The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Device Description

The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:

Antimicrobial gauze dressing
Avance Transparent Film or Avance Film with Safetac technology
Avance ViewPad

AI/ML Overview

This document is a 510(k) premarket notification for "Avance Gauze Dressing Kits," which are line additions to an existing Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the information typically associated with a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, expert involvement, and ground truth establishment) is not fully present in the document in the format you've requested for an AI model.

However, I can extract the relevant information regarding acceptance criteria and general statements about testing from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document states that "all predefined acceptance criteria were met" for the bench testing. However, the specific quantitative acceptance criteria are not detailed in this summary.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met (in accordance with ISO 10993)
Fluid Transport Efficiency	Performed as intended; did not negatively affect the ability of the NPWT system to transport fluid away from the wound.
Pressure Delivery	Performed as intended; pressure delivered in an acceptable manner.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for the bench testing. No clinical data was required or submitted, so there is no information on data provenance relating to clinical studies. The testing described is "non-clinical bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable and not provided. The testing described is bench testing, which typically relies on established engineering and materials science principles, not expert human assessment of images or patient data to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers, which this submission did not include.

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:

No MRMC study was done. This device is not an AI-assisted diagnostic tool; it is a medical dressing kit for Negative Pressure Wound Therapy.

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

This is not applicable as the device is not an algorithm or AI. The bench testing performed would be considered "standalone" in the sense that it evaluated the device's physical performance independently.

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

For biocompatibility, the ground truth would be established by the requirements of ISO 10993. For fluid transport and pressure delivery, the ground truth would be engineering specifications and functional parameters for NPWT systems, where "as intended" means meeting these predefined technical requirements.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dressing kits) and its non-clinical bench testing, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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Image /page/0/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 an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

November 3, 2016

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

Re: K161948

Trade/Device Name: Avance Gauze Dressing Kits Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 13, 2016 Received: July 15, 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 Actinclude 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 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.

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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.

David Krause -S

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) K161948

Device Name Avance Gauze Dressing Kits

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:	October 31, 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 Gauze Dressing Kits
Common Name:	NPWT Dressing Kits
Regulation Name:	Powered Suction Pump
Device Class:	Class II
Regulation Number:	21 CFR 878.4780
Product Code:	OMP
Predicate Device Information:	Venturi Gauze Wound Care Sets with Portal Drain (K151263)
Reference Device Information:	Avance Foam Dressing Kits with ViewPad (K141847)Avance Foam Dressing Kits with Transfer Pad (K122132)

Reason for 510(k) Submission:

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

Description of Devices:

The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:

Antimicrobial gauze dressing ●
. Avance Transparent Film or Avance Film with Safetac technology
. Avance ViewPad

Indications for Use:

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Technological Characteristics:

Feature	Avance Gauze Dressing Kits	Venturi Gauze Wound Care Sets with Portal Drain
510(k)clearance	Subject device	K151263
Manufacturer	Mölnlycke Health Care	Talley Group Ltd.
Common name	NPWT Dressing Kit	NPWT Dressing Kit
Regulation	21 CFR 878.4780	21 CFR 878.4780
Class name	Powered Suction Pump	Powered Suction Pump
Class	II	II
Product code	OMP	OMP
Functionalitywithin NPWTsystem	The Avance Gauze Dressing Kits contain all dressingcomponents necessary to administer NPWT using gauze asa wound filler material.	The Venturi Gauze Wound Care Sets with Portal Draincontain all dressing components necessary to administerNPWT using gauze as a wound filler material.
Indication foruse	The Avance NPWT system, with associated products, areindicated for patients who would benefit from a suctiondevice (negative pressure wound therapy), as it may promotewound healing via the removal of fluids, including irrigationand body fluids, wound exudate and infectious materials.Examples of appropriate wound types include: chronic,acute, traumatic, sub-acute and dehisced wounds, ulcers(such as pressure or diabetic), partial-thickness burns, flapsand grafts.	Venturi Gauze Wound Care Sets with Portal Drain areintended to be used with the Talley Group range of negativepressure wound therapy pumps. The Talley Group NPWTpumps are indicated for use for patients with acute or chronicwounds that may be benefitted by the application of continualnegative pressure to the wound for removal of fluids,including wound exudate, irrigation fluids, and infectiousmaterials.
KitComponents	• Antimicrobial gauze wound filler• Avance ViewPad• Avance Transparent Film or Avance Film withSafetac technology	• Antimicrobial gauze wound filler• Portal drain assembly• Adhesive film dressing• 20 mL saline• Wound ruler
Single use orReusable	Single use	Single use
Sterility	Individually packaged, sterilized and labelled components co-packed into non-sterile plastic pouch to form the dressing kit	Individually packaged, sterilized and labelled components co-packed into non-sterile plastic pouch to form the dressing kit

All technological differences between the predicate devices have been accounted for within the submission through defailed 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 kit components have been shown to be biocompatible for their intended use, in accordance with ISO 10993.

Bench testing has been performed to demonstrate that the line additions to the Avance NPWT System do not negatively affect the ability of the NPWT system to transport fluid away from the wound and that pressure is delivered in an acceptable manner. The subject Avance Gauze Dressing Kits performed as intended in the test setups, and all predefined acceptance criteria were met.

Clinical Data:

No clinical data was required to support substantial equivalence.

Conclusion:

The subject devices are 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

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.