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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from Medela AG for their Invia Motion Negative Pressure Wound Therapy System. It seeks to demonstrate substantial equivalence to previously cleared predicate devices, not to prove the device's efficacy through new clinical studies. Therefore, the information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device (such as performance metrics, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) is not present in this document.

This submission focuses on engineering, non-clinical, and usability testing to show that the new version of the device, despite some changes (like a new canister/tubing set and improved blockage detection), performs equivalently and safely to its predecessors.

Here's a breakdown of what can be extracted based on the provided document, and what cannot be answered as it's not relevant to a 510(k) for this type of device:

1. A table of acceptance criteria and the reported device performance

Since this is a mechanical/electromechanical device and not an AI/ML one, the acceptance criteria are based on functional performance, electrical safety, usability, and biocompatibility, rather than diagnostic accuracy metrics. The document summarizes the tests performed and states they were successful in demonstrating intended performance. Specific numerical "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (like sensitivity, specificity, AUC) are not applicable or provided here.

Acceptance Criterion (Type of Testing)	Reported Device Performance (Summary)
Electrical Safety	Complies with IEC 60601-1:2005 (3rd Ed.) and US deviations.
Electromagnetic Compatibility	Complies with IEC 60601-1-2: 2014 (4th Ed.).
Home Healthcare Use Safety	Complies with IEC 60601-1-11: 2015 (2nd Ed.).
Usability	Evaluated per IEC 60601-1-6: 2013 and IEC 62366: 2015; Usability validation study demonstrated correct and safe use.
Performance (Pressure at Wound)	Demonstrated steady rise to set vacuum, uniform/constant level, correspondence to selected level, and proper fluid removal using a wound model and simulated exudates.
Leakage Notifications	Tests confirmed correct behavior of leakage notification signals using wound model and simulated exudates.
Blockage Detection	Tests confirmed correct behavior of blockage notification signals using wound model and simulated exudates.
Motor Runtime/Lifetime	Bench testing verified 3000h runtime (3-year lifetime); confirmation of limited runtime for specific models performed during software testing.
Sterilization Process	Validated according to ISO 11135-1:2007 (including Annex A and B).
Shelf Life (Canister/Tubing)	Accelerated aging tests support 5-year shelf life per ASTM F1980-07.
Biocompatibility	Performed according to ISO 10993-1: 2009 (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity) at an accredited lab (NAMSA) under GLP requirements. Demonstrates safety.
Risk Analysis	Developed in accordance with ISO 14971: 2007.
Software V&V	Software verification and validation testing completed.

2. Sample size used for the test set and the data provenance

Not applicable in the context of an AI/ML test set for diagnostic accuracy. The "test set" here refers to physical tests on the device and its components (e.g., specific wound models for performance, various environmental conditions for electrical safety). The provenance is from Medela AG's internal R&D and external testing laboratories. These are non-clinical bench tests, not data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of this device refers to physical properties and functional accuracy (e.g., actual vacuum pressure, correct fluid flow, sterility). These are established by engineering standards and measurement, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth for image interpretation or diagnosis. This document pertains to device functionality and safety.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device, and no clinical studies (including MRMC studies) were required or performed. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Motion Negative Pressure Wound Therapy System to its predicate device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm with diagnostic performance or human-in-the-loop interaction for diagnosis. Its "performance" is its ability to generate negative pressure, collect exudate, and alert to issues.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established engineering and medical device standards, physical measurements, and simulated physiological conditions. Examples include:

Physical measurements: Verification of vacuum levels, fluid volume dispensed/removed, motor runtime.
Standards compliance: e.g., IEC 60601 series for electrical safety, ISO 14971 for risk management, ISO 11135-1 for sterilization, ISO 10993-1 for biocompatibility.
Simulated environments: Use of "wound models and simulated wound exudates" to test pressure delivery, leakage, and blockage detection.

8. The sample size for the training set

Not applicable. There is no AI/ML component requiring a training set for diagnostic or predictive purposes.

9. How the ground truth for the training set was established

Not applicable. See #8.

Summary

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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

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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

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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)

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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

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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

INTENDED USE:

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

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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.

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	Invia Endure (K141926)	Invia Motion (K113678)	Invia Motion
Indications forUse	The portable Medela InviaEndure Negative PressureWound Therapy (NPWT)system is indicated tocreate an environmentthat promotes woundhealing by secondary ortertiary (delayed primary)intention by preparing thewound bed for closure,reducing edema,promoting granulationtissue formation andperfusion, and byremoving exudates andinfectious material. It isintended for the use inhospitals, clinics, LongTerm Care (LTC) andHome Care (HC) settingson adult patients withchronic, acute, subacute,traumatic, dehiscedwounds, partial-thicknessburns, ulcers (such asdiabetic, neuropathic,pressure or venousinsufficiency), flaps andgrafts.	The portable Medela®Invia Motion negativepressure wound therapy(NPWT) system isindicated to create anenvironment thatpromotes wound healingby secondary or tertiary(delayed primary)intention by preparing thewound bed for closure,reducing edema,promoting granulationtissue formation andperfusion, and byremoving exudates andinfectious material. It isintended for the use inhospitals, clinics, LongTerm Care (LTC) andHome Care (HC) settingson adult patients withchronic, acute, subacute,traumatic, dehiscedwounds, partial-thicknessburns, ulcers (diabetic,neuropathic, pressure orvenous insufficiency),flaps and grafts.	The Invia Motion NegativePressure Wound Therapy(NPWT) system isindicated for patients whowould benefit from asuction device (NPWT) asit creates an environmentthat promotes woundhealing by secondary ortertiary (delayed primary)intention by preparing thewound bed for closure,reducing edema,promoting granulationtissue formation andperfusion, and byremoving exudate andinfectious material.The Invia Motion NPWTsystem is appropriate foruse for the followingindications:-Acute or subacutewounds-Chronic wounds-Dehisced wounds-Pressure ulcers-Diabetic/Neuropathiculcers-Venous insufficiencyulcers-Traumatic wounds-Partial thickness burns-Flaps and grafts
	Invia Endure (K141926)	Invia Motion (K113678)	Invia Motion
Contra-indications	• Malignancy in thewound• Untreated osteomyelitis• Non-enteric andunexplored fistulas• Necrotic tissue witheschar present• Exposed vasculature• Exposed nerves• Exposed anastomoticsite of blood vessels orbypasses• Exposed organs	• Malignancy in thewound• Untreated osteomyelitis• Non-enteric andunexplored fistulas• Necrotic tissue witheschar present• Exposed vasculature• Exposed nerves• Exposed anastomoticsite of blood vessels orbypasses• Exposed organs	• Necrotic tissue witheschar present• Untreated osteomyelitis• Non-enteric andunexplored fistulas• Malignancy in thewound• Exposed vasculature• Exposed nerves• Exposed anastomoticsite of blood vessels orbypasses• Exposed organs
PatientPopulation	Adults - single patient	Adults - single patient	Adults - single patient
Useful Life	3 years	60 days	Up to 3 years withdifferent run timesavailable
Environment ofUse	Hospitals, Clinics, LongTerm Care (LTC) andHome Care (HC) settings	Hospitals, Clinics, LongTerm Care (LTC) andHome Care (HC) settings	Hospitals, Clinics, LongTerm Care (LTC) andHome Care (HC) settings
User Control	Four button keypad(on/off, pressure setting,constant/intermittentmode, Mute acousticsignal / Info used pumptime)	Four button keypad(on/off, pressure setting,constant/intermittentmode, Mute acousticsignal / Info used pumptime)	Four button keypad(on/off, pressure setting,constant/intermittentmode, Mute acousticsignal / Info used pumptime)
Audio Indicator	Information signals asLeakage, Canister full,Battery low, Batterydischarged, internal fault,end of Lifetime	Information signals asLeakage, Canister full,Battery low, Batterydischarged, internal fault,end of Lifetime	Information signals asLeakage, Canister full,Blockage, Battery low,Battery discharged,Battery missing, Internalfault, end of Lifetime
	Invia Endure (K141926)	Invia Motion (K113678)	Invia Motion
Canister/Tubing Set	DisposableCanister/Tubing Set 0.15lwith single lumen tubingdirectly connected to thecanister. To connect thetubing connector to thewound drain tubing thereis a cone connector thatfits to the wound draintubing.	DisposableCanister/Tubing Set 0.15lwith single lumen tubingdirectly connected to thecanister. To connect thetubing connector to thewound drain tubing thereis a cone connector thatfits to the wound draintubing.	DisposableCanister/Tubing Set 0.15lwith double lumen tubingis directly connected tothe canister. The pumptubing and dressing tubingare connected via theQuick Connect.
Power Supply	100-240 Vac50/60Hz8W	100-240 Vac50/60Hz8W	100-240 Vac50/60Hz8W
Carrying Case	Case with shoulder or beltstrap	Case with shoulder or beltstrap	Case with shoulder or beltstrap
Y-Connector	Single lumen Y-connector	Single lumen Y-connector	Double lumen Y-connectorwith quick connector
Drain Adapter	Not applicable	Not applicable	Drain adapter with quickconnector
Suctioncapacityliters/min	1 l/min	1 l/min	1 l/min
Max. vacuummmHg/kPa	-175mmHg	-175mmHg	-175mmHg
	-23kPa	-23kPa	-23kPa
Min. vacuummmHq/kPa	-60mmHg	-60mmHg	-40mmHg
	-8kPa	-8kPa	-5kPa
VacuumRegulation type	Electric vacuum regulator	Electric vacuum regulator	Electric vacuum regulator
Vacuum Gaugetype	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 asensory threshold isreached.
	Invia Endure (K141926)	Invia Motion (K113678)	Invia Motion
BlockageDetection	Not applicable	Not applicable	An acoustic signal willsound and a blockagesymbol will appear on thedisplay when the InviaMotion NPWT pumpdetects a blockage intubing.
Runtime	Not applicable	60 days	Invia Motion – Endure,not applicableOther runtimes as statedin model name:Invia Motion – 120 DaysInvia Motion - 60 DaysInvia Motion - 30 DaysInvia Motion - 15 DaysInvia Motion - 7 Days
Battery type	NiMH	NiMH	NiMH
IP-Protection	IP-22	IP-22	IP-22
Type	BF	BF	BF
OperatingAmbientTemperatures	+5...+40°C	+5...+40°C	+5...+40°C
OperatingAmbientHumidity	15...93% R.L.	15...93% R.L.	15...93% R.L.
Canistercapacity [ml]	150ml	150ml	150ml
Weight [kg]	0.45kg	0.45kg	0.47 - 0.48kg
Dimensionsmm	173x96x51mm (0.15lcanister)	173x96x51mm (0.15lcanister)	176x97x52mm (0.15lcanister)
StandardSafety device	Bacteria / overflow /protection filter	Bacteria / overflow /protection filter	Bacteria / overflow /protection filter
	Invia Endure (K141926)	Invia Motion (K113678)	Invia Motion
NPWT Kits	Multiple available andsold separately	Multiple available andsold separately	Multiple available andsold separately
510(k)clearance forNPWT Kits	K113678 for Invia kitsK122132 for Avance kits	K113678 for Invia kitsK122132 for Avance kits	K113678 for Invia gauzekitsK151261 Invia FoamDressing Kit with ESI

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SUMMARY OF NON-CLINICAL TESTS:

The Invia Motion NPWT System complies with voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment. The following were completed in support of the substantial equivalence determination:

Risk Analysis developed in accordance with ISO 14971: 2007.
Software verification and validation testing.
Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (3rd . Edition) with US deviations per AAMI/ANSI ES60601-1:2005 standard and IEC 60601-1-2: 2014 (4th edition) standards, respectively
. Safety testing for use in the home per IEC 60601-1-11: 2015 (2"® edition) standard
. Usability was evaluated according to IEC 60601-1-6: 2013 (3″ Edition) and IEC 62366: 2015. A usability validation study was conducted to demonstrate the user can correctly and safely use the Invia Motion NPWT system.
. Performance testing was completed to demonstrate that the pressure at the wound is correct using a wound model and simulated wound exudates. These tests demonstrated a steady rise of the negative pressure at test onset to the set vacuum level, a uniform and constant level throughout the test period, that the vacuum level corresponds to the selected set vacuum level of the pump, and that the volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister. Constant fluid removal was observed with no evidence of fluid accumulation in the wound model seen.
. Tests to validate the proper functioning of the leakage notifications were performed using a wound model and simulated wound exudates. The test results confirm the blockage and leakage notification signals behave correctly.

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. Bench Testing verified a motor-runtime of 3000h, which corresponds to a 3-year lifetime. Confirmation of the limited runtime for models other than the Endure was performed as part of the software testing.
. The sterilization process for the Invia Motion canister/tubing was validated according to ISO 11135-1:2007 including Annex A (Biological Indicators) and B (Overkill Approach). Validation was carried out by the following cycles
- -Product Profile (pre-conditioning room, sterilizer chamber, de-gas cell) included in the Half Cycle
- Sub-lethal Cycle (Biological Indicators, Product Sterility and Bio Burden)
- -Half cycle (Biological Indicators and Bacteriostasis & Fungistasis)
- -Routine Cycles (Residuals EO and ECH)
Accelerated aging tests were performed to support this 5-year shelf life of the . canister/tubing set via methods published in FDA recognized standard ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
. Biocompatibility Testing was performed according to ISO 10993-1: 2009 at NAMSA, an accredited testing laboratory. The studies have been conducted according to the Good Laboratory Practice (GLP) requirements. The Canister/Tubing set was tested according to the following conditions according to FDA guidance from May 1, 1995 and ISO 10993-1: 2009:
- -Cytotoxicity 10993-5: 2009
- Sensitization 10993-10: 2010 -
- -Irritation or intracutaneous reactivity 10993-10: 2010
- -Systemic toxicity (acute) 10993-11: 2006

SUMMARY OF CLINICAL TESTS:

Clinical testing was not required to demonstrate the substantial equivalence of the Invia Motion Negative Pressure Wound Therapy System to its predicate device.

CONCLUSION:

The differences between the Invia Motion Negative Pressure Wound Therapy System and its predicate devices do not introduce a new intended use and do not raise new issues 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 nonclinical testing described, Medela AG concludes that the Invia Motion Negative Pressure Wound Therapy System is substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 878.4780 Powered suction pump.

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