(296 days)
No
The document describes a standard negative pressure wound therapy system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The device functions based on applying negative pressure and managing exudate, which are mechanical and control system functions, not AI/ML.
Yes
The device is indicated for promoting wound healing, reducing edema, and removing exudate and infectious material, which are all therapeutic actions.
No
Explanation: The device is described as a Negative Pressure Wound Therapy (NPWT) system designed to promote wound healing by applying suction, removing exudate, and managing the wound environment. It is a therapeutic device, not a diagnostic one, as it does not diagnose conditions or diseases.
No
The device description explicitly details hardware components such as suction pumps, DC-motors, membrane aggregates, displays, and rechargeable batteries, indicating it is a physical medical device system, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Invia Motion and Invia Liberty NPWT systems, along with their associated dressing kits, are used to apply negative pressure directly to wounds (open or closed surgical incisions) on the patient's body. Their function is to promote wound healing by removing exudate, reducing edema, and creating a favorable environment.
- Lack of Specimen Analysis: The description focuses on the mechanical action of applying negative pressure and managing the wound environment. There is no mention of analyzing biological specimens for diagnostic purposes.
The device is a therapeutic device used for wound management, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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 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
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
- Flaps and grafts
- Closed surgical incisions
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
Product codes
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Invia Motion NPWT system is intended for use in acute, extended and home care settings.
The Invia Liberty NPWT system is intended for use in acute, extended and home care settings.
The Invia Foam Dressing Kit with FitPad is intended for use in acute, extended and home care settings.
The Invia Gauze Dressing Kit with FitPad is intended for use in acute, extended and home care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
| 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
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)
| ☑ 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.
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)
| 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.
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)
| 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.
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.
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| Primary Predicate Device | Secondary Predicate Device | ||
|---|---|---|---|
| Invia Motion | Invia Motion (K161128) | ActiV.A.C. Therapy Unit (K120033) | |
| Indications for | |||
| Use | 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 | 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 it may promote 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 | The ActiVAC., InfoVAC., V.AC. ATS, | ||
| V.AC. Freedom, V.AC. Via, and V.A.C. | |||
| Simplicity Negative Pressure Wound | |||
| Therapy Systems are integrated wound | |||
| management systems for use in acute, | |||
| extended and home care settings. | |||
| When used on open wounds, they are | |||
| intended to create 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. | |||
| Open wound types include: chronic, acute, | |||
| traumatic, subacute and dehisced wounds, | |||
| partial-thickness burns, ulcers (such as | |||
| diabetic, pressure or venous insufficiency), | |||
| flaps and grafts. | |||
| When used on closed surgical incisions, they | |||
| are 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 exudates | |||
| via the application of negative pressure | |||
| wound | |||
| therapy. | |||
| 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 blood | |||
| vessels 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 blood | |||
| vessels or bypasses | |||
| • Exposed organs | Do not place foam dressings of the | ||
| V.A.C. Therapy System directly in | |||
| contact with exposed blood vessels, | |||
| anastomotic sites, organs or nerves. | |||
| • Malignancy in the wound | |||
| • Untreated osteomyelitis | |||
| • Non-enteric and unexplored | |||
| fistulas | |||
| • Necrotic tissue with eschar | |||
| present | |||
| • Sensitivity to silver (V.A.C. | |||
| GranuFoam Silver Dressing | |||
| only) | |||
| Environment of | |||
| Use | The Invia Motion NPWT system is | ||
| intended for use in acute, extended and | |||
| home care settings. | The Invia Motion NPWT system is | ||
| intended for use in acute, extended and | |||
| home care settings. | The ActiVAC., InfoVAC., V.AC. ATS, | ||
| V.AC. Freedom, V.AC. Via, and V.A.C | |||
| Simplicity Negative Pressure Wound | |||
| Therapy Systems are integrated wound | |||
| management 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, Disposable | |||
| Canister/Tubing Set 150ml disposable | |||
| canister with solidifier and double lumen | |||
| tubing, clamp and Quick-connector, 100- | |||
| 240 VAC 50/60 Hz 8W power supply, | |||
| carrying case, Y-connector, drain | |||
| adapter | Four button keypad, LCD Display, | ||
| Audio indicator, Disposable | |||
| Canister/Tubing Set 150ml disposable | |||
| canister with solidifier and double lumen | |||
| tubing, clamp and Quick-connector,100- | |||
| 240 VAC 50/60 Hz 8W power supply, | |||
| carrying case, Y-connector, drain | |||
| adapter | Power button and touch screen, Audio | ||
| indicator, ActiV.A.C. 300ml Canister | |||
| with Gel (1 disposable canister (sterile | |||
| fluid path), tubing, clamp and connector), | |||
| 100-240 VAC 50/60Hz 0.8A power | |||
| supply, carrying case, Y-connector, | |||
| Specifications | |||
| Max. vacuum | |||
| mmHg/kPa | -175mmHg | ||
| -23kPa | -175mmHg | ||
| -23kPa | -200 mmHg | ||
| Min. vacuum | |||
| mmHg/kPa | -40mmHg | ||
| -5kPa | -40mmHg | ||
| -5kPa | -25 mmHg | ||
| Therapy modes | Continuous & Intermittent | Continuous & Intermittent | Continuous & Intermittent |
| Runtime | Invia Motion - Endure, not applicable | ||
| Other runtimes as stated in model name: | |||
| Invia Motion – 120 Days | |||
| Invia Motion - 60 Days | |||
| Invia Motion - 30 Days | |||
| Invia Motion - 15 Days | |||
| Invia Motion - 7 Days | Invia Motion - Endure, not applicable | ||
| Other runtimes as stated in model name: | |||
| Invia Motion - 120 Days | |||
| Invia Motion - 60 Days | |||
| Invia Motion - 30 Days | |||
| Invia Motion - 15 Days | |||
| Invia 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 Ambient | |||
| Temperatures | +5...+40°C | +5...+40°C | +5...+40°C |
| Operating Ambient | |||
| Humidity | 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 |
| Dimensions | |||
| mm | 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 |
|---|
| ------------------------------------------------------------ |
| Primary Predicate | Secondary Predicate | ||
|---|---|---|---|
| Invia Liberty Negative Pressure Wound | |||
| Therapy System | Invia Liberty Negative Pressure Wound | ||
| Therapy 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 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 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 Medela® Invia Liberty Negative
Pressure Wound Therapy System is indicated
to help promote wound healing, through
means including drainage and removal of
infectious material or other fluids, under the
influence of continuous and/or intermittent
negative pressures, particularly for patients
with chronic, acute, traumatic, subacute and
dehisced wounds, partial-thickness burns,
ulcers (such as diabetic or pressure), flaps
and grafts. | The ActiVAC., InfoVAC., V.A.C. ATS, V.A.C. Freedom,
V.A.C. Via, and V.A.C. Simplicity Negative Pressure
Wound Therapy Systems are integrated wound
management systems for use in acute, extended and
home care settings.
When used on open wounds, they are intended to create
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. Open wound
types include: chronic, acute, traumatic, subacute and
dehisced wounds, partial-thickness burns, ulcers (such as
diabetic, pressure or venous insufficiency), flaps and
grafts.
When used on closed surgical incisions, they are 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 exudates via the
application of negative pressure wound
therapy. |
| | | Primary Predicate | Secondary Predicate |
| | Invia Liberty Negative Pressure Wound
Therapy System | Invia Liberty Negative Pressure Wound
Therapy 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 vessels
or 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 Therapy
dressing over exposed blood vessels or
organs - Do not place directly over anastomoses or
sutured vessels | Do not place foam dressings of the V.A.C.
Therapy System directly in contact with
exposed blood vessels, anastomotic sites,
organs or nerves.
• Malignancy in the wound
• Untreated osteomyelitis
• Non-enteric and unexplored fistulas
• Necrotic tissue with eschar present
Sensitivity to silver (V.A.C. GranuFoam
Silver 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 to
navigate menus), LCD Display, Audio
Indicator, Disposable Canister 0.8 l, 0.3 l,
Quick-connector double lumen tubing set,
Drain Adapter, Y-connector, 100-240 VAC
50/60Hz 20W Mains adapter, Docking
station, Carrying Case, Holder with standard
rail | Five button keypad (power and arrow keys to
navigate menus), LCD Display, Audio
Indicator, Disposable Canister 0.8 l, 0.3 l,
Quick-connector double lumen tubing set,
Drain Adapter, Y-connector, 100-240 VAC
50/60Hz 20W Mains adapter, Docking
station, Carrying Case, Holder with standard
rail | Power button and touch screen, Audio
indicator, ActiV.A.C. 300ml Canister with
Gel (1 disposable canister (sterile fluid path),
tubing, clamp and connector), 100-240 VAC
50/60Hz 0.8A power supply, carrying case,
Y-connector, |
| Specifications | | | |
| Max. vacuum
mmHg/kPa | - 200mmHg
-27kPa | - 200mmHg
-27kPa | -200 mmHg |
| Min. vacuum
mmHg/kPa | - 40mmHg
-5.3kPa | - 40mmHg
-5.3kPa | -25 mmHg |
| | | Primary Predicate | Secondary Predicate |
| | Invia Liberty Negative Pressure Wound
Therapy System | Invia Liberty Negative Pressure Wound
Therapy 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 Ambient
Temperatures | +5...+40°C | +5...+40°C | +5...+40°C |
| Operating Ambient
Humidity | 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 Granufoam | ||
| Dressing (K120033) | |||
| Indications for | |||
| Use | 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 | |||
| – Flaps and grafts | |||
| – Closed surgical incisions | 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 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 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. Simplicity | |||
| Negative Pressure Wound Therapy Systems are | |||
| integrated wound management systems for use | |||
| in acute, extended and home care settings. | |||
| When used on open wounds, they are intended | |||
| to create 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. Open | |||
| wound types include: chronic, acute, traumatic, | |||
| subacute and dehisced wounds, partial- | |||
| thickness burns, ulcers (such as diabetic, | |||
| pressure or venous insufficiency), flaps and | |||
| grafts. | |||
| When used on closed surgical incisions, they | |||
| are 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 exudates via | |||
| the application of negative pressure wound | |||
| therapy. | |||
| Primary Predicate | Secondary Predicate | ||
| Invia Foam Dressing Kits with FitPad | Invia Foam Dressing Kits with FitPad | ||
| (K170088) | VA.C Therapy System using Granufoam | ||
| Dressing (K120033) | |||
| Contra- | |||
| indications | Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception of | ||
| palliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vessels | |||
| or bypasses Exposed organs | Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception of | ||
| palliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vessels or | |||
| bypasses Exposed organs | Do not place foam dressings of the V.A.C. | ||
| Therapy System directly in contact with | |||
| exposed blood vessels, anastomotic sites, | |||
| organs or nerves. | |||
| V.A.C. therapy is contraindicated for patients | |||
| with: |
- Malignancy in the wound
- Untreated osteomyelitis
- Non-enteric and unexplored fistulas
- Necrotic tissue with eschar present
- Sensitivity to silver (V.A.C. GranuFoam
Silver Dressing only) |
| Environment of
Use | Acute, extended and home care settings | Acute, extended and home care settings | Hospital and Home |
| Application for
Closed Surgical
Incisions | Protect peri-incisional skin with
transparent film cut into strips. Protect the surgical incision with a
nonadherent contact layer (not part of kit) Apply the foam in strips to cover entire
incision length Apply transparent film allowing for
coverage of the foam strips and 3-5 cm
contact with intact skin Cut a small hole in transparent film and
Apply suction pad (FitPad) Connect the dressing tubing to the pump
tubing and turn on pump | Not applicable | Protect peri-incisional skin with V.A.C.
Drape, hydrocolloid or other transparent
film leaving suture line exposed Protect the surgical incision with a
nonadherent contact layer (not part of kit) Apply the foam in strips to cover entire
incision length Cut and place V.A.C. Drape allowing for
coverage of the foam strips and 3-5 cm
contact with intact skin Cut a small hole in drape and apply suction
pad (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 Granufoam
Dressing (K120033) |
| Dressing (to
pack the | Charcoal color Foam Pad | Charcoal color Foam Pad | Black foam pad |
| wound) | Uses a reticulated flexible polyether and
polyurethane hydrophobic foam material. | Uses a reticulated flexible polyether and
polyurethane hydrophobic foam material. | Uses reticulated polyurethane hydrophobic
foam material |
| Transparent
Film to seal the
wound | Invia Transparent Film
Polyurethane transparent film with acrylic
adhesive | Invia Transparent Film
Polyurethane transparent film with acrylic
adhesive | V.A.C.® Drape, with SENSAT.R.A.C.TM Pad
with connector |
| External
Suction
Interface | 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 x
Thickness) | 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 Film
Dimensions
(Length x
Width) | 32 cm x 26 cm | 32 cm x 26 cm | 30.5 x 26 cm |
| Operating
Ambient
Temperature | +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 Granufoam
Dressing (K120033) |
| Operating
Ambient
Pressure | +70 kPa...+106kPa | +70 kPa...+106kPa | Not specified |
| Storage
Ambient
Temperature | -20°C...+50°C | -20°C...+50°C | Not specified |
| Storage
Ambient
Humidity | 15%...93% | 15%...93% | Not specified |
| Sterilization
method | 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 Granufoam | ||
| Dressing (K120033) | |||
| Indications for | |||
| Use | 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 | 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 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.
Invia Gauze Dressing Kit with FitPad is
appropriate 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. Simplicity
Negative Pressure Wound Therapy Systems are
integrated wound management systems for use
in acute, extended and home care settings.
When used on open wounds, they are intended
to create 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. Open
wound types include: chronic, acute, traumatic,
subacute and dehisced wounds, partial-thickness
burns, ulcers (such as diabetic, pressure or
venous insufficiency), flaps and grafts.
When used on closed surgical incisions, they are
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 exudates via
the application of negative pressure wound
therapy. |
| | | Primary Predicate | Secondary Predicate |
| | Invia Gauze Dressing Kits with FitPad | Invia Gauze Dressing Kits with FitPad
(K170088) | V.A.C Therapy System using Granufoam
Dressing (K120033) |
| Contra-
indications | Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception of
palliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vessels
or bypasses Exposed organs | Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in wound (with exception of
palliative care to enhance quality of life) Exposed vasculature Exposed nerves Exposed anastomotic site of blood vessels or
bypasses Exposed organs | Do not place foam dressings of the V.A.C.
Therapy System directly in contact with exposed
blood vessels, anastomotic sites, organs or
nerves. - Malignancy in the wound
- Untreated osteomyelitis
- Non-enteric and unexplored fistulas
- Necrotic tissue with eschar present
Sensitivity to silver (V.A.C. GranuFoam Silver
Dressing only) |
| Environment of
Use | Acute, extended and home care settings | Acute, extended and home care settings | Healthcare and home care settings |
| Application for
Closed Surgical
Incisions | 1. Protect peri-incisional skin with transparent
film cut into strips.
- Protect the surgical incision with a
nonadherent contact layer (not part of kit) - Apply the gauze in strips to cover entire
incision length - Apply transparent film allowing for
coverage of the gauze strips and 3-5 cm
contact with intact skin - Cut a small hole in transparent film and
Apply suction pad (FitPad) - Connect the dressing tubing to the pump
tubing and turn on pump | Not applicable | 1. Protect peri-incisional skin with V.A.C.
Drape, hydrocolloid or other transparent
film leaving suture line exposed - Protect the surgical incision with a
nonadherent contact layer (not part of kit) - Apply the foam in strips to cover entire
incision length - Cut and place V.A.C. Drape allowing for
coverage of the foam strips and 3-5 cm
contact with intact skin - Cut a small hole in drape and apply suction
pad (SensaT.R.A.C) - Initiate V.A.C. Therapy |
| Dressing (to
pack the
wound) | Kerlix AMD Gauze | Kerlix AMD Gauze | Black foam pad
Uses reticulated polyurethane hydrophobic foam
material |
| | | Primary Predicate | Secondary Predicate |
| | Invia Gauze Dressing Kits with FitPad | Invia Gauze Dressing Kits with FitPad
(K170088) | VA.C Therapy System using Granufoam
Dressing (K120033) |
| Transparent
Film to seal the
wound | Invia Transparent Film (sterile).
Polyurethane transparent film with acrylic
adhesive | Invia Transparent Film (sterile).
Polyurethane transparent film with acrylic
adhesive | V.A.C.® Drape, with SENSAT.R.A.C.TM Pad
with connector |
| External
Suction
Interface | 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 | | | |
| Dressing
Dimensions
(Length x
Width x
Thickness) | Medium: 17 cm x 16 cm
Large: 370 cm x 11.4 cm | Medium: 17 cm x 16 cm
Large: 370 cm x 11.4 cm | Small: 10 cm x 7.5 cm x 3.2 cm
Medium: 18 cm x 12.5 cm x 3.2 cm
Large: 25 cm x 15 cm x 3.2 cm
X-Large: 60 cm x 30 cm x 1.5 cm |
| Sealing Film
Dimensions
(Length x
Width) | 32 cm x 26 cm | 32 cm x 26 cm | 30.5 x 26 cm |
| Operating
Ambient
Temperature | +5°C...+40°C | +5°C...+40°C | Not specified |
| Operating
Ambient
Pressure | +70 kPa...+106kPa | +70 kPa...+106kPa | Not specified |
| Storage
Ambient
Temperature | -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 Granufoam
Dressing (K120033) |
| Storage
Ambient
Humidity | 15%...93% | 15%...93% | Not specified |
| Sterilization
method | 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.