The Prevena Incision Management System 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.

AI/ML Overview

The provided text describes a 510(k) submission for the "Prevena Incision Management System with Customizable Dressing." The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria in the typical sense of a new clinical claim. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance is not present in this regulatory document.

However, based on the provided text, I can extract and infer some information regarding the "acceptance criteria" (understood here as the demonstration of substantial equivalence) and the studies conducted to support it.

1. Table of "Acceptance Criteria" and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally framed around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The key "performance" here is equivalence to the predicate.

Acceptance Criteria (Demonstrated Equivalence Aspect)	Reported Device Performance (as stated in submission)
Biocompatibility (per ISO 10993-1)	Testing conducted to assure safety, efficacy, and conformance to design specifications.
Delivery of Negative Pressure Wound Therapy (Equivalency of Customizable Dressing to Peel and Place Dressing)	The Prevena Incision Management System with Customizable Dressing was evaluated under design verification and validation tests. Testing demonstrates substantial equivalence in terms of both indications for use and delivered wound therapy.
Software Verification and Validation	Testing conducted.
Functional Components Equivalence	The subject device was found to be equivalent to the predicate device in delivery of negative pressure to the indicated wound type. The devices are equivalent in terms of functional components.
Indications for Use Equivalence	Same as predicate (Closed surgical incisions). Testing demonstrates substantial equivalence in terms of both indications for use and delivered wound therapy.
Therapy Unit Equivalence	Therapy unit is "Same as predicate" (Single patient use only; battery powered).

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

The document does not explicitly state the sample sizes for any test sets used in the biocompatibility, equivalency, or software verification and validation tests. The term "test set" as typically used in AI/Machine Learning evaluation (i.e., a dataset of cases used to evaluate an algorithm's performance) is not applicable here as this is a medical device regulatory submission focused on mechanical and functional equivalence, not an AI product.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the studies are likely laboratory-based and engineering verification/validation tests, not clinical studies with patient data in the typical sense.

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

This information is not applicable to the type of studies described. The "ground truth" for these tests would be established by engineering specifications, validated measurement techniques, and regulatory standards (e.g., ISO 10993-1) rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI datasets where expert opinions might differ. The studies mentioned (biocompatibility, equivalency testing, software V&V) are engineering and laboratory-based.

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

No MRMC comparative effectiveness study was done or mentioned. This device is not an AI-assisted diagnostic or prognostic tool for human readers; it is a negative pressure wound therapy system.

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

This question is not applicable. The device is a physical medical device (negative pressure wound therapy system), not an algorithm or AI.

7. The type of ground truth used

The "ground truth" in this context refers to the established standards or predicate device performance against which the new device is compared.

Engineering Specifications: For functional performance (e.g., negative pressure delivery).
Regulatory Standards: For biocompatibility (ISO 10993-1).
Predicate Device Performance: For demonstrating equivalence in indicated wound types, functional components, and therapy unit operation.

8. The sample size for the training set

Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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长121883

Image /page/0/Picture/1 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in bold, sans-serif font. A small registered trademark symbol is located to the right of the "I".

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510(k) SUMMARY Prevena Incision Management System with Customizable Dressing

OCT 1 1 2012

Submitter Information [21 CFR 807.929(a)(1)]
Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
Address	6203 Farinon DriveSan Antonio, TX 78249
Phone number	210-515-4368
Fax number	210-255-6727
EstablishmentRegistration Number	1625774
Name of contact person.	Shannon Scott, Regulatory Affairs Senior Manager
Date prepared	June 26, 2012
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietaryname	Prevena Incision Management System with Customizable Dressing
Common or usual name	Negative Pressure Wound Therapy System
Classification name	Negative Pressure Wound Therapy Powered Suction Pump (and components)
Classification panel	General and Plastic Surgery
Regulation	878.4780
Product Code(s)	OMP
Legally marketeddevice(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)]	Prevena Incision Management System (K100821)
Device description[21 CFR 807.92(a)(4)]	Negative pressure wound therapy system for application to surgically closedincisions.
Indications for use[21 CFR 807.92(a)(5)]	The Prevena Incision Management System is intended to manage theenvironment of surgical incisions that continue to drain following sutured orstapled closure by maintaining a closed environment and removing exudatevia the application of negative pressure wound therapy.
Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
The subject device was found to be equivalent to the predicate device in delivery of negative pressure tothe indicated wound type. The devices are equivalent in terms of functional components.
Characteristic	New DevicePrevena™ Incision ManagementSystem with CustomizableDressing	PredicatePrevena™ Incision Management Systemwith Peel and Place DressingK100821
Indicated wound types	Same as predicate	Closed surgical incisions
Dressing	Multiple dressing components	Single, one size, multi-layer dressing.

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Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in a bold, sans-serif font. There is a registered trademark symbol to the right of the "I".

Therapy unit	Same as predicate	Single patient use only; battery powered
Performance Data [21 CFR 807.92(b)]
[21 CFR 807.92(b)(1)]		Summary of non-clinical tests conducted for determination of substantial equivalence
	equivalence to the predicate device. The following tests were conducted:Biocompatibility testing according to ISO 10993-1	The Prevena Incision Management System with Customizable Dressing was evaluated under ofdesign verification and validation tests to assure safety, efficacy, conformance to design specifications and
Equivalency testing of the Prevena Customizable Dressing to the Prevena Peel and Place Dressingwith respect to delivery of negative pressure wound therapv
Software verification and validation testing
Summary of clinical tests conducted for determination of substantial equivalence or of clinicalinformation [21 CFR 807.92(b)(2)]
Clinical tests were conducted to demonstrate substantial equivalence with regard to device performance.
Conclusions drawn [21 CFR 807.92(b)(3)]
	of both indications for use and delivered wound therapy.	Testing demonstrates that the Prevena Incision Management System with Customizable Dressing and thePrevena Incision Management System with Peel and Place Dressing are substantially equivalent in terms

K121883
K1218212

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 11 2012

Kinetic Concepts USA, Incorporated % Ms. Shannon Scott Regulatory Affairs Senior Manager 6203 Farinon Drive San Antonio, Texas 78249

Re: K121883

Trade/Device Name: Prevena Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 7, 2012 Received: September 10, 2012

Dear Ms. Scott:

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. 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Shannon Scott

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely, yours,

Eric Keith

✔Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K121883

INDICATIONS FOR USE

K121883 510(k) Number (if known): _ Prevena Incision Management System Device Name: Indications for Use:

Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kane

(Posted November 13, 2003)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

311

510(k) Number K121883

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.