(269 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard pump functionality and safety features.
Yes
The device is indicated to help promote wound healing through drainage and removal of materials under negative pressure, which directly treats a medical condition.
No
The device is designed to promote wound healing by applying negative pressure to remove fluids and infectious material. It is a therapeutic device, not a diagnostic one, as it does not diagnose medical conditions.
No
The device description explicitly states that the system is comprised of a pump, canister/tubing set, power supply, carrying case, and kits, in addition to instructions. It also mentions hardware integration testing and electrical safety testing, indicating the presence of physical hardware components.
Based on the provided information, the Medela® Invia Liberty Negative Pressure Wound Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a therapy applied directly to a wound on a patient's body to promote healing by removing fluids and infectious material. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a suction pump and associated components designed to apply negative pressure to a wound. This aligns with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical/physical in its application to the wound.
In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Medela Invia Liberty system does not fit this definition.
N/A
Intended Use / Indications for Use
The Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product codes
OMP
Device Description
The Medela Invia Liberty Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Liberty NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Liberty is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare.
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Liberty NPWT pump provides continuous or intermittent operation.
The Invia Liberty NPWT system may be used in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity. The Invia Liberty NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.
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
Home or other health care facility by medical personnel or trained lay users.
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)
The Invia Liberty Negative Pressure Wound Therapy System has not been the subject of clinical testing.
Non-clinical tests performed:
- Risk Analysis
- Software Validation
- Hardware Integration Testing
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards, respectively
- Safety testing for use in the home per IEC 60601-1-11 standard
- Usability evaluation per the IEC 60601-1-6 and IEC 62366 Standards.
- Performance Testing demonstrating the functionality of the Invia Liberty pump in combination with the Medela Invia Gauze Kits and Avance Foam Kits. Testing with the gauze kits included use of the double lumen tubing and drain adaptor and testing of the foam kits also used with double lumen tubing with the Avance ViewPad.
- Testing of the quick connector demonstrating adequate tightness and tear-out force.
- Biocompatibility testing, including cytotoxicity, sensitization, irritation.
- Validation of cleaning methods for the reusable pump housing.
- Sterilization validation and confirmation of shelf life for the sterile tubing, Y-connector and drain adapter.
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/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" around the edge. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Medela AG % Ms. Adrienne Lenz Pathways Regulatory Consulting, LLC W324 S3649 County Road East Dousman, Wisconsin 53118
Re: K142626
Trade/Device Name: Invia Liberty Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: May 11, 2015 Received: May 12, 2015
Dear Ms. 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
1
device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142626
Device Name
Invia Liberty Negative Pressure Wound Therapy System
Indications for Use (Describe)
The Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
| 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
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: June 11, 2015
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:
Orlando Atunes Vice President Regulatory Affairs Medela AG
DEVICE:
TRADE NAME: Invia Liberty Negative Pressure Wound Therapy System
COMMON/USUAL NAME: Negative Pressure Wound Therapy Pump and Accessories
CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump
PRODUCT CODE: OMP
PREDICATE DEVICE(S):
K080357 Invia Wound Therapy
4
DEVICE DESCRIPTION:
The Medela Invia Liberty Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Liberty NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Liberty is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare.
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Liberty NPWT pump provides continuous or intermittent operation.
The Invia Liberty NPWT system may be used in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity. The Invia Liberty NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.
INTENDED USE:
The Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partialthickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Invia Liberty NPWT System uses the same fundamental technology as Invia Wound Therapy (K080357) for most features. The Invia Liberty NPWT System is identical to the Invia Wound Therapy in its indications for use and contraindications. The main differences between the Invia Liberty NPWT System and the predicate Invia Wound Therapy are:
- New double lumen pump tubing with 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 will ensure that the connection is easy to connect / disconnect and tight.
- . New Drain Adapter to connect quick connect tubing to drains
- New Y-Connector for quick connect compatibility
- Firmware change, including improved flush algorithm
- Housing material change to ABS to improve the stability and cleanability
- Additional IFU for patient in home care environment
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The table below summarizes the key specifications of the Invia Liberty NPWT System and the predicate devices.
| | Invia Liberty Negative
Pressure Wound
Therapy System | Invia Wound Therapy
(K080357) | Discussion |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient
Population | Adults | Adults | Identical. Pumps are
reusable and should be
cleaned and
disinfected between
patients. |
| Useful Life | 4000 hours | 4000 hours | Identical |
| Environment of
Use | Hospital and Home | Hospital and Home | Identical |
| User Interface | Five button keypad
(power and arrow keys
to navigate menus),
LCD Display, audio
indicators. | Five button keypad
(power and arrow keys
to navigate menus),
LCD Display, audio
indicators. | Identical |
| Accessories | • Disposable Canister
0.8 l, 0.3 l
• Quick connect
double lumen tubing
set
• Drain Adapter
• Y-connector
• Mains adapter
• Docking station
• Carrying Case
• Holder with
standard rail
• NPWT kits sold
separately | • Disposable Canister
0.8 l, 0.3 l
• Tubing set
• Y-connector
• Mains adapter
• Docking station
• Carrying Case
• Holder with
standard rail
• NPWT kits sold
separately | Equivalent. The tubing
set is modified with a
double lumen and
Quick Connector
coupling between the
pump tubing and the
drain adapter, which
now connects to the
Dressing Kits. All other
accessories are
identical. |
| Specifications | | | |
| Suction capacity
l/min | 5 l/min | 5 l/min | Identical |
| | Invia Liberty Negative
Pressure Wound
Therapy System | Invia Wound Therapy
(K080357) | Discussion |
| Max. vacuum
mmHg/kPa | - 200mmHg
-27kPa | - 200mmHg
-27kPa | Identical |
| Min. vacuum
mmHg/kPa | - 40mmHg
-5.3kPa | - 60mmHg
-8kPa | Equivalent. Minimum
vacuum level changed
to -40mmHg to enable
therapy for sensitive
wounds (i.e. burns) |
| Therapy modes | Continuous &
Intermittent | Continuous &
Intermittent | Identical |
| Canister capacity
[ml] | 300/800ml | 300/800ml | Identical |
| Weight [kg] | 1.0kg | 1.0kg | Identical |
| Dimensions
mm | 290x95x235mm
(0.3l canister) | 290x95x235mm
(0.31 canister) | Identical |
| Standard Safety
device | Bacteria / overflow /
protection filter | Bacteria / overflow /
protection filter | Identical |
| NPWT Kits | Multiple available
including the following | Multiple available
including the following | |
| Dressing (to pack
the wound) | Kerlix AMD Gauze or
Molnlyke foam | Kerlix AMD Gauze | Equivalent. Gauze Kits
used with Invia Liberty
and Invia Motion
pumps are cleared in
K113678. Molnlycke
foam kits are cleared in
K141847. |
| Sterile Saline | Winchester
Laboratories Sodium
Chloride 0.9%w/v | Winchester
Laboratories Sodium
Chloride 0.9%w/v | Identical |
| No sting barrier
film | 3M Cavilon No Sting
Barrier Film | 3M Cavilon No Sting
Barrier Film | Identical |
| | Invia Liberty Negative
Pressure Wound
Therapy System | Invia Wound Therapy
(K080357) | Discussion |
| Contact layer | 3M Tegaderm Contact
(OEM labeled) | 3M Tegaderm Contact
(Medela labeled) | Equivalent. Only the
labeling has changed.
The kits now include
original 3M labeling. |
| Dressing to seal
the wound | 3M Tegaderm Film
(OEM labeled) | 3M Tegaderm Film
(Medela labeled) | Equivalent. Only the
labeling has changed.
The kits now include
original 3M labeling. |
| Additional drain
seal material | Coloplast Stoma Paste | NA | Equivalent. The
Coloplast Stoma Paste
is used to fill crevices
or uneven surfaces to
improve seal in difficult
to dress areas. |
| Tape | HyTape | HyTape | Identical |
| Drains | Round channel (15 Fr),
Flat (10 mm), External
Suction Interface (ESI) | Round channel (15 Fr),
Flat (10 mm) | Equivalent. Drains,
including ESI, are
cleared via K113678 for
use with Invia Motion
and Invia Liberty
pumps. Selection of
drain is made by the
health care provider. |
6
7
SUMMARY OF NON-CLINICAL TESTS:
The Invia Liberty Negative Pressure Wound Therapy System complies with voluntary standards for electrical safety, electromagnetic compatibility, and safety of home use devices. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Software Validation ●
- Hardware Integration Testing
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC ● 60601-1-2 standards, respectively
8
- Safety testing for use in the home per IEC 60601-1-11 standard
- Usability evaluation per the IEC 60601-1-6 and IEC 62366 Standards.
- 0 Performance Testing demonstrating the functionality of the Invia Liberty pump in combination with the Medela Invia Gauze Kits and Avance Foam Kits. Testing with the gauze kits included use of the double lumen tubing and drain adaptor and testing of the foam kits also used with double lumen tubing with the Avance ViewPad.
- Testing of the quick connector demonstrating adequate tightness and tear-out force.
- Biocompatibility testing, including cytotoxicity, sensitization, irritation.
- Validation of cleaning methods for the reusable pump housing.
- Sterilization validation and confirmation of shelf life for the sterile tubing, Y-connector and drain adapter.
SUMMARY OF CLINICAL TESTS:
The Invia Liberty Negative Pressure Wound Therapy System has not been the subject of clinical testing.
CONCLUSION:
Medela AG considers the Invia Liberty Negative Pressure Wound Therapy System to be as safe as, as effective as, and substantially equivalent to the predicate devices.