The PREVENA RESTOR(TM) 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

The negative pressure technology for the subject device is the same as that for the predicate device systems. The PREVENA RESTOR™ dressing is a component of the PREVENA RESTOR™ Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing connected to a PREVENA RESTOR™ dressing placed over the incision site. The integrated one-piece dressing, which includes an occlusive film, provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together and removes fluid from the incision site into a canister fitted to the therapy unit.

AI/ML Overview

The provided text is a 510(k) summary for the PREVENA RESTOR™ Incision Management System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through clinical studies typical of novel algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an FDA 510(k) clearance for this device is not applicable in the way it might be for a new AI/ML-based diagnostic device requiring performance against clinical endpoints.

Instead, the submission relies on demonstrating that the new device (PREVENA RESTOR™) is substantially equivalent to previously cleared predicate devices (K180855, K161897, K153199) by comparing technological characteristics and showing that a specific performance aspect (delivery of continuous negative pressure) is equivalent.

Here's a breakdown of the relevant information provided, with explanations for why some requested elements are not present:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" were demonstrating substantial equivalence to predicate devices in areas such as design, materials, principles of operation, mode-of-action, safety, performance, type of packaging, and indications for use.
Reported Device Performance:
- Performance Claim: The PREVENA RESTOR™ Incision Management System is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (Summary)
Technological Equivalence:
- Same Indications for Use	Confirmed as same.
- Same choice of therapy unit	Confirmed as same.
- Dressing connects to existing therapy units	Confirmed.
- Dressings constructed from same materials	Confirmed.
- Sterilized in same type of packaging	Confirmed.
- Applied over same types of incisions/anatomical	Confirmed.
Functional Equivalence:
- Delivery of continuous negative pressure at -125 mmHg within specifications	Bench testing demonstrated substantial equivalence under worst-case conditions of air leak rate and fluid input over the intended duration of use.

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

Not Applicable in this context. The "test set" here refers to bench testing performed on the device itself, not a clinical data set or a dataset for an AI algorithm. The text describes "bench testing" to demonstrate performance, but does not specify sample sizes or data provenance for this engineering testing. It falls under "non-clinical 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)

Not Applicable. This device is a negative pressure wound therapy system, not a diagnostic AI/ML algorithm requiring expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" for its performance is its ability to mechanically deliver negative pressure as specified, which is evaluated through engineering bench tests, not expert review.

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

Not Applicable. As explained above, this is not a study assessing diagnostic performance where adjudication methods for ground truth would be relevant.

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 not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.

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

Not Applicable. This is a medical device, not a standalone algorithm.

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

Not Applicable in the traditional sense of diagnostic devices. For this mechanical device, the "ground truth" for its function is its ability to maintain a specified negative pressure. This is determined by engineering measurements against known physical standards and specifications during bench testing.

8. The sample size for the training set

Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary regarding the study:

The study referenced is "Bench testing" which demonstrated substantial equivalence to predicate devices. This bench testing focused on the device's ability to maintain continuous negative pressure at -125 mmHg within specifications under various conditions (worst-case air leak rate and fluid input) over its intended duration of use. The 510(k) states that "No clinical tests were necessary" and "No usability testing was required as there has been only minor changes to the user interface and to the Instructions for Use." This indicates that the regulatory pathway for this particular device relied entirely on non-clinical (bench) testing to demonstrate substantial equivalence, rather than extensive clinical trials or performance studies against defined clinical endpoints.

Summary

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February 15, 2019

KCI USA, Inc. Shannon Scott Sr. Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249

Re: K181507

Trade/Device Name: PREVENA RESTOR™ Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: January 16, 2019 Received: January 17, 2019

Dear Shannon 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. 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 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

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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.htm); 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) K181507

Device Name

PREVENA RESTOR(TM) Incision Management System

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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510(k) SUMMARY

PREVENA RESTOR™ Incision Management System

Submitter Information [21 CFR 807.92(a)(1)]
Name	KCI USA, Inc.
Address	6203 Farinon Drive
	San Antonio, TX 78249
Phone number	210-255-7433
Fax number	210-255-6727
EstablishmentRegistration Number	3005178245
Name of contactperson	Shannon Scott
Date prepared	February 15, 2019
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietaryname	PREVENA RESTOR™ Incision Management System
Common or usualname	Negative Pressure Wound Therapy System
Classification name	Negative Pressure Wound Therapy Powered Suction Pump
Classification panel	General and Plastic Surgery
Regulation	21 CFR 878.4780
Regulatory Class	II
Product Code(s)	OMP
Legally marketeddevice(s) to whichequivalence isclaimed[21 CFR 807.92(a)(3)]	Predicate 510(k) Number(s):K180855 K161897 K153199
Device description[21 CFR 807.92(a)(4)]	The negative pressure technology for the subject device is the same asthat for the predicate device systems.The PREVENA RESTOR™ dressing is a component of the PREVENARESTOR™ Incision Management System. The systems providesurgical incision management via the application of negative pressurewound therapy over an incision site that has been closed with suturesor staples. The systems are applied to the incision site immediatelyafter surgery for up to seven (7) days depending on the surgeon'spreference.The pump in the therapy unit delivers continuous negative pressure at-125 mmHg through tubing connected to a PREVENA RESTOR™dressing placed over the incision site. The integrated one-piecedressing, which includes an occlusive film, provides
	a negative pressure environment and protects the incision fromexternal contamination. The application of negative pressure draws theincision edges together and removes fluid from the incision site into acanister fitted to the therapy unit.
Indications for use[21 CFR 807.92(a)(5)]	The PREVENA RESTORTM Incision Management System is intendedto manage the environment of surgical incisions that continue to drainfollowing sutured or stapled closure by maintaining a closedenvironment and removing exudate via the application of negativepressure wound therapy.

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Image /page/4/Picture/1 description: The image is a logo for KCI, an Acelity company. The logo features a sphere on the left side, with a purple design on the bottom. To the right of the sphere, the letters "KCI" are displayed in a sans-serif font. Below the letters, the words "AN ACELITY COMPANY" are written in a smaller font.

510(k) SUMMARY

PREVENA RESTOR™ Incision Management System

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. Application of negative pressure to an incision site that is closed via staples or sutures helps draw the incision edges together and removes fluid from the incision site. The occlusive film of the dressing provides a negative pressure environment and protects the incision from external contamination.

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

Both device systems contain the same Indications for Use. ●
. The choice of therapy unit has not changed from the predicate systems.
The dressing is connected to the PREVENA PLUS™ 125 Therapy Unit, ACTIV.A.C.™ . Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit via a disposable canister and appropriate tubing connections.
. The dressings are constructed from the same materials and are sterilized in the same type of packaging.
The dressings are applied over the same types of incisions on the same anatomical ● locations.

The following design difference exists between the subject and predicate device:

The PREVENA RESTOR™ dressings include precision designed pre-cut foam. ●
The PREVENA RESTOR™ dressing are presented in various shapes and sizes. ●

Performance Data [21 CFR 807.92(b)]

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

Bench testing demonstrated that the subject PREVENA RESTOR™ dressing is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.

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Image /page/5/Picture/1 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. Below the letters is the text "AN ACELITY COMPANY" in a smaller font.

510(k) SUMMARY

PREVENA RESTOR™ Incision Management System

Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]

No clinical tests were necessary. No usability testing was required as there has been only minor changes to the user interface and to the Instructions for Use.

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

The subject PREVENA RESTOR™ Incision Management System and its identified predicate are substantially equivalent in terms of basal design, utilized materials, principles of operation, mode-of-action, safety, performance, type of packaging, and indications for use.

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.