The V.A.C. ® Via™ Therapy System is an integrated wound management system for use in acute, extended and home care settings. 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 exudates 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, it 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 exudates via the application of negative pressure wound therapy

Device Description

Negative pressure wound therapy system

AI/ML Overview

This is a 510(k) summary for the V.A.C.® Via™ Negative Pressure Wound Therapy System. This document does not describe a study that proves the device meets acceptance criteria in the manner typically associated with AI/ML device submissions. Instead, it demonstrates substantial equivalence to a predicate device. Therefore, many of the requested fields cannot be directly extracted or are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not applicable in this format):

The document does not explicitly state "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML devices. Instead, it focuses on demonstrating that the modified device performs "as designed" and is "substantially equivalent" to its predicate device. The performance data presented refers to engineering and quality assurance tests, not clinical performance in terms of wound healing outcomes.

Metric (if applicable for this device type)	Acceptance Criteria	Reported Device Performance
Negative Pressure Delivery	Conformance to design specifications	Confirmed therapy unit delivers negative pressure therapy
Software Functionality	Performs as designed	Software verification and validation testing confirmed performance as designed
Electrical Safety & EMC Standards	Meets applicable standards	Testing confirmed device meets all applicable electrical safety and electromagnetic compatibility standards
Battery Life	Adequate power for appropriate negative pressure	Testing demonstrated battery supplies adequate power for appropriate negative pressure

Specific Questions:

A table of acceptance criteria and the reported device performance:
- Please refer to the table above. It's a reinterpretation of what "acceptance criteria" might mean for this type of medical device submission. The document emphasizes functional and safety performance rather than clinical efficacy metrics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This is a 510(k) summary for a Negative Pressure Wound Therapy System, not an AI/ML device relying on a "test set" of patient data for performance evaluation. The "tests" mentioned are bench tests, software verification, and electrical safety tests, which do not involve patient data or typical clinical study designs.
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. The ground truth for electrical safety, software functionality, and negative pressure delivery is established by engineering standards and design specifications, not by clinical experts reviewing data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set of clinical images or patient data requiring expert adjudication.
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/ML device, and no MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device is a physical system delivering negative pressure.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance tests (e.g., negative pressure delivery, software function, electrical safety) is established by engineering design specifications, regulatory standards (like electrical safety and EMC), and physical measurements. It is not based on expert consensus, pathology, or outcomes data in the clinical sense directly for these performance tests. The device's efficacy in wound healing is covered by its indications for use which is established through prior clinical evidence for similar predicate devices.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set of data.
How the ground truth for the training set was established:
- Not applicable. No training set is used for this device.

Summary

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NOW 15 2013

510(k) SUMMARY

V.A.C. ® V.A.C. ® Via™ | V.A.C. ® Via™

Negative Pressure Wound Therapy System

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	08/23/2013
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietaryname	V.A.C. ® Via™ Negative Pressure Wound Therapy System
Common or usual name	Negative Pressure Wound Therapy System
Classification name	Negative Pressure Wound Therapy Powered Suction Pump
Regulation	878.4780
Product Code(s)	OMP
Legally marketeddevice(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)]	V.A.C. ® Via™ Negative Pressure Wound Therapy System, originally clearedunder 510(k) K093526 and K120033
Device description[21 CFR 807.92(a)(4)]	Negative pressure wound therapy system
Indications for use[21 CFR 807.92(a)(5)]	The V.A.C. ® Via™ Therapy System is an integrated wound managementsystem for use in acute, extended and home care settings. When used onopen wounds, it is intended to create an environment that promotes woundhealing by secondary or tertiary (delayed primary) intention by preparing thewound bed for closure, reducing edema, promoting granulation tissueformation and perfusion, and by removing exudates and infectious material.Open wound types include: chronic, acute, traumatic, subacute and dehiscedwounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venousinsufficiency), flaps and grafts.When used on closed surgical incisions, it is 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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Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a graphic on the left and the letters "KCI" on the right. The graphic on the left is a series of curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font.

510(k) SUMMARY

V.A.C. ® Via™

Negative Pressure Wound Therapy System

Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
Feature	V.A.C.® Via™ NPWT System(Modified Device)			V.A.C.® Via™ NPWT System(Predicate )
Therapy unit	Same as predicate			Software controlled pump for delivery ofnegative pressure wound therapy
• Operating Principle	Same as predicate			Software controlled pump for delivery ofnegative pressure wound therapy
• Pump Type	One brushed, DC powered, singlediaphragm pump			Two piezoelectric disc pumps
• Software	Software code drives theoperation of one conventionaldiaphragm pump			Software code drives the operation of twopiezoelectric pumps
• Housing Dimensions(inches)	Width	Length	Depth	Width	Length	Depth
	3.5	6.4	2.8	3.5	6.4	2.4
Therapy unit options	Same as predicate			Selectable negative pressure at either-125mmHg or -75mmHg
Dressing systemcomponents	Same as predicate			System consists of Granufoam ™Dressing, interface pad and tubing, andadhesive drape
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.® Via™ NPWT System was evaluated to ensure conformance to the design specifications.
The following bench tests were conducted:
• Performance testing to confirm therapy unit delivers negative pressure therapy
• Software verification and validation testing to confirm that therapy unit performs as designed
• Testing to confirm device meets all applicable electrical safety and electromagnetic compatibility standards.
• Battery life testing to demonstrate that the battery will supply adequate power to provide the appropriate negative pressure to the wound.

Information [21 CFR 807.92(b)(2)] Not applicable

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

Testing indicates that the V.A.C. ® Via™ NPWT System is substantially equivalent in terms of both
indications for use and fundamental scientific technology to the predicate p

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

· November 15, 2013

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

Re: K132741

Trade/Device Name: V.A.C. Via" 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 14, 2013 Received: October 17, 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

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Page 2 - Ms. Melanie Avila

... ... ... ..

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Mark N. Melkerson

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K 132741

Device Name

V.A.C. Via Negative Pressure Wound Therapy System

Indications for Use (Describe)

The V.A.C. @ Via™ Therapy System is an integrated wound management system for use in acute, excended and home care settings. 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 lissue formation and perfusion, and by removing exudates and infectious material. Open wound types include: chronic, acute, traumatic, subacute and debissed wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.

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

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Rediological Health (CDRH) (Signature)

Jivoung Dang -S

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.