Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a specific department or office within the FDA. April 6, 2017 Medela, AG % Julian Thorns Regulatory Affairs & Project Manager Prosystem AG Beim Strohhause 17 Hamburg, 20097 DE Re: K170088 Trade/Device Name: Invia Foam Dressing Kits With Fitpad, Invia Gauze Dressing Kits With Fitpad, Invia Fitpad, Invia Transparent Film Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: February 3, 2017 Received: February 6, 2017 Dear Julian Thorns: 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 {1}------------------------------------------------ with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K170088 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 it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing 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 Type of Use (Select one or both, as applicable) | <div> <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K170088 Device Name Invia Gauze Dressing Kit with FitPad #### Indications for Use (Describe) The Invia Gauze 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 it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing 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 | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | <div> <span> Over-The-Counter Use (21 CFR 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "medela" in bold, black font. To the right of the word is an orange logo. The logo is made up of three orange teardrop shapes that are arranged in a circular pattern. # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: DATE: January 24, 2017 # SUBMITTER Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone: +41 (0)41 561 66 71 Fax: +41 (0)41 769 51 00 # OFFICIAL CORRESPONDENT | | Mr. Markus Bütler | |--------|-------------------------| | | Medela AG | | | Lättichstrasse 4b | | | 6341 Baar / Switzerland | | Phone: | +41 (0)41 561 66 71 | | Fax: | +41 (0)41 769 51 00 | # DEVICE IDENTIFICATION | OVERALL TRADE NAME: | Invia Dressing Kits with FitPad | |----------------------|-------------------------------------------------------------------------| | TRADE NAME: | Invia Foam Dressing Kits with FitPad | | MODEL NUMBER: | 087.6221, 087.6222, 087.6223, 087.6224, 087.6225,<br>087.6226, 087.6227 | | TRADE NAME: | Invia Gauze Dressing Kits with FitPad | | MODEL NUMBER: | 087.7170, 087.7171, 087.7172 | | TRADE NAME: | Invia FitPad, Invia Transparent Film | | MODEL NUMBER: | 087.0028, 087.0030 | | COMMON/USUAL NAME: | Negative Pressure Wound Therapy System | | CLASSIFICATION NAME: | Negative Pressure Wound Therapy Powered Suction Pump | | PRODUCT CODE: | OMP | | REGULATION NUMBER: | per 21 CFR 878.4780 | | REVIEW PANEL: | General and Plastic Surgery | | DEVICE CLASS: | II | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "medela" in a bold, sans-serif font. To the right of the word is a logo consisting of three orange teardrop shapes arranged in a triangular pattern. The logo is simple and abstract, and it complements the text. # PREDICATE DEVICE(S) INVIA FOAM DRESSING KITS WITH FITPAD | DEVICE TRADE NAME: | Invia Foam Dressing Kit | |--------------------|-------------------------| |--------------------|-------------------------| APPLICANT: Medela AG 510(K) NO.: K151261 2. PREDICATE DEVICE | DEVICE TRADE NAME: | Avance® Foam Dressing Kits | |--------------------|------------------------------| | APPLICANT: | Molnlycke Health Care US LLC | | 510(K) NO.: | K141847 | # INVIA GAUZE DRESSING KITS WITH FITPAD | 1. PRIMARY PREDICATE DEVICE | | |-----------------------------|----------------------------------------| | DEVICE TRADE NAME: | Invia Motion | | APPLICANT: | Medela AG | | 510(K) NO.: | K113678 | | 2. PREDICATE DEVICE | | | DEVICE TRADE NAME: | KCI NPWT Gauze Dressing | | APPLICANT: | KCI USA, Inc. (Kinetic Concepts, Inc.) | | 510(K) NO.: | K123507 | {6}------------------------------------------------ # DEVICE DESCRIPTION ### INVIA FOAM DRESSING KITS WITH FITPAD The Invia Foam Dressing Kit with FitPad consists of a foam, a suction interface (Invia FitPad) and transparent film (one or more pieces depending on the kit size). The Invia Foam Dressing Kit with FitPad is available in four sizes. The foam is manufactured using a reticulate flexible polyether and polyurethane hydrophobic material, with a high tensile strength (20 PSI*) and charcoal color. The FitPad suction interface features a quick connecting interface to the canister tubing for easy and secure connection. The transparent film is designed with self-explanatory markings to facilitate the ease of use. ### INVIA GAUZE DRESSING KITS WITH FITPAD The Invia Foam Dressing Kit with FitPad consists of a gauze pad, one or two transparent films (depending on the kit size), a suction interface (Invia FitPad), and saline. The Invia Gauze Dressing Kit with FitPad is available in two sizes. ### INTENDED USE ### INVIA® FOAM DRESSING KIT WITH FITPAD The Invia Foam Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems. The Invia Motion and Invia Liberty NPWT systems are intended for use in acute, extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT system labeling for additional safety information and instruction for use. To help ensure safe and effective use, the Invia Foam Dressing Kits with FitPad are to be used only with the approved therapy units. The components of the Invia Foam Dressing Kit with FitPad are packaged sterile and are for single use only. Do not use if sterile package is damaged or opened prior to use. To apply Invia Foam Dressing Kit with FitPad, use clean/aseptic or sterile techniques in accordance with local protocol. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the word "medela" in bold, black font. To the right of the word is an orange graphic that appears to be three teardrop shapes arranged in a triangular pattern. The teardrop shapes are slightly curved and have a gradient effect, with the color fading from dark orange to light orange. ### INVIA® GAUZE DRESSING KIT WITH FITPAD Invia Gauze Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems. The Invia Motion and Invia Liberty NPWT systems are intended for use in acute, extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT System labeling for additional safety information and instruction for use. To help ensure safe and effective use, the Invia Gauze Dressing Kits with FitPad are to be used only with the approved therapy units. The components of the Invia gauze dressing kit with FitPad are packaged sterile and are for single use only. Do not use if sterile package is damaged or opened prior to use. To apply Invia gauze dressing kit with FitPad, use clean/aseptic or sterile techniques in accordance with local protocol. # DETERMINATION OF SUBSTANTIAL EQUIVALENCE # SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE The Invia Foam Dressing Kit and the predicate devices, Avance Foam Dressing Kits (K141847) and Invia Foam Dressing Kits (K151261), have the same indications for use, all use a reticulated flexible polyether based polyurethane hydrophobic foam dressing material, are provided sterile, offer kit sizes in similar dimensions, are provided with an external suction interface tubing, and are used for negative pressure wound therapy. The Invia Gauze Dressing Kit and the predicate devices, Invia Motion (K113678) and KCI NPWT Gauze Dressing (K123507), have the same indications for use, all use the same gauze as dressing material, are provided single packed and sterile, offer kit sizes in similar dimensions, are provided with a tubing with suction interface, and are used for negative pressure wound therapy. ### SUMMARY OF NON-CLINICAL TESTS: The Invia Dressing Kits with FitPad comply with voluntary standards for risk management, biocompatibility, and sterilization. The following data were provided in support of the substantial equivalence determination: - . Risk Analysis developed in accordance with ISO 14971:2007. - . Biocompatibility studies in accordance with: EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-12, EN ISO 10993-18 - . Sterilization Validation in accordance with ISO 11135:2014 - Analysis on Accelerated Aging according to ASTM F1980 - Packaging Validation in accordance with DIN EN ISO 11607-1 - Transport Validation - Usability testing in accordance with EN 62366:2008 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Medela, a company that specializes in breastfeeding products and medical vacuum technology. The logo consists of the word "medela" in black, sans-serif font, followed by a stylized orange flower-like symbol. The symbol is composed of three teardrop-shaped petals arranged in a triangular formation. - . Performance testing which demonstrates that Invia Dressing Kits have the ability to accurately generate and maintain pressure under usage conditions in combination with the intended suction pumps SUMMARY OF CLINICAL TESTS: A clinical study was conducted according to the ISO 10993-10 (Annex C) to demonstrate that the Invia transparent film (adhesive drape) of the Invia Dressing Kits with FitPad is not a significant skin irritant. ### CONCLUSION: The differences between the Invia Dressing Kits with FitPad and its predicate devices do not introduce a new intended use and do not raise new questions of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of clinical and nonclinical testing described, Medela AG concludes that the Invia Dressing Kits with FitPad are substantially equivalent to the legally marketed predicate devices and do not raise new questions of safety and effectiveness.