(116 days)
Not Found
No
The summary describes a software-controlled pump for negative pressure wound therapy, but there is no mention of AI or ML capabilities, image processing, or data training/testing.
Yes
The device is intended to create an environment that promotes wound healing by secondary or tertiary intention, and is used to treat various wound types and surgical incisions. This qualifies it as a therapeutic device.
No
The device is a wound management system that promotes wound healing through the application of negative pressure, not for diagnosis.
No
The device description explicitly states that the therapy unit is a component of the system and provides negative pressure via a software-controlled diaphragm pump. This indicates the presence of hardware components beyond just software.
Based on the provided text, the V.A.C.VIA™ Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes a system that applies negative pressure to wounds to promote healing. This is a physical therapy applied directly to the body, not a test performed on samples taken from the body.
- Device Description: The description details a pump and tubing system that delivers negative pressure. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
Therefore, the V.A.C.VIA™ Therapy System is a therapeutic device, specifically a negative pressure wound therapy system, and not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute, extended and home care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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: 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: 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: General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance on 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: 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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);
1
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
2
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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3
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 Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-515-4059 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 30098970215 |
| Name of contact | |
| person | Melanie Avila |
| Date prepared | February 27, 2018 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | V.A.C.VIA™ Negative Pressure Wound Therapy Unit |
| Common or usual | |
| name | 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 marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | |
| [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 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. |
4
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)]
5
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.