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

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 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 Type of Use (Select one or both, as applicable) | <span style="text-decoration: overline;">X</span> 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 {3}------------------------------------------------ 510(k) Number (if known) K172145 #### Device Name Invia Liberty Negative Pressure Wound Therapy System #### Indications for Use (Describe) 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 Type of Use (Select one or both, as applicable) | <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 GER 801 Subpart C) </span> </div> | #### 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 {4}------------------------------------------------ 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 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 Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <line stroke="black" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> </span> 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.* 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 {5}------------------------------------------------ 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 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 Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <line stroke="black" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> </span> 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.* 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 {6}------------------------------------------------ # 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 {7}------------------------------------------------ # 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: 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 {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. 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 ## INVIA LIBERTY NPWT SYSTEM 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 {9}------------------------------------------------ (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 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 # 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. 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 {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. 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 # 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. {11}------------------------------------------------ | | | Primary Predicate Device | Secondary Predicate Device | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Invia Motion | Invia Motion (K161128) | ActiV.A.C. Therapy Unit (K120033) | | Indications for<br>Use | The Invia Motion Negative Pressure Wound<br>Therapy (NPWT) system is indicated for<br>patients who would benefit from a suction<br>device (Negative Pressure Wound Therapy)<br>as when used on open wounds it creates an<br>environment that promotes wound healing by<br>secondary or tertiary (delayed primary)<br>intention by preparing the wound bed for<br>closure, reducing edema, promoting<br>granulation tissue formation and perfusion,<br>and by removing exudate and infectious<br>material.<br>When used on closed surgical incisions, the<br>Invia Motion NPWT system is also intended<br>to manage the environment of surgical<br>incisions that continue to drain following<br>sutured or stapled closure by maintaining a<br>closed environment and removing exudate<br>via the application of Negative Pressure<br>Wound Therapy.<br>The Invia Motion NPWT system is<br>appropriate for use for the following<br>indications:<br>– Acute or subacute wounds<br>– Chronic wounds<br>– Dehisced wounds<br>– Pressure ulcers<br>– Diabetic/Neuropathic ulcers<br>– Venous insufficiency ulcers<br>– Traumatic wounds<br>– Partial thickness burns<br>– Flaps and grafts<br>– Closed surgical incisions | The Invia Motion Negative Pressure Wound<br>Therapy (NPWT) system is indicated for<br>patients who would benefit from a suction<br>device (Negative Pressure Wound Therapy)<br>as it may promote wound healing by<br>secondary or tertiary (delayed primary)<br>intention by preparing the wound bed for<br>closure, reducing edema, promoting<br>granulation tissue formation and perfusion,<br>and by removing exudate and infectious<br>material.<br>The Invia Motion NPWT system is<br>appropriate for use for the following<br>indications:<br>– Acute or subacute wounds<br>– Chronic wounds<br>– Dehisced wounds<br>– Pressure ulcers<br>– Diabetic/Neuropathic ulcers<br>– Venous insufficiency ulcers<br>– Traumatic wounds<br>– Partial thickness burns<br>– Flaps and grafts | The ActiVAC., InfoVAC., V.AC. ATS,<br>V.AC. Freedom, V.AC. Via, and V.A.C.<br>Simplicity Negative Pressure Wound<br>Therapy Systems are integrated wound<br>management systems for use in acute,<br>extended and home care settings.<br>When used on open wounds, they are<br>intended to create an environment that<br>promotes wound healing by secondary or<br>tertiary (delayed primary) intention by<br>preparing the wound bed for closure,<br>reducing edema, promoting granulation<br>tissue formation and perfusion, and by<br>removing exudate and infectious material.<br>Open wound types include: chronic, acute,<br>traumatic, subacute and dehisced wounds,<br>partial-thickness burns, ulcers (such as<br>diabetic, pressure or venous insufficiency),<br>flaps and grafts.<br>When used on closed surgical incisions, they<br>are also intended to manage the environment<br>of<br>surgical incisions that continue to drain<br>following sutured or stapled closure by<br>maintaining a<br>closed environment and removing exudates<br>via the application of negative pressure<br>wound<br>therapy. | | | | Primary Predicate Device | Secondary Predicate Device | | | Invia Motion | Invia Motion (K161128) | ActiV.A.C. Therapy Unit (K120033) | | Contraindications | • Necrotic tissue with eschar present<br>• Untreated osteomyelitis<br>• Non-enteric and unexplored fistulas<br>• Malignancy in the wound<br>• Exposed vasculature<br>• Exposed nerves<br>• Exposed anastomotic site of blood<br>vessels or bypasses<br>• Exposed organs | • Necrotic tissue with eschar present<br>• Untreated osteomyelitis<br>• Non-enteric and unexplored fistulas<br>• Malignancy in the wound<br>• Exposed vasculature<br>• Exposed nerves<br>• Exposed anastomotic site of blood<br>vessels or bypasses<br>• Exposed organs | Do not place foam dressings of the<br>V.A.C. Therapy System directly in<br>contact with exposed blood vessels,<br>anastomotic sites, organs or nerves.<br>• Malignancy in the wound<br>• Untreated osteomyelitis<br>• Non-enteric and unexplored<br>fistulas<br>• Necrotic tissue with eschar<br>present<br>• Sensitivity to silver (V.A.C.<br>GranuFoam Silver Dressing<br>only) | | Environment of<br>Use | The Invia Motion NPWT system is<br>intended for use in acute, extended and<br>home care settings. | The Invia Motion NPWT system is<br>intended for use in acute, extended and<br>home care settings. | The ActiVAC., InfoVAC., V.AC. ATS,<br>V.AC. Freedom, V.AC. Via, and V.A.C<br>Simplicity Negative Pressure Wound<br>Therapy Systems are integrated wound<br>management systems for use in acute,<br>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,<br>Audio indicator, Disposable<br>Canister/Tubing Set 150ml disposable<br>canister with solidifier and double lumen<br>tubing, clamp and Quick-connector, 100-<br>240 VAC 50/60 Hz 8W power supply,<br>carrying case, Y-connector, drain<br>adapter | Four button keypad, LCD Display,<br>Audio indicator, Disposable<br>Canister/Tubing Set 150ml disposable<br>canister with solidifier and double lumen<br>tubing, clamp and Quick-connector,100-<br>240 VAC 50/60 Hz 8W power supply,<br>carrying case, Y-connector, drain<br>adapter | Power button and touch screen, Audio<br>indicator, ActiV.A.C. 300ml Canister<br>with Gel (1 disposable canister (sterile<br>fluid path), tubing, clamp and connector),<br>100-240 VAC 50/60Hz 0.8A power<br>supply, carrying case, Y-connector, | | Specifications | | | | | Max. vacuum<br>mmHg/kPa | -175mmHg<br>-23kPa | -175mmHg<br>-23kPa | -200 mmHg | | Min. vacuum<br>mmHg/kPa | -40mmHg<br>-5kPa | -40mmHg<br>-5kPa | -25 mmHg | | Therapy modes | Continuous & Intermittent | Continuous & Intermittent | Continuous & Intermittent | | Runtime | Invia Motion - Endure, not applicable<br>Other runtimes as stated in model name:<br>Invia Motion – 120 Days<br>Invia Motion - 60 Days<br>Invia Motion - 30 Days<br>Invia Motion - 15 Days<br>Invia Motion - 7 Days | Invia Motion - Endure, not applicable<br>Other runtimes as stated in model name:<br>Invia Motion - 120 Days<br>Invia Motion - 60 Days<br>Invia Motion - 30 Days<br>Invia Motion - 15 Days<br>Invia Motion – 7 Days | Not applicable | | | | Primary Predicate Device | Secondary Predicate Device | | | Invia Motion…