The V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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.

The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C. Uta Negative Pressure Wound Therapy System with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Device Description

The V.A.C. VeraFlo Cleanse Choice Dressing System is intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System to deliver negative pressure wound therapy (NPWT) as well as facilitate the instillation of fluid to the wound.

The V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing cleared under K103156. The only difference between the two systems is the configuration of the dressing.

The subject system has a dressing that is designed with 3 separate layers. The predicate dressing, on the other hand, is a single spiral shaped rod configuration. The materials of the dressing are the same.

AI/ML Overview

The provided document is a 510(k) premarket notification for the V.A.C. VeraFlo Cleanse Choice Dressing System, which is a modification of an existing device, the V.A.C. VeraFlo Cleanse Dressing System (K103156). The document focuses on demonstrating substantial equivalence to the predicate device, rather than providing a detailed clinical study report with extensive statistical analysis of performance metrics. Therefore, some of the requested information, particularly regarding specific performance metrics for acceptance criteria and human superiority studies, is not explicitly available in the document in the format requested.

However, I can extract and infer information about the acceptance criteria and the study conducted to prove the device meets these criteria based on the provided text.

Acceptance Criteria and Reported Device Performance

The document states that the new device is "substantially equivalent" to the predicate device, implying that its performance should be comparable. The key performance aspects tested relate to the mechanical properties of the dressing and its ability to function within the V.A.C. Ulta Negative Pressure Wound Therapy (NPWT) System for both negative pressure delivery and instillation.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (V.A.C. VeraFlo Cleanse Choice Dressing System)
Mechanical Properties (Tensile Strength)	For the dressing material (polyurethane ester foam with 0.1% w/v carbon black colorant), the tensile strength should be ≥230kPa, matching the predicate device.	Pass (Implies ≥230kPa)
Negative Pressure Delivery	The dressing, as part of the V.A.C. Ulta NPWT System, must effectively create negative pressure within the sealed wound bed. (Implied: similar efficacy to predicate device).	Confirmed (by bench verification testing)
Instillation Solution Distribution	The dressing must effectively distribute instillation solution throughout the wound surface when used with the V.A.C. Ulta NPWT System. (Implied: similar efficacy to predicate device).	Confirmed (by bench verification testing)
Biocompatibility	Given the same materials as the predicate, it is implied that the device meets biocompatibility standards. (Not explicitly stated as an "acceptance criterion" in this section, but a fundamental requirement for medical devices).	Not explicitly stated, but implied by "Same as predicate" in materials.
Sterilization	Must achieve a Sterility Assurance Level (SAL) of 10-6.	Same as predicate (Gamma Irradiation to SAL of 10-6)
Packaging	Sterile packaging.	Same as predicate (Thermoformed tray of PETG with a Tyvek lid)
Shelf Life	Must demonstrate a shelf life of 2 years.	Same as predicate (2 years)
Overall Functionality	The system, with the new dressing configuration, should function identically to the predicate device in terms of delivering NPWT and controlled delivery of topical wound treatment solutions/suspensions, for the same indications for use. This is the overarching goal of demonstrating "substantial equivalence" despite the change in dressing configuration.	Confirmed (by bench and animal testing, demonstrating substantial equivalence)

Study Details

The study described is a bench verification testing and animal testing conducted to demonstrate substantial equivalence to a legally marketed predicate device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact numerical sample sizes for the bench or animal testing. It states "Bench Verification testing was performed" and "Bench and animal testing have demonstrated."
- Data Provenance: The document does not explicitly state the country of origin of the data. Given KCI USA, Inc. is based in San Antonio, Texas, it is highly likely the testing was conducted in the USA or by labs commissioned by them. The studies are prospective in nature, as they were conducted to verify the performance of the new device configuration.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of verification study for a device modification (dressing configuration) typically relies on engineering specifications and established biological response models, rather than expert human interpretation of images or patient outcomes for "ground truth." The "ground truth" here is adherence to mechanical and functional specifications derived from the predicate device's performance and general wound healing principles. Therefore, it's unlikely a panel of experts established "ground truth" in the way it would for AI/diagnostic studies. Engineers and scientists involved in the testing would have evaluated the results against pre-defined success criteria.
Adjudication method for the test set:
- Not applicable in the context of this type of engineering and animal testing. Adjudication methods like "2+1" are relevant for expert consensus in diagnostic or clinical trial settings. Here, data would be analyzed against quantitative or qualitative pass/fail criteria.
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, an MRMC comparative effectiveness study was not done. This study concerns a medical device, specifically a wound dressing system, not an AI or diagnostic imaging system that would involve human readers or AI assistance in interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the test set was based on engineering specifications and functional performance criteria derived from the predicate device and established medical device standards. For instance, the tensile strength has a hard numerical "ground truth" (≥230kPa). For negative pressure and instillation distribution, the ground truth is successful operation mimicking the predicate device in controlled bench and animal models.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning system that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

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

June 20, 2016

Kci Usa, Inc. (kinetic Concepts, Inc.) % Melanie Avila Senior Manager, Regulatory Affairs Kci Usa, Inc. 6203 Farinon Drive San Antonio, Texas 78249

Re: K160451

Trade/Device Name: V. A.c. Veraflo Cleanse Choice Dressing System For Use With The V.a.c. Ulta ... Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: February 16, 2016 Received: February 18, 2016

Dear Melanie Avila:

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

{1}------------------------------------------------

the quality systems (OS) 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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160451

Device Name

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta Negative Pressure Wound Therapy System

Indications for Use (Describe)

The V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

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)
---------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------

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."

{3}------------------------------------------------

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the V.A.C. VeraFlo Cleanse Choice Dressing System is provided below.

SUBMITTER 1.

KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249

Contact Person: Melanie Avila Senior Manager, Regulatory Affairs KCI USA, Inc. Telephone: 210-515-4059 Fax: 210-255-6727 Email: melanie.avila@kci1.com Date Prepared: February 16, 2016

2. DEVICE

Name of Device: V.A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta Negative Pressure Wound Therapy (NPWT) System Common Name: Negative Pressure Wound Therapy Powered Suction Pump Classification Regulation: 21 CFR 878.4780 Regulatory Class: II Product Code: OMP Panel: General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Device: VeraFlo Cleanse Dressing System (K103156)

DEVICE DESCRIPTION 4.

{4}------------------------------------------------

INDICATIONS FOR USE 5.

The V.A.C. VeraFlo Cleanse Choice Dressing System is intended to be used with the V.A.C. Ulta Negative Pressure Wound Therapy System. The indications for use as follows:

The V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C. Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Both the subject system and the predicate system are intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System. Both systems have the ability to deliver topical wound solutions and suspensions in the wound bed as well as delivery of negative pressure wound therapy. There is no change to the indications for use.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

Similarities 6.1.

The V.A.C VeraFlo Cleanse Choice Dressing System is nearly identical to that of the predicate V.A.C VeraFlo Cleanse Dressing System (cleared under K103156). Both systems have the same materials, sterilization, and packaging.

The subject V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing System cleared under K103156. Both dressings of these systems are made from the identical open cell, reticulated, grey polyurethane ester foam stock material.

6.2. Differences

The only difference between the proposed and the predicate system is the configuration of the dressing component. The subject system has a dressing that is provided in three separate layers in an oval shape to allow for flexibility in treating wounds of various depths. The predicate dressing is a tubular shaped rod and is split along the longitudinal axis by the user for ease of configuring.

For convenience purposes, the table below compares the subject and predicate systems.

{5}------------------------------------------------

	Proposed Device	Predicate Device
510(k) Number	K160451	K103156
Applicant	Same as predicate	KCI USA, Inc.
Trade name	V. A.C. VeraFlo Cleanse ChoiceDressing System for use with theV.A.C. Ulta Negative PressureWound Therapy System	V. A.C. VeraFlo Cleanse Dressing System for usewith the V.A.C. Ulta Negative Pressure WoundTherapy System
ClassificationRegulation	Same as predicate	878.4780
Product Code	Same as predicate	OMP
Indications forUse	Same as predicate	The V.A.C.Ulta Negative Pressure Wound TherapySystem is an integrated wound management systemthat provides Negative Pressure Wound Therapywith an instillation option.The V.A.C.Ulta Negative Pressure Wound TherapySystem in the absence of instillation is intended tocreate an environment that promotes wound healingby secondary or tertiary (delayed primary) intentionby preparing the wound bed for closure, reducingedema, promoting granulation tissue formation andperfusion, and by removing exudate and infectiousmaterial.The instillation option is indicated for patients whowould benefit from vacuum assisted drainage andcontrolled delivery of topical wound treatmentsolutions and suspensions over the wound bed.The V.A.C.Ulta Negative Pressure Wound TherapySystem with and without instillation is indicated forpatients with chronic, acute, traumatic, sub-acute anddehisced wounds, partial-thickness burns, ulcers(such as diabetic, pressure and venous insufficiency),flaps and grafts.
DressingSystemComponents	Same as predicate	V.A.C. VeraT.R.A.C. Pad Assembly
	V.A.C. VeraFlo Cleanse ChoiceDressing has 3 layer design	V.A.C. VeraFlo Cleanse Dressing has a tubularshaped rod design
	Same as predicate	V.A.C. Ruler
	Same as predicate	3MTM CavilonTM Skin Prep
	Same as predicate	V.A.C. Advanced Drape
NPWTTherapySystem Design	Same as predicate	The VeraFlo Cleanse Dressing System is intendedfor use with the V.A.C. Ulta NPWT system.The NPWT system consists of:• Software controlled therapy unit• Canister
	Proposed Device	Predicate Device
		Negative pressure tubing and sensing pad Instillation tubing and pad Foam wound dressing and polyurethane occlusive drape
NPWT SystemOperatingPrinciple	Same as predicate	The V.A.C. Ulta NPWT system delivers softwarecontrolled negative pressure to the wound site. Theopen cells of the foam dressing to which the therapyunit is connected enable distribution of the negativepressure across the surface of the wound, while thetubing transfers accumulated fluids to the canister.The NPWT system also provides automated deliveryof instillation fluids into the wound bed betweennegative pressure therapy cycles.
Materials	Skin contact material:Same as predicate	Skin contact material:Occlusive drape (polyurethane film with acrylicadhesive)
	Wound contact material:Same as predicate	Wound contact material:Polyurethane ester foam
	Same as predicate	0.1% w/v carbon black colorant
	Same as predicate	Density in lb/ft3: 5.1 - 6.3
PerformanceTesting	Same as predicate	Verification testing was performed to confirm:mechanical properties (tensile testing) the dressing, as part of the V.A.C. Ulta NegativePressure Wound Therapy System, deliversnegative pressure the dressing distributes instillation solutionthroughout the wound surface
MechanicalProperties(TensileStrength)	Pass	≥230kPa
Sterilization	Same as predicate	Gamma Irradiation to SAL of 10-6
SterilePackaging	Same as predicate	Thermoformed tray of PETG with a Tyvek lid
Shelf life	Same as predicate	2 years

{6}------------------------------------------------

{7}------------------------------------------------

7. PERFORMANCE DATA

Bench Verification testing was performed to confirm:

mechanical properties (tensile testing) ●
the dressing, as part of the V.A.C. Ulta Negative Pressure Wound Therapy System creates negative pressure within the sealed wound bed
the dressing distributes instillation solution throughout the wound surface

CONCLUSIONS 8.

The only difference between the proposed and the predicate dressing systems is the configuration of the dressing. The subject system has a dressing that is provided in three separate layers in an oval shape to allow for flexibility in treating wounds of various depths. The predicate dressing is a tubular shaped rod and is split along the longitudinal axis by the user for ease of configuring.

Bench and animal testing have demonstrated that the subject V.A.C VeraFlo Cleanse Choice Dressing System is substantially equivalent to the predicate V.A.C VeraFlo Cleanse Dressing System (K103156).

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.