K Number

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

Manufacturer

Medela AG

Date Cleared

2016-12-01

(224 days)

Product Code

OMP

Regulation Number

878.4780

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113678, K141926

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard medical device components and functionalities like pumps, canisters, power supplies, and user interfaces. There is no mention of AI, ML, image processing, or data analysis beyond basic device operation and safety monitoring. The performance studies described are standard engineering and biological tests, not AI/ML model validation.

Therapeutic

Yes.

The device promotes wound healing by secondary or tertiary intention, reduces edema, promotes granulation tissue formation and perfusion, and removes exudate and infectious material, which are all therapeutic actions.

Diagnostic

The device is a Negative Pressure Wound Therapy (NPWT) system, which is a therapeutic device used to promote wound healing by removing exudate and infectious material, reducing edema, and promoting granulation tissue formation. Its intended use focuses on treatment rather than diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is comprised of a pump, canister/tubing set, power supply, and carrying case, which are all hardware components. The summary also details extensive hardware testing (electrical safety, performance, sterilization, biocompatibility, etc.).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes a device that applies negative pressure to a wound to promote healing. This is a physical therapy applied directly to the patient's body.
Device Description: The device is a pump system designed to create and maintain negative pressure. It collects exudate and infectious material, but it does not analyze biological samples in vitro (outside the body) to provide diagnostic information.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) for diagnostic purposes. The device's function is therapeutic, not diagnostic.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes

OMP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults

Intended User / Care Setting

Hospitals, Clinics, Long Term Care (LTC) and Home Care (HC) settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Tests:

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 (2nd edition) standard.
Usability testing: Evaluated according to IEC 60601-1-6: 2013 (3rd 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: 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.
Leakage notification tests: Performed using a wound model and simulated wound exudates. The test results confirm the blockage and leakage notification signals behave correctly.
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.
Sterilization process validation: For the Invia Motion canister/tubing, validated according to ISO 11135-1:2007 including Annex A (Biological Indicators) and B (Overkill Approach). Validation was carried out by specific cycles (Product Profile, Sub-lethal Cycle, Half cycle, Routine Cycles).
Accelerated aging tests: Performed to support a 5-year shelf life of the canister/tubing set via ASTM F1980-07.
Biocompatibility Testing: Performed according to ISO 10993-1: 2009 at NAMSA, an accredited testing laboratory, according to GLP requirements. The Canister/Tubing set was tested for Cytotoxicity (10993-5: 2009), Sensitization (10993-10: 2010), Irritation or intracutaneous reactivity (10993-10: 2010), and 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K113678, K141926

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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 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

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

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.

	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
Type	BF	BF	BF
Operating
Ambient
Temperatures	+5...+40°C	+5...+40°C	+5...+40°C
Operating
Ambient
Humidity	15...93% R.L.	15...93% R.L.	15...93% R.L.
Canister
capacity [ml]	150ml	150ml	150ml
Weight [kg]	0.45kg	0.45kg	0.47 - 0.48kg
Dimensions
mm	173x96x51mm (0.15l
canister)	173x96x51mm (0.15l
canister)	176x97x52mm (0.15l
canister)
Standard
Safety 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 and
sold separately	Multiple available and
sold separately	Multiple available and
sold separately
510(k)
clearance for
NPWT Kits	K113678 for Invia kits
K122132 for Avance kits	K113678 for Invia kits
K122132 for Avance kits	K113678 for Invia gauze
kits
K151261 Invia Foam
Dressing Kit with ESI

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.

. 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.