The V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

When used on open wounds, it is intended to create 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The V.A.C. GranuFoam Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

When used on closed surgical incisions, it 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 exudates via the application of negative pressure wound therapy.

Device Description

The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System, model number 60600, is a therapy unit capable of providing Negative Pressure Wound Therapy for up to four wounds simultaneously with individual wound channel controls and feedback. The device is intended to be used only in acute care.

The V.A.C.Rx4™ NPWT System consists of a four-channel therapy unit, disposable exudate canisters and dressings. The V.A.C.Rx4™ NPWT System utilizes the same KCI dressing systems and canisters that have been cleared for use with the predicate device system.

The software-controlled therapy unit applies a selectable range of negative pressure wound therapy to the wound bed or incision site. It can provide continuous or intermittent application of negative pressure wound therapy to the wound in the selectable range of 50mmHg to 200mmHg (in increments of 25mmHg). The dressing, to which the therapy unit is connected, enables distribution of the negative pressure wound therapy across the surface of the wound or incision, while the tubing transfers accumulated fluids such as wound exudates and infectious material to a disposable canister. The device can operate either by a mains power supply or internal battery.

AI/ML Overview

For the KCI USA, Inc. V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System, the provided document details bench testing and a usability study rather than a traditional study with acceptance criteria for device performance related to treatment efficacy. The substantial equivalence determination is based on the device's functional similarity to a predicate device and successful verification of its engineering and usability aspects.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table format for treatment efficacy. Instead, it relies on demonstrating substantial equivalence to the predicate device through various tests. The reported performance relates to the device's ability to deliver negative pressure wound therapy as intended and its usability.

Aspect Tested	Acceptance Criteria (Implied by Substantial Equivalence and Bench Testing)	Reported Device Performance
Delivery of Negative Pressure (50, 125, 200 mmHg)	Substantially equivalent to the InfoV.A.C. Therapy Unit in delivering negative pressure at specified levels and conditions.	Bench testing demonstrated that the V.A.C.Rx4™ is substantially equivalent to the InfoV.A.C. Therapy Unit in the delivery of negative pressure wound therapy at 50, 125, and 200 mmHg under an air leak rate of 1.4 lpm in both continuous and intermittent modes and under both wet and dry conditions.
Performance with Dressing Configurations	Ability to provide NPWT within specification to each of the cleared dressing configurations for each channel.	The ability of the V.A.C. Rx4™ Therapy Unit to provide NPWT within specification to each of the dressing configurations was confirmed for each channel.
Control of Negative Pressure, Fluid Management, Alarms	Ability to control negative pressure wound therapy, manage fluid, and not generate false or unexpected alerts or alarms during normal operation.	The ability of the therapy unit to control negative pressure wound therapy, manage fluid and not generate false or unexpected alerts or alarms during normal operation was confirmed.
Usability (Safety & Effectiveness)	Intended users can safely and effectively perform critical tasks for intended use in the expected use environment, and no use errors leading to unacceptable risk of harm are likely to occur. Risk levels (occurrence/severity) reduced as far as possible.	Summative usability evaluation with 15 subjects from three user groups (Surgeon/Physician, Surgical Scrub/Theatre Nurse, and Acute Care Nurse) performing approximately 50 usability tasks in a simulated use environment demonstrated that intended users could safely and effectively perform critical tasks, and identified no use errors likely to lead to unacceptable harm. Risk levels were determined to be reduced to as low as reasonably practicable.

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing: The document does not specify a numerical "sample size" for the bench testing beyond stating that the V.A.C.Rx4™ was tested under various conditions and configurations (continuous/intermittent modes, wet/dry conditions, different pressure levels, and with various dressing configurations for each of the four channels). Data provenance is internal (KCI USA, Inc.) and prospective, as it describes the testing performed for this specific device for its 510(k) submission.
Usability Evaluation (Simulated-Use Testing):
- Sample Size: 15 subjects.
- Data Provenance: Prospective, generated specifically for this device submission within a simulated use environment. The country of origin is not explicitly stated but can be inferred as the USA, given the submitting company's location and FDA submission.

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

Bench Testing: Not applicable in the sense of expert-established ground truth for clinical outcomes. The "ground truth" here is the established scientific and engineering principles for negative pressure wound therapy and the performance of the predicate device.
Usability Evaluation: The "ground truth" or reference for safe and effective use during the usability study would have been the defined critical tasks and expected user interactions established by human factors engineering principles and potentially validated by subject matter experts in negative pressure wound therapy usage. The subjects themselves were representative users from key healthcare professional groups: Surgeon/Physician, Surgical Scrub/Theatre Nurse, and Acute Care Nurse. The number of experts involved in the design or evaluation protocol of the usability study, or in interpreting the results, is not specified, but the users involved were qualified practitioners.

4. Adjudication Method for the Test Set

Bench Testing: Not applicable. Performance was measured against predefined engineering specifications and compared to the predicate device.
Usability Evaluation: Not explicitly stated as a formal adjudication method. However, "Multiple formative evaluations led to the selection of an optimal user interface design," indicating an iterative design and evaluation process. The summative evaluation involved observing user performance on critical tasks, and a "residual risk analysis" was performed. This implies direct observation and assessment of user interaction against safety and effectiveness criteria.

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

No, an MRMC comparative effectiveness study was not done. The V.A.C. Rx4™ is a hardware device for wound therapy, not an imaging or diagnostic AI device where reader performance is typically assessed.

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

Not applicable. The V.A.C. Rx4™ System is a medical device that assists in wound management through applied negative pressure, not an AI algorithm performing diagnostic or predictive functions. The "algorithm" here refers to the software controlling the pump, which was tested during bench testing within the context of the device's functionality. The usability study evaluated the human-device interaction.

7. Type of Ground Truth Used

Bench Testing: Engineering specifications, physical measurements of pressure, flow rates, alarm functionality, and comparison to the predicate device's established performance.
Usability Evaluation: Defined critical tasks, user safety and effectiveness criteria, and human factors engineering principles.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would have been its design and development process, informed by engineering principles and previous device designs like the predicate.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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

December 9, 2016

KCI USA, Inc. Kristen Hopewell Senior Manager Risk Management and Post Market Surveillance 6203 Farinon Drive San Antonio, Texas 78249

Re: K160487

Trade/Device Name: VAC Rx4 Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: November 4, 2016 Received: November 7, 2016

Dear Kristen Hopewell:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -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) K160487

Device Name

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System

Indications for Use (Describe)

The V.A.C. GranuFoam Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

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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Image /page/3/Picture/0 description: The image shows the logo for KCI, an Acelity Company. The logo features a stylized graphic to the left of the letters "KCI". Below the letters is the text "An Acelity Company" in a smaller font. The logo is black and white.

V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System

Submitter Information [21 CFR 807.92(a)(1)]
Name	KCI USA, Inc.
Address	6203 Farinon Drive
	San Antonio, TX 78249
Phone number	210-515-4162
Fax number	210-255-6727
EstablishmentRegistration Number	3005178245
Name of contactperson	Kristen Weniger Hopewell
Date prepared	November 4 2016
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietaryname	V.A.C.Rx4TM Negative Pressure Wound Therapy (NPWT) System
Common or usualname	Negative Pressure Wound Therapy System
Classification name	Negative Pressure Wound Therapy Powered Suction Pump (andcomponents)
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) Numbers:InfoV.A.C.® Therapy System - K063740 (Market entry) InfoV.A.C.® Therapy System - K120033 (Expanded Indication) Reference 510(k) Numbers: Clearance of dressing systems/canistersfor use with predicate InfoV.A.C. Therapy System:InfoV.A.C.® Therapy System for use with V.A.C® Dressings (V.A.C.®GranuFoam Dressing, V.A.C.® GranuFoam Silver Dressing, V.A.C.®WhiteFoamTM Dressing) and InfoV.A.C.® 500ml and 1000mlCanisters - K063740 PrevenaTM Dressing with V.A.C.® Therapy System includingInfoV.A.C.® Therapy System - K121883

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Image /page/4/Picture/0 description: The image shows the logo for KCI, an Acelity Company. The logo features the letters "KCI" in a bold, sans-serif font. To the left of the letters, there is a graphic of curved lines that resemble a stylized medical device. Below the letters, the text "An Acelity Company" is written in a smaller, sans-serif font.

V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System

•	KCI® NPWT Gauze Dressing with V.A.C.® Therapy System including InfoV.A.C.® Therapy System - K123507
Device description [21 CFR 807.92(a)(4)]	The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System, model number 60600, is a therapy unit capable of providing Negative Pressure Wound Therapy for up to four wounds simultaneously with individual wound channel controls and feedback. The device is intended to be used only in acute care.
	The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System consists of a four-channel therapy unit, disposable exudate canisters and dressings. The V.A.C.Rx4™ NPWT System utilizes the same KCI dressing systems and canisters that have been cleared for use with the predicate device system.

	Currently Marketed Disposable System Components	Reference 510(k) Clearance of Disposable (most recent)
Canisters
	InfoV.A.C.® Canisters (500ml and 1000ml canisters)	K100657
	Dressing system (consisting of dressing, drape and tubing set)
	V.A.C.® GranuFoam Dressing	K133276
	V.A.C.® GranuFoam Silver Dressing	K133276
	V.A.C.® WhiteFoam™ Dressing	K133276
	Prevena™ Peel & Place and Prevena™ Customizable	K153199
	Prevena™ Peel & Place	K161897
	KCI® NPWT Gauze Dressings	K133276

	The software-controlled therapy unit applies a selectable range of negative pressure wound therapy to the wound bed or incision site. It can provide continuous or intermittent application of negative pressure wound therapy to the wound in the selectable range of 50mmHg to 200mmHg (in increments of 25mmHg). The dressing, to which the therapy unit is connected, enables distribution of the negative pressure wound therapy across the surface of the wound or incision, while the tubing transfers accumulated fluids such as wound exudates and infectious material to a disposable canister. The device can operate either by a mains power supply or internal battery.
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Image /page/5/Picture/0 description: The image shows the logo for KCI, which is an Acelity Company. The logo consists of the letters "KCI" in a bold, sans-serif font. To the left of the letters, there is a graphic of several horizontal lines that curve inward. Below the logo, the words "An Acelity Company" are written in a smaller, sans-serif font.

V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System

Indications for use[21 CFR 807.92(a)(5)]	The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) Systemis an integrated wound management system for use in acute caresettings and other professional healthcare environments where productuse is conducted by or under the supervision of a qualified healthcareprofessional.
	When used on open wounds, it is intended to create an environmentthat 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 removingexudate and infectious material. Open wound types include: chronic,acute, traumatic, subacute and dehisced wounds, partial-thicknessburns, ulcers (such as diabetic, pressure or venous insufficiency), flapsand grafts.
	The V.A.C. GranuFoam Silver™ Dressing is an effective barrier tobacterial penetration and may help reduce infection in the above woundtypes.
	When used on closed surgical incisions, it is also intended to managethe environment of surgical incisions that continue to drain followingsutured or stapled closure by maintaining a closed environment andremoving exudates via the application of negative pressure woundtherapy.
Comparison of the Technological Characteristics (i.e., design, material, chemicalcomposition, 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 thepredicate device. The software-controlled therapy unit applies a selectable range of negativepressure wound therapy and modes. The dressing, to which the therapy unit is connected,enables distribution of the negative pressure wound therapy across the surface of the wound orincision, while the tubing transfers accumulated fluids such as wound exudates and infectiousmaterial to a disposable canister.
At a high level, the subject device and predicate device are based on the following sametechnological elements:
• The Negative Pressure Wound Therapy System includes a negative pressure woundtherapy unit, canisters and dressings that are applied to an open wound or over anincision site. One of the following dressings may be selected by the clinician:

V.A.C.® Dressings (V.A.C ® GranuFoam, V.A.C.® GranuFoam Silver, V.A.C.® O WhiteFoam™)
Prevena™ Peel & Place™ or Customizable™ Dressing o
KCI® NPWT Gauze Dressing o

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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 graphic to the left of the letters "KCI" in a bold, sans-serif font. Below the letters, in a smaller font, is the text "An Acelity Company". The logo is black and white.

V.A.C.Rx4™ Neqative Pressure Wound Therapy (NPWT) System

Fluid is collected into a disposable canister. One of the following canisters may be . selected by the clinician:
- InfoV.A.C.® 500 ml Canister o
- InfoV.A.C.® 1000 ml Canister o
e The negative pressure wound therapy unit can provide continuous or intermittent application of negative pressure wound therapy in the selectable range of 50 - 200 mmHg (in increments of 25mmHg)
. The therapy unit provides alarms that indicate when negative pressure wound therapy may be compromised (e.g., visual and audible alarms indicating an air leak in the system, when the canister is full, canister not engaged, blockage, therapy inactive, pressure deviations, system errors, internal temperature or low battery).
. The device can operate either by a mains power supply or internal battery.

The following differences exist between the subject and predicate device:

V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System has four independent . channels whereas the predicate provides one therapy channel. Each therapy channel consists of its individual canister and an interface with associated controls to provide NPWT for that channel.
. The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System contains additional alarms to monitor unit position and battery temperature.
The software for the V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System . does not contain optional help functions, patient versus clinician access, therapy setting guides, log tools, on screen therapy history information, or wound image / measurement features.
The V.A.C.Rx4™ Neqative Pressure Wound Therapy (NPWT) System is not intended to . be used in the home care setting whereas the predicate is indicated for acute, extended and home care settings.

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 V.A.C.Rx4™ is substantially equivalent to the . InfoV.A.C. Therapy Unit in the delivery of negative pressure wound therapy at 50, 125, and 200 mmHq under an air leak rate of 1.4 Ipm in both continuous and intermittent modes and under both wet and dry conditions.
Additionally, the ability of the V.A.C. Rx4™ Therapy Unit to provide NPWT within ● specification to each of the dressing configurations was confirmed for each channel. The ability of the therapy unit to control of negative pressure wound therapy, manage fluid and not generate false or unexpected alerts or alarms during normal operation was confirmed.

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Image /page/7/Picture/0 description: The image shows the logo for KCI, an Acelity Company. The logo consists of two parts: a stylized graphic on the left and the text "KCI" on the right. The graphic is composed of several curved lines arranged in a parallel fashion, creating an abstract shape. Below the graphic and the text "KCI" is the text "An Acelity Company".

V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System

Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)1

No clinical tests were necessary.

However, the user interface was evaluated via simulated-use testing with users' representative of the use specification. Multiple formative evaluations led to the selection of an optimal user interface design in terms of use-safety and effectiveness.

Summative usability evaluation of the final user interface design was performed using 15 subjects from three users groups (Surgeon/Physician, Surgical Scrub/Theatre Nurse, and Acute Care Nurse). Subjects performed approximately 50 usability tasks in a simulated use environment.

The results of summative testing and a residual risk analysis demonstrate that intended users of the V.A.C. Rx4 Therapy System can safely and effectively perform critical tasks for the intended use in the expected use environment and that no use errors that may lead to unacceptable risk of harm are likely to occur. Risk levels [occurrence/severity] have been reduced as far as possible and any additional modifications would not further reduce risk.

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

The V.A.C.Rx4TM Negative Pressure Wound Therapy System and its predicate InfoV.A.C. Therapy System (K063740 & K120033) are substantially equivalent in terms of safety, function 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.