V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U by KCI USA, INC. (KINETIC CONCEPTS, INC.)

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

Device Description

A negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the V.A.C.Ulta™ Negative Pressure Wound Therapy System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Negative Pressure Wound Therapy (NPWT) Delivery: Delivery of NPWT at -50, -125, and -200 mmHg in a comparable manner to currently marketed V.A.C. NPWT Systems.	Equivalent negative pressure wound therapy delivered. Testing demonstrated that the V.A.C.Ulta System delivers equivalent negative pressure wound therapy at -50, -125 and -200 mmHg compared to currently marketed V.A.C. NPWT Systems.
Combined NPWT and Intermittent Fluid Instillation Performance: Ability to deliver both NPWT and intermittent fluid instillation within specification over a continuous 96-hour period.	System met performance specifications. Testing demonstrated the system met performance specifications over a continuous 96-hour period for the delivery of both NPWT and intermittent fluid instillation.
Fluid Instillation Accuracy and Safety: Ability to instill fluids within specified ranges and volumes, provide alarms and controls during negative pressure and instillation therapy, and provide a maximum flow rate equivalent to the predicate device.	All requirements were met. Testing demonstrated that all requirements pertaining to fluid instillation accuracy, volume, alarm and control functions during therapy, and maximum flow rate equivalence to the predicate device were met.
New Foam Dressing Mechanical Properties: Demonstrate appropriate mechanical properties for use during instillation.	Appropriate mechanical properties confirmed. Mechanical properties testing of the new foam dressing confirmed appropriate mechanical properties for use during instillation.
New Drape Peel Force: Peel force equivalent to the currently marketed V.A.C. Drape.	Equivalent to currently marketed V.A.C. Drape. Peel force testing of the new drape documents that it is equivalent to the currently marketed V.A.C. Drape.
Software Verification and Validation: Conformance of software to the requirements of the software requirements specification.	Software meets requirements. Software verification and validation testing confirms that the software meets the requirements of the software requirements specification.
Biocompatibility: Conformance to ISO 10993-1 standards.	Device is biocompatible. Biocompatibility testing was performed in accordance with ISO 10993-1 standards, and results demonstrated that the device is biocompatible according to these standards.

Study Details

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for the test set (number of devices tested, number of dressings, etc.).
- The document does not specify the data provenance (country of origin, retrospective/prospective). All tests appear to be bench tests.
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):
- The document does not mention the use of experts to establish a ground truth for the test set. The tests described are engineering/bench tests against specified performance parameters.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the studies described are bench tests with quantifiable outcomes against design specifications, not subjective assessments requiring 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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical therapy system, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not an algorithm. The "standalone" performance here refers to the device's ability to meet its specifications independently, which was assessed through the described bench testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the tests appears to be the design specifications and established predicate device performance for the V.A.C.Ulta™ System. For example, NPWT delivery was compared to "currently marketed V.A.C. NPWT Systems," and flow rates were compared to the "predicate." Biocompatibility was assessed against ISO 10993-1 standards.
The sample size for the training set:
- This is not applicable. The device is a physical medical system, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- This is not applicable. As there is no training set for a machine learning model, no ground truth was established for it.

Summary

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K100657 pg 10+3

510(k) SUMMARY

	V.A.C.Ulta™ Negative Pressure Wound Therapy System
Date prepared	July 26, 2010
510(k) owner	KCI USA, Inc.
Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
Address	6203 Farinon Drive; San Antonio, Texas 78249
Fax number	210 255-6727
Name of contact person	Margaret Marsh
Contact telephone number	1 800 275-4524; Request Regulatory Affairs.
Name of the device
Trade or proprietary name	V.A.C.Ulta™ Negative Pressure Wound Therapy System(V.A.C.Ulta™ Therapy System)
Common or usual name	Instillation and negative pressure wound therapy system
Classification name	Negative Pressure Wound Therapy Powered Suction Pump(and components)
Legally marketed device(s) to which equivalence is claimed	V.A.C. Instillamat Device (K021501 and K091585)
Device description	A negative pressure wound therapy system with an instillation featurewhich allows controlled delivery and drainage of topical wound treatmentsolutions and suspensions
Device design	Negative pressure wound therapy system, in which instillation of topicalwound treatment solutions and suspensions and negative pressurewound therapy is provided via software controlled pumps. Instillationsolutions and negative pressure are delivered through tubing to foamdressings in the wound covered by an occlusive drape. Softwaremonitors both negative pressure during negative pressure wound therapyas well as positive pressure during instillation of fluids to the wound bed.Software also provides controls for help and alarm functions.
Intended use of the device	The V.A.C.Ulta Negative Pressure Wound Therapy System is anintegrated wound management system that provides Negative PressureWound Therapy with an instillation option.
	Negative Pressure Wound Therapy in the absence of instillation isintended to create an environment that promotes wound healing bysecondary or tertiary (delayed primary) intention by preparing the woundbed for closure, reducing edema, promoting granulation tissue formationand perfusion, and by removing exudate and infectious material.
	The instillation option is indicated for patients who would benefit fromvacuum assisted drainage and controlled delivery of topical woundtreatment solutions and suspensions over the wound bed.The V.A.C.Ulta™ Negative Pressure Wound Therapy System with andwithout instillation is indicated for patients with chronic, acute, traumatic,sub-acute and dehisced wounds, partial-thickness burns, ulcers (such asdiabetic, pressure and venous insufficiency), flaps and grafts.
Summary of thetechnologicalcharacteristics ofthe devicecompared to thepredicate device	Feature	V.A.C.Ulta TherapySystem	V.A.C. Instill TherapySystem
	Dressingsystem	Same as predicate	Foam based dressing withocclusive drape
	Pressuresensing	Same as predicate	Via sensing pad in tubing line
	Therapyunit	Same as predicate	Software controlled pumps fordelivery of negative pressurewound therapy and controlleddelivery of instillation fluids
Summary of testsconducted	The V.A.C.Ulta Therapy System and components were evaluated under anumber of design verification and validation tests that assureconformance to design specifications.The following bench tests were conducted on the V.A.C.Ulta TherapySystem:Ability of the V.A.C.Ulta System to deliver NPWT in a comparablemanner to currently marketed V.A.C. NPWT Systems wasassessed at -50, -125 and -200 mmHg. Testing demonstratedthat the V.A.C.Ulta System delivers equivalent negative pressurewound therapy. The ability of the V.A.C. Ulta System to deliver both NPWT andintermittent fluid instillation within specification was assessed overa continuous 96 hours period. Testing demonstrated the systemmet performance specifications. Testing was conducted to confirm the ability of the therapy unit toinstill fluids within specified ranges and volumes, to providealarms and controls during negative pressure and instillationtherapy, and to provide a maximum flow rate that is equivalent tothat provided by the predicate. Testing demonstrated that allrequirements were met. Mechanical properties testing of the new foam dressing (under

V.A.C.Ulta™ Negative Pressure Wound Therapy System SEP 1 7 2010

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	appropriate mechanical properties for use during instillation.• Peel force testing of the new drape documents that it isequivalent to the currently marketed V.A.C. Drape.• Software verification and validation testing confirms that thesoftware meets the requirements of the software requirementsspecification.Biocompatibility testing was performed in accordance to ISO 10993-1standards, and results demonstrated that the device is biocompatibleaccording to these standards.
Conclusions drawn	Testing demonstrates that the V.A.C.Ulta™ Therapy System issubstantially equivalent in terms of both indications for use andtechnology to the predicate product.

appropriate mechanical properties for use during instillation.• Peel force testing of the new drape documents that it isequivalent to the currently marketed V.A.C. Drape.• Software verification and validation testing confirms that thesoftware meets the requirements of the software requirementsspecification.Biocompatibility testing was performed in accordance to ISO 10993-1standards, and results demonstrated that the device is biocompatibleaccording to these standards.

Conclusions drawn

Testing demonstrates that the V.A.C.Ulta™ Therapy System issubstantially equivalent in terms of both indications for use andtechnology to the predicate product.

Kloobs7
1993073

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus-like symbol with three intertwined lines, representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

KCI USA, Inc. % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249

SEP 1 7 2010

Re: K100657

Trade/Device Name: V.A.C. Ulta Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: July 26, 2010 Received: July 28, 2010

Dear Ms. Marsh:

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. Ilsting 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

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Page 2 - Ms. Margaret Marsh

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

For

Dir

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100657

INDICATIONS FOR USE

510(k) Number (if known): K100657 Device Name: V.A.C.Ulta Negative Pressure Wound Therapy System

SEP 1 7 2010

Indications for Use:

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.

Over-The-Counter Use × Prescription Use 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)

David KraybillPage _ of _

(Posted November 13, 2003)

(Division Sign-Division of Surgicat. Orthopedic. and Restorative Devices

510(k) Number K60657

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.