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 is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large. The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847: Avance ViewPad, Avance Foam (green), Avance Transparent Film.

AI/ML Overview

This document describes the FDA 510(k) clearance for the Molnlycke Health Care US, LLC Avance Foam Dressing Kit - XL. This is an add-on to an existing Negative Pressure Wound Therapy (NPWT) system. As such, the submission focuses on demonstrating that the new component (the XL foam dressing) does not negatively impact the overall system's safety and effectiveness compared to the previously cleared system.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a specific table with acceptance criteria values and reported device performance. It generally states that "all predefined acceptance criteria were met" for the bench tests conducted.

2. Sample sized 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 size for the bench tests. It only mentions that "Bench testing has been performed." The data provenance (country of origin, retrospective/prospective) is not mentioned.

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. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software. No experts were used to establish ground truth in the context of diagnostic interpretation.

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

This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software.

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 information is not applicable. No MRMC study was conducted as this is not an AI/diagnostic software.

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

This information is not applicable. This is not an AI algorithm.

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

For the non-clinical testing, the "ground truth" would be established engineering and functional specifications for the NPWT system's ability to transport fluid and deliver pressure. The document implicitly states that these functional requirements were met.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

This information is not applicable as there is no training set.

Summary of Device Acceptance Criteria and Study:

The Avance Foam Dressing Kit - XL is an addition to an existing Negative Pressure Wound Therapy (NPWT) system. The acceptance criteria focus on demonstrating that this new, larger dressing component does not negatively affect the overall system's functional performance and biocompatibility.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

The document does not provide specific numerical acceptance criteria or performance metrics but states compliance.

Acceptance Criterion (Inferred)	Reported Device Performance
Biocompatibility in accordance with ISO 10993	Shown to be biocompatible for the intended use.
Ability to transport fluid away from the wound	Performed as intended; predefined acceptance criteria were met.
Ability to deliver pressure in accordance with pump settings	Performed as intended; predefined acceptance criteria were met.

Study Details:

Type of Study: Non-clinical bench testing.
Sample Size: Not specified for the bench tests.
Data Provenance: Not specified.
Ground Truth Establishment: For bench testing, the ground truth would be based on engineering specifications and validated test methods for fluid transport and pressure delivery within NPWT systems.
Clinical Data: No clinical data was required or submitted to support substantial equivalence.
AI/Machine Learning Specifics: Not applicable; this device is a physical medical dressing, not an AI algorithm.

Summary

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

November 4, 2016

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

Re: K161935

Trade/Device Name: Avance Foam Dressing Kit - XL Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 13, 2016 Received: July 14, 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 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) K161935

Device Name Avance Foam Dressing Kit - XL

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:	July 13, 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 Foam Dressing Kit - XL
Common Name:	NPWT Dressing Kit
Regulation Name:	Powered Suction Pump
Device Class:	Class II
Regulation Number:	21 CFR 878.4780
Product Code:	OMP
Predicate Device Information:	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 Foam Dressing Kit -XL.

Description of Devices:

The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847:

Avance ViewPad
Avance Foam (green)
. Avance Transparent Film

Indication for Use:

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appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

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Technological Characteristics:

Feature	Avance Foam Dressing Kits - XL	Avance Foam Dressing Kits
510(k) clearance	Subject device	K141847
Manufacturer	Mölnlycke Health Care	Mölnlycke Health Care
Common name	Dressing kit component for NPWT system	Dressing kit component for NPWT system
Regulation	21 CFR 878.4780	21 CFR 878.4780
Class name	Powered Suction Pump	Powered Suction Pump
Class	II	II
Product code	OMP	OMP
Functionality within NPWT system	The Avance Foam Dressing Kit - XL contains alldressing components necessary to administerNPWT using foam as a wound filler material.	The Avance Foam Dressing Kits contain all dressingcomponents necessary to administer NPWT usingfoam as a wound filler material.
Indication for use	The Avance NPWT system, with associatedproducts, are indicated for patients who wouldbenefit from a suction device (negative pressurewound therapy), as it may promote wound healingvia the removal of fluids, including irrigation andbody fluids, wound exudate and infectious materials.Examples of appropriate wound types include:chronic, acute, traumatic, sub-acute and dehiscedwounds, ulcers (such as pressure or diabetic),partial-thickness burns, flaps and grafts.	The Avance NPWT system, with associatedproducts, are indicated for patients who wouldbenefit from a suction device (negative pressurewound therapy), as it may promote wound healingvia the removal of fluids, including irrigation andbody fluids, wound exudate and infectious materials.Examples of appropriate wound types include:chronic, acute, traumatic, sub-acute and dehiscedwounds, ulcers (such as pressure or diabetic),partial-thickness burns, flaps and grafts.
Dressing kit components	● Avance ViewPad (I pc)● Avance Foam, XL (2 pcs)● Avance Transparent Film (6 pcs)	(size L: largest size of comparable K141847 kit)● Avance ViewPad (1 pc)● Avance Foam, L (1 pc)● Avance Transparent Film (2 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 and has been shown to be biocompatible for the 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 and that pressure is delivered in accordance with the pump settings. The subject Avance Foam Dressing Kit - XL 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.