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

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.

AI/ML Overview

This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "Invia White Foam NPWT". It outlines the device's characteristics, intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required.

Therefore, many of the requested details about acceptance criteria, study sample size, expert involvement, and ground truth establishment for a human-AI comparative study or standalone algorithm performance are not applicable to this document. This submission did not involve a study for an AI-powered diagnostic device, but rather a negative pressure wound therapy (NPWT) foam.

However, I can extract the information related to the acceptance criteria and performance of this non-AI device from the "Summary of Non-Clinical Tests" section.

Here's a breakdown of the requested information, indicating where it's not applicable (N/A) for this specific FDA submission:

1. A table of acceptance criteria and the reported device performance

Based on the "SUMMARY OF NON-CLINICAL TESTS" section, the device's performance was evaluated against established standards and predicate device performance.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Risk Management	Device risk analysis completed and acceptable.	Risk Analysis performed. (Explicitly stated)
Sterility & Shelf Life	Sterilization information compliant with 2016 guidance; demonstrated sterility and a 2-year shelf life.	Sterilization information provided according to 2016 guidance, Invia White Foam NPWT is gamma sterilized and has been shown to have a shelf life of 2-years. (Explicitly stated)
Biocompatibility	Biocompatibility evaluation and testing completed according to ISO-10993 Part 1; direct contact with the tissue is considered safe for the intended use.	Biocompatibility evaluation and testing completed according to 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. (Explicitly stated)
Usability/Human Factors	Usability Engineering Report prepared following FDA's 2016 guidance; device found to be safe and effective for intended users, uses, and environments when used with cleared components.	A Usability Engineering Report was prepared following FDA's 2016 guidance. 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. (Explicitly stated)
Functional Performance (Fluid Removal)	Functionality and performance in conjunction with Invia Foam Dressing Kit, Invia Liberty, and Invia Motion pumps across minimal and maximal pressure settings in a wound model, under various worst-case scenarios and experimental settings. This includes constant vacuum value, efficient liquid removal, and proper notification functionality.	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. (Explicitly stated)
Equivalence to Predicate (PVA Foam)	Equivalent performance to the predicate Genadyne PVA White Foam (K142646) in terms of vacuum performance and suction of fluid in a wound model across specified pressure settings, under worst-case conditions.	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. (Explicitly stated)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This refers to the number of physical devices or samples tested in the non-clinical studies (e.g., how many foam samples for biocompatibility, how many units for sterilization testing, how many test runs in the wound model). The document does not specify the exact number of samples tested for each non-clinical evaluation (e.g., "The Invia White Foam was tested..." rather than "100 samples of the Invia White Foam were tested...").
Data Provenance: The document does not specify the country of origin for the data or whether the non-clinical studies were prospective or retrospective. These types of studies are inherently prospective as they involve conducting new tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This device is a negative pressure wound therapy foam, not an AI-powered diagnostic device that requires expert review for "ground truth" establishment in a clinical setting. The "ground truth" for its performance is based on engineering and materials science principles and direct measurement of physical properties (e.g., pressure, fluid removal).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. As above, this is not an AI diagnostic study requiring multi-reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI diagnostic device. No human-in-the-loop studies or MRMC studies were conducted. The non-clinical studies focused on the performance of the device itself and its equivalence to predicate devices, not on human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI algorithm. Its "standalone performance" refers to its physical and functional properties, as described in the table above, not an algorithmic output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established by:

Adherence to recognized standards (e.g., ISO-10993 for biocompatibility).
Direct measurement against physical and functional specifications (e.g., achieving constant vacuum, efficient fluid removal).
Comparative performance against a legally marketed predicate device in a wound model.

8. The sample size for the training set

N/A. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

N/A. As above, this is not an AI device, so there is no training set or ground truth establishment in that context.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K180415

Device Name Invia White Foam NPWT

Indications for Use (Describe)

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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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

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DEVICE DESCRIPTION:

INTENDED USE:

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

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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 withFitPad (K170088)	Genadyne XLR8 White FoamDressing 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 BiotechnologiesIncorporated
510(k) Number	-	K170088	K142646
Product code	OMP	OMP	OMP
Indications forUse	The Invia White Foam inconjunction with the Invia FoamDressing Kits with FitPad, the InviaMotion and Invia Liberty NegativePressure Wound Therapy (NPWT)systems is indicated for patients whowould benefit from a suction device(Negative Pressure Wound Therapy)as it creates an environment thatpromotes wound healing bysecondary or tertiary (delayedprimary) intention by preparing thewound bed for closure, reducingedema, promoting granulation tissueformation and perfusion, and byremoving exudate and infectiousmaterial.The Invia White Foam is appropriatefor 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 withFitPad in conjunction with the InviaMotion and Invia LibertyNegative Pressure Wound Therapy(NPWT) systems is indicated forpatients who would benefitfrom a suction device (NegativePressure Wound Therapy) as itcreates an environment thatpromotes wound healing bysecondary or tertiary (delayedprimary) intention by preparing thewound bed for closure, reducingedema, promoting granulation tissueformation and perfusion, and byremoving exudate and infectiousmaterial.The Invia Foam Dressing Kit withFitPad is appropriate for use for thefollowing 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 FoamDressing Kit is intended to be usedin conjunction with the GenadyneA4-XLR8 WoundVacuum System (K090638) todeliver negative pressure woundtherapy to the wound. Genadyne A4-XLR8 WoundVacuum System is indicated forpatients who would benefit from asuction device particularly as thedevice may promotewound healing by the removal ofexcess exudates, infectious materialand tissue debris.XLR8 White Foam Dressing isappropriate for use on the followingwounds:• Pressure ulcers• Diabetic/Neuropathic Ulcers• Venous insufficiency Ulcers• Traumatic wounds• Post-operative and dehiscedsurgical wounds• Skin flap and grafts
	Subject Device	Predicate 1	Predicate 2
	Invia White Foam NPWT	Invia Foam Dressing Kit withFitPad (K170088)	Genadyne XLR8 White FoamDressing Kit (K142646)
Contraindications	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
Environmentof Use	acute, extended and home caresettings	acute, extended and home caresettings	Hospital, long term care and homesettings
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 1cmLarge 15 cm x 10 cm x 1 cm	Small 10 cm x 8 cm x 3 cmMedium 19 cm x 12.5 cm x 3 cmLarge 25 cm x 15 cm x 3 cmX Large 60 cm x 30 cm x 1.5 cm	Small 10 cm x 7.5 cm x 1cmMedium 15 cm x 10 cm x 1 cmLarge 20 cm x 15 cm x 1 cm
OperatingAmbientTemperatures	+5 - +40 °C	+5 - +40 °C	Unknown
OperatingAmbientHumidity	15 - 93%	15 - 93%	Unknown
OperatingPressure	70 - 106 kPa	70 - 106 kPa	Unknown
StorageAmbientTemperatures	-20 - +50°C	-20 - +50°C	Unknown
StorageAmbientHumidity	15 - 93%	15 - 93%	Unknown
StoragePressure	70 - 106 kPa	70 - 106 kPa	Unknown
PackagingType	Aluminium foilpacked moistened with sterile water	Tyvec/Foil pouchpacked dry	Aluminium foilpacked moistened with sterile water
Sterile	Yes	Yes	Yes
SterilizationMethod	Gamma radiation	Ethylene oxide	Gamma radiation
Vacuumtherapy range	-40 - -200mmHg	-40 - -200mmHg	-40 - -230mmHg
Principles ofoperation	Open cell foam, hydrophilic, poresize 900 - 1200 microns, strongertensile strength than PU foam	Open cell foam, hydrophobic, poresize 600-800 microns	Hydrophilic, stronger tensile strengththan 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 withFitPad (K170088)	Genadyne XLR8 White FoamDressing Kit (K142646)
Features	White, Open cell foam, softer thanPU foam, decreased in-growth ofgranulation, , high tensile strength>150 kPa than PU foam,	Charcoal black, open cell foam	White, Open cell foam, softer thanPU foam, decreased in-growth ofgranulation,, high tensile strength>150 kPa than PU foam,

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Medela AG, Invia White Foam Dressing

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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

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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.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.