V.A.C.ULTA Negative Pressure Wound Therapy System
Device Facts
| Record ID | K203316 |
|---|---|
| Device Name | V.A.C.ULTA Negative Pressure Wound Therapy System |
| Applicant | Kci, A Part of 3M Health Care Business Group |
| Product Code | OMP · General, Plastic Surgery |
| Decision Date | Oct 27, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 (V.A.C.® Therapy) with an instillation option (Veraflo™ Therapy). V.A.C.® 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. Veraflo™ 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. V.A.C.® 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 Story
Integrated wound management system providing negative pressure wound therapy (NPWT) and instillation therapy. System comprises vacuum pump, instillation pump, tubing, and foam dressings. Vacuum pump removes exudate; instillation pump delivers topical solutions. Used in acute care/ICU settings by clinicians. Software monitors pressure, controls therapy parameters, and manages alarms. New Smart Instill™ feature determines solution volume based on pressure decay after negative pressure application. Clinicians use touch screen interface to set parameters and view therapy status. System promotes wound healing by reducing edema, removing infectious material, and preparing wound bed for closure. Benefits include controlled wound cleansing and automated exudate removal.
Clinical Evidence
No clinical tests were necessary. Human factors engineering assessment conducted with 30 nurses and doctors confirmed new features are safe and usable.
Technological Characteristics
Software-controlled vacuum and instillation pumps. Components include PVC tubing, polyurethane drapes, and foam dressings. System features touch screen interface, custom lithium battery, and AC power. Connectivity includes on-device monitoring and alarm systems. Software-based pressure sensing and control.
Indications for Use
Indicated for patients with chronic, acute, traumatic, sub-acute, dehisced wounds, partial-thickness burns, ulcers (diabetic, pressure, venous insufficiency), flaps, and grafts. Also indicated for temporary bridging of abdominal wall openings and management of draining surgical incisions. Contraindications not specified.
Regulatory Classification
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.
Predicate Devices
- V.A.C.® Ulta Negative Pressure Wound Therapy System (K162790)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
October 27, 2021
KCI, a part of 3M Health Care Business Group Margaret Marsh Regulatory Affairs Advanced Specialist 6203 Farinon Drive San Antonio, Texas 78249
Re: K203316
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: September 23, 2021 Received: September 27, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K203316
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 (V.A.C.® Therapy) with an instillation option ( Veraflo™ Therapy).
· V.A.C.® 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.
· Veraflo™ 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.
· V.A.C.® 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)
| <span style="text-decoration: overline;">X</span> 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}------------------------------------------------
| Date prepared | October 27, 2021 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Submitter information [21 CFR 807.929(a)(1)] | |
| Name | KCI, now a part of 3M Health Care Business Group |
| Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| Fax number | 210 255-6727 |
| Establishment<br>Registration<br>Number | 3009897021 |
| Name of contact<br>person | Margaret Marsh, Regulatory Affairs Advanced Specialist |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or<br>proprietary name | V.A.C.® Ulta Negative Pressure Wound Therapy System |
| Common or usual<br>name | Negative pressure wound therapy system with an instillation option |
| Classification<br>name | Negative Pressure Wound Therapy Powered Suction Pump<br>(and components) |
| Legally marketed device(s) to which equivalence is claimed<br>[21 CFR 807.92(a)(3)] | |
{4}------------------------------------------------
## Device description [21 CFR 807.92(a)(4)]
The V.A.C. 8 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 therapy for the removal of wound exudate and instilled solutions when applied. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillations and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for setting therapy parameters as well as help and alarm functions.
## Indications for Use [21 CFR 807.92(a)(5)]
The V.A.C. 8 Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option (Veraflo™ Therapy).
- V.A.C.® 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, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
- . Veraflo™ 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. 8 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.
- V.A.C.® 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 ೧ 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 O maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
{5}------------------------------------------------
| Comparison To Predicate Table [21 CFR 807.92(a)(6)] | | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparator | Subject Device | Predicate Device |
| Trade name | V.A.C.® Ulta Negative Pressure Wound Therapy<br>System | V.A.C.® Ulta Negative Pressure Wound<br>Therapy System |
| Therapy Unit<br>Model number | Same as predicate | ULTDEV 01/US |
| 510(k)<br>Submitter/Holder | Same as predicate; however, KCI is now apart of 3M<br>Health Care Business | KCI USA, Inc. |
| 510(k) number | K203316 | K162790 |
| Indications for Use | Same as predicate:<br>The V.A.C.® Ulta Negative Pressure Wound Therapy<br>System is an integrated wound management system that<br>provides Negative Pressure Wound Therapy (V.A.C.®<br>Therapy) with an instillation option (Veraflo™ Therapy).<br>V.A.C.® Therapy in the absence of instillation is<br>intended to create an environment that promotes<br>wound healing by secondary or tertiary (delayed<br>primary) intention by preparing the wound bed for<br>closure, reducing edema, promoting granulation<br>tissue formation and perfusion, and by removing<br>exudate and infectious material.Veraflo™ Therapy is indicated for patients who<br>would benefit from vacuum assisted drainage and<br>controlled delivery of topical wound treatment<br>solutions and suspensions over the wound bed | The V.A.C.® Ulta Negative Pressure Wound Therapy<br>System is an integrated wound management system that<br>provides Negative Pressure Wound Therapy (V.A.C.®<br>Therapy) with an instillation option (Veraflo™ Therapy).<br>V.A.C.® Therapy in the absence of instillation is<br>intended to create an environment that promotes<br>wound healing by secondary or tertiary (delayed<br>primary) intention by preparing the wound bed for<br>closure, reducing edema, promoting granulation<br>tissue formation and perfusion, and by removing<br>exudate and infectious material.Veraflo™ Therapy is indicated for patients who<br>would benefit from vacuum assisted drainage and<br>controlled delivery of topical wound treatment<br>solutions and suspensions over the wound bed |
| Comparator | Subject Device | Predicate Device |
| Indications for Use,<br>continued | The V.A.C.® Ulta Negative Pressure Wound Therapy<br>System with and without instillation is indicated for<br>patients with chronic, acute, traumatic, subacute and<br>dehisced wounds, partial- thickness burns, ulcers (such as<br>diabetic, pressure and venous insufficiency), flaps and<br>grafts.<br>V.A.C.® Therapy in the absence of instillation may also be<br>used for:<br>The temporary bridging of abdominal wall openings<br>where primary closure is not possible and/or repeat<br>abdominal entries are necessary and for open<br>abdominal wounds with exposed viscera including,<br>but not limited to, abdominal compartment<br>syndrome. The intended care setting is a closely<br>monitored area within the acute care hospital, such<br>as the ICU. The abdominal dressing will most often<br>be applied in the operating theater. | The V.A.C.® Ulta Negative Pressure Wound Therapy<br>System with and without instillation is indicated for<br>patients with chronic, acute, traumatic, subacute and<br>dehisced wounds, partial- thickness burns, ulcers (such as<br>diabetic, pressure and venous insufficiency), flaps and<br>grafts.<br>V.A.C.® Therapy in the absence of instillation may also be<br>used for:<br>The temporary bridging of abdominal wall openings<br>where primary closure is not possible and/or repeat<br>abdominal entries are necessary and for open<br>abdominal wounds with exposed viscera including,<br>but not limited to, abdominal compartment<br>syndrome. The intended care setting is a closely<br>monitored area within the acute care hospital, such<br>as the ICU. The abdominal dressing will most often<br>be applied in the operating theater. |
| | The management of the environment of surgical<br>incisions that continue to drain following sutured or<br>stapled closure by maintaining a closed environment<br>and removing exudate via the application of negative<br>pressure wound therapy. | The management of the environment of surgical<br>incisions that continue to drain following sutured or<br>stapled closure by maintaining a closed environment<br>and removing exudate via the application of negative<br>pressure wound therapy. |
| Components of the indication | | |
| Care setting | Same as predicate | The V.A.C.® Ulta Negative Pressure Wound Therapy Unit is for acute care<br>settings only; it is not intended for use in home care. |
| Duration of<br>therapy | Same as predicate | Duration of therapy is determined by the instructions for use for the wound<br>care dressing applied.<br>• For V.A.C.® Granufoam, V.A.C. Whitefoam and Veraflo™ Dressings,<br>the typical duration is 3 days between dressing changes.<br>• The AbThera™ Open Abdomen Dressing has a 3- day use life.<br>• The Prevena™ Incision Management Dressings may be used for up to 7 |
| Comparator | Subject Device | Predicate Device |
| Wound types | Same as predicate. | V.A.C.® and Veraflo™ Therapies are intended for use with chronic, acute, traumatic, subacute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. The AbThera™ Open Abdomen Dressing is intended for use in 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 Prevena™ Incision Management Dressings are intended to be used on closed surgical incisions |
| Wound sizes | Same as predicate, except for the addition of a<br>Large size of the Veraflo Cleanse Choice<br>Dressing. | Dressings are provided in various sizes and shapes for wounds/incisions of various sizes and configurations. |
| Mechanisms of<br>action | Same as predicate | NPWT (applies to all indicated wound types): Helps hold the wound edges together Removes wound exudates and infectious materials. Reduces edema V.A.C.® and Veraflo™ Therapies also promote granulation tissue formation and perfusion Veraflo™ Therapy also cleanses the wound with appropriate topical wound solutions |
| Technology | Same as predicate | Software controlled application of negative pressure therapy via a vacuum pump and instillation therapy via an instillation pump. |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
# K203316
| | | | V.A.C.® Ulta Negative Pressure Wound Therapy System | | | |
|--|--|--|-----------------------------------------------------|--|--|--|
|--|--|--|-----------------------------------------------------|--|--|--|
| Comparator | Subject Device | Predicate Device |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System design | Same as predicate | Therapy system consists of:<br>Software controlled therapy unit 500 and 1000 mL exudate canisters Instillation cassette (Veraflo™ Therapy only) Single pad tubing set for delivery of NPWT Single and dual pad tubing sets for delivery of both instillation and negative pressure (Veraflo™ Therapy only) |
| | Same as predicate | Dressings:<br>V.A.C.® Granufoam, Granufoam Silver, Whitefoam Dressings, Veraflo™, Veraflo Cleanse™, and Veraflo Cleanse Choice™ Dressings Prevena™ Incision Management Dressings AbThera™ Open Abdomen Dressings |
| Operating<br>Principle | Same as predicate | Therapy unit delivers software controlled negative pressure to the wound site. The open cells of the foam dressing to which the therapy unit is connected enable distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.<br>Therapy unit also provides automated delivery of instillation fluids into the wound bed via an instillation pump between negative pressure therapy cycles. After a user-selected soak time, fluids are removed into the canister via application of negative pressure in the next negative pressure wound therapy cycle. |
| | The operating principle for the determination of the instill volume provided by the new Smart Instill™ Feature is based on the decay in pressure after application of negative pressure to the dressed wound site. | |
| Comparator | Subject Device | Predicate Device |
| Performance Specifications | | |
| V.A.C. Negative<br>Pressure Wound<br>Therapy<br>(for V.A.C.<br>Therapy Cycle) | Same as predicate | Continuous mode and intermittent (“DPC”) modes Continuous negative pressure range: -25 to -200 mmHg in 25 mmHg increments DPC mode: 1 to 10 minutes to rise up and 1 to 10 minutes to fall down (in 1 minute increments each); target negative pressure range: -50 to-200 mmHg in 25 mmHg increments |
| Prevena™<br>Therapy Cycle | Same as predicate | Continuous negative pressure at -125 mmHg, |
| AbThera™<br>Therapy Cycle | Same as predicate | Continuous negative pressure at -100, 125, and 150 mmHg |
| Veraflo™<br>Therapy Cycle | Same as predicate<br><br>Smart Instill™ Feature: Dressing Saturation<br>must be achieved for the instilled volume within<br>12 hours, without creating an overfill condition. | Volume delivered by pump: 6 mL to 500 mL Instill hold time (time in wound bed, called "soak time"): 1 sec to 30 min Instillation solution pressure limit: 3 psi Negative pressure time: 3 min to 12 hrs Negative pressure mode: continuous or DPC Negative pressure range: -50 to -200 mmHg in 25 mmHg increments Not provided |
| Performance testing | Same as predicate. | Verification data confirms that the specified negative pressure and<br>instillation performance specifications have been met. |
{9}------------------------------------------------
{10}------------------------------------------------
| Comparator | Subject Device | Predicate Device | | |
|------------------------------------------------------|-------------------|--------------------------|--------|-------|
| Therapy Unit | | | | |
| • Dimensions –<br>with empty<br>canister<br>(inches) | Same as predicate | Width | Length | Depth |
| | | 8.55 | 10.25 | 7.25 |
| • Weight –<br>with empty<br>500 mL<br>canister | Same as predicate | 8 lbs (without cassette) | | |
| • User<br>interface | Same as predicate | Touch screen | | |
| • Software<br>Level of<br>Concern | Same as predicate | Moderate | | |
{11}------------------------------------------------
# K203316 510(k) SUMMARY
## V.A.C.® Ulta Negative Pressure Wound Therapy System
| Comparator | Subject Device | Predicate Device |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Software Controls | Same as predicate | The embedded software accepts user instructions for initiating and<br>modifying therapy via a touch screen. |
| | Same as predicate | Software controls include the user selection of negative pressure therapy<br>parameters as well as negative pressure therapy application and<br>monitoring. It also controls user selection of instillation therapy<br>parameters as well as application and monitoring of therapy. |
| | Same as predicate, with the addition of:<br>• Smart Instill™ Feature provides the<br>clinician an additional option to select the<br>solution volume setpoint (applicable to<br>Veraflo™ Therapy only).<br>• On-Screen Help Animations are now<br>provided for the most frequent alarm/alert<br>states (applicable to V.A.C.® Therapy,<br>Veraflo™ Therapy, Prevena™ Therapy,<br>and AbThera™ Therapy).<br>• Postponement Feature allows for the<br>postponement of Veraflo™ Therapy for up<br>to 60 hours while still providing V.A.C.®<br>Therapy.<br>• Therapy Inactive Alarm Delay allows for<br>dressing changes to occur without triggering<br>a Therapy Inactive Alarm (applicable to<br>both V.A.C.® and Veraflo™ Therapies). | The software also provides controls for alarms and a variety of optional<br>features for the user, such as:<br>• Seal Check Leak Detector<br>• Dressing Soak Tool (Veraflo™ Therapy only)<br>• Fill Assist Tool (Veraflo™ Therapy only)<br>• Test Cycle Tool (Veraflo ™Therapy only)<br>• Wound Imaging Tool for viewing uploaded wound images and<br>calculating wound area/volume<br>• History Tool for alarm, therapy and patient history logs<br>• Utilities Tool to set system preferences such as language, unit<br>measures, dates, etc.<br>• Help Tool to provide on screen help. This tool provides<br>additional information regarding alarms/alerts and how to<br>resolve them, operation of therapies and cleaning instructions.<br>• Information Tool to allow access to the current therapy settings<br>and the therapy summary tabs. |
| Comparator | Subject Device | Predicate Device |
| Alarms | | |
| • System Notifications | | |
| | Same as predicate | Battery Exhausted |
| • V.A.C. Therapy Alerts/Alarms | | |
| | Same as predicate | System Error Alarm (at Power ON)<br>V.A.C.® Therapy Blockage Alarm (Therapy Interrupted) |
| | | V.A.C.® Therapy Canister Full Alarm (Therapy Interrupted) |
| | | V.A.C.® Therapy Canister Not Engaged Alarm |
| |…
