(156 days)
No
The document describes a standard negative pressure wound therapy system with acoustic and optical alarms for variances and faults. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, prediction, or decision-making. The performance studies focus on electrical safety and compatibility, not algorithmic performance.
Yes
The device is intended to create an environment that promotes wound healing by secondary or tertiary intention, preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and removing exudates and infectious material, which are all therapeutic actions.
No
Explanation: The device creates an environment to promote wound healing by removing exudates and infectious material, not diagnose conditions. Its intended use focuses on therapy, not diagnosis.
No
The device description explicitly states that the system is comprised of a physical pump, canister/tubing set, power supply, and other hardware components, in addition to software.
Based on the provided information, the Medela Invia Endure Negative Pressure Wound Therapy (NPWT) system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Medela Invia Endure NPWT system is a therapeutic device. It applies negative pressure directly to a wound on the patient's body to promote healing. It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly describes a therapeutic application for wound healing, not diagnostic testing.
Therefore, the Medela Invia Endure NPWT system falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The portable Medela Invia Endure Nessure 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 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, neuropethic, pressure or venous insufficiency), flaps and grafts.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Medela Invia Endure Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Endure NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Endure is also compatible with separately cleared Avance NPWT kits manufactured by Mölnlyke Healthcare (K122132).
The Invia Endure 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 Endure NPWT pump is intended for a single patient's entire therapy for continuous or intermittent operation. It has lifetime of at least three years.
The Invia Endure NPWT system is intended for use 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 Endure 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
adult patients
Intended User / Care Setting
hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients / medical personnel or trained lay users adhering to the instructions for use.
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 Endure 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
- . 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 60601-1-10 standard ●
SUMMARY OF CLINICAL TESTS:
The Invia Endure has not been the subject of clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113678 Medela Invia Motion Negative Pressure Wound Therapy System, K080357 Medela Invia Wound Therapy
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Medela AG Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman, Wisconsin 53118
Re: K141926
Trade/Device Name: Invia Endure Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 14, 2014 Received: November 17, 2014
Dear Ms. 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
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.
Sincerely yours,
Binita SDAshar -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
Invia Endure Negative Pressure Wound Therapy System
Indications for Use (Describe)
The portable Medela Invia Endure Nessure 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 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, neuropethic, pressure or venous insufficiency), 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Medela AG Invia Endure Negative Pressure Wound Therapy System
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: December 18, 2014
SUBMITTER:
Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 561 66 71 Fax +41 (0)41 561 51 00
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC Phone 262-290-0023
SECONDARY CONTACT PERSON:
Orlando Antunes Vice President Regulatory Affairs Medela AG
DEVICE:
TRADE NAME: Invia Endure
COMMON/USUAL NAME: Negative Pressure Wound Therapy System
CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump
PRODUCT CODE: OMP
PREDICATE DEVICE(S):
K080357 Medela Invia Wound Therapy
K113678 Medela Invia Motion Negative Pressure Wound Therapy System (Primary predicate)
4
Medela AG Invia Endure Negative Pressure Wound Therapy System
DEVICE DESCRIPTION:
The Medela Invia Endure Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Endure NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Endure is also compatible with separately cleared Avance NPWT kits manufactured by Mölnlyke Healthcare (K122132).
The Invia Endure 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 Endure NPWT pump is intended for a single patient's entire therapy for continuous or intermittent operation. It has lifetime of at least three years.
The Invia Endure NPWT system is intended for use 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 Endure NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.
INTENDED 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, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropethic, pressure or venous insufficiency), flaps and grafts.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Invia Endure NPWT System uses the same fundamental technology as the Invia Motion for most features. The Invia Endure is identical to the Invia Motion in its indications for use and contraindications. The user interface, device hardware and accessories are also identical. The main difference is that Invia Endure does not include a 60 day lifetime. In this respect the Invia Endure NPWT System functions in the same manner as the Invia Wound Therapy predicate device, which also does not have a lifetime timer. The difference in lifetime between Invia Endure and Invia Motion is implemented in the system firmware.
5
Medela AG
Invia Endure Negative Pressure Wound Therapy System
SUMMARY OF NON-CLINICAL TESTS:
The Invia Endure 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
- . 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 60601-1-10 standard ●
SUMMARY OF CLINICAL TESTS:
The Invia Endure has not been the subject of clinical testing.
CONCLUSION:
The differences between the Invia Endure 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 Endure Negative Pressure Wound Therapy System is substantially equivalent to the legally marketed predicate device.