The PREVENA PLUS Incision Management System (No Ag) is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy.

The PREVENA PLUS DUO Incision Management System (No Ag) is 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.

Device Description

Negative pressure wound therapy system for application to surgically closed incisions. The system consists of a therapy unit (PREVENA PLUS™ 125 Therapy Unit, ACTIVAC™ Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit), dressing and canister. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. Application of negative pressure wound therapy to an incision site that is closed via staples or sutures helps draw the incision edges together and remove fluid from the incision site into a canister fitted to the therapy unit. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference.

AI/ML Overview

The provided document is a 510(k) premarket notification for the PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Management System (No Ag). This document, while detailing the process of seeking FDA clearance for a medical device, does not contain the acceptance criteria or a study proving the device meets those criteria in the typical format of an AI/ML-based diagnostic device.

The device described is a negative pressure wound therapy system, a physical medical device, not a software or AI-driven diagnostic tool that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Therefore, the questions related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "ground truth establishment for training set") are not applicable to the information provided in this document.

The acceptance criteria in this context are related to the safety, efficacy, and conformance to design specifications of the physical device, and its substantial equivalence to a predicate device.

However, I can extract the relevant information from the document regarding the device's validation:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Category	Reported Device Performance (Summary of Tests Conducted)
Safety & Efficacy	- System Performance Testing
	- Biocompatibility testing in accordance with ISO 10993-1
Conformance to Design Specifications & Equivalency	- Material specification equivalency testing with respect to Horizontal Wicking performance

Note: The document states "Conclusions drawn: The PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Managements Systems (No Ag) are substantially equivalent to the predicate device systems with respect to indications for use and technology." This "substantial equivalence" is the primary acceptance criterion for 510(k) clearance, rather than specific performance metrics against a defined "ground truth" as seen in AI/ML diagnostic tools.

2. Sample size used for the test set and the data provenance:

The document does not specify sample sizes for the system performance, biocompatibility, or material equivalency tests.
Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These are typically in a detailed study report, not the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the studies conducted are engineering and biocompatibility tests on a physical device, not diagnostic performance evaluations requiring expert review against a ground truth.

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

Not applicable for the types of tests described.

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:

Not applicable. This is a physical medical device, not an AI-based diagnostic tool that assists human readers.

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

Not applicable. This is a physical medical device.

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

For "System Performance Testing," the ground truth would be the device's design specifications for negative pressure delivery, fluid removal, etc.
For "Biocompatibility testing," the ground truth would be established by ISO 10993-1 standards (e.g., absence of cytotoxicity, irritation, sensitization).
For "Material specification equivalency testing with respect to Horizontal Wicking performance," the ground truth would be the performance of the predicate device and established material specifications for wicking.
No "expert consensus," "pathology," or "outcomes data" in the typical sense of diagnostic ground truth is mentioned for these engineering/material tests.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires training data.

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

Not applicable.

Summary

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

November 22, 2019

KCI USA, Inc. Patricia Lopez Sr. Regulatory Affairs Specialist 6203 Farinon Drive San Antonio, Texas 78249

Re: K190697

Trade/Device Name: PREVENA PLUS Incision Management System (No Ag) PREVENA PLUS DUO Incision Management System (No Ag) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 23, 2019 Received: October 24, 2019

Dear Patricia Lopez:

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.

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

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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,

Kimberly M. Ferlin, Ph.D. Assistant Director (acting) 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)

Device Name PREVENA PLUS™ Incision Management System (No Ag)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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Indications for Use

510(k) Number (if known)

Device Name PREVENA PLUS DUO™ Incision Management System (No Ag)

Indications for Use (Describe)

mulations for ood (Socially)
The PREVENA PLUS DUO Incision Management System (No Ag) is 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the logo for KCI, an Acelity company. The logo features a stylized sphere on the left, with a portion of it colored in a gradient of purple and pink. To the right of the sphere are the letters "KCI" in a bold, sans-serif font, colored in gray. Below the letters, in a smaller font, is the text "AN ACELITY COMPANY".

510(K) SUMMARY

Submitter Information [21 CFR 807.929(a)(1)]
Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
Address	6203 Farinon DriveSan Antonio, TX 78249
EstablishmentRegistrationNumber	1625774
Contact person,by name, title,phone number,fax number and e-mail address	Shannon ScottSenior Director, Regulatory AffairsTelephone: (210) 515-7433E-mail: Shannon.Scott@Acelity.com
Alternate contactperson, by name,title, phonenumber, faxnumber and e-mail address	Terrie McDanielInterim VP, Global Regulatory AffairsTelephone: (210) 515-4248E-mail: Terrie.McDaniel@Acelity.com
Date prepared	22 Nov 2019
Name of the device [21 CFR 807.92(a)(2)]
Trade orproprietary name	PREVENA PLUS Incision Management System (No Ag) PREVENA PLUS DUO Incision Management System (No Ag)
Common or usualname	Negative Pressure Wound Therapy System
Classificationname	Negative Pressure Wound Therapy Powered Suction Pump (andcomponents)
Classificationpanel	General and Plastic Surgery
Regulation	878.4780
Product Code(s)	OMP
Legally marketeddevice(s) to whichequivalence isclaimed[21 CFR807.92(a)(3)]	PREVENA PLUS Incision Management System (K173426) PREVENA PLUS DUO Incision Management Systems with PEEL &PLACE Dressings (K161897)
Devicedescription[21 CFR807.92(a)(4)]	PREVENA PLUS Incision Management System with PREVENA PEEL& PLACE Dressing (No Ag) with SENSAT.R.A.C. Technology PREVENA PEEL & PLACE Dressing (No Ag) with SENSAT.R.A.C.Technology

	• PREVENA PLUS Incision Management System with PREVENA PLUSCUSTOMIZABLE Dressing (No Ag)
	• PREVENA PLUS CUSTOMIZABLE Dressing (No Ag) withSENSAT.R.A.C. Technology
	• PREVENA PLUS DUO Incision Management System with PEEL &PLACE Dressings (No Ag) with SENSATRAC Technology
	Negative pressure wound therapy system for application to surgicallyclosed incisions. The system consists of a therapy unit (PREVENA PLUS™125 Therapy Unit, ACTIVAC™ Therapy Unit, V.A.C. ULTA™ Therapy Unit, orV.A.C. RX4™ Therapy Unit), dressing and canister. The pump in the therapyunit delivers continuous negative pressure at -125 mmHg through tubing toa dressing placed over the incision site. Application of negative pressurewound therapy to an incision site that is closed via staples or sutures helpsdraw the incision edges together and remove fluid from the incision site intoa canister fitted to the therapy unit. The occlusive drape of the dressingprovides a negative pressure environment and protects the incision fromexternal contamination. The systems are applied to the incision siteimmediately after surgery for up to seven (7) days depending on thesurgeon's preference.
Indications foruse[21 CFR807.92(a)(5)]	The PREVENA PLUS Incision Management System (No Ag) (or PREVENAPLUS DUO Incision Management System (No Ag)) is intended to managethe environment of surgical incisions that continue to drain followingsutured or stapled closure by maintaining a closed environment andremoving exudate via the application of negative pressure wound therapy.

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Image /page/5/Picture/0 description: The image shows the logo for KCI, an Acelity company. The logo features a sphere with a purple swirl at the bottom left. To the right of the sphere are the letters "KCI" in a sans-serif font. Below the letters is the text "AN ACELITY COMPANY" in a smaller font.

Comparison of the Technological Characteristics (i.e., design, material, chemical composition, energy source) with the Predicate Device [21 CFR 807.92(a)(6)]

Negative Pressure Wound Therapy is the technological principal for both the subject and predicate devices

At a high level, the subject device and predicate device are based on the following same technological elements:

. The dressings are applied over the incision site in the operating room.
. The dressing is connected to the selected therapy unit (PREVENA PLUS™ 125 Therapy Unit, ACTIVAC™ Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit) via a disposable canister and, where appropriate, tubing connectors.
. The selected negative pressure therapy unit provides -125 mmHg of negative pressure continuously to the dressing for a maximum of 7 days.
A tubing set connects the dressing to the canister to deliver negative pressure from the ● pump and for removal of incision fluids.
Incision fluid is collected into the disposable canister in the therapy unit.

The following technological differences exist between the subject and predicate device:

The dressings have been modified by not adding silver to the patient/wound contacting . interface layer (wicking interface layer)
Incorporation of the SENSAT.R.A.C. Pad Tubing set associated modifications are, .
- . SENSAT.R.A.C. Pad Tubing set has replaced the PREVENA Tubing set and PREVENA V.A.C. Connector

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Image /page/6/Picture/0 description: The image shows the logo for KCI, an Acelity company. The logo features a stylized sphere on the left, with a purple and white gradient. To the right of the sphere are the letters "KCI" in a sans-serif font, rendered in a metallic gray color. Below the letters, in a smaller font size, is the text "AN ACELITY COMPANY".

V.A.C. Y-Connector has replaced the PREVENA Y-Connector, a system ● component of the PREVENA PLUS DUO Incision Management Systems (No Ag)

Performance Data [21 CFR 807.92(b)]

Summary of tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]

The PREVENA PLUS Incision Management System (No Aq) and PREVENA PLUS DUO Incision Management Systems (No Ag) were evaluated to assure safety, efficacy, conformance to design specifications and equivalence to the predicate device. The following tests were conducted:

. System Performance Testing
. Biocompatibility testing in accordance with ISO 10993-1
. Material specification equivalency testing with respect to Horizontal Wicking performance

Conclusions drawn [21 CFR 807.92(b)(3)]

The PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Managements Systems (No Ag) are substantially equivalent to the predicate device systems with respect to indications for use and technology.

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.