Avance Solo Negative Pressure Wound Therapy (NPWT) System

K203369 · Molnlycke Health Care Us, LLC · OMP · Jul 1, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203369
• Device Name: Avance Solo Negative Pressure Wound Therapy (NPWT) System
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Jul 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Avance Solo NPWT System manages wounds via negative pressure; system includes battery-powered pump, 50 mL canister, border dressing, and polyurethane foam filler. Pump maintains nominal -125 mmHg pressure; exudate managed via dressing absorption/evaporation; excess fluid collected in canister. Used in healthcare facilities and home settings by healthcare professionals or patients. Pump is single-patient use with 14-day lifespan; single-button operation with visual/audible alarms. Device promotes healing by removing exudate and infectious material. Healthcare providers use system to manage wound environment; output affects clinical decision-making by providing continuous negative pressure therapy to facilitate wound closure.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, biocompatibility (ISO 10993-1), electrical safety (AAMI ES 60601-1, IEC 60601-1-2/6/8/11), and summative usability testing.

Technological Characteristics

Powered suction pump; -125 mmHg nominal pressure; 14-day lifespan; 2 AA lithium batteries. Components: polyurethane foam, soft silicone border dressing, 50 mL canister. Sterilization: EtO. Software: IEC 62304 compliant. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring negative pressure wound therapy for chronic, acute, traumatic, subacute, dehisced wounds, ulcers (diabetic, venous, pressure), surgically closed incisions, flaps, and grafts. Suitable for adults in healthcare facilities and home care settings.

Regulatory Classification

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.

Predicate Devices

• PICO Single Use NPWT System (K163387)
• ActiVAC Therapy Unit (K120033)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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, LLC<br>5445 Triangle Parkway, Suite 400<br>Peachtree Corners, GA 30092<br>Registration Number: 3004763499<br>Owner/Operator Number: 8030877 |
| Official Correspondent: | Megan Bevill<br>Manager, Regulatory Affairs<br>Tel: [phone]<br>email: [e-mail] |
| Trade/Proprietary Names: | Avance Solo Negative Pressure Wound Therapy (NPWT)<br>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)<br>ActiVAC Therapy Unit (K120033) |

#### Description of Device:

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.

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#### Intended Use/Indication for Use:

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.

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## Technological Characteristics:

| Feature | Avance Solo NPWT System | PICO Single Use NPWT System | ActiVAC Therapy Unit | Substantial Equivalence<br>Comments (comparison<br>to primary predicate<br>unless otherwise stated) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>clearance | K203369 (subject device) | K163387 | K120033 | NA |
| Rationale for<br>inclusion | 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 Therapy<br>Powered Suction Pump | Negative Pressure Wound Therapy<br>Powered Suction Pump | Negative Pressure Wound Therapy<br>Powered 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 for<br>use/Intended<br>use | The Avance Solo NPWT System is<br>indicated for patients who would<br>benefit from wound management<br>via the application of negative<br>pressure wound therapy,<br>particularly as the device may<br>promote wound healing through the<br>removal of exudate, infectious<br>material.<br>Avance Solo NPWT System is<br>indicated for removal of low to<br>moderate amounts of exudates<br>from chronic, acute, traumatic,<br>subacute and dehisced wounds,<br>ulcers (such as diabetic, venous or<br>pressure), surgically closed<br>incisions, flaps, and grafts.<br>Avance Solo NPWT System is<br>intended for use by healthcare<br>professionals for therapy on<br>patients in healthcare facilities and<br>home care settings. | PICO is indicated for patients who<br>would benefit from a suction device<br>(negative pressure wound therapy)<br>as it may<br>promote wound healing via removal<br>of low to moderate levels of<br>exudate and infectious materials.<br>Appropriate wound types include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and dehisced wounds<br>- Partial-thickness burns<br>- Ulcers (such as diabetic or<br>pressure)<br>- Flaps and grafts<br>- Closed surgical incisions<br>PICO Single Use Negative<br>Pressure Wound Therapy System<br>is suitable for use in both hospital<br>and homecare setting. | The ActiVAC NPWT System is an<br>integrated wound management<br>system for use in acute, extended<br>and home care settings.<br>When used on open wound, it is<br>intended to create an environment<br>that promotes wound healing by<br>secondary or tertiary (delayed<br>primary) intention by preparing the<br>wound bed for closure, reducing<br>edema, promoting granulation<br>tissue formation and perfusion, and<br>by removing exudate and infectious<br>material. Open wound types<br>includes: chronic, acute, traumatic,<br>subacute and dehisced wounds,<br>partial thickness burns, ulcers<br>(such as diabetic, pressure, or<br>venous insufficiency), flaps and<br>grafts.<br>When used on closed surgical<br>incision, they are also intended to<br>manage the environment of<br>surgical incisions that continue to | Minor differences in<br>formatting with no impact<br>on substantial<br>equivalence; primary<br>predicate device does not<br>explicitly include venous<br>ulcers in indicated wound<br>types, but secondary<br>predicate does |
| | | | drain following sutured or stapled<br>closure by maintaining a closed<br>environment and removing<br>exudates via the application of<br>negative pressure wound therapy. | |
| Use<br>environment | Healthcare facilities and home care<br>setting | Hospital and homecare setting | Hospital and homecare setting | Same |
| System<br>components | Pump<br>Canister<br>Border dressing with fixation strips<br>Foam | Pump<br>Border dressing with fixation strips<br>Foam | Pump<br>Canister<br>Transfer port<br>Cover film<br>Foam | Avance Solo NPWT<br>System utilizes both the<br>exudate<br>absorption/evaporation<br>properties of the border<br>dressing as well as a<br>canister for collection of<br>excess exudate. PICO<br>Single Use NPWT System<br>handles exudate only<br>through<br>absorption/evaporation in<br>the border dressing (i.e., it<br>does not utilize a<br>canister). In both<br>systems, most of the<br>wound fluids are handled<br>through evaporation<br>through the dressing; the<br>Avance Solo Canister<br>serves as a backup for<br>excess exudate. Despite<br>this difference, both<br>systems are capable of<br>delivering effective<br>negative pressure wound<br>therapy and removing<br>excess wound exudate<br>and are therefore<br>substantially equivalent. |
| Performance<br>specification | -125 mmHg (nominal) | -80 mmHg (nominal) | -125 mmHg (nominal) (default<br>setting) | Preclinical and clinical<br>literature suggests that<br>delivery of negative<br>pressure within the range<br>of -50mmHg to -150 |
| | | | | mmHg induces safe and<br>effective NPWT. Because<br>both the Avance Solo<br>NPWT System and PICO<br>Single Use NPWT System<br>are specified to deliver<br>negative pressure within<br>the clinically acceptable<br>range, the performance<br>specification difference<br>does not impact<br>substantial equivalence. |
| Pump useful<br>life | 14 days | 7 days | NA (multiple patient use) | Differences in useful life<br>do not impact substantial<br>equivalence; the total time<br>of treatment is not<br>determined by the lifetime<br>of the pumps, as<br>continued therapy with<br>either system can be<br>provided by connecting a<br>new pump. |
| Pump power<br>source | Two AA Lithium batteries | Two AA Lithium batteries | Battery and AC powered | Same as primary<br>predicate |
| Sterility | System components are supplied<br>sterile; sterilization is achieved by<br>EtO | System components are supplied<br>sterile; sterilization is achieved by<br>EtO | Pump is not supplied sterile<br>Canister has a sterile fluid path;<br>sterilization is achieved by radiation<br>Transfer port, cover film, and foam<br>are supplied sterile; sterilization is<br>achieved by radiation | Same as primary<br>predicate |

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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.