(116 days)
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, the V.A.C.VIA™ 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 by removing exudates and infectious material. Open wound types include: chronic, acute, traunatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, the V.A.C.VIA™ is intended to manage the environment of surgical incisions that continue to drain following sutured closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The negative pressure technology for the subject device is the same as that of the predicate device.
The therapy unit is a component of the therapy system which provides negative pressure wound therapy to the wound site for up to 7 days.
Negative pressure is created by the therapy unit by means of one software-controlled diaphragm pump which allows for a lightweight, single use therapy unit that provides for negative pressure wound therapy at either -75 or -125 mmHg. Negative pressure is delivered to the wound site through tubing to a dressing placed over the wound site.
This FDA 510(k) Summary describes a medical device, the V.A.C.VIA™ Negative Pressure Wound Therapy Unit, and its substantial equivalence to a predicate device. As such, the information provided is limited to what is relevant for a 510(k) submission, which focuses on demonstrating equivalence rather than comprehensive performance studies with detailed acceptance criteria typically found in clinical trials for novel devices.
Therefore, many of the requested elements (detailed performance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established) are not explicitly present in the provided document.
Here's an overview based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Bench testing demonstrated that the V.A.C.VIA™ Therapy Unit is substantially equivalent to the predicate therapy unit in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input during a 3 and 7-day test."
Specific numerical acceptance criteria for pressure delivery, air leak rate, or fluid input are not provided. However, the device is considered to have met the performance expectations by demonstrating "substantial equivalence" to the predicate device under these challenging conditions.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance |
|---|---|---|
| Negative Pressure Delivery | Delivery of continuous negative pressure at -125 mmHg within specifications. | Demonstrated substantial equivalence to the predicate therapy unit in delivering continuous negative pressure at -125 mmHg within specifications. |
| Air Leak Rate | Performance maintained under worst-case air leak rate conditions. | Performed within specifications under worst-case air leak rate conditions. |
| Fluid Input | Performance maintained under worst-case fluid input conditions. | Performed within specifications under worst-case fluid input conditions. |
| Duration of Therapy | Performance maintained during 3 and 7-day test periods. | Performed within specifications during 3 and 7-day test periods. |
| Electrical Safety | Compliance with various IEC/ANSI/AAMI standards (e.g., ES60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11). | Confirmed to meet the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text); IEC 60601-1-2 Ed. 4.0 2014-02; IEC 60601-1-6 Ed. 3.1 2013-10; IEC 60601-1-8 Ed. 2.1 2012-11; IEC 60601-1-11 Ed. 2.0 2015-01. |
| Electromagnetic Emissions | Compliance with IEC 60601-1-2. | Confirmed to meet IEC 60601-1-2 Edition 4.0 2014-02. |
| Usability | No change to user interface or Instructions for Use, therefore no usability testing required. | No usability testing was deemed necessary. |
| Battery Safety | Compliance with IEC 62133 Edition 2.0 2012-12 for the new lithium battery. | New lithium battery verified to meet IEC 62133 Edition 2.0 2012-12. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "worst case conditions of air leak rate and fluid input" for the bench testing.
- Data Provenance: The study was "bench testing." No country of origin is specified for the data, and it is inherently prospective as it involves testing the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The study was bench testing of physical performance parameters (negative pressure, air leak, fluid input, electrical safety). There was no "ground truth" in the clinical sense established by human experts.
4. Adjudication Method:
Not applicable, as there was no expert review or human assessment of clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This was bench testing of a physical device. A MRMC study is relevant for diagnostic or AI-assisted interpretation tasks.
6. Standalone Performance:
Yes, the performance testing was standalone in the sense that it measured the device's physical performance parameters directly, without human intervention in the continuous delivery of negative pressure, the management of air leaks, or fluid input during the test duration. However, it's not "standalone" in the AI sense of an algorithm operating without human oversight, as this is a mechanical pump.
7. Type of Ground Truth Used:
For the performance aspects, the "ground truth" was based on engineering specifications and recognized international standards (e.g., for electrical safety, battery safety). For the "delivery of continuous negative pressure," the ground truth would be the expected pressure output based on the device's design and a reference standard measurement.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
In summary of the study:
The study involved bench testing to demonstrate that the updated V.A.C.VIA™ Negative Pressure Wound Therapy Unit is substantially equivalent to its predicate device (K132741). The testing focused on the device's ability to maintain continuous negative pressure (-125 mmHg) under simulated "worst-case" conditions for air leaks and fluid input over 3 and 7-day periods. Additionally, the device was confirmed to meet various electrical safety and performance standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11) and the new lithium battery met IEC 62133. No clinical or usability testing was deemed necessary due to the nature of the changes (internal components and external power supply updates) and the unchanged user interface and instructions for use.
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March 2, 2018
KCI USA, Inc. Melanie Avila Senior Manager, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K173447
Trade/Device Name: V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: January 31, 2018 Received: February 1, 2018
Dear Melanie 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 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);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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Indications for Use
510(k) Number (if known)
K173447
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, extended and home care settings.
When used on open wounds, the V.A.C.VIA™ 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 by removing exudates and infectious material. Open wound types include: chronic, acute, traunatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, the V.A.C.VIA™ is intended to manage the environment of surgical incisions that continue to drain following sutured closure by maintaining a closed environment and removing exudates 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)
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510(k) SUMMARY
V.A.C.VIA™ Negative Pressure Wound Therapy Unit
| Submitter Information [21 CFR 807.92(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. |
| Address | 6203 Farinon DriveSan Antonio, TX 78249 |
| Phone number | 210-515-4059 |
| Fax number | 210-255-6727 |
| EstablishmentRegistration Number | 30098970215 |
| Name of contactperson | Melanie Avila |
| Date prepared | February 27, 2018 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietaryname | V.A.C.VIA™ Negative Pressure Wound Therapy Unit |
| Common or usualname | Negative Pressure Wound Therapy Unit |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump |
| Classification panel | General and Plastic Surgery |
| Regulation | 21 CFR 878.4780 |
| Regulatory Class | II |
| Product Code(s) | OMP |
| Legally marketeddevice(s) to whichequivalence isclaimed[21 CFR 807.92(a)(3)] | K132741 |
| Device description[21 CFR 807.92(a)(4)] | The negative pressure technology for the subject device is the same asthat of the predicate device.The therapy unit is a component of the therapy system which providesnegative pressure wound therapy to the wound site for up to 7 days.Negative pressure is created by the therapy unit by means of onesoftware-controlled diaphragm pump which allows for a lightweight,single use therapy unit that provides for negative pressure woundtherapy at either -75 or -125 mmHg. Negative pressure is delivered tothe wound site through tubing to a dressing placed over the wound site. |
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510(k) SUMMARY
V.A.C.VIA™ Negative Pressure Wound Therapy Unit
| Indications for use [21 CFR 807.92(a)(5)] | The V.A.C.VIA™ Therapy System is an integrated wound management environment that helps maintain negative pressure and protects the wound from external contamination. system for use in acute, extended and home care settings. |
|---|---|
| When used on open wounds, the V.A.C.VIA™ 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, the V.A.C.VIA™ 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. |
Comparison of the Technological Characteristics (i.e., design, material, chemical composition, energy source) with the Predicate Device [21 CFR 807.92(a)(6)]
Similarities between the subject device and predicate device:
- A disposable negative pressure pump (therapy unit) provides negative pressure at either - 125 mmHg or -75 mmHg for up to7 days.
- The dressings are connected to the therapy unit via a disposable canister and tubing set.
- Wound exudate is collected into the disposable canister
- The therapy unit provides alarms that indicate when negative pressure wound therapy may be compromised (e.g., visual and audible alarms indicating an air leak in the system, when there is blockage, batteries are low).
- The therapy unit interface provides access to therapy via an On/Off button. It also provides alarm indicators, alarm mute button, power and battery indicators, as well as a therapy life indicator.
- The intended use and instructions for use are identical to that of the predicate device.
Differences between the subject and predicate device:
- Internal components of the therapy unit, such as the pump, boards, tubing and sensors have been updated to address obsolescence and manufacturability issues.
- The external power supply has also been updated.
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
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510(k) SUMMARY V.A.C.VIA™ Negative Pressure Wound Therapy Unit
- Bench testing demonstrated that the V.A.C.VIA™ Therapy Unit is substantially equivalent . to the predicate therapy unit in the delivery of continuous negative pressure at 125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 3 and 7 day test. Electrical safety and electromechanical emissions testing confirm that the subject therapy . unit meets the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And o A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD) IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: o General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests. IEC 60601-6 Edition 3.1 2013-10 - Medical Electrical Equipment - Part 1-6: O General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability IEC 60601-1-8 Edition 2.1 2012-11 Medical Electrical Equipment - Part 1-8: O General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems In Medical Electrical Equipment and Medical Electrical Systems IEC 60601-1-11 Edition 2.0 2015-01 - Medical Electrical Equipment – Part 1-11: o General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment The new lithium battery has been verified to meet IEC 62133 Edition 2.0 2012-12. ● 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. No usability testing was required, as there has been no change to the user interface or to the Instructions for Use.
Conclusions drawn [21 CFR 807.92(b)(3)]
The V.A.C.VIA™ Therapy Unit and its predicate unit are substantially equivalent in terms of safety, performance and indications for use.
§ 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.