.Its intended use is with patients who have openabdominal wounds with exposed viscera andorgans, and including but not limited to patients withabdominal compartment syndrome. It is intendedfor use in acute hospital settings (trauma, generaland plastic surgery wards) and should ideally beapplied in the operating theatre. The dressing kit isintended for use together with the Avance MaxNPWT pump and its accessories.	The Avance Foam Abdominal Dressing Kit isindicated for temporary bridging of abdominal wallopenings where primary closure is not possibleand/or repeat abdominal entries may be required.Its intended use is with patients who have openabdominal wounds with exposed viscera andorgans, and including but not limited to patients withabdominal compartment syndrome.
Dressing kit components	● Avance ViewPad (1 pc)● Avance Abdominal Foam (2 pcs)● Avance Transparent Film (4 pcs)● Avance Organ Contact Layer (1 pc)	● Avance Transfer Pad (I pc)● Avance Abdominal Foam (2 pcs)● Avance Film with Safetac technology (4 pcs)● Avance Organ Contact Layer (1 pc)
Single use or Reusable	Single use	Single use
Sterility	EtO	EtO

All technological differences between the subject and peen accounted for within the submission through detailed device comparisons, nonclinical testing, and other means. Technological differences have been shown to raise of safety or effectiveness.

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Non-Clinical Testing:

The subject device has been evaluated in accordance with ISO 10993-1 and have been shown to meet the criteria for their intended use.

Bench testing has been performed to demonstrate that the line addition to the Avance NPWT System does not negatively affect the ability of the NPWT system to transport fluid away from the wound. The subject Avance Abdominal Dressing Kit performed as intended in the test setup, and all predefined acceptance criteria were met.

Clinical Data:

No clinical data was required to support substantial equivalence.

Conclusion:

The subject device is substantially equivalent to the predicate and reference devices with respect to design, technological characteristics, intended use, and conformance to standard requirements.

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.