Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply

Q: Who is the manufacturer of Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply?

Medela AG filed the 510(k) submission for Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply (K161128).

Q: What is the FDA product code for Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply?

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

Q: What is the regulatory pathway for Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply?

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

Q: Who can help prepare an FDA 510(k) submission like Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply?

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.

K161128 · Medela AG · OMP · Dec 1, 2016 · General, Plastic Surgery

Device Facts

Record ID	K161128
Device Name	Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
Applicant	Medela AG
Product Code	OMP · General, Plastic Surgery
Decision Date	Dec 1, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) 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 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

Device Story

Invia Motion is a portable, AC/DC or battery-powered NPWT system for hospital, clinic, LTC, and home use. It consists of a pump, 0.15L canister/tubing set, power supply, and carrying case. The pump uses a DC-motor with membrane aggregate to provide continuous or intermittent suction (up to -175 mmHg). It features a double-lumen tubing system: a larger lumen for exudate removal and a smaller lumen for air flushing to prevent blockages. The device monitors pressure and detects blockages/leaks, providing visual and acoustic alerts via an MMI display. It is a single-patient-use device with varying operational runtimes (7 days to 3 years). Healthcare providers or patients operate the device to manage wound exudate and promote granulation. The system helps prepare the wound bed for closure, potentially reducing healing time and clinical intervention requirements.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366), and performance testing using a wound model with simulated exudates to verify pressure regulation, fluid removal, and blockage/leakage notification accuracy.

Technological Characteristics

Powered suction pump (Class II, OMP). Materials: Biocompatible (ISO 10993). Energy: AC/DC (100-240V) or rechargeable NiMH battery. Sensing: Electric vacuum sensor. Connectivity: Standalone. Sterilization: EO (ISO 11135-1). Form factor: Portable, 0.47-0.48kg. Software: Embedded firmware for vacuum regulation, blockage detection, and user interface alerts. IP-22 rated.

Indications for Use

Indicated for adult patients requiring suction (NPWT) to promote healing of acute, subacute, chronic, dehisced, traumatic wounds, pressure/diabetic/neuropathic/venous ulcers, partial-thickness burns, flaps, and grafts. Contraindications: malignancy in wound, untreated osteomyelitis, non-enteric/unexplored fistulas, necrotic tissue with eschar, 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 Motion Negative Pressure Wound Therapy System (K113678)
Invia Endure Negative Pressure Wound Therapy System (K141926)

Reference Devices

Invia gauze kits (K113678)
Avance kits (K122132)
Invia Foam Dressing Kit with ESI (K151261)

Related Devices

K113678 — INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM · Medela AG · Oct 1, 2012
K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System · Medela AG · Jul 26, 2022
K142626 — Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters · Medela AG · Jun 12, 2015
K141926 — INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM · Medela AG · Dec 19, 2014
K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand) · Med Way, Inc. · Aug 19, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 1, 2016 Medela Ag % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324s3649 County Road E Dousman. Wisconsin 53118 Re: K161128 Trade/Device Name: Invia Motion-endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/tubing Set 0.151, Invia Motion Carrying Case, Power Supply Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: October 26, 2016 Received: October 31, 2016 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 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 {1}------------------------------------------------ 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 yours. # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K161128 #### Device Name Invia Motion Negative Pressure Wound Therapy System Invia Motion - Endure. Invia Motion - 120 days. Invia Motion - 30 days. Invia Motion - 30 days. Invia Motion - 15 days. Invia Motion - 7 days, Invia Motion Canister/ Tubing Set 0.151, Invia Motion Carrying Case, Charger #### Indications for Use (Describe) The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) 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 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 | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------------| | | Prescription Use (Part 21 GER 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 "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 # K161128 In accordance with 21 CFR 807.92 the following summary of information is provided: DATE: October 26, 2016 #### 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 Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023 SECONDARY CONTACT PERSON: Markus Bütler Vice President Quality Assurance Medela AG DEVICE: TRADE NAME: Invia Motion COMMON/USUAL NAME: Negative Pressure Wound Therapy System CLASSIFICATION NAMES: 878.4780 Powered Suction Pump PRODUCT CODE: OMP | PREDICATE DEVICE(S): | | |----------------------|--| |----------------------|--| K113678 Invia Motion Negative Pressure Wound Therapy System K141926 Invia Endure Negative Pressure Wound Therapy System {4}------------------------------------------------ # DEVICE DESCRIPTION: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is available in six versions with different run times: - । 7 Days - -15 Days - -30 Days - -60 Days - -120 Days - -Endure: lasts for one patients entire therapy, max. 3 years The Invia Motion Negative Pressure Wound Therapy system is comprised of the Invia Motion pump, Invia Motion Canister/Tubing Set 0.15l, Invia Motion Power Supply and Invia Motion Carrying Case. Additionally, several separately cleared accessories and kits are compatible with the Invia Motion NPWT System. The Invia Motion 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. The Invia Motion NPWT pump provides treatment status through a display and acoustic signals. It 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. #### INTENDED USE: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) 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 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 {5}------------------------------------------------ ### DETERMINATION OF SUBSTANTIAL EQUIVALENCE: #### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE The Invia Motion Negative Pressure Wound Therapy System uses the same fundamental technology as the predicate pumps for most features. With the exception of minor wording changes to align the indications for use with other Medela NPWT products, the indications for use and the indicated wound types are the same as those of the predicate devices. These changes do not alter the intended use of the device. The main differences between the Invia Motion NPWT System and the predicate devices are: - . New Invia Motion Canister/Tubing Set 0.15l with double lumen tubing, optimized tubing dimensions with no narrow points at the connector and quick connector coupling. The smaller lumen (air flush tubing) flushes air to remove exudate from the larger lumen. Larger lumen (suction tubing) removes the fluid from the wound into the canister. The quick connector ensures that the connection is easy to connect / disconnect and tight. - . An improved flush function through the entire tubing from the canister down to the wound which allows pressure measured at the pump to correspond to pressure at the wound site and blockage detection - . Visual and acoustic notifications if the pump detects blockage in the tubing from the canister to the wound dressing, and - A battery compartment door so the battery can be disposed of separately The table below summarizes the key differences between the Invia Motion NPWT System and the predicate devices. {6}------------------------------------------------ | | Invia Endure (K141926) | Invia Motion (K113678) | Invia Motion | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The portable Medela Invia Endure Negative Pressure Wound Therapy (NPWT) system is indicated 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 exudates and infectious material. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropathic, pressure or venous insufficiency), flaps and grafts. | The portable Medela® Invia Motion negative pressure wound therapy (NPWT) system is indicated 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 exudates and infectious material. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (diabetic, neuropathic, pressure or venous insufficiency), flaps and grafts. | The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) 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 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 | | | Invia Endure (K141926) | Invia Motion (K113678) | Invia Motion | | Contra- indications | • Malignancy in the wound • Untreated osteomyelitis • Non-enteric and unexplored fistulas • Necrotic tissue with eschar present • Exposed vasculature • Exposed nerves • Exposed anastomotic site of blood vessels or bypasses • Exposed organs | • Malignancy in the wound • Untreated osteomyelitis • Non-enteric and unexplored fistulas • Necrotic tissue with eschar present • 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 | | Patient Population | Adults - single patient | Adults - single patient | Adults - single patient | | Useful Life | 3 years | 60 days | Up to 3 years with different run times available | | Environment of Use | Hospitals, Clinics, Long Term Care (LTC) and Home Care (HC) settings | Hospitals, Clinics, Long Term Care (LTC) and Home Care (HC) settings | Hospitals, Clinics, Long Term Care (LTC) and Home Care (HC) settings | | User Control | Four button keypad (on/off, pressure setting, constant/intermittent mode, Mute acoustic signal / Info used pump time) | Four button keypad (on/off, pressure setting, constant/intermittent mode, Mute acoustic signal / Info used pump time) | Four button keypad (on/off, pressure setting, constant/intermittent mode, Mute acoustic signal / Info used pump time) | | Audio Indicator | Information signals as Leakage, Canister full, Battery low, Battery discharged, internal fault, end of Lifetime | Information signals as Leakage, Canister full, Battery low, Battery discharged, internal fault, end of Lifetime | Information signals as Leakage, Canister full, Blockage, Battery low, Battery discharged, Battery missing, Internal fault, end of Lifetime | | | Invia Endure (K141926) | Invia Motion (K113678) | Invia Motion | | Canister/ Tubing Set | Disposable Canister/Tubing Set 0.15l with single lumen tubing directly connected to the canister. To connect the tubing connector to the wound drain tubing there is a cone connector that fits to the wound drain tubing. | Disposable Canister/Tubing Set 0.15l with single lumen tubing directly connected to the canister. To connect the tubing connector to the wound drain tubing there is a cone connector that fits to the wound drain tubing. | Disposable Canister/Tubing Set 0.15l with double lumen tubing is directly connected to the canister. The pump tubing and dressing tubing are connected via the Quick Connect. | | Power Supply | 100-240 Vac 50/60Hz 8W | 100-240 Vac 50/60Hz 8W | 100-240 Vac 50/60Hz 8W | | Carrying Case | Case with shoulder or belt strap | Case with shoulder or belt strap | Case with shoulder or belt strap | | Y-Connector | Single lumen Y-connector | Single lumen Y-connector | Double lumen Y-connector with quick connector | | Drain Adapter | Not applicable | Not applicable | Drain adapter with quick connector | | Suction capacity liters/min | 1 l/min | 1 l/min | 1 l/min | | Max. vacuum mmHg/kPa | -175mmHg | -175mmHg | -175mmHg | | | -23kPa | -23kPa | -23kPa | | Min. vacuum mmHq/kPa | -60mmHg | -60mmHg | -40mmHg | | | -8kPa | -8kPa | -5kPa | | Vacuum Regulation type | Electric vacuum regulator | Electric vacuum regulator | Electric vacuum regulator | | Vacuum Gauge type | Electric vacuum sensor | Electric vacuum sensor | Electric vacuum sensor | | Therapy modes | Continuous & Intermittent | Continuous & Intermittent | Continuous & Intermittent | | Air Flush | Not applicable | Not applicable | Adaptive air flush when a sensory threshold is reached. | | | Invia Endure (K141926) | Invia Motion (K113678) | Invia Motion | | Blockage Detection | Not applicable | Not applicable | An acoustic signal will sound and a blockage symbol will appear on the display when the Invia Motion NPWT pump detects a blockage in tubing. | | Runtime | Not applicable | 60 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 | | Battery type | NiMH | NiMH | NiMH | | IP-Protection | IP-22 | IP-22 | IP-22…