(176 days)
The V.A.C. ® 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 exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
The ActiV.A.C.® Therapy Unit is designed for the application of V.A.C. Therapy in the acute, extended and home care settings. The software-controlled therapy unit applies negative pressure to the wound bed. The open cells of the V.A.C. ® 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. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing. Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via an IrDA or USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.
The provided K063692 document is a 510(k) premarket notification for the ActiV.A.C.® Therapy Unit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel studies.
Here's an analysis based on the information provided, explicitly addressing each point requested, even if the information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) document for the ActiV.A.C.® Therapy Unit does not define explicit acceptance criteria in quantifiable terms for a new study. Instead, it relies on demonstrating equivalence to a predicate device (V.A.C. Freedom® Therapy Unit) through technological characteristics and existing clinical data for the predicate.
Therefore, a table of acceptance criteria and reported device performance as typically understood for a new study isn't presented in this document. The "performance" is implicitly deemed acceptable if it is equivalent to the predicate.
| Acceptance Criteria (Not explicitly stated for new study) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| *Implicit: Equivalent technological and performance | The ActiV.A.C.® Therapy Unit and the V.A.C. Freedom® Therapy Unit have the same technology and performance specifications for the delivery of negative pressure wound therapy. The ActiV.A.C.® Therapy Unit provides optional, ancillary features that make it easier to use by the caregiver and patient, improving upon the predicate in elements affecting safety and usability. Verification and validation testing confirmed conformance to design specifications for these new features. Existing clinical data for the predicate's safe use are considered applicable to the ActiV.A.C.® Therapy Unit. |
| specifications to the predicate device.* | |
| Implicit: New ancillary features meet specifications. | Nonclinical tests (verification and validation) were performed on the new optional, ancillary features to assure conformance to design specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No new clinical "test set" in the context of typical AI/medical device performance evaluation was used. The submission relies on existing clinical data for the predicate device and nonclinical (engineering) verification/validation for the new features.
- Data Provenance: The "clinical data" referenced is from "randomized controlled trials, literature reports, and registry/MDR databases" related to the predicate V.A.C. Freedom® Therapy Unit. The country of origin is not specified, but these are generally international sources if not specified otherwise. This data is retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As no new clinical "test set" requiring ground truth establishment by experts for performance evaluation was conducted, this information is not provided. The study relies on existing clinical evidence from the predicate.
4. Adjudication Method for the Test Set
Not applicable. No new clinical "test set" requiring adjudication for ground truth was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This document pertains to a hardware device (negative pressure wound therapy unit) with software control and optional ancillary features, not an AI or imaging diagnostic algorithm applied to human interpretation. Therefore, an MRMC study and AI assistance effect size are not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a therapy unit, not an AI algorithm performing a diagnostic task. Its "performance" involves delivering negative pressure therapies and managing alarms, which are functions of the integrated system, not a standalone algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus) doesn't directly apply here. Instead, the "truth" for the device's function is its ability to:
- Deliver negative pressure wound therapy with performance characteristics equivalent to the predicate.
- Monitor and maintain target pressure.
- Signal alarms correctly (tubing blockages, full canister, low battery, leaks).
- Perform its ancillary features (Seal Check, Therapy Settings Guide, screen guard, data export, log tool) as designed.
These are verified through engineering analysis, verification, and validation testing against design specifications and comparison to the predicate's established performance. The clinical safety and efficacy are inferred from the predicate device's substantial body of clinical data and literature.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves training data in the typical sense. The "training" for the device's development involves engineering design, prototyping, and iterative testing, not a dataset for algorithm training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the development and testing of the device's functions (e.g., proper pressure delivery, correct alarm activation) would be engineering specifications, validated measurement equipment, and established medical standards for negative pressure wound therapy.
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K063692 page 1/3
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JUN - 7 2007
| Date prepared | May 31, 2007 |
|---|---|
| 510(k) Owner | |
| Name | KCI USA, Inc. |
| Address | 8023 Vantage Drive, San Antonio, TX 78230 |
| Fax number | 210 255-6727 |
| Name of contactperson | Margaret Marsh; Senior Manager, Regulatory Affairs |
| Name of the device | |
| Trade orproprietary name | ActiV.A.C.® Therapy Unit |
| Common or usualname | Negative pressure wound therapy device |
| Classificationname | Powered suction pump |
| Legally marketeddevice to whichequivalence isclaimed | The predicate device is the V.A.C. Freedom® Therapy Unit,which was cleared for market entry in the V.A.C.® Family ofProducts 510(k) K032310. It was also included in the V.A.C.®Therapy System 510(k) K062227 which provided text relatingto the mechanism of action for inclusion into the Indicationsfor Use statement. |
| Device description | The ActiV.A.C.® Therapy Unit is designed for the applicationof V.A.C. Therapy in the acute, extended and home caresettings. The software-controlled therapy unit appliesnegative pressure to the wound bed. The open cells of theV.A.C. ® Foam Dressing to which the therapy unit isconnected enable distribution of the negative pressure acrossthe surface of the wound, while the tubing transfersaccumulated fluids to the canister. The software monitors andmaintains target pressure and alarms as needed to helpassure target pressure is maintained and constant therapy isdelivered. The safety features of the system includeadditional alarms, such as those that signal for tubingblockages, a full or missing collection canister, inactivetherapy, low battery, and leaks in the seal of the dressing.Optional ancillary features include: Seal Check™ foridentifying dressing leaks, a Therapy Settings Guide thatprovides options for therapy settings based on therecommendations in the KCI Clinical Guidelines, a screenguard feature that prevents unintentional screen changes, anexportable Therapy History Report via an IrDA or USB dataport, and a Log Tool for recording canister changes, dressingchanges and dressing pieces used. |
| Intended use of thedevice | The V.A.C.® Therapy System is an integrated woundmanagement system for use in acute, extended and homecare settings. It is intended to create an environment thatpromotes wound healing by secondary or tertiary (delayedprimary) intention by preparing the wound bed for closure,reducing edema, promoting granulation tissue formation andperfusion, and by removing exudate and infectious material. Itis indicated for patients with chronic, acute, traumatic,subacute and dehisced wounds, partial-thickness burns,ulcers (such as diabetic or pressure), flaps and grafts.The V.A.C.® GranuFoam® Silver™ Dressing is an effectivebarrier to bacterial penetration and may help reduce infectionin the above wound types. |
| Differences inintended use from thepredicate | The intended use of the device has not changed from thepredicate. |
| Summary of thetechnologicalcharacteristics of thedevice compared tothe predicate device | ActiV.A.C.® Therapy Unit and the V.A.C. Freedom® TherapyUnit have the same technology and performancespecifications for the delivery of negative pressure woundtherapy. The ActiV.A.C.® Therapy Unit provides optional,ancillary features that make it easier to use by the caregiverand patient. |
| Summary ofnonclinical tests | The new optional, ancillary features were evaluated under anumber of verification and validation tests in order to assureconformance to design specifications. |
| Summary of clinicaltests | A review of a large body of clinical data from randomizedcontrolled trials, literature reports, and registry/MDRdatabases documents the safe use of the predicate V.A.C.®Freedom® Therapy Unit in the home care setting.An engineering analysis of device performance documentsthat the ActiV.A.C.® and V.A.C. Freedom® are equivalent inthe delivery of negative pressure wound therapy, and thatActiV.A.C.® improves upon V.A.C. Freedom® in the elementsthat affect safety and usability in the home care setting. Thisanalysis concludes that the existing clinical data can be usedto predict the safety of the ActiV.A.C.® Therapy System in thehome care setting. |
| Conclusions drawnfrom the nonclinicaland clinical tests thatdemonstrate that thedevice is as safe, aseffective, andperforms as well as orbetter than thepredicate device | Verification and validation testing conducted under designcontrol requirements document that the ActiV.A.C.® TherapyUnit and the predicate V.A.C. Freedom® Therapy Unit areequivalent in terms of technology and performancespecifications for the delivery of negative pressure woundtherapy. New optional ancillary features have beendetermined to meet performance specifications. Clinical datasupporting the safe use of the V.A.C. Freedom® Therapy Unitin the home care setting are also applicable to the ActiV.A.C.®Therapy Unit. |
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Public Health Service
APR - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K063692
Trade/Device Name: ActiV.A.C.® Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: May 1, 2007 Received: May 2, 2007
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of June 7, 2007.
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 (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.
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
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Page 2 - Ms. Christy Oviatt
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Ex Pete Ramirez
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K063692 Device Name: ActiV.A.C. ® Therapy Unit
Indications for Use:
The V.A.C. 9 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 exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partialthickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
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(Division Sign- () Division of General, Restorative, and Neurological Devices
510(k) Number
Prescription Use × Over-The-Counter 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
(Posted November 13, 2003)
§ 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.