(208 days)
Not Found
No
The document describes a standard negative pressure wound therapy pump with adjustable pressure and different modes. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to promote wound healing, which is a therapeutic effect, by preparing the wound bed, reducing edema, promoting granulation tissue formation, and removing exudates and infectious material.
No
The device is described as a suction pump for wound healing by promoting granulation tissue formation and removing exudates, not for diagnosing conditions.
No
The device description explicitly details a physical pump, canisters, tubing, and other hardware components, indicating it is not solely software.
Based on the provided text, the Invia Ease Negative Pressure Wound Therapy (NPWT) system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device that applies negative pressure to wounds to promote healing. This is a physical therapy applied directly to the patient's body.
- Device Description: The device is described as a "suction pump" and its components are related to applying and managing negative pressure on a wound. There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or methods for analyzing biological specimens.
In Vitro Diagnostic devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Invia Ease NPWT system operates externally on the wound itself.
N/A
Intended Use / 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.
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
Product codes
OMP
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.
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
Adult - multiple patient
Intended User / Care Setting
Acute, extended and home care 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:
The Invia Ease NPWT System complies with voluntary standards for sterilization, biocompatibility, electrical safety, electromagnetic compatibility, use in acute, extended and home care settings and usability. The following performance data are provided in support of the substantial equivalence determination:
- Risk analysis in accordance with ISO 14971: 2019, Medical Devices - Application of Risk Management to Medical Devices.
- Testing in accordance with the following standards and regulations:
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and O A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General requirements for Basic Safety and Essential Performance.
- IEC 60601-1-6; 2013 Medical electrical equipment Part 1-6: General o requirements for basic safety and essential performance - Collateral standard: Usability
- Medical electrical equipment Part 1-8: General IEC 60601-1-8: 2020 о requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-11:2015, Medical Electrical Equipment Part 1-11: General o requirements for Basic Safety and Essential Performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014 (Edition 4.0), Medical electrical equipment Part 1-2: General o requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- AIM Standard 7351731 Rev. 2.00 2017-02-23, Medical Electrical Equipment and o System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- ANSI IEEE C63.27-2017, American National Standard for Evaluation of Wireless o Coexistence
- IEC 62133-2 Edition 1.0 2017-02. Secondary cells and batteries containing alkaline о or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- ISO 10079-1 Third Edition 2015-11-01, Medical suction equipment Part 1: o Electrically powered suction equipment [Including: Amendment 1 (2018)]
- FCC, 47 C.F.R. Part 15 Subparts B and C o
- Sterilization and shelf-life information in accordance with the FDA Guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- A biocompatibility evaluation was completed according to the FDA Guidance document Use . of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and draft guidance document Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.
The subject device was evaluated for cytotoxicity, intracutaneous reactivity, skin sensitization. - The software/firmware verification and validation were provided in accordance with the FDA Guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for the subject devices was considered as a "Moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain. Additionally, a cybersecurity evaluation was performed according to the FDA Guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- The usability testing was conducted to validate the use in acute, extended and home care settings in accordance with the recommendations of the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices
- Bench testing was conducted to check that specifications were met under conditions of . Intermittent as well as Constant therapy modes with power supplied from both the internal battery and external AC/DC power adaptor and with each compatible dressing kit.
List of bench testing performed:
Performance Test of Invia Ease with all Medela AG cleared dressing kits
Vacuum Performance Test (with leak)
Noise Test
Pump Endurance Test
Pump Tightness Test
IP Protection - IP22 Test
Filter Test
Battery Run time Test
Display Stability Test
Transport Validation Invia Ease Pump & Accessories
Summary of Clinical Tests:
Clinical testing was not needed to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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 | Similar |
| Electrical
Safety | Meets IEC 60601-1 Standard | Meets IEC 60601-1 Standard | Same |
| Electromagnetic
Compatibility | Meets IEC 6060-1-2 Standard | Meets IEC 6060-1-2 Standard | Same |
| Electrical
Insulation
Class | Class II (double insulated) | Class II (double insulated) | Same |
| Compatible
Dressings | Invia Foam Dressing Kit with FitPad
s/m/l/xl (3 pcs) (087.6221/22/23/24)
s/m/l (15 pcs) (087.6225/26/27)
Invia Gauze Dressing Kit with FitPad
med/large (3 pcs) (087.7170/71)
med (15 pcs) (087.7172)
Invia FitPad (sterile) (087.0028)
Invia Transparent Film (087.0030)
Invia Abdominal Dressing Kit (087.6250)
Invia Silverlon NPWT
Antimicrobial Wound Contact Dressing,
10 x 12 cm (US) (087.7001)
12 x 20 cm (US) (087.7002)
Invia White Foam NPWT, PVA foam dressing
small (087.6303)
large (087.6304) | Invia Foam Dressing Kit with FitPad
s/m/l/xl (3 pcs) (087.6221/22/23/24)
s/m/l (15 pcs) (087.6225/26/27)
Invia Gauze Dressing Kit with FitPad
med/large (3 pcs) (087.7170/71)
med (15 pcs) (087.7172)
Invia FitPad (sterile) (087.0028)
Invia Transparent Film (087.0030)
Invia Abdominal Dressing Kit (087.6250)
Invia Silverlon NPWT
Antimicrobial Wound Contact Dressing,
10 x 12 cm (US) (087.7001)
12 x 20 cm (US) (087.7002)
Invia White Foam NPWT, PVA foam dressing
small (087.6303)
large (087.6304) | Same |
6
7
8
9
10
Summary of Non-Clinical Tests
The Invia Ease NPWT System complies with voluntary standards for sterilization, biocompatibility, electrical safety, electromagnetic compatibility, use in acute, extended and home care settings and usability. The following performance data are provided in support of the substantial equivalence determination:
- Risk analysis in accordance with ISO 14971: 2019, Medical Devices - Application of Risk Management to Medical Devices.
- Testing in accordance with the following standards and regulations: ●
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and O A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General requirements for Basic Safety and Essential Performance.
- IEC 60601-1-6; 2013 Medical electrical equipment Part 1-6: General o requirements for basic safety and essential performance - Collateral standard: Usability
- Medical electrical equipment Part 1-8: General IEC 60601-1-8: 2020 о requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-11:2015, Medical Electrical Equipment Part 1-11: General o requirements for Basic Safety and Essential Performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014 (Edition 4.0), Medical electrical equipment Part 1-2: General o requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- AIM Standard 7351731 Rev. 2.00 2017-02-23, Medical Electrical Equipment and o System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- ANSI IEEE C63.27-2017, American National Standard for Evaluation of Wireless o Coexistence
- IEC 62133-2 Edition 1.0 2017-02. Secondary cells and batteries containing alkaline о or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- ISO 10079-1 Third Edition 2015-11-01, Medical suction equipment Part 1: o Electrically powered suction equipment [Including: Amendment 1 (2018)]
- FCC, 47 C.F.R. Part 15 Subparts B and C o
- Sterilization and shelf-life information in accordance with the FDA Guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- A biocompatibility evaluation was completed according to the FDA Guidance document Use . of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and draft guidance document Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.
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| Component | Biocompatibility Test | ISO Standard |
|---|---|---|
| Canister | Cytotoxicity | ISO 10993-5 |
| Canister | Intracutaneous reactivity | ISO 10993-10 |
| Canister | Sensitization | ISO 10993-10 |
| Tubing | Cytotoxicity | ISO 10993-5 |
| Tubing | Intracutaneous reactivity | ISO 10993-10 |
| Tubing | Sensitization | ISO 10993-10 |
The subject device was evaluated for cytotoxicity, intracutaneous reactivity, skin sensitization:
- The software/firmware verification and validation were provided in accordance with the FDA Guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for the subject devices was considered as a "Moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain. Additionally, a cybersecurity evaluation was performed according to the FDA Guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- . The usability testing was conducted to validate the use in acute, extended and home care settings in accordance with the recommendations of the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices
- Bench testing was conducted to check that specifications were met under conditions of . Intermittent as well as Constant therapy modes with power supplied from both the internal battery and external AC/DC power adaptor and with each compatible dressing kit.
| List of bench testing performed |
|---|
| Performance Test of Invia Ease with all Medela AG cleared dressing kits |
| Vacuum Performance Test (with leak) |
| Noise Test |
| Pump Endurance Test |
| Pump Tightness Test |
| IP Protection - IP22 Test |
| Filter Test |
| Battery Run time Test |
| Display Stability Test |
| Transport Validation Invia Ease Pump & Accessories |
Summary of Clinical Tests
Clinical testing was not needed to support substantial equivalence.
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Conclusions
The tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device in terms of safety and effectiveness.