(260 days)
No
The device description and performance studies focus on the physical properties and function of a wound dressing foam used in conjunction with NPWT systems, with no mention of AI or ML.
Yes
The device is indicated for promoting wound healing by creating an environment that benefits from a suction device (Negative Pressure Wound Therapy), which includes reducing edema, promoting granulation tissue formation and perfusion, and removing exudate and infectious material. These are all therapeutic effects.
No
The device is a wound dressing (foam) used in negative pressure wound therapy (NPWT) systems. Its intended use is to promote wound healing by creating an environment for closure and removing exudate, not to diagnose a condition.
No
The device description clearly states that the Invia White Foam is a physical, sterile, polyvinyl alcohol (PVA) foam intended for use as a wound dressing. It is a tangible component of a negative pressure wound therapy system, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Invia White Foam is a wound dressing used in conjunction with Negative Pressure Wound Therapy (NPWT) systems. Its function is to create an environment that promotes wound healing by applying suction to the wound bed, removing exudate, and promoting tissue formation.
- Lack of Diagnostic Testing: The description clearly outlines the device's role in wound treatment and management. There is no mention of it being used to analyze samples or provide diagnostic information about a patient's health status.
Therefore, the Invia White Foam is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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 White Foam is appropriate for use for the following wounds:
- Acute or sub-acute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Invia White Foam is a single packed, sterile, polyvinyl alcohol (PVA) foam intended for use in conjunction with the previously cleared Invia Foam Dressing Kit with FitPad (K170088), Invia Motion (K161128) and Invia Liberty (K142626) negative pressure wound therapy (NPWT) systems. It is a stand-alone wound dressing used as an alternative or as a supplement to the wound dressing in the Invia Foam Dressing Kit with FitPad. The Invia White Foam is available in two sizes (small, large). The Invia White Foam is for use by healthcare professionals in acute, extended and home care settings.
The Invia White Foam NPWT is an open cell, hydrophilic, PVA foam moistened in sterile water. Like other NPWT foams, the Invia White Foam NPWT is an effective wound dressing, allowing a controlled application of sub-atmospheric pressure to the local wound environment to remove wound exudate. The Invia White Foam NPWT allows the passage of fluid through the foam and away from the wound bed. The foam can be used with both constant and intermittent NPWT delivery. It is able to be cut to size to suit a particular wound size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (e.g., Acute, sub-acute, chronic, dehisced, pressure ulcers, diabetic/neuropathic ulcers, venous insufficiency ulcers, traumatic, partial thickness burns, flaps and grafts).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional only / 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 following data were provided in support of the substantial equivalence determination:
- Risk Analysis.
- Sterilization information is provided according to the 2016 guidance document. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The Invia White Foam NPWT is gamma sterilized and has been shown to have a shelf life of 2-years.
- Biocompatibility evaluation and testing was completed according to the FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All tests passed demonstrating the biocompatibility of the Invia White Foam for its intended use.
- A Usability Engineering Report was prepared following FDA's 2016 guidance document Applying Human Factors and Usability Engineering to Medical Devices. It concludes that the Invia White Foam NPWT, used in conjunction with the previously cleared Invia Foam Dressing Kits with FitPad components (K170088) has been found to be safe and effective for the intended users, uses and use environments.
- The Invia White Foam was tested to verify its functionality and performance in conjunction with the Invia Foam Dressing Kit with FitPad, the Invia Liberty, and the Invia Motion pumps at the minimal and maximal pressure settings using a wound model. Various worst case scenarios and experimental setting combinations were applied to validate the system performance. The Invia Liberty and the Invia Motion pumps both showed a constant vacuum value within the wound model, with efficient liquid removal discharged through the external suction interface and draining into the canister. In addition, the notification information functionality was found to be in accordance with pump specifications.
- The Invia White Foam was tested to demonstrate equivalent performance to the predicate Genadyne PVA White Foam (K142646). Testing of the Invia White Foam NPWT in conjunction with the Invia Foam Dressing Kit with FitPad, the Invia Liberty and the Invia Motion pumps in comparison to the Genadyne XLR8 pump together with Genadyne's White Polyvinyl Alcohol (PVA) Foam across the specified pressure settings using a wound model was performed. The test results confirm equivalent vacuum performance and suction of fluid in the wound model throughout the entire duration of test when applying the worst case conditions.
SUMMARY OF CLINICAL TESTS:
Clinical testing was not required to demonstrate the substantial equivalence of the Invia White Foam NPWT to its predicate devices.
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.
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.
Not Found
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2018
Medela AG c/o Adrienne Lenz Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005
Re: K180415
Trade/Device Name: Invia White Foam NPWT Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 28, 2018 Received: October 1, 2018
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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Cynthia Chang -S
- for 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) K180415
Device Name Invia White Foam NPWT
Indications for Use (Describe)
The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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 White Foam is appropriate for use for the following wounds:
- Acute or sub-acute 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 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: November 1, 2018
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 R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. T 202-737-4292
SECONDARY CONTACT PERSON:
Judith Bernardo Global RA Director Medela AG
DEVICE:
TRADE NAME: Invia White Foam NPWT COMMON/USUAL NAME: Negative Pressure Wound Therapy Dressing Kit CLASSIFICATION NAMES: 878.4780 Powered Suction Pump REVIEW PANEL: General and Plastic Surgery PRODUCT CODE: OMP
PREDICATE DEVICE(S):
K170088 Medela Invia Foam Dressing Kit with FitPad
K142646 Genadyne XLR8 White Foam Dressing Kit
4
DEVICE DESCRIPTION:
The Invia White Foam is a single packed, sterile, polyvinyl alcohol (PVA) foam intended for use in conjunction with the previously cleared Invia Foam Dressing Kit with FitPad (K170088), Invia Motion (K161128) and Invia Liberty (K142626) negative pressure wound therapy (NPWT) systems. It is a stand-alone wound dressing used as an alternative or as a supplement to the wound dressing in the Invia Foam Dressing Kit with FitPad. The Invia White Foam is available in two sizes (small, large). The Invia White Foam is for use by healthcare professionals in acute, extended and home care settings.
The Invia White Foam NPWT is an open cell, hydrophilic, PVA foam moistened in sterile water. Like other NPWT foams, the Invia White Foam NPWT is an effective wound dressing, allowing a controlled application of sub-atmospheric pressure to the local wound environment to remove wound exudate. The Invia White Foam NPWT allows the passage of fluid through the foam and away from the wound bed. The foam can be used with both constant and intermittent NPWT delivery. It is able to be cut to size to suit a particular wound size.
INTENDED USE:
The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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 White Foam is appropriate for use for the following wounds:
- Acute or sub-acute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
5
TECHNOLOGY:
The proposed Invia White Foam NPWT has similar indications for use and uses the same fundamental technology as the legally marketed predicate devices to which substantial equivalency is claimed, the Invia Foam Dressing Kit with FitPad (K170088) and Genadyne XLR8 White Foam Dressing Kit (K142646).
| Subject Device | Predicate 1 | Predicate 2 | |
|---|---|---|---|
| Invia White Foam NPWT | Invia Foam Dressing Kit with | ||
| FitPad (K170088) | Genadyne XLR8 White Foam | ||
| Dressing Kit (K142646) | |||
| Picture | Image: Invia White Foam NPWT | Image: Invia Foam Dressing Kit with FitPad (K170088) | Image: Genadyne XLR8 White Foam Dressing Kit (K142646) |
| Manufact./Name | Medela AG | Medela AG | Genadyne Biotechnologies |
| Incorporated | |||
| 510(k) Number | - | K170088 | K142646 |
| Product code | OMP | OMP | OMP |
| Indications for | |||
| Use | The Invia White Foam in | ||
| conjunction with the Invia Foam | |||
| Dressing Kits with FitPad, the Invia | |||
| Motion and Invia Liberty Negative | |||
| Pressure Wound Therapy (NPWT) | |||
| systems is indicated for patients who | |||
| would benefit from a suction device | |||
| (Negative Pressure Wound Therapy) | |||
| 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 White Foam is appropriate | |||
| for use for the following wounds: | |||
| • Acute or sub-acute wounds | |||
| • Chronic wounds | |||
| • Dehisced wounds | |||
| • Pressure ulcers | |||
| • Diabetic/neuropathic ulcers | |||
| • Venous insufficiency ulcers | |||
| • Traumatic wounds | |||
| • Partial thickness burns | |||
| • Flaps and grafts | The Invia Foam Dressing Kit with | ||
| FitPad in conjunction with the Invia | |||
| Motion and Invia Liberty | |||
| Negative Pressure Wound Therapy | |||
| (NPWT) systems is indicated for | |||
| patients who would benefit | |||
| from a suction device (Negative | |||
| Pressure Wound Therapy) 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 Foam Dressing Kit with | |||
| FitPad is appropriate for use for the | |||
| following wounds: | |||
| • Acute or sub-acute wounds | |||
| • Chronic wounds | |||
| • Dehisced wounds | |||
| • Pressure ulcers | |||
| • Diabetic/neuropathic ulcers | |||
| • Venous insufficiency ulcers | |||
| • Traumatic wounds | |||
| • Partial thickness burns | |||
| • Flaps and grafts | Genadyne XLR8 White Foam | ||
| Dressing Kit is intended to be used | |||
| in conjunction with the Genadyne | |||
| A4-XLR8 Wound | |||
| Vacuum System (K090638) to | |||
| deliver negative pressure wound | |||
| therapy to the wound. Genadyne A4- | |||
| XLR8 Wound | |||
| Vacuum System is indicated for | |||
| patients who would benefit from a | |||
| suction device particularly as the | |||
| device may promote | |||
| wound healing by the removal of | |||
| excess exudates, infectious material | |||
| and tissue debris. | |||
| XLR8 White Foam Dressing is | |||
| appropriate for use on the following | |||
| wounds: | |||
| • Pressure ulcers | |||
| • Diabetic/Neuropathic Ulcers | |||
| • Venous insufficiency Ulcers | |||
| • Traumatic wounds | |||
| • Post-operative and dehisced | |||
| surgical wounds | |||
| • Skin flap and grafts | |||
| Subject Device | Predicate 1 | Predicate 2 | |
| Invia White Foam NPWT | Invia Foam Dressing Kit with | ||
| FitPad (K170088) | Genadyne XLR8 White Foam | ||
| Dressing Kit (K142646) | |||
| Contraindicati | |||
| ons | Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in 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 | Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in 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 | Unknown |
| Environment | |||
| of Use | acute, extended and home care | ||
| settings | acute, extended and home care | ||
| settings | Hospital, long term care and home | ||
| settings | |||
| User | healthcare professional only | healthcare professional only | healthcare professional only |
| Therapy modes | Constant and intermittent use | Constant and intermittent use | Constant and intermittent use |
| Dimensions | Small 10 cm x 7.5 cm x 1cm | ||
| Large 15 cm x 10 cm x 1 cm | Small 10 cm x 8 cm x 3 cm | ||
| Medium 19 cm x 12.5 cm x 3 cm | |||
| Large 25 cm x 15 cm x 3 cm | |||
| X Large 60 cm x 30 cm x 1.5 cm | Small 10 cm x 7.5 cm x 1cm | ||
| Medium 15 cm x 10 cm x 1 cm | |||
| Large 20 cm x 15 cm x 1 cm | |||
| Operating | |||
| Ambient | |||
| Temperatures | +5 - +40 °C | +5 - +40 °C | Unknown |
| Operating | |||
| Ambient | |||
| Humidity | 15 - 93% | 15 - 93% | Unknown |
| Operating | |||
| Pressure | 70 - 106 kPa | 70 - 106 kPa | Unknown |
| Storage | |||
| Ambient | |||
| Temperatures | -20 - +50°C | -20 - +50°C | Unknown |
| Storage | |||
| Ambient | |||
| Humidity | 15 - 93% | 15 - 93% | Unknown |
| Storage | |||
| Pressure | 70 - 106 kPa | 70 - 106 kPa | Unknown |
| Packaging | |||
| Type | Aluminium foil | ||
| packed moistened with sterile water | Tyvec/Foil pouch | ||
| packed dry | Aluminium foil | ||
| packed moistened with sterile water | |||
| Sterile | Yes | Yes | Yes |
| Sterilization | |||
| Method | Gamma radiation | Ethylene oxide | Gamma radiation |
| Vacuum | |||
| therapy range | -40 - -200mmHg | -40 - -200mmHg | -40 - -230mmHg |
| Principles of | |||
| operation | Open cell foam, hydrophilic, pore | ||
| size 900 - 1200 microns, stronger | |||
| tensile strength than PU foam | Open cell foam, hydrophobic, pore | ||
| size 600-800 microns | Hydrophilic, stronger tensile strength | ||
| than PU foam | |||
| Foam Material | Polyvinyl alcohol foam | Polyurethane foam | Polyvinyl alcohol foam |
| Subject Device | Predicate 1 | Predicate 2 | |
| Invia White Foam NPWT | Invia Foam Dressing Kit with | ||
| FitPad (K170088) | Genadyne XLR8 White Foam | ||
| Dressing Kit (K142646) | |||
| Features | White, Open cell foam, softer than | ||
| PU foam, decreased in-growth of | |||
| granulation, , high tensile strength |
150 kPa than PU foam, | Charcoal black, open cell foam | White, Open cell foam, softer than
PU foam, decreased in-growth of
granulation,, high tensile strength
150 kPa than PU foam, |
6
Medela AG, Invia White Foam Dressing
7
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF NON-CLINICAL TESTS:
The following data were provided in support of the substantial equivalence determination:
- Risk Analysis. ●
- Sterilization information is provided according to the 2016 guidance document . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The Invia White Foam NPWT is gamma sterilized and has been shown to have a shelf life of 2-years
- . Biocompatibility evaluation and testing was completed according to the FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All tests passed demonstrating the biocompatibility of the Invia White Foam for its intended use.
- A Usability Engineering Report was prepared following FDA's 2016 guidance . document Applying Human Factors and Usability Engineering to Medical Devices. It concludes that the Invia White Foam NPWT, used in conjunction with the previously cleared Invia Foam Dressing Kits with FitPad components (K170088) has been found to be safe and effective for the intended users, uses and use environments.
- The Invia White Foam was tested to verify its functionality and performance in . conjunction with the Invia Foam Dressing Kit with FitPad, the Invia Liberty, and the Invia Motion pumps at the minimal and maximal pressure settings using a wound model. Various worst case scenarios and experimental setting combinations were applied to validate the system performance. The Invia Liberty and the Invia Motion pumps both showed a constant vacuum value within the wound model, with efficient liquid removal discharged through the external suction interface and draining into the canister. In addition, the notification information functionality was found to be in accordance with pump specifications.
- The Invia White Foam was tested to demonstrate equivalent performance to the ● predicate Genadyne PVA White Foam (K142646). Testing of the Invia White Foam NPWT in conjunction with the Invia Foam Dressing Kit with FitPad, the Invia Liberty and the Invia Motion pumps in comparison to the Genadyne XLR8
8
pump together with Genadyne's White Polyvinyl Alcohol (PVA) Foam across the specified pressure settings using a wound model was performed. The test results confirm equivalent vacuum performance and suction of fluid in the wound model throughout the entire duration of test when applying the worst case conditions.
SUMMARY OF CLINICAL TESTS:
Clinical testing was not required to demonstrate the substantial equivalence of the Invia White Foam NPWT to its predicate devices.
CONCLUSION:
Medela AG considers the Invia White Foam NPWT to be substantially equivalent to the predicate devices.