The Invia Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Invia Liberty NPWT System.

Device Description

The Invia Abdominal Dressing Kit consists of an Organ Contact Layer (OCL), two foam pads, four transparent films and a suction interface (Invia FitPad).

-The OCL is an oval polyurethane film with fenestrations intended to protect the abdominal content and enable fluid drainage from the abdomen.
-The foam pad is an oval hydrophobic polyurethane foam with open cell structure intended to be placed over the OCL in order to distribute the negative pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
-The transparent film is a thin transparent polyurethane film with acrylic adhesive intended to fixate the wound filler and seal tight to the skin.
The Invia FitPad is intended to distribute negative pressure to the wound and transport exudates from the abdominal cavity to the canister of the Invia Liberty Negative Pressure Wound Therapy (NPWT) pump.
The components of the Invia Abdominal Dressing Kit are packaged sterile and are for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the Medela AG Invia Abdominal Dressing Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel drug or high-risk device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, a standalone study, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is largely not directly applicable or available in this document. This submission relies heavily on non-clinical tests to show that the new device performs similarly to its predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical outcome. Instead, it demonstrates performance equivalence through non-clinical testing by comparing the Invia Abdominal Dressing Kit to its predicate. The "acceptance" can be inferred as successfully demonstrating equivalent functionality in laboratory settings.

Acceptance Criterion (Inferred from non-clinical testing)	Reported Device Performance
Pressure Stability within Wound Model: Constant vacuum values maintained within 10% of setpoint.	Both the Invia Abdominal Dressing Kit and the predicate (Mölnlycke Avance Abdominal Dressing Kit) maintained constant vacuum values within the wound model. Testing demonstrated that the pressure at the wound is within 10% of the setpoint using a wound model for multiple vacuum settings over 30 minutes and 73 hours.
Effective Removal of Simulated Wound Exudate: Efficient liquid discharge through the interface and draining into the pump canister.	Both the Invia Abdominal Dressing Kit and the predicate demonstrated efficient liquid being discharged through the interface and draining into the pump canister at their intended settings. Testing further demonstrated effective removal of simulated wound exudate from the wound model for multiple vacuum settings over 30 minutes and 73 hours. Comparison to the predicate showed equivalent performance with NaCl exudate removal over 30 minutes.
Leakage and Blockage Notification Functionality: Verification of intended operation.	Tests were performed for a short period of time to verify the leakage and blockage notification functionality is in accordance with the description in the Invia Liberty Pump Instructions for use. The results were successful.
Sterility: Sterility Assurance Level (SAL) of at least 10^-6.	The ethylene oxide sterilization process was validated according to ISO 11135-1:2007, establishing that an SAL of at least 10^-6 is provided by the cycle and that EO residuals meet the limits in ANSI/AAMI/ISO 10993-7.
Packaging Integrity and Shelf Life: Packaging integrity maintained, 2-year shelf life supported.	The sealed Tyvek packaging underwent environmental conditioning, transit simulation and integrity testing (visual inspection per ASTM F1886, bubble leak integrity testing per ASTM F2096 and peel strength testing per ASTM F88), with successful results implied. Accelerated aging tests were performed to support this 2-year shelf life via methods published in FDA recognized standard ASTM F1980-07.
Biocompatibility: Meet requirements for prolonged contact and hemocompatibility.	Biocompatibility testing for foam, transparent film, and suction port evaluated endpoints for an external communicating device in prolonged contact with tissue/bone/dentin, including Hemocompatibility. Biocompatibility testing for the Organ Contact Layer (OCL) followed requirements for an implant device in prolonged contact with tissue/bone, including Hemocompatibility. Successful results (i.e., compliance with standards) are implied.
Usability: Low error rates in performance scenarios.	Human factors validation testing included 15 surgeons. Results show very low error rates observed for the performance scenarios, indicating successful usability.

2. Sample Size for Test Set and Data Provenance:

Non-clinical Performance Testing (Wound Model): The document mentions "a wound model, simulated wound exudates, and multiple pressure sensors." It also states "Multiple vacuum settings over 30 minutes and 73 hours were used." However, a specific numerical sample size (e.g., number of test runs, number of models) is not provided. The provenance is laboratory testing.
Human Factors Validation Testing: "15 surgeons" were used. The provenance is internal usability testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Usability Experts: "Three usability experts" conducted heuristic evaluations. No specific qualifications beyond "usability experts" are provided in the document.
Surgeons for Human Factors Validation: "15 surgeons with experience operating on open abdomens" were used. This indicates relevant expertise for the device's intended use. No further detailed qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set:

There is no mention of an adjudication method in the context of the non-clinical or human factors testing. These were primarily performance-based or observation-based assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Abdominal Dressing Kit to its predicate device." This type of study focuses on device performance in a laboratory setting compared to a predicate, not how human readers improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable. The Invia Abdominal Dressing Kit is a physical medical device (dressing kit for negative pressure wound therapy), not an AI algorithm. Its performance is inherent to its physical properties and interaction with the NPWT system, not an algorithm.

7. Type of Ground Truth Used:

Non-clinical Performance Testing: The "ground truth" was established by physical measurements and simulated conditions within a controlled laboratory wound model, using established scientific principles and comparison to a legally marketed predicate device under identical test conditions.
Human Factors Validation: The "ground truth" was established by observing user performance (surgeons) against predefined usability scenarios and identifying errors or successful task completion.

8. Sample Size for the Training Set:

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set was Established:

This question is not applicable as there is no training set.

In summary:

This 510(k) submission primarily relies on non-clinical (laboratory) performance testing and human factors validation (usability) to demonstrate substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. The "acceptance criteria" are therefore implicit in the successful demonstration that the device performs functionally and safely at least as well as the predicate in relevant non-clinical and simulated use environments.

Summary

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February 1, 2019

Medela AG % 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: K182191

Trade/Device Name: Invia Abdominal Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP, FTL Dated: January 3, 2019 Received: January 3, 2019

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 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/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.

Kimberly Ferlin -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) K182191

Device Name Invia Abdominal Dressing Kit

Indications for Use (Describe)

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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Medela AG

510(k) Summary - K182191

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: January 31, 2019

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 Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. T (202)737-4292

SECONDARY CONTACT PERSON:

Judith Bernardo Global RA Director & Team Leader Global RA Healthcare Medela AG

DEVICE:

TRADE NAME: Invia Abdominal Dressing Kit

COMMON/USUAL NAME: Negative Pressure Wound Therapy Dressing Kit, Mesh, Surgical, Polymeric

CLASSIFICATION NAMES: 878.4780 Powered Suction Pump, 878.3300 Surgical mesh

PRODUCT CODE: OMP, FTL

PREDICATE DEVICE(S):

K130852 Mölnlycke Avance Foam Abdominal Dressing Kit K170088 Invia FitPad Dressing Kit (Reference Device) K142626 Invia Liberty Negative Pressure Wound Therapy System (Reference Device)

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DEVICE DESCRIPTION:

The Invia Abdominal Dressing Kit consists of an Organ Contact Layer (OCL), two foam pads, four transparent films and a suction interface (Invia FitPad).

-The OCL is an oval polyurethane film with fenestrations intended to protect the abdominal content and enable fluid drainage from the abdomen.
-The foam pad is an oval hydrophobic polyurethane foam with open cell structure intended to be placed over the OCL in order to distribute the negative pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
-The transparent film is a thin transparent polyurethane film with acrylic adhesive intended to fixate the wound filler and seal tight to the skin.
The Invia FitPad is intended to distribute negative pressure to the wound and transport | exudates from the abdominal cavity to the canister of the Invia Liberty Negative Pressure Wound Therapy (NPWT) pump.

The components of the Invia Abdominal Dressing Kit are packaged sterile and are for single use only.

INTENDED USE:

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The Invia Abdominal Dressing Kit is substantially equivalent to the Mölnlycke Abdominal Dressing Kit (K130852), which has equivalent indications for use, intended use and technological characteristics. Additionally, the film, foam and FitPad components used within the Medela Invia Abdominal Dressing kit are identical to those cleared for use in NPWT in 510(k) K170088 Invia Foam Dressing Kit with FitPad. Reference is also given to the Invia Liberty NPWT System (K142626) as the compatible pump used with the Invia Abdominal Dressing Kit.

The table below summarizes the key differences between the Invia Abdominal Dressing Kit and the predicate device.

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	Predicate Device	Invia Abdominal Dressing
	Mölnlycke Avance FoamAbdominal Dressing Kit(K130852)	Kit
Indications for Use	The Avance Foam AbdominalDressing Kit is indicated fortemporary bridging of abdominalwall openings whereprimary closure is not possibleand/or repeat abdominal entries maybe required. Its intended use is withpatients who have open abdominalwounds with exposed viscera andorgans, and including but not limitedto patients with abdominalcompartment syndrome. It isintended for use in acute hospitalsettings (trauma, general and plasticsurgery wards) and should ideally beapplied in the operating theatre. Thedressing kit is intended for usetogether with the Avance NPWTpump and its accessories.	The Invia Abdominal Dressing Kitis indicated for temporary bridgingof abdominal wall openings whereprimary closure is not possibleand/or repeat abdominal entries maybe required. Its intended use is withpatients who have open abdominalwounds with exposed viscera andorgans, and including but not limitedto patients with abdominalcompartment syndrome. It isintended for use in acute hospitalsettings (trauma, general and plasticsurgery wards) and should ideally beapplied in the operating theatre. Thedressing kit is intended for usetogether with the Invia LibertyNPWT System.
Contra-indications	• Direct positioning NPWT (foam orgauze dressings) over exposedorgans, large veins and arteries,anastomotic sites, tendons or nerves• Malignancy in wounds• Untreated osteomyelitis• Non-enteric or unexplored fistulas• Undebrided wound with necrotictissue and eschar present	• Direct positioning of NPWT foamover exposed organs, large veinsand arteries, anastomotic sites,tendons or nerves (unless suitablycovered with the Organ ContactLayer)• Necrotic tissue with eschar present• Untreated osteomyelitis• Non-enteric and unexploredfistulas• Malignancy in wound
Intended Use	Its intended use is with patients whohave open abdominal wounds withexposed viscera and organs, andincluding but not limited to patientswith abdominal compartmentsyndrome. It is intended for use inacute hospital settings (trauma,general and plastic surgery wards)and should ideally be applied in theoperating theatre. The dressing kit isintended for use together with theAvance NPWT pump and itsaccessories.	The intended use of the InviaAbdominal Dressing Kit togetherwith Invia Liberty NPWT system isto manage patients with openabdominal wounds with exposedviscera and organs, and includingbut not limited to patients withabdominal compartmentsyndrome. It is intended for use inacute hospital settings (trauma,general and plastic surgery wards)and should ideally be applied in theoperating theatre by a trainedphysician.
	Predicate DeviceMölnlycke Avance FoamAbdominal Dressing Kit(K130852)	Invia Abdominal DressingKit
Environment of Use	It is intended for use in acutehospital settings (trauma, general andplastic surgery wards) and shouldideally be applied in the operatingtheatre.	It is intended for use in acutehospital settings (trauma, generaland plastic surgery wards) andshould ideally be applied in theoperating theatre by a trainedphysician.
Compatible NPWT System	Avance NPWT Pump (K142626,K080357)Suction capacity 5l/minMax. Vacuum -200 mmHg/-27kPaMin. Vacuum -60 mmHg/-5.3kPa	Invia Liberty Negative PressureWound Therapy System (K142626,K080357)Suction capacity 5l/minMax. Vacuum -200 mmHg/-27 kPaMin. Vacuum -40 mmHg/-5.3 kPa
Recommended AbdominalWound Pressure Setting	-120 mmHg	-125 mmHg
Recommended AbdominalWound Pump Setting	Constant Mode	Constant Mode
Dressing (to pack thewound)	Green Foam PadUses a reticulated flexiblepolyurethane hydrophobic foammaterial	Charcoal Foam PadUses a reticulated flexible polyetherand polyurethane hydrophobic foammaterial.
Transparent Film (to sealthe wound)	Avance® Film with SafetactechnologyPolyurethane film coated with a softsilicone adhesive	Invia Transparent FilmVancive MED-9531S (AveryDennison)Polyurethane transparent film withacrylic adhesive
External suction interface(ESI)	Avance Transfer Pad (single lumen)Tubing material: PVCTape: Acrylic adhesive	Invia FitPad (double lumen tubingwith Quick-Connector)Tubing material: PVC, RO 1007K20131 70 SBody material: PVC, RO 1011K20108 65 SDouble Adhesive Tape: Avery MED1832
	Predicate DeviceMölnlycke Avance FoamAbdominal Dressing Kit(K130852)	Invia Abdominal DressingKit
Organ contact layer (OCLto protect the abdominalcontent and enable fluiddrainage from the abdomen)	Soft / flexible 60 micron PUR filmOval 600x800 mm5 mm fenestrations in square pattern	Soft / flexible 60 micron PUR filmOval 600x800 mm5 mm fenestrations in square pattern
Packaging	Single Use Dressing Kit is packedsterile. Components are wrapped inrepellent nonwoven wrap and packedin transparent unit pouch.	Single Use Dressing Kit is doublepouched packed sterile in aTyvec/Foil pouch
Foam Dimensions (1 x w x h)	38 cm × 25 cm × 2 cm (oval)	38 cm x 25 cm x 2 cm (oval)
Sterilization method	Ethylene oxide sterilized	Ethylene oxide sterilized
Shelf life	Not available	2 years

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SUMMARY OF NON-CLINICAL TESTS:

The following were completed in support of the substantial equivalence determination:

Risk Analysis developed in accordance with ISO 14971: 2007. ●
A usability process, following the recommendations of the FDA guidance document . Applying Human Factors and Usability Engineering to Medical Devices (Feb. 3, 2016), was used in the development and evaluation of the usability of the Invia Abdominal Wound Dressing.
- Three usability experts conducted the heuristic evaluations of the dressing kit and O dressing kit IFU.
- o A use-related risk analysis of the dressing kit was also developed.
- Human factors validation testing of Invia Abdominal Dressing Kit included 15 о surgeons with experience operating on open abdomens, representing the expected end users of this product. Participants completed validation sessions that included training representative of that provided in actual use followed by a decay period of one hour before completing usability testing scenarios related to realistic product use. Results of the validation study were successful, with very low error rates observed for the performance scenarios.

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Performance testing demonstrated the functionality of the Invia Abdominal Dressing Kit . in combination with the separately cleared compatible NPWT pump as compared to the cleared predicate abdominal dressing kit with its compatible NPWT pump. Testing was completed to demonstrate that the pressure at the wound is within 10% of the setpoint using a wound model, simulated wound exudates, and multiple pressure sensors within the wound model. Testing further demonstrated effective removal of simulated wound exudate from the wound model. Multiple vacuum settings over 30 minutes and 73 hours were used to demonstrate both short and long term performance in pressure stability and removal of simulated wound exudate. Tests were also performed for a short period of time to verify the leakage and blockage notification functionality is in accordance with the description in the Invia Liberty Pump Instructions for use. Comparison to the predicate Mölnlycke Avance Abdominal Dressing Kit (K130852) with its compatible pump was made to demonstrate equivalent performance with NaCl exudate removal over 30 minutes. Results demonstrated that both the Invia Abdominal Dressing Kit and the Ayance Foam Abdominal Dressing Kit maintained constant vacuum values within the wound model, with efficient liquid being discharged through the interface and draining into the pump canister at their intended settings. The data demonstrate adequate vacuum performance of the Abdominal Dressing Kit and substantial equivalence to the predicate Mölnlycke Avance Abdominal Dressing Kit (K130852).
The ethylene oxide sterilization process was validated according to ISO 11135-1:2007 ● including Annex A (Biological Indicators) and B (Overkill Approach). A sub-lethal cycle (biological indicators, bacteriostatic and fungistasis, product sterility and bioburden), half cycle (biological indicator) and routine cycles (EO and ECH residuals) were performed to establish that an SAL of at least 10° is provided by the cycle and that EO residuals meet the limits in ANSI/AAMI/ISO 10993-7.
The sealed Tyvek packaging underwent environmental conditioning, transit simulation and integrity testing, which include visual inspection per ASTM F1886, bubble leak integrity testing per ASTM F2096 and peel strength testing per ASTM F88.
. Accelerated aging tests were performed to support this 2-year shelf life via methods published in FDA recognized standard ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
The Foam, Transparent Film and Suction Port (FitPad) in their final finished form are ● identical to the Foam. Transparent Film and Suction Port (FitPad) cleared in K170088. Due to the extended use of the foam and film, the following biocompatibility endpoint was evaluated in addition to those recommended for an external communicating device in prolonged contact with tissue/bone/dentin according to the 2016 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" : Hemocompatibility. Biocompatibility Testing was also performed for the OCL according to the Good Laboratory Practice requirements and biocompatibility evaluation endpoints for an implant device in prolonged contact with tissue/ bone as listed in the aforementioned 2016 FDA biocompatibility guidance document. The following additional biocompatibility endpoint was also assessed for the OCL: Hemocompatibility.

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Medela AG

SUMMARY OF CLINICAL TESTS:

Clinical testing was not required to demonstrate the substantial equivalence of the Invia Abdominal Dressing Kit to its predicate device.

CONCLUSION:

The differences between the Invia Abdominal Dressing Kit and its predicate device 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 Abdominal Dressing Kit is substantially equivalent to the legally marketed predicate device.

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.