Who is the manufacturer of Invia White Foam NPWT?

Medela AG filed the 510(k) submission for Invia White Foam NPWT (K180415).

What is the FDA product code for Invia White Foam NPWT?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Invia White Foam NPWT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Invia White Foam NPWT?

Invia Foam Dressing Kit with FitPad (K170088); Genadyne XLR8 White Foam Dressing Kit (K142646).

Who can help prepare an FDA 510(k) submission like Invia White Foam NPWT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Invia White Foam NPWT

K180415 · Medela AG · OMP · Nov 2, 2018 · General, Plastic Surgery

Device Facts

Record ID	K180415
Device Name	Invia White Foam NPWT
Applicant	Medela AG
Product Code	OMP · General, Plastic Surgery
Decision Date	Nov 2, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, 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 White Foam is appropriate for use for 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

Device Story

Invia White Foam is a sterile, hydrophilic, open-cell polyvinyl alcohol (PVA) foam dressing; used as a wound interface for negative pressure wound therapy (NPWT). It is designed to be cut to size and placed in the wound bed; connected to Medela Invia Motion or Invia Liberty NPWT pumps via Invia Foam Dressing Kit with FitPad. The foam facilitates the application of sub-atmospheric pressure to the wound; promotes healing by removing exudate and infectious material, reducing edema, and encouraging granulation tissue formation. Used by healthcare professionals in acute, extended, and home care settings. The device allows fluid passage away from the wound bed; supports both constant and intermittent therapy modes. Benefits include wound bed preparation for closure and improved perfusion.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including performance validation of vacuum delivery and fluid removal in a wound model, biocompatibility testing per ISO 10993, and a usability engineering report.

Technological Characteristics

Material: Polyvinyl alcohol (PVA) foam. Pore size: 900-1200 microns. Form factor: Sterile, moistened, cut-to-size sheets. Energy: Passive interface for external NPWT pump. Sterilization: Gamma radiation. Connectivity: Mechanical interface to NPWT pump system.

Indications for Use

Indicated for patients requiring negative pressure wound therapy for acute, sub-acute, chronic, dehisced, pressure, diabetic/neuropathic, venous insufficiency, and traumatic wounds, as well as partial thickness burns, flaps, and grafts.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

Invia Foam Dressing Kit with FitPad (K170088)
Genadyne XLR8 White Foam Dressing Kit (K142646)

Reference Devices

Invia Motion (K161128)
Invia Liberty (K142626)
Genadyne A4-XLR8 Wound Vacuum System (K090638)

Related Devices

K170088 — Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film · Medela AG · Apr 6, 2017
K223388 — Invia® Integrated Dressing · Medela AG · Jul 7, 2023
K213853 — RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large · Smith and Nephew Medical Limited · Feb 10, 2023
K151261 — Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large · Medela AG · Oct 7, 2015
K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM · Molnlycke Health Care · Jan 17, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. November 2, 2018 Medela AG c/o Adrienne Lenz Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005 Re: K180415 Trade/Device Name: Invia White Foam NPWT Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 28, 2018 Received: October 1, 2018 Dear Adrienne Lenz: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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. # Cynthia Chang -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) K180415 Device Name Invia White Foam NPWT #### Indications for Use (Describe) The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, 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 White Foam is appropriate for use for 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> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ 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}------------------------------------------------ ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: DATE: November 1, 2018 #### SUBMITTER: Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 769 51 51 Fax + 41 (0)41 769 51 00 #### PRIMARY CONTACT PERSON: Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. T 202-737-4292 #### SECONDARY CONTACT PERSON: Judith Bernardo Global RA Director Medela AG ### DEVICE: TRADE NAME: Invia White Foam NPWT COMMON/USUAL NAME: Negative Pressure Wound Therapy Dressing Kit CLASSIFICATION NAMES: 878.4780 Powered Suction Pump REVIEW PANEL: General and Plastic Surgery PRODUCT CODE: OMP ### PREDICATE DEVICE(S): K170088 Medela Invia Foam Dressing Kit with FitPad K142646 Genadyne XLR8 White Foam Dressing Kit {4}------------------------------------------------ # DEVICE DESCRIPTION: The Invia White Foam is a single packed, sterile, polyvinyl alcohol (PVA) foam intended for use in conjunction with the previously cleared Invia Foam Dressing Kit with FitPad (K170088), Invia Motion (K161128) and Invia Liberty (K142626) negative pressure wound therapy (NPWT) systems. It is a stand-alone wound dressing used as an alternative or as a supplement to the wound dressing in the Invia Foam Dressing Kit with FitPad. The Invia White Foam is available in two sizes (small, large). The Invia White Foam is for use by healthcare professionals in acute, extended and home care settings. The Invia White Foam NPWT is an open cell, hydrophilic, PVA foam moistened in sterile water. Like other NPWT foams, the Invia White Foam NPWT is an effective wound dressing, allowing a controlled application of sub-atmospheric pressure to the local wound environment to remove wound exudate. The Invia White Foam NPWT allows the passage of fluid through the foam and away from the wound bed. The foam can be used with both constant and intermittent NPWT delivery. It is able to be cut to size to suit a particular wound size. ## INTENDED USE: The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, 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 White Foam is appropriate for use for 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 {5}------------------------------------------------ # TECHNOLOGY: The proposed Invia White Foam NPWT has similar indications for use and uses the same fundamental technology as the legally marketed predicate devices to which substantial equivalency is claimed, the Invia Foam Dressing Kit with FitPad (K170088) and Genadyne XLR8 White Foam Dressing Kit (K142646). | | Subject Device | Predicate 1 | Predicate 2 | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Invia White Foam NPWT | Invia Foam Dressing Kit with FitPad (K170088) | Genadyne XLR8 White Foam Dressing Kit (K142646) | | Picture | Image: Invia White Foam NPWT | Image: Invia Foam Dressing Kit with FitPad (K170088) | Image: Genadyne XLR8 White Foam Dressing Kit (K142646) | | Manufact./Name | Medela AG | Medela AG | Genadyne Biotechnologies Incorporated | | 510(k) Number | - | K170088 | K142646 | | Product code | OMP | OMP | OMP | | Indications for Use | The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, 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 White Foam is appropriate for use for 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 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 for 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 | Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4- XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris. XLR8 White Foam Dressing is appropriate for use on the following wounds: • Pressure ulcers • Diabetic/Neuropathic Ulcers • Venous insufficiency Ulcers • Traumatic wounds • Post-operative and dehisced surgical wounds • Skin flap and grafts | | | Subject Device | Predicate 1 | Predicate 2 | | | Invia White Foam NPWT | Invia Foam Dressing Kit with FitPad (K170088) | Genadyne XLR8 White Foam Dressing Kit (K142646) | | Contraindicati ons | 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 | Unknown | | Environment of Use | acute, extended and home care settings | acute, extended and home care settings | Hospital, long term care and home settings | | User | healthcare professional only | healthcare professional only | healthcare professional only | | Therapy modes | Constant and intermittent use | Constant and intermittent use | Constant and intermittent use | | Dimensions | Small 10 cm x 7.5 cm x 1cm Large 15 cm x 10 cm x 1 cm | Small 10 cm x 8 cm x 3 cm Medium 19 cm x 12.5 cm x 3 cm Large 25 cm x 15 cm x 3 cm X Large 60 cm x 30 cm x 1.5 cm | Small 10 cm x 7.5 cm x 1cm Medium 15 cm x 10 cm x 1 cm Large 20 cm x 15 cm x 1 cm | | Operating Ambient Temperatures | +5 - +40 °C | +5 - +40 °C | Unknown | | Operating Ambient Humidity | 15 - 93% | 15 - 93% | Unknown | | Operating Pressure | 70 - 106 kPa | 70 - 106 kPa | Unknown | | Storage Ambient Temperatures | -20 - +50°C | -20 - +50°C | Unknown | | Storage Ambient Humidity | 15 - 93% | 15 - 93% | Unknown | | Storage Pressure | 70 - 106 kPa | 70 - 106 kPa | Unknown | | Packaging Type | Aluminium foil packed moistened with sterile water | Tyvec/Foil pouch packed dry | Aluminium foil packed moistened with sterile water | | Sterile | Yes | Yes | Yes | | Sterilization Method | Gamma radiation | Ethylene oxide | Gamma radiation | | Vacuum therapy range | -40 - -200mmHg | -40 - -200mmHg | -40 - -230mmHg | | Principles of operation | Open cell foam, hydrophilic, pore size 900 - 1200 microns, stronger tensile strength than PU foam | Open cell foam, hydrophobic, pore size 600-800 microns | Hydrophilic, stronger tensile strength than PU foam | | Foam Material | Polyvinyl alcohol foam | Polyurethane foam | Polyvinyl alcohol foam | | | Subject Device…