The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Motion NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Motion NPWT system is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Liberty NPWT system is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

The Invia Gauze Dressing Kit with FitPad in comunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

Device Description

The labeling of the Invia Motion Negative Pressure Wound Therapy (NPWT) System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad has been modified to expand the indications for use to include closed surgical incisions. When used on closed surgical incisions, the devices are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

INVIA MOTION NPWT SYSTEM
The Invia Motion Negative Pressure Wound Therapy system is available in six versions with different run times. The Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Motion NPWT pump is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Motion suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.

INVIA LIBERTY NPWT SYSTEM
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Liberty NPWT pump is a multi-patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Liberty NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.
A variety Negative Pressure Wound Therapy Kits are available for use with the Invia Motion and Invia Liberty NPWT Systems, including the Invia Foam Dressing Kits with FitPad.

INVIA FOAM AND GAUZE DRESSING KITS WITH FITPAD
The Invia FitPad Kit Assortment includes Foam Kits in sizes Small, Medium, Large and X-Large as well as Gauze Kits with FitPad in sizes Medium and Large. The Invia Foam and Gauze Dressing Kits with FitPad provide a double lumen suction interface (FitPad) with Quickconnector. The double lumen suction interface allows flushing down to the dressing and detection of blockage along the entire length of tubing, controlling pressure at the wound site and enabling for easy and secure connection between canister tubing and dressing tubing.

AI/ML Overview

This document describes the premarket notification for the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems, and their associated Foam and Gauze Dressing Kits with FitPad. The submission seeks to expand the indications for use to include closed surgical incisions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a "table of acceptance criteria" with numerical targets and corresponding device performance values in a typical format for a medical device study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implied by demonstrating substantial equivalence to predicate devices for the new expanded indication (closed surgical incisions) and by successful completion of various non-clinical performance and safety tests.

The "reported device performance" is described qualitatively through these tests.

Implied Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device operation does not introduce new or increased risks for closed surgical incisions.	Potential risks associated with the new closed surgical incision were evaluated in accordance with ISO 14971:2007 (Risk Management for Medical Devices). The usability engineering process, including human factors validation testing, demonstrated that the design promotes safe use and mitigates critical, safety-related errors. Software verification and validation testing for non-significant changes were completed. Electromagnetic compatibility testing per IEC 60601-1-2:2014 (4th edition) was completed. Verification that EO and ECH residuals remain below maximum specified levels in compliance with ISO 10993-7 (Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals) was completed.
Effectiveness/Performance (Closed Surgical Incision Application): The device effectively manages the environment of closed surgical incisions by creating and maintaining negative pressure and removing exudate.	Performance testing demonstrated: - A steady rise of negative pressure at test onset to the set vacuum level. - A uniform and constant vacuum level throughout the test period. - The vacuum level corresponds to the selected set vacuum level of the pump. - The volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister. - Constant fluid removal was observed with no evidence of fluid accumulation on top of the closed surgical incisional wound model. - Compared equivalently to the predicate ActiV.A.C. Therapy Unit (K120033) for use on closed surgical incisions.
Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices for the expanded indication.	The non-clinical tests described demonstrate that the device is substantially equivalent to the predicate devices for the new indication of closed surgical incisions. The differences do not introduce new intended uses or raise different questions of safety and effectiveness.
Functional Equivalence: Non-significant changes to components (software, hardware, labeling, sterile packaging) maintain performance.	Software verification and validation testing were completed for non-significant changes.

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 primarily describes non-clinical performance testing using simulated wound models.

Sample size: Not explicitly stated as a numerical count of "cases" or "patients." Performance testing was conducted on "a closed surgical incision model and simulated wound exudates." The typical approach for such tests involves a sufficient number of runs or samples to demonstrate consistent performance within the system. Specific sample sizes for individual tests (e.g., bioburden, materials testing) are not detailed.
Data Provenance: The studies are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human patients. Therefore, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply. The submitter is Medela AG, based in Baar Zug, Switzerland, implying the tests were likely conducted under their quality system, possibly internally or at contract labs.

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 is a non-clinical submission, and no ground truth established by medical experts (like radiologists) is relevant or mentioned. The "ground truth" for the performance testing cited would be engineering specifications and validated test methods to measure parameters like pressure, flow, and fluid removal accuracy against established standards and predicate device performance.

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

Not applicable. As a non-clinical performance study using simulated models, there is no need for adjudication by human experts as would be required for clinical image interpretation or diagnostic performance studies. The "results" are objective measurements.

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. The submission is for Negative Pressure Wound Therapy (NPWT) systems and dressings, which are physical medical devices, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its mechanical and functional design.

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

For the non-clinical performance testing, the "ground truth" is based on:

Engineering Specifications: The device's predetermined operational parameters (e.g., set vacuum levels, flow rates).
Validated Test Methods: Standardized procedures for measuring device performance (e.g., pressure output, fluid removal volume).
Predicate Device Performance: Direct comparison to the established performance characteristics of the legally marketed predicate devices (ActiV.A.C. Therapy Unit K120033).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that uses training sets.

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

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. The logo is simple and professional, and it is easily recognizable.

May 9, 2018

Medela AG % Adrienne Lenz Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street NW Suite 1200 Washington, DC 20005-5929 US

Re: K172145

Trade/Device Name: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion - 120 days, Invia Motion -60 days, Invia Motion - 30 days, Invia Motion - 15 days, Invia Motion - 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: April 6, 2018

Dear Adrienne Lenz:

Received: April 9, 2018

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

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801); medical device reporting of medical device-related 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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510(k) Number (if known) K172145

Device Name

Invia Motion Negative Pressure Wound Therapy System

Invia Motion - Endure, Invia Motion - 120 days, Invia Motion - 30 days, Invia Motion - 15 days, Invia Motion - 7 days

Indications for Use (Describe)

The Invia Motion NPWT system is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K172145

Device Name

Invia Liberty Negative Pressure Wound Therapy System

Indications for Use (Describe)

The Invia Liberty NPWT system is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

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

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 GER 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K172145

Device Name Invia Foam Dressing Kit with FitPad

Indications for Use (Describe)

The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K172145

Device Name Invia Gauze Dressing Kit with FitPad

Indications for Use (Describe)

The Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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K172145 510(k) Summary

In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:

DATE: May 8, 2018

SUBMITTER:

Medela AG Lättichstrasse 4b Baar Zug, Switzerland CH-6341 Phone: +41-41-7695151-651 Fax: + 41-41-769 51- 00

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. Phone: 202-737-4292 Fax: (202) 737-9329

SECONDARY CONTACT PERSON:

Judith Bernardo Global RA Director & Team Leader Global RA Healthcare Medela AG

DEVICE:

TRADE NAME: Invia Motion Negative Pressure Wound Therapy System (Invia Motion -Endure, Invia Motion - 120 days, Invia Motion - 60 days, Invia Motion - 30 days, Invia Motion - 15 days, Invia Motion - 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Foam Dressing Kit with FitPad, Invia Gauze Dressing Kit with FitPad

510(K) NUMBER: K172145

COMMON/USUAL NAME: Negative Pressure Wound Therapy System

CLASSIFICATION NAMES: 878.4780 Powered Suction Pump

CLASS: CLASS II

PRODUCT CODE: OMP

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PREDICATE DEVICE(S):

Invia Motion Negative Pressure Wound Therapy System (all models) (K161128) Invia Liberty Negative Pressure Wound Therapy System (K142626) Invia Foam Dressing Kits with FitPad (K170088) ActiV.A.C. Therapy Unit (K120033) VA.C Therapy System using Granufoam Dressing (K120033)

DEVICE DESCRIPTION:

INVIA MOTION NPWT SYSTEM

The Invia Motion Negative Pressure Wound Therapy system is available in six versions with different run times. The Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Motion NPWT pump is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.

The Invia Motion suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.

INVIA LIBERTY NPWT SYSTEM

The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Liberty NPWT pump is a multi-patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Liberty NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.

The Invia Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power

{8}------------------------------------------------

actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.

A variety Negative Pressure Wound Therapy Kits are available for use with the Invia Motion and Invia Liberty NPWT Systems, including the Invia Foam Dressing Kits with FitPad.

INVIA FOAM AND GAUZE DRESSING KITS WITH FITPAD

The Invia FitPad Kit Assortment includes Foam Kits in sizes Small, Medium, Large and X-Large as well as Gauze Kits with FitPad in sizes Medium and Large. The Invia Foam and Gauze Dressing Kits with FitPad provide a double lumen suction interface (FitPad) with Quickconnector. The double lumen suction interface allows flushing down to the dressing and detection of blockage along the entire length of tubing, controlling pressure at the wound site and enabling for easy and secure connection between canister tubing and dressing tubing.

INTENDED USE:

INVIA MOTION NPWT SYSTEM

The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds, it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia Motion NPWT system is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

INVIA LIBERTY NPWT SYSTEM

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(delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia Liberty NPWT system is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

INVIA FOAM DRESSING KITS WITH FITPAD

The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds, it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns

{10}------------------------------------------------

Flaps and grafts

– Closed surgical incisions

INVIA GAUZE DRESSING KITS WITH FITPAD

The Invia Gauze Dressing Kit with FitPad in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:

Acute or subacute wounds
Chronic wounds
Dehisced wounds
Pressure ulcers
Diabetic/Neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns
Flaps and grafts
Closed surgical incisions

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The Invia Motion NPWT System, Invia Liberty NPWT System and Invia Dressing Kits with FitPad use the same fundamental technology as the predicate versions and equivalent technology to the ActiV.A.C. Therapy Unit and Granufoam Dressing (K120033) as shown in Tables 5.1 -5.4. The Invia Motion NPWT System, Invia Liberty NPWT System and Invia Dressing Kits with FitPad are identical to the predicate versions for all indications except the addition of closed surgical incisions. All indications, including the new indication for closed surgical incisions are the same as those of the ActiV.A.C. Therapy Unit (K120033).

Additional non-significant changes to the hardware, software, labeling and sterile packaging of the Invia Liberty NPWT System were reported.

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		Primary Predicate Device	Secondary Predicate Device
	Invia Motion	Invia Motion (K161128)	ActiV.A.C. Therapy Unit (K120033)
Indications forUse	The Invia Motion Negative Pressure WoundTherapy (NPWT) system is indicated forpatients who would benefit from a suctiondevice (Negative Pressure Wound Therapy)as when used on open wounds it creates anenvironment that promotes wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promotinggranulation tissue formation and perfusion,and by removing exudate and infectiousmaterial.When used on closed surgical incisions, theInvia Motion NPWT system is also intendedto manage the environment of surgicalincisions that continue to drain followingsutured or stapled closure by maintaining aclosed environment and removing exudatevia the application of Negative PressureWound Therapy.The Invia Motion NPWT system isappropriate for use for the followingindications:– Acute or subacute wounds– Chronic wounds– Dehisced wounds– Pressure ulcers– Diabetic/Neuropathic ulcers– Venous insufficiency ulcers– Traumatic wounds– Partial thickness burns– Flaps and grafts– Closed surgical incisions	The Invia Motion Negative Pressure WoundTherapy (NPWT) system is indicated forpatients who would benefit from a suctiondevice (Negative Pressure Wound Therapy)as it may promote wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promotinggranulation tissue formation and perfusion,and by removing exudate and infectiousmaterial.The Invia Motion NPWT system isappropriate for use for the followingindications:– Acute or subacute wounds– Chronic wounds– Dehisced wounds– Pressure ulcers– Diabetic/Neuropathic ulcers– Venous insufficiency ulcers– Traumatic wounds– Partial thickness burns– Flaps and grafts	The ActiVAC., InfoVAC., V.AC. ATS,V.AC. Freedom, V.AC. Via, and V.A.C.Simplicity Negative Pressure WoundTherapy Systems are integrated woundmanagement systems for use in acute,extended and home care settings.When used on open wounds, they areintended to create an environment thatpromotes wound healing by secondary ortertiary (delayed primary) intention bypreparing the wound bed for closure,reducing edema, promoting granulationtissue formation and perfusion, and byremoving exudate and infectious material.Open wound types include: chronic, acute,traumatic, subacute and dehisced wounds,partial-thickness burns, ulcers (such asdiabetic, pressure or venous insufficiency),flaps and grafts.When used on closed surgical incisions, theyare also intended to manage the environmentofsurgical incisions that continue to drainfollowing sutured or stapled closure bymaintaining aclosed environment and removing exudatesvia the application of negative pressurewoundtherapy.
		Primary Predicate Device	Secondary Predicate Device
	Invia Motion	Invia Motion (K161128)	ActiV.A.C. Therapy Unit (K120033)
Contraindications	• Necrotic tissue with eschar present• Untreated osteomyelitis• Non-enteric and unexplored fistulas• Malignancy in the wound• Exposed vasculature• Exposed nerves• Exposed anastomotic site of bloodvessels or bypasses• Exposed organs	• Necrotic tissue with eschar present• Untreated osteomyelitis• Non-enteric and unexplored fistulas• Malignancy in the wound• Exposed vasculature• Exposed nerves• Exposed anastomotic site of bloodvessels or bypasses• Exposed organs	Do not place foam dressings of theV.A.C. Therapy System directly incontact with exposed blood vessels,anastomotic sites, organs or nerves.• Malignancy in the wound• Untreated osteomyelitis• Non-enteric and unexploredfistulas• Necrotic tissue with escharpresent• Sensitivity to silver (V.A.C.GranuFoam Silver Dressingonly)
Environment ofUse	The Invia Motion NPWT system isintended for use in acute, extended andhome care settings.	The Invia Motion NPWT system isintended for use in acute, extended andhome care settings.	The ActiVAC., InfoVAC., V.AC. ATS,V.AC. Freedom, V.AC. Via, and V.A.CSimplicity Negative Pressure WoundTherapy Systems are integrated woundmanagement systems for use in acute,extended and home care settings.
		Primary Predicate Device	Secondary Predicate Device
	Invia Motion	Invia Motion (K161128)	ActiV.A.C. Therapy Unit (K120033)
User Interface	Four button keypad, LCD Display,Audio indicator, DisposableCanister/Tubing Set 150ml disposablecanister with solidifier and double lumentubing, clamp and Quick-connector, 100-240 VAC 50/60 Hz 8W power supply,carrying case, Y-connector, drainadapter	Four button keypad, LCD Display,Audio indicator, DisposableCanister/Tubing Set 150ml disposablecanister with solidifier and double lumentubing, clamp and Quick-connector,100-240 VAC 50/60 Hz 8W power supply,carrying case, Y-connector, drainadapter	Power button and touch screen, Audioindicator, ActiV.A.C. 300ml Canisterwith Gel (1 disposable canister (sterilefluid path), tubing, clamp and connector),100-240 VAC 50/60Hz 0.8A powersupply, carrying case, Y-connector,
Specifications
Max. vacuummmHg/kPa	-175mmHg-23kPa	-175mmHg-23kPa	-200 mmHg
Min. vacuummmHg/kPa	-40mmHg-5kPa	-40mmHg-5kPa	-25 mmHg
Therapy modes	Continuous & Intermittent	Continuous & Intermittent	Continuous & Intermittent
Runtime	Invia Motion - Endure, not applicableOther runtimes as stated in model name:Invia Motion – 120 DaysInvia Motion - 60 DaysInvia Motion - 30 DaysInvia Motion - 15 DaysInvia Motion - 7 Days	Invia Motion - Endure, not applicableOther runtimes as stated in model name:Invia Motion - 120 DaysInvia Motion - 60 DaysInvia Motion - 30 DaysInvia Motion - 15 DaysInvia Motion – 7 Days	Not applicable
		Primary Predicate Device	Secondary Predicate Device
	Invia Motion	Invia Motion (K161128)	ActiV.A.C. Therapy Unit (K120033)
IP-Protection	IP-22	IP-22	IPX0
Type	BF	BF	B
Operating AmbientTemperatures	+5...+40°C	+5...+40°C	+5...+40°C
Operating AmbientHumidity	15...93% R.L.	15...93% R.L.	0...95% R.L.
Canister capacity[ml]	150ml	150ml	300 ml
Weight [kg]	0.47 - 0.48kg	0.47 - 0.48kg	1.08 kg
Dimensionsmm	176x97x52mm (with canister)	176x97x52mm (with canister)	19.3 x 15.2 x 6.49 cm

TABLE 5.1 COMPARISON OF INVIA MOTION TO PREDICATE DEVICE

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TABLE 5.2 COMPARISON OF INVIA LIBERTY TO PREDICATE DEVICES
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		Primary Predicate	Secondary Predicate
	Invia Liberty Negative Pressure WoundTherapy System	Invia Liberty Negative Pressure WoundTherapy System (K142626)	ActiV.A.C. Therapy Unit (K120033)
Indications for Use	The Invia Liberty Negative Pressure Wound Therapy(NPWT) system is indicated for patients who wouldbenefit from a suction device (Negative Pressure WoundTherapy) as when used on open wounds it creates anenvironment that promotes wound healing by secondaryor tertiary (delayed primary) intention by preparing thewound bed for closure, reducing edema, promotinggranulation tissue formation and perfusion, and byremoving exudate and infectious material.When used on closed surgical incisions, the Invia LibertyNPWT system is also intended to manage theenvironment of surgical incisions that continue to drainfollowing sutured or stapled closure by maintaining aclosed environment and removing exudate via theapplication of Negative Pressure Wound Therapy.The Invia Liberty NPWT system is appropriate for usefor the following indications:– Acute or subacute wounds– Chronic wounds– Dehisced wounds– Pressure ulcers– Diabetic/Neuropathic ulcers– Venous insufficiency ulcers– Traumatic wounds– Partial thickness burns– Flaps and grafts– Closed surgical incisions	The Medela® Invia Liberty NegativePressure Wound Therapy System is indicatedto help promote wound healing, throughmeans including drainage and removal ofinfectious material or other fluids, under theinfluence of continuous and/or intermittentnegative pressures, particularly for patientswith chronic, acute, traumatic, subacute anddehisced wounds, partial-thickness burns,ulcers (such as diabetic or pressure), flapsand grafts.	The ActiVAC., InfoVAC., V.A.C. ATS, V.A.C. Freedom,V.A.C. Via, and V.A.C. Simplicity Negative PressureWound Therapy Systems are integrated woundmanagement systems for use in acute, extended andhome care settings.When used on open wounds, they are intended to createan environment that promotes wound healing bysecondary or tertiary (delayed primary) intention bypreparing the wound bed for closure, reducing edema,promoting granulation tissue formation and perfusion, and byremoving exudate and infectious material. Open woundtypes include: chronic, acute, traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers (such asdiabetic, pressure or venous insufficiency), flaps andgrafts.When used on closed surgical incisions, they are alsointended to manage the environment ofsurgical incisions that continue to drain followingsutured or stapled closure by maintaining aclosed environment and removing exudates via theapplication of negative pressure woundtherapy.
		Primary Predicate	Secondary Predicate
	Invia Liberty Negative Pressure WoundTherapy System	Invia Liberty Negative Pressure WoundTherapy System (K142626)	ActiV.A.C. Therapy Unit (K120033)
Contra-indications	- Necrotic tissue with eschar present– Untreated osteomyelitis- Non-enteric and unexplored fistulas– Malignancy in the wound– Exposed vasculature– Exposed nerves- Exposed anastomotic site of blood vesselsor bypasses- Exposed organs	- Malignancy of the wound- Untreated osteomyelitis- Unmanaged malnutrition– Non-enteric fistula– Unexplored fistula- Necrotic tissue with eschar present– Do not place Invia Wound Therapydressing over exposed blood vessels ororgans- Do not place directly over anastomoses orsutured vessels	Do not place foam dressings of the V.A.C.Therapy System directly in contact withexposed blood vessels, anastomotic sites,organs or nerves.• Malignancy in the wound• Untreated osteomyelitis• Non-enteric and unexplored fistulas• Necrotic tissue with eschar presentSensitivity to silver (V.A.C. GranuFoamSilver Dressing only)
Environment of Use	Acute, extended and home care settings	Home or other health care facility	Acute, extended and home care settings
User Interface	Five button keypad (power and arrow keys tonavigate menus), LCD Display, AudioIndicator, Disposable Canister 0.8 l, 0.3 l,Quick-connector double lumen tubing set,Drain Adapter, Y-connector, 100-240 VAC50/60Hz 20W Mains adapter, Dockingstation, Carrying Case, Holder with standardrail	Five button keypad (power and arrow keys tonavigate menus), LCD Display, AudioIndicator, Disposable Canister 0.8 l, 0.3 l,Quick-connector double lumen tubing set,Drain Adapter, Y-connector, 100-240 VAC50/60Hz 20W Mains adapter, Dockingstation, Carrying Case, Holder with standardrail	Power button and touch screen, Audioindicator, ActiV.A.C. 300ml Canister withGel (1 disposable canister (sterile fluid path),tubing, clamp and connector), 100-240 VAC50/60Hz 0.8A power supply, carrying case,Y-connector,
Specifications
Max. vacuummmHg/kPa	- 200mmHg-27kPa	- 200mmHg-27kPa	-200 mmHg
Min. vacuummmHg/kPa	- 40mmHg-5.3kPa	- 40mmHg-5.3kPa	-25 mmHg
		Primary Predicate	Secondary Predicate
	Invia Liberty Negative Pressure WoundTherapy System	Invia Liberty Negative Pressure WoundTherapy System (K142626)	ActiV.A.C. Therapy Unit (K120033)
Therapy modes	Continuous & Intermittent	Continuous & Intermittent	Continuous & Intermittent
IP-Protection	IP-33	IP-33	IPX0
Type	BF	BF	B
Operating AmbientTemperatures	+5...+40°C	+5...+40°C	+5...+40°C
Operating AmbientHumidity	15...93% R.L.	15...93% R.L.	0...95% R.L.
Canister capacity[ml]	300/800ml	300/800ml	300 ml

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		Primary Predicate	Secondary Predicate
	Invia Foam Dressing Kits with FitPad	Invia Foam Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
Indications forUse	The Invia Foam Dressing Kit with FitPad inconjunction with the Invia Motion and Invia LibertyNegative Pressure Wound Therapy (NPWT) systemsis indicated for patients who would benefit from asuction device (Negative Pressure Wound Therapy)as when used on open wounds it creates anenvironment that promotes wound healing bysecondary or tertiary (delayed primary) intention bypreparing the wound bed for closure, reducingedema, promoting granulation tissue formation andperfusion, and by removing exudate and infectiousmaterial.When used on closed surgical incisions, the InviaFoam Dressing Kit with FitPad is also intended tomanage the environment of surgical incisions thatcontinue to drain following sutured or stapled closureby maintaining a closed environment and removingexudate via the application of Negative PressureWound Therapy.The Invia Foam Dressing Kit with FitPad isappropriate for use for the following indications:– Acute or subacute wounds– Chronic wounds– Dehisced wounds– Pressure ulcers– Diabetic/Neuropathic ulcers– Venous insufficiency ulcers– Traumatic wounds– Partial thickness burns– Flaps and grafts– Closed surgical incisions	The Invia Foam Dressing Kit with FitPad inconjunction with the Invia Motion and InviaLiberty Negative Pressure Wound Therapy(NPWT) systems is indicated for patients whowould benefit from a suction device (NegativePressure Wound Therapy) as it creates anenvironment that promotes wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promoting granulationtissue formation and perfusion, and byremoving exudate and infectious material.The Invia Foam Dressing Kit with FitPad isappropriate for use on the following wounds:– Acute or sub-acute wounds– Chronic wounds– Dehisced wounds– Pressure ulcers– Diabetic/neuropathic ulcers– Venous insufficiency ulcers– Traumatic wounds– Partial thickness burns– Flaps and grafts	The ActiVAC., InfoVAC., V.AC. ATS, V.AC.Freedom, V.AC. Via, and V.A.C. SimplicityNegative Pressure Wound Therapy Systems areintegrated wound management systems for usein acute, extended and home care settings.When used on open wounds, they are intendedto create an environment that promotes woundhealing by secondary or tertiary (delayedprimary) intention by preparing the wound bedfor closure, reducing edema, promotinggranulation tissue formation and perfusion, andbyremoving exudate and infectious material. Openwound types include: chronic, acute, traumatic,subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic,pressure or venous insufficiency), flaps andgrafts.When used on closed surgical incisions, theyare also intended to manage the environment ofsurgical incisions that continue to drainfollowing sutured or stapled closure bymaintaining aclosed environment and removing exudates viathe application of negative pressure woundtherapy.
		Primary Predicate	Secondary Predicate
	Invia Foam Dressing Kits with FitPad	Invia Foam Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
Contra-indications	Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception ofpalliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vesselsor bypasses Exposed organs	Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception ofpalliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vessels orbypasses Exposed organs	Do not place foam dressings of the V.A.C.Therapy System directly in contact withexposed blood vessels, anastomotic sites,organs or nerves.V.A.C. therapy is contraindicated for patientswith:- Malignancy in the wound- Untreated osteomyelitis- Non-enteric and unexplored fistulas- Necrotic tissue with eschar present- Sensitivity to silver (V.A.C. GranuFoamSilver Dressing only)
Environment ofUse	Acute, extended and home care settings	Acute, extended and home care settings	Hospital and Home
Application forClosed SurgicalIncisions	Protect peri-incisional skin withtransparent film cut into strips. Protect the surgical incision with anonadherent contact layer (not part of kit) Apply the foam in strips to cover entireincision length Apply transparent film allowing forcoverage of the foam strips and 3-5 cmcontact with intact skin Cut a small hole in transparent film andApply suction pad (FitPad) Connect the dressing tubing to the pumptubing and turn on pump	Not applicable	Protect peri-incisional skin with V.A.C.Drape, hydrocolloid or other transparentfilm leaving suture line exposed Protect the surgical incision with anonadherent contact layer (not part of kit) Apply the foam in strips to cover entireincision length Cut and place V.A.C. Drape allowing forcoverage of the foam strips and 3-5 cmcontact with intact skin Cut a small hole in drape and apply suctionpad (SensaT.R.A.C) Initiate V.A.C. Therapy
		Primary Predicate	Secondary Predicate
	Invia Foam Dressing Kits with FitPad	Invia Foam Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
Dressing (topack the	Charcoal color Foam Pad	Charcoal color Foam Pad	Black foam pad
wound)	Uses a reticulated flexible polyether andpolyurethane hydrophobic foam material.	Uses a reticulated flexible polyether andpolyurethane hydrophobic foam material.	Uses reticulated polyurethane hydrophobicfoam material
TransparentFilm to seal thewound	Invia Transparent FilmPolyurethane transparent film with acrylicadhesive	Invia Transparent FilmPolyurethane transparent film with acrylicadhesive	V.A.C.® Drape, with SENSAT.R.A.C.TM Padwith connector
ExternalSuctionInterface	Invia FitPad (double lumen tubing with Quick-Connector)	Invia FitPad (double lumen tubing with Quick-Connector)	SENSAT.R.A.C.TM Pad with connector
Specifications
Foam	Small: 10 cm x 8 cm x 3 cm	Small: 10 cm x 8 cm x 3 cm	Small: 10 cm x 7.5 cm x 3.2 cm
Dimensions(Length x	Medium: 19 cm x 12.5 cm x 3 cm	Medium: 19 cm x 12.5 cm x 3 cm	Medium: 18 cm x 12.5 cm x 3.2 cm
Width xThickness)	Large: 25 cm x 15 cm x 3 cm	Large: 25 cm x 15 cm x 3 cm	Large: 25 cm x 15 cm x 3.2 cm
	X-Large: 60 cm x 30 cm x 1.5 cm	X-Large: 60 cm x 30 cm x 1.5 cm	X-Large: 60 cm x 30 cm x 1.5 cm
Sealing FilmDimensions(Length xWidth)	32 cm x 26 cm	32 cm x 26 cm	30.5 x 26 cm
OperatingAmbientTemperature	+5°C...+40°C	+5°C...+40°C	Not specified
		Primary Predicate	Secondary Predicate
	Invia Foam Dressing Kits with FitPad	Invia Foam Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
OperatingAmbientPressure	+70 kPa...+106kPa	+70 kPa...+106kPa	Not specified
StorageAmbientTemperature	-20°C...+50°C	-20°C...+50°C	Not specified
StorageAmbientHumidity	15%...93%	15%...93%	Not specified
Sterilizationmethod	Ethylene oxide sterilized	Ethylene oxide sterilized	Irradiation sterilized
Shelf life	2 years	2 years	3 years

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		Primary Predicate	Secondary Predicate
	Invia Gauze Dressing Kits with FitPad	Invia Gauze Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
Indications forUse	The Invia Gauze Dressing Kit with FitPad in conjunctionwith the Invia Motion and Invia Liberty Negative PressureWound Therapy (NPWT) systems is indicated for patientswho would benefit from a suction device (Negative PressureWound Therapy) as when used on open wounds it creates anenvironment that promotes wound healing by secondary ortertiary (delayed primary) intention by preparing the woundbed for closure, reducing edema, promoting granulationtissue formation and perfusion, and by removing exudateand infectious material.When used on closed surgical incisions, the Invia GauzeDressing Kit with FitPad is also intended to manage theenvironment of surgical incisions that continue to drainfollowing sutured or stapled closure by maintaining a closedenvironment and removing exudate via the application ofNegative Pressure Wound Therapy.The Invia Gauze Dressing Kit with FitPad is appropriate foruse for the following indications:– Acute or subacute wounds– Chronic wounds– Dehisced wounds– Pressure ulcers- Diabetic/Neuropathic ulcers- Venous insufficiency ulcers– Traumatic wounds- Partial thickness burns– Flaps and grafts- Closed surgical incisions	The Invia Gauze Dressing Kit with FitPad inconjunction with the Invia Motion and InviaLiberty Negative PressureWound Therapy (NPWT) systems is indicatedfor patients who would benefit from a suctiondevice (Negative PressureWound Therapy) as it creates an environmentthat promotes wound healing by secondary ortertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promoting granulationtissue formation and perfusion,and by removing exudate and infectiousmaterial.Invia Gauze Dressing Kit with FitPad isappropriate for use on the following wounds:— Acute or sub-acute wounds- Chronic wounds- Dehisced wounds– Pressure ulcers– Diabetic/neuropathic ulcers– Venous insufficiency ulcers– Traumatic wounds– Partial thickness burns- Flaps and Grafts	The ActiVAC., InfoVAC., V.AC. ATS, V.AC.Freedom, V.AC. Via, and V.A.C. SimplicityNegative Pressure Wound Therapy Systems areintegrated wound management systems for usein acute, extended and home care settings.When used on open wounds, they are intendedto create an environment that promotes woundhealing by secondary or tertiary (delayedprimary) intention by preparing the wound bedfor closure, reducing edema, promotinggranulation tissue formation and perfusion, andbyremoving exudate and infectious material. Openwound types include: chronic, acute, traumatic,subacute and dehisced wounds, partial-thicknessburns, ulcers (such as diabetic, pressure orvenous insufficiency), flaps and grafts.When used on closed surgical incisions, they arealso intended to manage the environment ofsurgical incisions that continue to drainfollowing sutured or stapled closure bymaintaining aclosed environment and removing exudates viathe application of negative pressure woundtherapy.
		Primary Predicate	Secondary Predicate
	Invia Gauze Dressing Kits with FitPad	Invia Gauze Dressing Kits with FitPad(K170088)	V.A.C Therapy System using GranufoamDressing (K120033)
Contra-indications	Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception ofpalliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vesselsor bypasses Exposed organs	Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception ofpalliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vessels orbypasses Exposed organs	Do not place foam dressings of the V.A.C.Therapy System directly in contact with exposedblood vessels, anastomotic sites, organs ornerves.- Malignancy in the wound- Untreated osteomyelitis- Non-enteric and unexplored fistulas- Necrotic tissue with eschar presentSensitivity to silver (V.A.C. GranuFoam SilverDressing only)
Environment ofUse	Acute, extended and home care settings	Acute, extended and home care settings	Healthcare and home care settings
Application forClosed SurgicalIncisions	1. Protect peri-incisional skin with transparentfilm cut into strips.2. Protect the surgical incision with anonadherent contact layer (not part of kit)3. Apply the gauze in strips to cover entireincision length4. Apply transparent film allowing forcoverage of the gauze strips and 3-5 cmcontact with intact skin5. Cut a small hole in transparent film andApply suction pad (FitPad)6. Connect the dressing tubing to the pumptubing and turn on pump	Not applicable	1. Protect peri-incisional skin with V.A.C.Drape, hydrocolloid or other transparentfilm leaving suture line exposed2. Protect the surgical incision with anonadherent contact layer (not part of kit)3. Apply the foam in strips to cover entireincision length4. Cut and place V.A.C. Drape allowing forcoverage of the foam strips and 3-5 cmcontact with intact skin5. Cut a small hole in drape and apply suctionpad (SensaT.R.A.C)6. Initiate V.A.C. Therapy
Dressing (topack thewound)	Kerlix AMD Gauze	Kerlix AMD Gauze	Black foam padUses reticulated polyurethane hydrophobic foammaterial
		Primary Predicate	Secondary Predicate
	Invia Gauze Dressing Kits with FitPad	Invia Gauze Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
TransparentFilm to seal thewound	Invia Transparent Film (sterile).Polyurethane transparent film with acrylicadhesive	Invia Transparent Film (sterile).Polyurethane transparent film with acrylicadhesive	V.A.C.® Drape, with SENSAT.R.A.C.TM Padwith connector
ExternalSuctionInterface	Invia FitPad (double lumen tubing with Quick-Connector)	Invia FitPad (double lumen tubing with Quick-Connector)	SENSAT.R.A.C.TM Pad with connector
Specifications
DressingDimensions(Length xWidth xThickness)	Medium: 17 cm x 16 cmLarge: 370 cm x 11.4 cm	Medium: 17 cm x 16 cmLarge: 370 cm x 11.4 cm	Small: 10 cm x 7.5 cm x 3.2 cmMedium: 18 cm x 12.5 cm x 3.2 cmLarge: 25 cm x 15 cm x 3.2 cmX-Large: 60 cm x 30 cm x 1.5 cm
Sealing FilmDimensions(Length xWidth)	32 cm x 26 cm	32 cm x 26 cm	30.5 x 26 cm
OperatingAmbientTemperature	+5°C...+40°C	+5°C...+40°C	Not specified
OperatingAmbientPressure	+70 kPa...+106kPa	+70 kPa...+106kPa	Not specified
StorageAmbientTemperature	-20°C...+50°C	-20°C...+50°C	Not specified
		Primary Predicate	Secondary Predicate
	Invia Gauze Dressing Kits with FitPad	Invia Gauze Dressing Kits with FitPad(K170088)	VA.C Therapy System using GranufoamDressing (K120033)
StorageAmbientHumidity	15%...93%	15%...93%	Not specified
Sterilizationmethod	Ethylene oxide sterilized	Ethylene oxide sterilized	Irradiation sterilized
Shelf life	2 years	2 years	3 years

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SUMMARY OF NON-CLINICAL TESTS:

The Invia Motion NPWT System, Invia Liberty NPWT System and Invia Dressing Kits with FitPad underwent the following in support of the substantial equivalence determination for the new closed surgical incision indication:

Potential risks associated with the new closed surgical incision were evaluated in accordance with ISO 14971: 2007.
. A usability engineering process, following the recommendations of the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (Feb. 3, 2016), was used in the development and evaluation of the usability of the devices for treatment of closed surgical incisions. This included a human factors validation test which demonstrated that the design of the system and materials promote safe use and mitigate the possibility for critical, safety-related errors to the extent that is reasonable or possible for the scenarios tested.
Performance testing was completed to demonstrate that the pressure at the incision is ● correct using a closed surgical incision model and simulated wound exudates. These tests demonstrated a steady rise of the negative pressure at test onset to the set vacuum level, a uniform and constant level throughout the test period, that the vacuum level corresponds to the selected set vacuum level of the pump, and that the volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister. Constant fluid removal was observed with no evidence of fluid accumulation on top of the closed surgical incisional wound model. The testing also compared the devices to the predicate ActiV.A.C. Therapy Unit using Granufoam Dressing (K120033) and demonstrated equivalent performance for use on closed surgical incisions.

Additional testing to support non-significant changes to the Invia Liberty NPWT System since its previous clearance included:

Software verification and validation testing
Electromagnetic compatibility testing per IEC 60601-1-2: 2014 (4th edition) ●
Verification that EO and ECH residuals remain below maximum specified levels in ● compliance with ISO 10993-7.

Additional testing to support non-significant changes to the Invia Motion NPWT System since its previous clearance included:

Software verification and validation testing. .

SUMMARY OF CLINICAL TESTS:

Clinical testing was not required to demonstrate the substantial equivalence of the Invia Motion NPWT System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad or Invia Gauze Dressing Kit with FitPad to its respective predicate device.

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CONCLUSION:

The differences between the Invia Motion NPWT System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad and its respective predicate devices do not introduce a new intended use and do not raise different questions of safety and effectiveness. Verification and validation testing demonstrated that no adverse effects have been introduced by these differences and that the devices perform as intended.

From the results of nonclinical testing described, Medela AG concludes that the Invia Motion NPWT System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad are substantially equivalent to the legally marketed 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.