The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.

Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.

Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.

Device Description

Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy.

. Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
. Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
. Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
. Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds

Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml.

Avance Solo NPWT System is intended for adults.

AI/ML Overview

The provided text is a 510(k) summary for the Avance Solo Negative Pressure Wound Therapy (NPWT) System. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed.

However, the request asks for information regarding acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for test sets.
Number and qualifications of experts for ground truth.
Adjudication method for test sets.
MRMC comparative effectiveness study results (human readers improve with AI vs without AI assistance).
Standalone (algorithm only) performance.
Type of ground truth (consensus, pathology, outcomes).
Training set sample size and ground truth establishment.

The provided document does not contain information related to AI/algorithm performance, human reader studies, or how ground truth for an AI model would be established (e.g., expert consensus, pathology). It focuses on the safety and effectiveness of a physical medical device (a Negative Pressure Wound Therapy system) through bench testing, biocompatibility, software validation, and electrical safety testing.

Therefore, I cannot fulfill the request using only the provided text as it does not describe an AI medical device or a study of the type requested (e.g., MRMC, standalone algorithm performance).

Specifically, the document states:

"No clinical data was provided to support substantial equivalence." (Page {8})
It describes "Non-Clinical Testing" which includes:
- Biocompatibility
- Bench testing (fluid transport, pressure delivery, alarm functionality, device lifetime, pressure safety)
- Software validation (IEC 62304)
- Electromagnetic compatibility and electrical safety testing (various IEC/AAMI standards)
- Human factors/usability testing.

The "Bench testing" section does mention acceptance criteria were met, but it does not provide a detailed table, sample sizes for "test sets" in the context of an AI model, expert involvement for ground truth, or MRMC studies as it pertains to the performance of a physical device.

If the request implies that the provided text describes an AI device or a study involving an AI component, that is incorrect. The device is a traditional medical device for wound therapy.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 1, 2021

Molnlycke Health Care US, LLC Megan Bevill Manager, Regulatory Affairs 5445 Triangle Parkwav Suite 400 Peachtree Corners, Georgia 30092

Re: K203369

Trade/Device Name: Avance Solo Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: Mav 28, 2021 Received: June 1, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lixin Liu, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203369

Device Name

Avance Solo Negative Pressure Wound Therapy (NPWT) System

Indications for Use (Describe)

The Avance Solo NPWT System is indicated for patients who would management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.

Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulch as diabetic, venous or pressure). surgically closed incisions. flaps. and grafts.

Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.

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

X 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:	June 30, 2021
Applicant:	Mölnlycke Health Care US, LLC5445 Triangle Parkway, Suite 400Peachtree Corners, GA 30092Registration Number: 3004763499Owner/Operator Number: 8030877
Official Correspondent:	Megan BevillManager, Regulatory AffairsTel: 770-547-9196email: megan.bevill@molnlycke.com
Trade/Proprietary Names:	Avance Solo Negative Pressure Wound Therapy (NPWT)System
Regulation Name:	Negative Pressure Wound Therapy Powered Suction Pump
Device Class:	II
Regulation Number:	21 CFR 878.4780
Product Code:	OMP
Predicate Device Name(s):	PICO Single Use NPWT System (K163387)ActiVAC Therapy Unit (K120033)

Description of Device:

. Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
. Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
. Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
. Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds

Avance Solo NPWT System is intended for adults.

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Intended Use/Indication for Use:

Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.

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Technological Characteristics:

Feature	Avance Solo NPWT System	PICO Single Use NPWT System	ActiVAC Therapy Unit	Substantial EquivalenceComments (comparisonto primary predicateunless otherwise stated)
510(k)clearance	K203369 (subject device)	K163387	K120033	NA
Rationale forinclusion	Subject of submission	Primary predicate device	Secondary predicate device	NA
Manufacturer	Mölnlycke Health Care	Smith & Nephew Medical Inc.	KCI USA, Inc.	NA
Regulation	21 CFR 878.4780	21 CFR 878.4780	21 CFR 878.4780	Same
Class name	Negative Pressure Wound TherapyPowered Suction Pump	Negative Pressure Wound TherapyPowered Suction Pump	Negative Pressure Wound TherapyPowered Suction Pump	Same
Class	II	II	II	Same
Product Name	Avance Solo NPWT System	PICO Single Use NPWT System	ActiVAC Therapy Unit	NA
Product code	OMP	OMP	OMP	Same
Indication foruse/Intendeduse	The Avance Solo NPWT System isindicated for patients who wouldbenefit from wound managementvia the application of negativepressure wound therapy,particularly as the device maypromote wound healing through theremoval of exudate, infectiousmaterial.Avance Solo NPWT System isindicated for removal of low tomoderate amounts of exudatesfrom chronic, acute, traumatic,subacute and dehisced wounds,ulcers (such as diabetic, venous orpressure), surgically closedincisions, flaps, and grafts.Avance Solo NPWT System isintended for use by healthcareprofessionals for therapy onpatients in healthcare facilities andhome care settings.	PICO is indicated for patients whowould benefit from a suction device(negative pressure wound therapy)as it maypromote wound healing via removalof low to moderate levels ofexudate and infectious materials.Appropriate wound types include:- Chronic- Acute- Traumatic- Subacute and dehisced wounds- Partial-thickness burns- Ulcers (such as diabetic orpressure)- Flaps and grafts- Closed surgical incisionsPICO Single Use NegativePressure Wound Therapy Systemis suitable for use in both hospitaland homecare setting.	The ActiVAC NPWT System is anintegrated wound managementsystem for use in acute, extendedand home care settings.When used on open wound, it isintended to create an environmentthat promotes wound healing bysecondary or tertiary (delayedprimary) intention by preparing thewound bed for closure, reducingedema, promoting granulationtissue formation and perfusion, andby removing exudate and infectiousmaterial. Open wound typesincludes: chronic, acute, traumatic,subacute and dehisced wounds,partial thickness burns, ulcers(such as diabetic, pressure, orvenous insufficiency), flaps andgrafts.When used on closed surgicalincision, they are also intended tomanage the environment ofsurgical incisions that continue to	Minor differences informatting with no impacton substantialequivalence; primarypredicate device does notexplicitly include venousulcers in indicated woundtypes, but secondarypredicate does
			drain following sutured or stapledclosure by maintaining a closedenvironment and removingexudates via the application ofnegative pressure wound therapy.
Useenvironment	Healthcare facilities and home caresetting	Hospital and homecare setting	Hospital and homecare setting	Same
Systemcomponents	PumpCanisterBorder dressing with fixation stripsFoam	PumpBorder dressing with fixation stripsFoam	PumpCanisterTransfer portCover filmFoam	Avance Solo NPWTSystem utilizes both theexudateabsorption/evaporationproperties of the borderdressing as well as acanister for collection ofexcess exudate. PICOSingle Use NPWT Systemhandles exudate onlythroughabsorption/evaporation inthe border dressing (i.e., itdoes not utilize acanister). In bothsystems, most of thewound fluids are handledthrough evaporationthrough the dressing; theAvance Solo Canisterserves as a backup forexcess exudate. Despitethis difference, bothsystems are capable ofdelivering effectivenegative pressure woundtherapy and removingexcess wound exudateand are thereforesubstantially equivalent.
Performancespecification	-125 mmHg (nominal)	-80 mmHg (nominal)	-125 mmHg (nominal) (defaultsetting)	Preclinical and clinicalliterature suggests thatdelivery of negativepressure within the rangeof -50mmHg to -150
				mmHg induces safe andeffective NPWT. Becauseboth the Avance SoloNPWT System and PICOSingle Use NPWT Systemare specified to delivernegative pressure withinthe clinically acceptablerange, the performancespecification differencedoes not impactsubstantial equivalence.
Pump usefullife	14 days	7 days	NA (multiple patient use)	Differences in useful lifedo not impact substantialequivalence; the total timeof treatment is notdetermined by the lifetimeof the pumps, ascontinued therapy witheither system can beprovided by connecting anew pump.
Pump powersource	Two AA Lithium batteries	Two AA Lithium batteries	Battery and AC powered	Same as primarypredicate
Sterility	System components are suppliedsterile; sterilization is achieved byEtO	System components are suppliedsterile; sterilization is achieved byEtO	Pump is not supplied sterileCanister has a sterile fluid path;sterilization is achieved by radiationTransfer port, cover film, and foamare supplied sterile; sterilization isachieved by radiation	Same as primarypredicate

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Non-Clinical Testing:

(Biocompatibility) The subject devices have been evaluated in accordance with ISO 10993-1 and have been shown to meet the criteria for the relevant endpoints, based on the characterization of contact with respect to nature and duration. The results meet the relevant ISO 10993-XX criteria for their intended use. The endpoints included cytotoxicity, sensitization, acute systemic toxicity, materialmediated pyrogenicity, subacute/subchronic toxicity, implantation, and genotoxicity.

(Bench testing) Bench testing has been performed to demonstrate that the Avance Solo NPWT System is capable of effectively transporting fluid away from the wound and that pressure is delivered in accordance with the pump settings. Test setups addressed both low (0.6 g/cm²/24 hours) and moderately (1.1 g/cm²/24 hours) exuding wounds, with and without wound filler. In addition, alarm functionality, device lifetime, and pressure safety mechanism testing was conducted. The subject Avance Solo NPWT System performed as intended in the test setups, and all predefined acceptance criteria were met.

(Software validation) Software validation has been conducted in accordance with IEC 62304:2006 + A1:2015.

(Electromagnetic compatibility and electrical safety testing)

The Avance Solo NPWT System has been shown to comply with the relevant medical electrical equipment standards:

AAMI ES 60601-1: 2005 +A2 +A1, Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance
. IEC 60601-1-2: 2014, Medical electrical equipment: General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
. IEC 60601-1-6: 2010 + A1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8: 2006 + A1:2012. Medical electrical equipment -- Part 1-8: General requirements . for basic safety and essential performance -- Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
. IEC 60601-1-11: 2015. Medical electrical equipment: General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

(Human factors/usability) Summative usability testing has been performed with the two identified user qroups (healthcare professionals and patients/lay persons).

Clinical Data:

No clinical data was provided to support substantial equivalence.

Conclusion:

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics as well as performance and electrical safety testing. The Avance Solo NPWT System is as safe and effective, and performs as well as the predicate devices.

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.