Who is the manufacturer of Invia Ease Negative Pressure Wound Therapy (NPWT) System?

Medela AG filed the 510(k) submission for Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112).

What is the FDA product code for Invia Ease Negative Pressure Wound Therapy (NPWT) System?

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 Ease Negative Pressure Wound Therapy (NPWT) System?

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

What are the predicate devices for Invia Ease Negative Pressure Wound Therapy (NPWT) System?

Invia Liberty NPWT system (K172145).

Who can help prepare an FDA 510(k) submission like Invia Ease Negative Pressure Wound Therapy (NPWT) System?

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 Ease Negative Pressure Wound Therapy (NPWT) System

K214112 · Medela AG · OMP · Jul 26, 2022 · General, Plastic Surgery

Device Facts

Record ID	K214112
Device Name	Invia Ease Negative Pressure Wound Therapy (NPWT) System
Applicant	Medela AG
Product Code	OMP · General, Plastic Surgery
Decision Date	Jul 26, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Invia Ease 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 exudates and infectious material. When used on closed surgical incisions, the Invia Ease 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 (NPWT). The Invia Ease NPWT system is intended for use in acute, extended and home care settings.

Device Story

Invia Ease NPWT System is a portable, reusable suction pump for negative pressure wound therapy. It applies controlled negative pressure to wounds to promote healing by removing exudate and infectious material, reducing edema, and preparing the wound bed. Used in acute, extended, and home care settings by clinicians or patients. Input consists of vacuum pressure settings (continuous or intermittent) managed via a touchscreen interface. The device monitors pressure via an electric sensor and provides visual/acoustic feedback for alarms (e.g., blockage, canister full, low battery). It utilizes an adaptive air flush mechanism to maintain therapy. Output is the maintenance of a closed, negative-pressure environment at the wound site. Benefits include improved wound bed preparation and management of surgical incision drainage. The device is used with specific Medela canisters and dressings.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including vacuum performance, pump endurance, battery run-time, noise, and IP22 ingress protection testing. Biocompatibility testing (cytotoxicity, intracutaneous reactivity, sensitization) performed per ISO 10993 standards. Usability testing conducted per human factors guidance.

Technological Characteristics

Powered suction pump; Class II; IP22 rated. Materials: Canister and tubing tested for biocompatibility (ISO 10993). Energy: Internal 7.2V 5000mAh Li-Ion battery or external AC/DC adapter. Vacuum range: -40 to -200 mmHg. Connectivity: Standalone. Software: Embedded, moderate level of concern. Sterilization: Provided sterile (dressings). Features: Touchscreen interface, electric vacuum sensor, adaptive air flush, acoustic/visual alarm system per IEC 60601-1-8.

Indications for Use

Indicated for adult patients requiring negative pressure wound therapy for acute, subacute, chronic, dehisced, pressure, diabetic/neuropathic, venous insufficiency, or traumatic wounds, partial thickness burns, flaps, grafts, or closed surgical incisions. Contraindicated for necrotic tissue with eschar, untreated osteomyelitis, non-enteric/unexplored fistulas, malignancy (except palliative), exposed vasculature, nerves, anastomotic sites, or organs.

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 Liberty NPWT system (K172145)

Submission Summary (Full Text)

{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 26, 2022 Medela AG Mike McAndrew Director of Ouality and Regulatory Americas Lattichstrasse 4b Baar, 6340 Switzerland Re: K214112 Trade/Device Name: Invia Ease Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: June 15, 2022 Received: June 21, 2022 Dear Mike McAndrew: 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. Although this letter refers to your product as a device, please be aware 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 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Julie Morabito, Ph.D. Assistant Director DHT4B: Division of of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K214112 Device Name Invia Ease NPWT system #### Indications for Use (Describe) The Invia Ease 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 exudates and infectious material. When used on closed surgical incisions, the Invia Ease 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 (NPWT). The Invia Ease NPWT system is intended for use in acute, extended and home care settings. The Invia Ease NPWT system is appropriate 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 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 "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}------------------------------------------------ ### Medela AG Invia Ease NPWT system Traditional 510(k) ### 510(k) Summary Information (K214112) In accordance with 21 C.F.R. §807.92(a) the following summary of information is provided: | Date Summary Prepared: | July 12, 2022 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter/Applicant: | Medela AG Lättichstrasse 4b CH 6340 Baar Switzerland Phone: +41 41 562 51 51 Fax: +41 41 562 51 00 | | Primary Contact Person: | Mike McAndrew In representation of Medela AG Head of Quality and Regulatory Americas at Medela LLC Phone: +1 815 578 2376 Email: Mike.McAndrew@medela.com | | Device Information | Trade/Device Name: Invia Ease NPWT System Regulation Name: Powered Suction Pump Regulation Number: 21 CFR§878.4780 Common Name: Negative Pressure Wound Therapy Pump and Accessories Device Classification Name: 878.4780 Powered Suction Pump Product Code: OMP Regulatory Class: II Review Panel: General & Plastic Surgery | | Predicate Device Information | K172145 Manufacturer: Medela AG Device Name: Invia Liberty NPWT system The predicate device has not been subject to a design related recall. | {4}------------------------------------------------ # Device Description The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a suction pump designed to help promote wound healing through Negative Pressure Wound Therapy (NPWT). The Invia Ease pump is reusable and portable pump intended to be used in acute, extended and home care settings. The Invia Ease pump provides adjustable negative pressure with constant and intermittent therapy modes. Invia Ease NPWT System comprises the Invia Ease pump and the following accessories: Invia Ease canisters with integrated tubing, Invia Ease carrying case, Invia Ease handle, Invia Ease IV pole/ bed holder, and Invia Ease charger US. The Invia Ease user interface includes two tactile buttons: an on/off button on the side of the pump and a mute button on the top of the pump. The pump is also equipped with a large touchscreen display on top of the pump, a status indicator bar on the front-side of the pump, which wraps around the side of the pump, as well as a charging port below the on/off button. Optical status of the pump is provided on the touchscreen and acoustic notifications are also used. The pump is used with 300 ml, 500 ml and 1000 ml canisters that include a release button and canister tubing with Quick-Connector. The pump is compatible with Invia dressings (NPWT dressings from Medela AG) that interface via the Quick-Connector. Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only. # Indications for Use The Invia Ease 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 exudates and infectious material. When used on closed surgical incisions, the Invia Ease 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 (NPWT). The Invia Ease NPWT System is intended for use in acute, extended and home care settings. The Invia Ease NPWT System is appropriate for the following indications: - Acute or subacute wounds - - Chronic wounds - - Dehisced wounds - - Pressure ulcers - - Diabetic/Neuropathic ulcers - - Venous insufficiency ulcers - {5}------------------------------------------------ - Traumatic wounds - - Partial thickness burns - - Flaps and grafts - - Closed surgical incisions - # Comparison of Technological Characteristics The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a modified version of the Invia Liberty NPWT System, which was most recently cleared in K172145. The Invia Ease NPWT pump has the same intended use, similar indications for use, and has equivalent fundamental technology as the legally marketed predicate device to which substantial equivalency is claimed. Both Invia Ease NPWT System and Invia Liberty use an equivalent suction aggregate to create the necessary vacuum in the same manner and provide same therapy modes: continuous and intermittent. | Characteristic | Invia Liberty NPWT System (Predicate Device K172145) | Invia Ease NPWT System (Subject Device K214112) | Comment | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product code | OMP | OMP | Same | | 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 Ease 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 exudates and infectious material. When used on closed surgical incisions, the Invia Ease 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. | Equivalent. The use environment is added, but it is already included in the Instructions for Use of the predicate device | | Characteristic | Invia Liberty NPWT System (Predicate Device K172145) | Invia Ease NPWT System (Subject Device K214112) | Comment | | Contra- indications | 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 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 | The Invia Ease NPWT system is intended for use in acute, extended and home care settings. The Invia Ease NPWT System is appropriate 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 Contraindications: - Necrotic tissue with eschar present - Untreated osteomyelitis - Non-enteric and unexplored fistulas - Malignancy in the 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 | Similar | | Intended Use | Negative Pressure Wound Therapy | Negative Pressure Wound Therapy | Same | | Patient population | Adult - multiple patient | Adult - multiple patient | Same | | Environment of Use | Acute, extended and home care settings | Acute, extended and home care settings | Same | | Weight | 1.0 kg | 1.1 kg | Similar | | Dimensions (l x w x h) | 170 x 90 x 150 (without canister) | 175 x 90 x 125mm (without canister) | Similar | | | 290 x 95 x 235 mm (with 300 ml canister) | 203 x 90 x125 (with 300 ml canister) | | | Characteristic | Invia Liberty NPWT System (Predicate Device K172145) | Invia Ease NPWT System (Subject Device K214112) | Comment | | Standard safety device | Bacteria and overflow protection filter | Bacteria and overflow protection filter | Same | | Useful Life | 4000 hours | 2000 hours | Similar. Both devices provide sufficient life for clinical use. | | Software | Embedded | Embedded | Same | | IP Protection class | IP33 | IP22 | Similar. Both devices provide adequate protection from ingress of dust or water. | | Protection type | BF | BF | Same | | Operating ambient temperatures | +5 °C to +40°C | +5 °C to +40°C | Same | | Operating ambient humidity | 15...93% RH | 15 to 90% RH (non-condensing) | Similar. Both devices meet IEC 60601 standards | | Canister capacity | 300 ml 800 ml | 300 ml 500 ml 1000 ml | Similar. Both devices offer multiple canister sizes to meet market needs. | | User Control | Five button keypad (power and arrow keys to navigate menus) | Mute button, On/Off Button and touch screen | Similar. Both devices provide user controls for similar functions. | | Visual indicator | LCD display | LED Light indicator status | Similar | | Characteristic | Invia Liberty NPWT System (Predicate Device K172145) | Invia Ease NPWT System (Subject Device K214112) | Comment | | Audio indicator | Low battery Tube flushing Loss of negative pressure | "Low priority" alarms: – Battery low – Temperature high – No canister detected – Pump in wrong position "Medium priority" alarms: – Pause reminder – Battery empty – Internal temperature exceeded – High leakage – Blockage – Canister full – Defective charger – Pump error | Similar. The subject device's approach to audio indicators uses more modern technology and meets IEC 60601- 1-8 alarm standard for Low and Medium priority alarms. | | Max. vacuum | -200 mmHg / -27 KPa | -200 mmHg / -27 KPa | Same | | Min. vacuum | -40 mmHg / -5.3 KPa | -40 mmHg / -5.3 KPa | Same | | Vacuum regulation type | Electric vacuum regulator controlled by Software | Electric vacuum regulator controlled by Software | Same | | Vacuum gauge type | Electric vacuum sensor, digital dial | Electric vacuum sensor, digital dial | Same | | Therapy modes | Continuous & intermittent | Continuous & intermittent | Same | | Air Flushing | Adaptive air flush when a sensory threshold is reached. | Adaptive air flush when a sensory threshold is reached | Same | | Blockage Detection | An acoustic signal will sound and a blockage symbol will appear on the display when the Invia Liberty NPWT pump detects a blockage in tubing. | An acoustic signal will sound and a blockage symbol will appear on the touch screen. | Same | | Power Source – Direct Plug- in | Switching Power Supply • Input: 100-240VAC, 50/60Hz, 0.8A max. • Output: 12VDC, 2A (Max) • Off the Shelf plug connection to pump | Switching Power Supply • Input: 100-240VAC, 50/60Hz, 0.8A max. • Output: 12VDC, 2A (Max) • Custom magnetic connection to pump | Similar | | Characteristic | Invia Liberty NPWT System (Predicate Device K172145) | Invia Ease NPWT System (Subject Device K214112) | Comment | | Power Source – Internal Battery | Rechargeable Li-Ion battery (2 cells) 7.4VDC – 2500mAh | Rechargeable Li-Ion battery (4 cells) 7.2VDC – 5000mAh…

Invia Ease Negative Pressure Wound Therapy (NPWT) System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Invia Ease Negative Pressure Wound Therapy (NPWT) System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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