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.

Instillation Therapy 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.

Negative Pressure Wound Therapy in the absence of instillation may also be used for:

The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Device Description

The V.A.C.ULTA™ Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions.

The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative pressure therapy for the removal of wound exudate and when applicable instilled solutions. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillation solutions and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure during negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for help and alarm functions.

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 document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for a specific "device." Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and a human factors assessment. The "acceptance criteria" can be inferred from the tests performed and their documented positive results.

Acceptance Criterion (Inferred from testing)	Reported Device Performance
Software Assessment: Compliance with FDA Guidance for Software in Medical Devices.	Assessed in accordance with FDA Guidance, May 11, 2005.
Electrical Safety & Electromagnetic Compatibility: Conformance to specific IEC/AAMI/ANSI standards.	Certified as conforming with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012; IEC 60601-1-6:2013; IEC 60601-1-8: 2012-11; IEC 60601-1-2: 2007-03.
Negative Pressure Performance (PREVENA Therapy settings): Delivery of negative pressure within established parameters (-125 mmHg, continuous mode).	Results documented that selection of PREVENA Therapy settings resulted in delivery of negative pressure within established parameters.
Negative Pressure Performance (ABTHERA Therapy settings): Delivery of negative pressure within established parameters (-100, -125 and -150 mmHg, continuous mode).	Results documented that selection of ABTHERA Therapy settings resulted in delivery of negative pressure within established parameters.
Negative Pressure Performance (General): Performance during wound exudate removal, maximum air leak rate, worst-case dressing configurations, and maximum use life of dressings.	Negative pressure performance testing was conducted for these aspects. (Implied successful demonstration of performance within acceptable limits, though specific numerical results aren't provided in the summary).
Human Factors Engineering: New software features and labeling can be safely and effectively used by intended users.	Assessed with 30 subject nurses and doctors; indicated new features could be safely and effectively used by all test subjects.

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

Software and Electrical/EMC Testing: The sample sizes for these tests are not explicitly stated in terms of "cases" or "patients." These are typically engineering and laboratory tests performed on the device itself.
Negative Pressure Performance Testing: The sample size for materials/configurations tested is not explicitly stated. This would involve laboratory testing of the device under various conditions (exudate, leaks, dressing configurations) rather than human subjects.
Human Factors Engineering Assessment (Test Set):
- Sample Size: 30 subject nurses and doctors.
- Data Provenance: This was a prospective study, likely conducted in a controlled environment (e.g., simulation lab, usability testing facility) to assess the new software features. The country of origin is not specified but would presumably be the US given the FDA submission.

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

For the non-clinical engineering tests (software, electrical, negative pressure performance), the "ground truth" is established by the specifications and standards themselves, and the expertise lies with the engineers and testing personnel who perform and verify compliance. The number and qualifications of these experts are not detailed in this summary.
For the human factors engineering assessment, the "ground truth" is the ability of all 30 subject nurses and doctors to safely and effectively use the new features. These 30 subjects are the "test set" and implicitly establish the "ground truth" through their direct interaction and feedback, as they represent the intended end-users. Their overarching qualification is that they are healthcare professionals (nurses and doctors) who would typically use such a device. The summary does not specify their years of experience or sub-specialties.

4. Adjudication Method for the Test Set

Non-clinical Tests: Adjudication is typically based on whether the device meets predefined technical specifications and standards. This would involve internal engineering verification and validation processes, and potentially third-party certification. The summary does not detail a specific adjudication method beyond stating that the device was "certified" and "documented" to meet standards.
Human Factors Engineering Assessment: The summary states that the assessment "indicated that the new features could be safely and effectively used by all test subjects." This implies a consensus or universal success among the 30 subjects, effectively meaning no formal "adjudication" (like 2+1) was needed if all participants demonstrated safe and effective use. If there were discrepancies or difficulties, a different adjudication mechanism might have been employed, but it is not mentioned.

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, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (Negative Pressure Wound Therapy System) with updated software features. It is not an AI-powered diagnostic or interpretive device, so an MRMC study comparing human readers with and without AI assistance is not applicable here.

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

Not applicable. The V.A.C.ULTA™ system is a therapy device that involves a human operator to apply and manage the therapy. It does not contain an "algorithm" in the sense of an AI or diagnostic algorithm that performs a standalone function without human interaction for which standalone performance would be measured. The software updates are for user enhancements and control of the therapy, not an autonomous diagnostic or interpretive function.

7. The type of ground truth used

Non-clinical performance specifications and user experience.
- For software, electrical safety, EMC, and negative pressure performance, the ground truth is established by adherence to recognized national and international standards (e.g., AAMI/ANSI ES60601-1, IEC 60601 series) and the internal performance specifications of the device (e.g., specific mmHg ranges for therapy).
- For the human factors assessment, the ground truth is the demonstrable ability of typical users (nurses and doctors) to safely and effectively operate the device with its new features.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission for a non-AI medical device. The software updates are for user interface and control enhancements, not for an AI model that requires a "training set" of data.

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

Not applicable. As there is no AI model requiring a training set, the concept of establishing ground truth for a training set does not apply here.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

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

January 26, 2017

KCI USA, Inc. (Kinetic Concepts, Inc.) Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249

Re: K162790

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: Class II Product Code: OMP Dated: December 29, 2016 Received: December 30, 2016

Dear Margaret 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, 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.

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

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,

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) K162790

Device Name

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.

· 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.

· Instillation Therapy 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 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.

· Negative Pressure Wound Therapy in the absence of instillation may also be used for:

o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

o The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

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}------------------------------------------------

510(k) SUMMARY

V.A.C.ULTA™ Negative Pressure Wound Therapy System

Date prepared	January 24, 2017
Submitter information [21 CFR 807.929(a)(1)]
Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
Address	6203 Farinon Drive; San Antonio, Texas 78249
Fax number	210 255-6727
EstablishmentRegistrationNumber	3009897021
Name of contactperson	Margaret Marsh, Technical Director, Regulatory Affairs
Name of the device [21 CFR 807.92(a)(2)]
Trade orproprietary name	V.A.C.ULTA™ Negative Pressure Wound Therapy System(V.A.C.ULTA™ Therapy System)
Common orusual name	Negative pressure wound therapy system with an instillation option
Classificationname	Negative Pressure Wound Therapy Powered Suction Pump(and components)
Legally marketed device(s) to which equivalence is claimed[21 CFR 807.92(a)(3)]
V.A.C.ULTA™ Negative Pressure Wound Therapy System (K100657)
Device description [21 CFR 807.92(a)(4)]
The V.A.C.ULTA™ Negative Pressure Wound Therapy System is a negative pressure wound therapysystem with an instillation feature which allows controlled delivery and drainage of topical wound treatmentsolutions and suspensions
The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negativepressure therapy for the removal of wound exudate and when applicable instilled solutions. Theinstillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps aresoftware controlled. Instillation solutions and negative pressure are delivered through tubing to foamdressings in the wound covered by an occlusive drape. Software monitors both negative pressure duringnegative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed.Software also provides controls for help and alarm functions
Indications for Use [21 CFR 807.92(a)(5)]
The V.A.C.ULTA™ Negative Pressure Wound Therapy System is an integrated wound managementsystem that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation is intended to create anenvironment that promotes wound healing by secondary or tertiary (delayed primary) intention bypreparing the wound bed for closure, reducing edema, promoting granulation tissue formation andperfusion, and by removing exudate and infectious material.Instillation Therapy is indicated for patients who would benefit from vacuum assisted drainage andcontrolled 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 forpatients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers(such as diabetic, pressure and venous insufficiency), flaps and grafts.

The temporary bridging of abdominal wall openings where primary closure is not possible O and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The

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

510(k) SUMMARY V.A.C.ULTA™ Negative Pressure Wound Therapy System

abdominal dressing will most often be applied in the operating theater.

The management of the environment of surgical incisions that continue to drain following o sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Comparison of the technological characteristics with the predicate device [21 CFR 807.92(a){6)]

At a high level, the subject devices and predicate devices are based on the following same technological elements:

Both device systems provide the same previously indicated therapies (V.A.C. Therapy, ● V.A.C.VERAFLO Therapy, PREVENA Incision Management Therapy and ABTHERA Open Abdomen Therapy.
They both use the same dressing components and therapy unit disposables. ●
. They both have the same technology and specifications or delivery of negative pressure and instillation therapies.

The following technological differences exist between the subject and predicate devices:

The V.A.C.ULTA Therapy Unit software has been revised to provide the following user enhancements:

The therapy unit now provides on screen options for selection of labeled parameters for PREVENA and ABTHERA Therapies; the options also provide therapy specific alert notifications and help features.
. There are now updated user pathways for the V.A.C. and VERAFLO Therapy settings to allow for immediate selection of the default settings with an advanced settings pathway option for experienced users.
Optional ancillary features have been added to facilitate use, such as a Wound Imaging Tool. History . Tool to access therapy, patient and alarm histories, and an Information Tool to access current therapy settinas.

Performance Data [21 CFR 807.92(b)]

Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]

Software has been assessed in accordance with FDA Guidance, Guidance for the Content of ● Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005.
. Therapy unit has been certified as conforming with the following electrical safety and electromagnetic standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012: o Edition 1.)
- IEC 60601-1-6:2013, Medical electrical equipment Part 1-6: General Requirements for Basic O Safety and Essential Performance - Collateral Standard: Usability: 2013-10, Edition 3.1
- IEC 60601-1-8: 2012-11, Medical Electrical equipment Part 1-8: Basic Safety and Essential O Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems In Medical Electrical Equipment and Medical Electrical System; Edition 2.1
- IEC 60601-1-2: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements for Basic O Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. (General II (ES/EMC); Edition 3.
Neqative pressure performance testing was conducted wound exudate, maximum air ● leak rate, worst case dressing configuration and for the maximum use life of the dressings. The results documented that selection of PREVENA and ABTHERA Therapy settings on the Therapy Unit resulted in delivery of neqative pressure within established parameters for PREVENA Therapy (-125 mmHg, continuous mode) and for ABTHERA Therapy (-100, -125 and -150 mmHg, continuous mode).

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

No clinical tests were necessary. However human factors engineering assessment with 30 subject nurses

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

510(k) SUMMARY V.A.C.ULTA™ Negative Pressure Wound Therapy System

and doctors indicated that the new features could be safely and effectively used by all test subjects.

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

The subject device with software modifications is equivalent to the predicate device:

There has been no change to the intended use of the unit; the proposed modifications to the ● indications for use statement reflect a consolidation of uses for which the therapy unit has been previously cleared.
There has been no change to the technology delivering negative pressure and instillation therapy. . Performance specifications remain unchanged.
Human factors engineering assessment documents that the changes to the therapy unit software and ● its associated labeling to provide ease of use features are safe and effective for their intended 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.