The Invia® Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds 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.

When used on closed surgical incisions, the Invia Integrated Dressing is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Integrated Dressing is appropriate for the following indications:

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
Closed surgical incisions

Device Description

The Invia Integrated Dressing is a sterile NPWT dressing, consisting of: a pad area designed to evenly distribute the negative pressure and to draw off the exudate, a perforated silicone adhesive wound contact layer to provide a gentle but secure adhesion to the skin, and a double lumen tubing with Quick-connector to connect the dressing to the Invia NPWT pumps.

The Invia Integrated Dressing is available in three different sizes as shown below.

Description	Invia® Integrated Dressing
REF (modelnumber)	101035697	101035698	101035699
Pad area size	10cm x 10cm	10cm x 15cm	10cm x 25cm
Dressing Size	18cm x 18cm	18cm x 23cm	18cm x 33cm

The Invia Integrated Dressing is designed to be compatible with the Invia Negative Pressure Wound Therapy Systems (Invia® Liberty NPWT suction pump, cleared via K142626 and K172145) and Invia® Motion (cleared via K161128 and K172145) and Invia® Ease suction pumps (K214112).

For wounds greater than 0.5 cm in depth, it is likely that a wound filler needs to be used with the Invia Integrated Dressing to ensure adequate treatment of all the wound surfaces. The Invia Integrated Dressing can be used with the wound filler accessory, Invia Black Foam NPWT. The Invia Black Foam NPWT is available in one size as shown below.

Description	Invia® Black Foam NPWT
REF (model number)	101035701
Foam pad size	10 x 8 x 3 cm

AI/ML Overview

The provided text is a 510(k) summary for the Medela AG Invia® Integrated Dressing, a negative pressure wound therapy (NPWT) dressing. This document establishes that no clinical studies were required or performed for the substantial equivalence determination of this device. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance, including details like sample size, expert qualifications, and adjudication methods, cannot be fully answered from this regulatory document.

Specifically:

No clinical studies were conducted to prove device performance or establish acceptance criteria related to a specific clinical outcome. The acceptance criteria are based on non-clinical (bench, human factors, and animal) testing and similarity to a predicate device.

Here's what can be extracted and inferred from the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted, direct "reported device performance" against clinical acceptance criteria is not available in the provided text. The performance reported below is from non-clinical studies demonstrating equivalence to the predicate device and compliance with safety standards.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Risk Analysis Compliance	In accordance with ISO 14971:2019.
Sterility	Complies with FDA Guidance; Ethylene oxide sterilized.
Biocompatibility	Evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), pyrogenicity, subchronic toxicity); results deemed acceptable.
Human Factors	Summative human factors study performed; objectives met, demonstrating safe and effective use by lay users without preventable use errors causing harm.
Bench Testing	Specifications met, performance equivalence to predicate demonstrated (Invia® Foam Dressing Kit with FitPad). Verified compatibility with Medela Invia NPWT Systems and various wound fillers.
Animal Testing (Durability)	Can be left in place for up to 7 days without adverse local tissue reactions (macroscopic or histopathological).

Information Not Available (or not applicable due to lack of clinical study):

Sample size used for the test set and the data provenance: Not applicable for clinical performance as no clinical test set was used for proving efficacy. Non-clinical studies would have their own sample sizes (e.g., number of animals for animal testing, number of participants for human factors, etc.), but these details are not provided in the summary beyond mentioning that studies were conducted. Data provenance for non-clinical tests is typical manufacturing/testing data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a performance study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
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: Not applicable. This device is an NPWT dressing, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used: For the non-clinical animal study, the ground truth was animal tissue observation (macroscopic and histopathological findings) for adverse reactions due to prolonged dressing application. For other non-clinical tests, it was compliance with specifications and standards.
The sample size for the training set: Not applicable as no machine learning/AI model was developed.
How the ground truth for the training set was established: Not applicable.

In summary, the K223388 submission relies entirely on non-clinical testing to demonstrate that the Invia® Integrated Dressing is substantially equivalent to existing predicate devices and meets safety and performance requirements without introducing new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

July 7, 2023

Medela AG % Adrienne Lenz Principal Medical Device Regulatory Expert Hyman, Phelps, & McNamara 700 Thirteenth Street, N.W. Washington, District of Columbia 20005

Re: K223388

Trade/Device Name: Invia® Integrated Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: June 6, 2023 Received: June 6, 2023

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 may, 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 aware 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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Julie A. Morabito -S

Julie A. Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223388

Device Name Invia ® Integrated Dressing

Indications for Use (Describe)

The Invia Integrated Dressing is appropriate for the following indications:

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
Closed surgical incisions

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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K223388

510(k) Summary Information

In accordance with 21 C.F.R. §807.92(a) the following summary of information is provided:

Date Summary Prepared:	July 7, 2023
Submitter/Applicant:	Medela AGLättichstrasse 4bCH 6340 BaarSwitzerlandPhone: +41 41 562 51 51Fax: +41 41 562 51 00
Primary Contact Person:	Adrienne LenzPrincipal Medical Device Regulatory ExpertHyman, Phelps & McNamara P.C.Phone: (202) 737-4292Email: ALenz@hpm.com
Device Information	Trade/Device Name: Invia® Integrated DressingRegulation Name: Powered suction pumpRegulation Number: 21 C.F.R. § 878.4780Common Name: Negative Pressure Wound TherapySystemDevice Classification Name: Powered suction pumpProduct Code: OMPRegulatory Class: IIReview Panel: General & Plastic Surgery
Predicate Device Information	Invia Foam Dressing Kits With FitPadK172145Manufacturer: Medela AG
Reference Device Information	PICO 7 Single Use Negative Pressure Wound TherapySystemK202157Manufacturer: Smith & Nephew Medical Limited

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Device Description

The Invia Integrated Dressing is available in three different sizes as shown below.

Description	Invia® Integrated Dressing
REF (modelnumber)	101035697	101035698	101035699
Pad area size	10cm x 10cm	10cm x 15cm	10cm x 25cm
Dressing Size	18cm x 18cm	18cm x 23cm	18cm x 33cm

Table 5-1: Invia Integrated Dressing covered by this 510(k)

Table 5-2: Invia Black Foam NPWT model covered by this 510(k)

Description	Invia® Black Foam NPWT
REF (model number)	101035701
Foam pad size	10 x 8 x 3 cm

Indications for Use

The Invia Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds 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 Integrated Dressing is appropriate for the following indications:

Acute or sub-acute wounds 트
트 Chronic wounds

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Dehisced wounds ■
י Pressure ulcers
י Diabetic/neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Partial thickness burns ■
Flaps and grafts
Closed surgical incisions

Comparison of Technological Characteristics

Invia® Integrated Dressing has same intended use, same indications for use, and has equivalent fundamental technology as the legally marketed predicate device to which substantial equivalency is claimed.

	Subject Device	Predicate Device	Reference Device
Characteristics	InviaDressingIntegrated	Invia Foam Dressing Kitwith FitPad (K172145)	PICO 7 (K202157)
Product code	OMP	OMP	OMP
Intended Use	Dressing for NegativePressure Wound Therapy	Dressing for NegativePressure Wound Therapy	Dressing for negativepressure wound therapy.
Indication for use	The Invia Integrated Dressingin conjunction with the InviaNPWT Systems is indicatedfor patients who wouldbenefit from a suction device(NPWT) as when used onopen wounds it creates anenvironment that promoteswound healing by secondaryor tertiary (delayed primary)intention by preparing thewound bed for closure,reducing edema, promotinggranulation tissue formationand perfusion, and byremoving exudate andinfectious material.When used on closed surgicalincisions, the Invia IntegratedDressing is also intended tomanage the environment ofsurgical incisions thatcontinue to drain followingsutured or stapled closure by	The Invia Foam Dressing Kitwith FitPad in conjunctionwith the Invia Motion andInvia Liberty NegativePressure Wound Therapy(NPWT) Systems isindicated for patients whowould benefit from a suctiondevice (Negative PressureWound Therapy) as whenused on open wounds itcreates an environment thatpromotes wound healing bysecondary or tertiary(delayed primary) intentionby preparing the wound bedfor closure, reducing edema,promoting granulation tissueformation and perfusion, andby removing exudate andinfectious material.When used on closedsurgical incisions, the InviaFoam Dressing Kit withFitPad is also intended tomanage the environment ofsurgical incisions that	PICO 7 is indicated forpatients who would benefitfrom a suction device(NPWT) as it may promotewound healing via removalof low to moderate levels ofexudate and infectiousmaterials.Appropriate wound typesinclude:- Chronic- Acute- Traumatic- Subacute and dehiscedwounds- Partial-thickness burns- Ulcers (such as diabeticor pressure)- Flaps and grafts- Closed SurgicalincisionsPICO 7 Single Use NegativePressure Wound TherapySystem is suitable for use

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Characteristics	Subject Device		Predicate Device	Reference Device
	InviaDressing	Integrated	Invia Foam Dressing Kitwith FitPad (K172145)	PICO 7 (K202157)
	maintaining a closedenvironment and removingexudate via the application ofNegative Pressure WoundTherapy.		continue to drain followingsutured or stapled closure bymaintaining a closedenvironment andremoving exudates via theapplication of NegativePressure Wound Therapy.	both in a hospital andhomecare setting.
	The Invia Integrated Dressingis appropriate for use for thefollowing indications:- Acute or sub-acutewounds- Chronic wounds- Dehisced wounds- Pressure ulcers- Diabetic/neuropathiculcers- Venous insufficiencyulcers- Traumatic wounds- Partial thickness burns- Flaps and grafts- Closed surgical incisions		The Invia Foam Dressing Kitwith FitPad is appropriatefor use for the followingindications:- Acute or sub-acutewounds- Chronic wounds- Dehisced wounds- Pressure ulcers- Diabetic/neuropathiculcers- Venous insufficiencyulcers- Traumatic wounds- Partial thickness burns- Flaps and grafts- Closed surgicalincisions
Contraindications	The Invia Integrated Dressinghas the followingcontraindications:		The Invia Foam Dressing Kitwith FitPad has thefollowing contraindications:	Pico 7 is contraindicated for:
	- Necrotic tissue witheschar present- Untreated osteomyelitis- Non-enteric andunexplored fistulas- Malignancy in wound(with exception ofpalliative care to enhancequality of life)- Exposed vasculature- Exposed nerves- Exposed anastomotic siteof blood vessels orbypasses- Exposed organs		- Necrotic tissue witheschar present- Untreated osteomyelitis- Non-enteric andunexplored fistulas- Malignancy in thewound- Exposed vasculature- Exposed nerves- Exposed anastomoticsite of blood vessels orbypasses- Exposed organs	- Patients withmalignancy in thewound bed or marginsof the wound (except inpalliative care toenhance quality of life).- Previously confirmedand untreatedosteomyelitis.- Non-enteric undunexplored fistulas.- Necrotic tissue witheschar present.- Exposed arteries, veins,nerves or organs.- Exposed anastomicsites.
				PICO 7 should not be usedfor the purpose of:
				- Emergency airwayaspiration
	Subject Device	Predicate Device	Reference Device
Characteristics	InviaDressingIntegrated	Invia Foam Dressing Kitwith FitPad (K172145)	PICO 7 (K202157)
			Pleural, mediastinal orchest tube drainageSurgical suction
Patientpopulation	Adults	Adults	Adults
Use environment	Hospital and home	Hospital and home	Hospital and home
Model number	Art.No 101035697Art.No 101035698Art.No 101035699	Art.No. 087.6221(3 pcs)Art.No 087.6222(3 pcs)Art.No 087.6223(3 pcs)Art.No 087.6224(3 pcs)Art.No 087.6225(15 pcs)Art.No 087.6226(15 pcs)Art.No 087.6227(15 pcs)	Art.no 66802007
Dimensionsspecifications(Length x Width)	Small: 18cm x 18cmMedium: 18cm x 23cmLarge: 18cm x 33cm	Small: 10cm x 8cmMedium: 19cm x 12.5cmLarge: 25cm x 15cmX-Large: 60cm x 30cm	10cm x 20 cm10 cm x 30 cm10 cm x 40 cm15 cm x 15 cm15 cm x 20 cm15 cm x 30 cm20 cm x 20 cm25 cm x 25 cm
Sterility	Ethylene oxide sterilized	Ethylene oxide sterilized	Ethylene oxide sterilized
Exudate handling	Canister	Canister	Dressing
Therapeuticpressure	-40mmHg to -200mmHgwith Invia Liberty-40mmHg to -175mmHgwith Invia Motion-40mmHg to -200mmHgwith Invia Ease	-40mmHg to 200mmHg with InviaLiberty-40mmHg to 175mmHg with InviaMotion-40mmHg to 200mmHg with InviaEase	-80mmHg (nominal)
Modeofoperation	Constant	ConstantIntermittent	Constant
MaximumDressing changeinterval of thedressing	Up to 7 days (if withoutwound filler)	Up to 3 days	Up to 7 days (if withoutwound filler)
MaximumDressing changeinterval whenusing dressingwith foam	Up to 3 days	Up to 3 days	Up to 3 days
Characteristics	Subject DeviceInviaIntegratedDressing	Predicate DeviceInvia Foam Dressing Kitwith FitPad (K172145)	Reference DevicePICO 7 (K202157)
Wound filler	Invia Black Foam NPWT	Invia Foam Dressing Kitwith FitPad	Smith&Nephew Inc. Foamor gauze wound fillers.
Wound fillerSterilizationmethod	Ethylene oxide sterilized	Ethylene oxide sterilized	Ethylene oxide sterilized
Compatibilitywith other woundfiller included inthe kits	Invia Foam Dressing Kit with FitPad (K172145) Invia White Foam (K180415) Invia Gauze Dressing Kit (K172145)	Black foam included in the Invia Foam Dressing Kit with FitPad (K172145) White foam include in Invia White Foam (K180415) Gauze included in Invia Gauze Dressing Kit (K172145)	Smith&Nephew Inc. Foam dressing filler (REF 60801021) Gauze dressing filler (66801020)

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Summary of Non-Clinical Tests

The Invia® Integrated Dressing and Invia® Black Foam NPWT wound filler comply with voluntary standards for sterilization, biocompatibility and usability. The following performance data are provided in support of the substantial equivalence determination:

. Risk analysis in accordance with ISO 14971:2019. Medical Devices - Application of Risk Management to Medical Devices.
. Sterilization information in accordance with the FDA's Guidance document entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." (January 2016).
. A biocompatibility evaluation was completed according to the FDA's Guidance document entitled "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" (Sept. 2020). The Invia Integrated Dressing and the Invia Black Foam NPWT were categorized as having prolonged contact with breached or compromised surfaces. The following biological endpoints were evaluated based on this categorization: Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Systemic toxicity (acute), Pyrogenicity, and Subchronic toxicity (subacute toxicity).
A summative human factors study was performed for the Invia Integrated Dressing ● following the FDA Guidance document "Applying Human Factors and Usability Engineering to Medical Devices" dated February 03, 2016. Overall, the objectives of the study were met, which demonstrated that the product can be used safely and effectively by lay users without patterns of preventable use errors that may cause harm to the user.
Bench testing was conducted to check that specifications were met and to demonstrate . performance equivalence to the predicate Invia® Foam Dressing Kit with FitPad. Verification and validation tests have been executed for the Invia® Integrated Dressing in combination with all Medela Invia NPWT Systems: Invia® Liberty, Invia® Motion and Invia Ease. Additionally, the subject device has been tested in combination with the following wound fillers: Invia® Black Foam NPWT, the black foam wound fillers included in the Invia® Foam Dressing Kit with FitPad, the Invia® White Foam, and the gauze wound filler included in the Invia® Gauze Dressing Kit.
Animal Testing was conducted to demonstrate that the subject device can be left in place ● over the wound for up to 7 days, before proceeding with the dressing change, without any adverse local tissue reactions, macroscopically or histopathologically. This study was conducted in compliance with the OECD Principles of Good Laboratory Practice (as revised in 1997), which are in conformity with other international GLP regulations (21 CFR Part 58).

Summary of Clinical Tests

Clinical testing was not required to support substantial equivalence.

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Conclusions

The differences between the Invia® Integrated Dressing and its predicate device, Invia Foam Dressing Kits With FitPad, do not introduce a new intended use and do not raise different questions of safety and effectiveness. Verification and validation testing demonstrated that no adverse effects have been introduced by these differences and that the devices perform as intended.

From the results of nonclinical testing, Medela AG concludes that the Invia® Integrated Dressing 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.