The ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.

When used on open wounds, they are 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.

When used on closed surgical incisions, they are 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

V.A.C. Therapy Wound Dressings for use with KCI's V.A.C. NPWT System.

AI/ML Overview

This 510(k) summary is for V.A.C.® Therapy Wound Dressings, which are components of the V.A.C.® Negative Pressure Wound Therapy System. This submission appears to be for a modification to the dressings, as it compares the "Modified Device" to a "Predicate" and states that "The V.A.C. ® Dressing System was evaluated to ensure conformance to the design specifications."

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format with specific pass/fail thresholds. Instead, it lists the types of non-clinical tests performed to ensure conformance to design specifications and that the modified device meets user requirements. The "reported device performance" is implicitly that the device conformed to these specifications and met user requirements.

Test Type	Reported Device Performance
Peel adhesion testing	Device was evaluated to ensure conformance to design specifications. (Implied: Conformed)
Moisture vapor transmission rate (MVTR) testing	Device was evaluated to ensure conformance to design specifications. (Implied: Conformed)
Biocompatibility testing (ISO 10993-1)	Device was evaluated to ensure conformance to design specifications. (Implied: Conformed)
Study on healthy human volunteers	Conducted to ensure that the proposed modified device meets user requirements, as there is no reliable method for measuring these requirements on the bench. (Implied: Device met user requirements)

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

The document mentions a "study conducted on healthy human volunteers" but does not specify the sample size for this study. The data provenance (country of origin, retrospective/prospective) is also not specified.

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)

This is not applicable as the described study was on "healthy human volunteers" to assess user requirements, not to establish a "ground truth" for a diagnostic or AI-driven system. There is no mention of experts establishing a ground truth in the context of this submission.

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

This is not applicable as no adjudication method is mentioned for the study on healthy human volunteers. The study's purpose was to assess user requirements, not to evaluate diagnostic accuracy requiring adjudication.

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. The document explicitly states: "There was no clinical study conducted." The nature of the device (wound dressings) and the described tests do not suggest a need for such a study.

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

This is not applicable. The device is a physical wound dressing system, not an algorithm or AI system.

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

This is not applicable in the traditional sense of a diagnostic or AI device. The "ground truth" or reference for the healthy human volunteer study would have been the user requirements themselves, which the device was designed to meet.

8. The sample size for the training set

This is not applicable as this is a medical device (wound dressings) and not an AI/algorithm-based product requiring a training set.

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

This is not applicable for the same reason as above (not an AI/algorithm-based product).

Summary

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510(k) SUMMARY

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NOV 1 9 2013

-K133276.page 1.of 2

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V.A.C. ® Therapy Wound Dressings

Submitter Information [21 CFR 807.929(a)(1)]
Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
Address	6203 Farinon DriveSan Antonio, TX 78249
Phone number	210-515-4059
Fax number	210-255-6727
EstablishmentRegistration Number	1625774
Name of contact person	Melanie Avila
Date prepared	10/23/2013
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietary name	V.A.C. ® Negative Pressure Wound Therapy System
Common or usual name	Negative Pressure Wound Therapy System
Classification name	Negative Pressure Wound Therapy Powered Suction Pump (and components)
Regulation	878.4780
Product Code(s)	OMP
Legally marketed device(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)]	V.A.C. Therapy Wound Dressings cleared for use under multiple 510(k)s forthe KCI V.A.C. Therapy Negative Pressure Wound Therapy Systems. Themost recent 510(k) was K120033.
Device description[21 CFR 807.92(a)(4)]	V.A.C. Therapy Wound Dressings for use with KCI's V.A.C. NPWT System.
Indications for use[21 CFR 807.92(a)(5)]	The ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, andV.A.C. Simplicity Negative Pressure Wound Therapy Systems are integratedwound management systems for use in acute, extended and home caresettings.When used on open wounds, they are intended to create an environment thatpromotes wound healing by secondary or tertiary (delayed primary) intentionby preparing the wound bed for closure, reducing edema, promotinggranulation tissue formation and perfusion, and by removing exudate andinfectious material. Open wound types include: chronic, acute, traumatic,subacute and dehisced wounds, partial-thickness burns, ulcers (such asdiabetic, pressure or venous insufficiency), flaps and grafts.When used on closed surgical incisions, they are also intended to manage theenvironment of surgical incisions that continue to drain following sutured orstapled closure by maintaining a closed environment and removing exudatesvia the application of negative pressure wound therapy.

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ਸ਼ਾਪੂ

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510(k) SUMMARY

V.A.C. ® Therapy Wound Dressings

Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]

Characteristic	V.A.C. ® Therapy Wound Dressing System (Modified Device)	V.A.C. ® Therapy Wound Dressing System (Predicate)
Indicated Wound Type	Same as predicate	Chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts
Dressing	Same as predicate	Multiple dressing components

Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
The V.A.C. ® Dressing System was evaluated to ensure conformance to the design specifications.
The following tests were conducted:

Peel adhesion testing
Moisture vapor transmission rate (MVTR) testing
Biocompatibility testing according to ISO10993-1
Study conducted on healthy human volunteers, under design validation (210 CFR 820.30(g)), to ensure that the proposed modified device meets user requirements

Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
There was no clinical study conducted, however, a study was conducted on healthy human volunteers, under design validation (210 CFR 820.30(g)), to ensure that the proposed modified device meets user requirements as there is no reliable method for measuring these requirements on the bench.
Conclusions drawn [21 CFR 807.92(b)(3)]
Testing indicates that the modified V.A.C. ® Therapy Wound Dressing System is substantially equivalent in terms of both indications for use and fundamental scientific technology to the predicate product.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three curved lines representing arms or wings.

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

KCI USA, Incorporated Ms. Melanie Avila Regulatory Affairs Project Manager 6203 Fairnon Drive San Antonio, Texas 78249

November 19, 2013

Re: K133276

Trade/Device Name: V.A.C. Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 23, 2013 Received: October 24, 2013

Dear Ms. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Melanie Avila

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ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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/Industrv/default.htm.

Sincerely vours.

Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting 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): __ K.133276 Device Name: _ V.A.C. ® Drape Indications for Use:

The ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are Integrated wound management systems for use in acute, extended and home care settings.

Prescription Use Over-The-Counter Use ਮ 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)

Page | of | |

(Posted November 13, 2003)

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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.