(114 days)
The V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The V.A.C. Via™ NPWT System consists of the following components:
• A sterile dressing system applied to the wound and connected via tubing to a therapy unit that generates negative pressure at the wound
• A sterile, disposable canister that collects wound exudates removed via the negative pressure
The KCI V.A.C. Via™ NPWT System is a negative pressure wound therapy device. The provided text outlines the acceptance criteria and supporting studies for its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Biocompatibility (Testing in accordance to ISO 10993-1 standards) | Conformance to ISO 10993-1 standards demonstrated. |
| Electrical Safety (Testing in accordance to IEC 60601-1 and UL 60601-1) | Conformance to IEC 60601-1 and UL 60601-1 standards demonstrated. |
| Electromagnetic Compatibility (EMC) (Testing in accordance to AAMI/ANSI/IEC 60601-1-2) | Conformance to AAMI/ANSI/IEC 60601-1-2 standards demonstrated. |
| Usability (Testing in accordance to IEC 60601-1-6) | Conformance to IEC 60601-1-6 standards demonstrated. |
| Alarm Systems (Testing in accordance to IEC 60601-1-8) | Conformance to IEC 60601-1-8 standards demonstrated. |
| Software Controls Verification and Validation (Ensure delivery of user selected negative pressure and continuous or intermittent therapy setting, pressure monitoring, and function of alarms) | Software controls verified and validated to ensure delivery of user selected negative pressure and continuous or intermittent therapy setting, pressure monitoring, and function of alarms. |
| Functional Ability (Deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days) | Verification testing confirmed the functional ability of the V.A.C. Via™ NPWT System to deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days. |
| Drape Adhesive Properties (Rheology and peel testing to demonstrate equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive) | Rheology and peel testing of the drape adhesive demonstrated equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive. The different monomer composition of the acrylic adhesive was chosen to improve sealing performance in the moist wound environment. |
| Human Factors Testing (Ensure inherent design features and labeling facilitate correct usage and effective response to alarms) | Human Factors testing ensured inherent design features and labeling facilitate correct usage and effective response to alarms. |
| Clinical Equivalence (Comparison of clinical outcomes or performance to predicate device) | "None required for determining substantial equivalence." The overall conclusion is that "Testing demonstrates that the V.A.C. Via™ NPWT System and ActiV.A.C.® Therapy System are substantially equivalent in terms of both indications for use and safe and effective delivery of negative pressure wound therapy." This implies that the device is expected to perform clinically similar to the predicate device based on its technological equivalence and successful non-clinical testing. |
2. Sample Sizes and Data Provenance for Test Set:
- The document describes non-clinical tests (biocompatibility, electrical safety, EMC, usability, alarm systems, software verification, functional ability, drape adhesive properties, human factors). These types of tests typically do not involve patient data or "test sets" in the same way clinical studies do. Instead, they involve validated laboratory methods and engineering tests using the device itself or its components.
- Data Provenance: The tests conducted are standard regulatory compliance tests. The 'origin' of the data is the internal testing conducted by KCI USA, Inc. as part of their device development and regulatory submission.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
- This information is not provided in the given text. For the types of non-clinical engineering and regulatory tests performed, the "ground truth" is typically established by adherence to recognized international standards (e.g., ISO, IEC, AAMI/ANSI) and internal design specifications, rather than expert consensus on a test set of medical cases. Human Factors testing would involve users, but the number and qualifications are not specified.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text. Adjudication methods like "2+1" or "3+1" are characteristic of clinical studies involving expert review of patient data, which were explicitly stated as "none required" for this device's substantial equivalence determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not mentioned or conducted. The submission explicitly states "No clinical tests conducted for determination of substantial equivalence." This type of study would typically be part of clinical efficacy evaluation, which was not deemed necessary for this 510(k) submission.
6. Standalone (Algorithm Only) Performance Study:
- This device is a physical medical device (Negative Pressure Wound Therapy System), not an algorithm or AI software. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The software controls were verified and validated as part of the overall system's functionality.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is primarily based on:
- International and national medical device standards (e.g., ISO 10993-1, IEC 60601-1, UL 60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8).
- Internal design specifications for functions like negative pressure delivery, exudate transfer, and alarm operation.
- Predicate device characteristics for comparison of technological features and adhesive properties.
8. Sample Size for the Training Set:
- This information is not applicable as the device is a physical medical device and not an AI/ML algorithm that undergoes a "training set" in the conventional sense. The "training" for a physical device involves its design and engineering iterations, followed by verification and validation, as opposed to data-driven training of a model.
9. How the Ground Truth for the Training Set was Established:
- As the concept of a "training set" for an AI/ML algorithm is not applicable, the establishing of ground truth for such a set is also not relevant to this device's submission. The documentation focuses on demonstrating the device meets established engineering, safety, and performance standards.
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510(k) V.A.C. Via™ NPWT System February 26, 2010
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510(k) SUMMARY
MAR 1 0 2010
7
V.A.C.Via™ Negative Pressure Wound Therapy System
| Date prepared | February 26, 2010 |
|---|---|
| 510(k) owner | |
| • Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| • Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| • Phone number | 210 406-4602 |
| • Fax number | 210 255-6727 |
| • Name of contact person | Randall Wheeland |
| Name of the device | |
| • Trade or proprietary name | V.A.C. Via™ NPWT System |
| • Common or usual name | Negative pressure wound therapy system |
| • Classification name | Negative pressure wound therapy powered suction pump (and components) |
| • Legally marketed device(s) to which equivalence is claimed | KCI ActiV.A.C.® Therapy System510(k) Numbers: K063692 and K091585 |
| Device description | |
| • Device design | The V.A.C. Via™ NPWT System consists of the following components:• A sterile dressing system applied to the wound and connected via tubing to a therapy unit that generates negative pressure at the wound• A sterile, disposable canister that collects wound exudates removed via the negative pressure |
| • Intended use of the device | The V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as |
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Image /page/1/Picture/1 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in a bold, sans-serif font. The lines are arranged in a parallel fashion, creating a sense of movement or flow. A registered trademark symbol is present to the right of the letter "I".
510(k)
V.A.C. Via™ NPWT System
February 26, 2010
| Summary of thetechnologicalcharacteristicsof the devicecompared tothe predicatedevice | Feature | V.A.C.Via™ NPWTSystem | Predicate NPWTSystem |
|---|---|---|---|
| Indicated woundtypes | Same | Chronic, acute,traumatic, subacute anddehisced wounds,partial-thickness burns,ulcers (such as diabetic,pressure or venousinsufficiency), flaps andgrafts | |
| Therapy unit | Same | Software controlled,battery and AC powerednegative pressure pumpwith a single usedisposable fluidcollection canister | |
| Foam dressing | Same except the acrylicadhesive of the drapehas a different monomercomposition which waschosen to improvesealing performance inthe moist woundenvironment | V.A.C.® GranuFoamreticulated polyurethanefoam wound dressing,adhesive drape made ofpolyurethane film withacrylic adhesive thatcreates a sealed woundenvironment, andinterface pad and tubingset used to transfernegative pressure fromthe therapy unit to thewound, drawingexudates from the woundinto the fluid collectioncanister | |
| The V.A.C. Via™ NPWT System and the predicate both create the samenegative pressure wound healing environment. | |||
| Summary of non-clinical testsconducted fordetermination ofsubstantialequivalence | Testing in accordance to ISO 10993-1 standards was conducted forbiocompatibilityTesting in accordance to IEC 60601-1 and UL 60601-1 was conducted forelectrical safetyTesting in accordance to AAMI/ANSI/IEC 60601-1-2 was conducted forelectromagnetic compatibility.Testing in accordance to IEC 60601-1-6 was conducted for usabilityTesting in accordance to IEC 60601-1-8 was conducted for alarm systemsThe V.A.C. Via™ NPWT System and components were also evaluated toensure conformance to design specifications and establish equivalence tothe predicate device, as follows:Verification and validation of software controls to ensure delivery of userselected negative pressure and continuous or intermittent therapysetting, pressure monitoring, and function of alarms |
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510(k)
V.A.C. Via™ NPWT System
February 26, 2010
¥093526
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| Verification testing to ensure functional ability of the V.A.C. Via™ NPWT System to deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days Rheology and peel testing of the drape adhesive to demonstrate equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive Human Factors testing to ensure inherent design features and labeling facilitate correct usage and effective response to alarms | |
|---|---|
| Summary ofclinical testsconducted fordetermination ofsubstantialequivalence | None required for determining substantial equivalence |
| Conclusionsdrawn | Testing demonstrates that the V.A.C. Via™ NPWT System and ActiV.A.C.® Therapy System are substantially equivalent in terms of both indications for use and safe and effective delivery of negative pressure wound therapy |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1-0 2010
KCI USA, Inc. % Mr. Randall Wheeland Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K093526
Trade/Device Name: V.A.C. Via™ Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: February 26, 2010 Received: March 1, 2010
Dear Mr. Wheeland:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Randall Wheeland
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K093526
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INDICATIONS FOR USE
510(k) Number (if known): K093526
Device Name: V.A.C.Via™ Negative Pressure Wound Therapy System
Indications for Use:
The V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
(Posted November 13, 2003)
Daniel Kane for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093526
§ 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.