(176 days)
No
The description focuses on software-controlled pressure regulation, alarms, and data logging, with no mention of AI or ML algorithms for decision-making or analysis.
Yes
The device is intended to promote wound healing, reduce edema, promote tissue formation, and remove exudate, which are all therapeutic actions.
No
The device is described as an "integrated wound management system" that applies negative pressure to promote wound healing. Its functions are therapeutic, such as removing exudate, promoting tissue formation, and maintaining pressure, and it does not make any diagnoses.
No
The device description clearly states it is a "software-controlled therapy unit" that applies negative pressure and includes hardware components like tubing, a canister, and a therapy unit. While software is a key part of its function, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage wounds by applying negative pressure to promote healing. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The device description details a system that applies negative pressure to a wound bed, removes exudate, and monitors pressure. This is a physical therapy device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze biological samples (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Anatomical Site: The device is applied to the "Wound bed," which is a direct application to the patient's body, not an in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
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.
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)
Nonclinical tests: The new optional, ancillary features were evaluated under a number of verification and validation tests in order to assure conformance to design specifications.
Clinical tests: A review of a large body of clinical data from randomized controlled trials, literature reports, and registry/MDR databases documents the safe use of the predicate V.A.C.® Freedom® Therapy Unit in the home care setting. An engineering analysis of device performance documents that the ActiV.A.C.® and V.A.C. Freedom® are equivalent in the delivery of negative pressure wound therapy, and that ActiV.A.C.® improves upon V.A.C. Freedom® in the elements that affect safety and usability in the home care setting. This analysis concludes that the existing clinical data can be used to predict the safety of the ActiV.A.C.® Therapy System in the home care setting.
Conclusions: Verification and validation testing conducted under design control requirements document that the ActiV.A.C.® Therapy Unit and the predicate V.A.C. Freedom® Therapy Unit are equivalent in terms of technology and performance specifications for the delivery of negative pressure wound therapy. New optional ancillary features have been determined to meet performance specifications. Clinical data supporting the safe use of the V.A.C. Freedom® Therapy Unit in the home care setting are also applicable to the ActiV.A.C.® Therapy Unit.
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.
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
K063692 page 1/3
Image /page/0/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. A registered trademark symbol is located to the bottom right of the letter "I".
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 contact | |
| person | Margaret Marsh; Senior Manager, Regulatory Affairs |
| Name of the device | |
| Trade or | |
| proprietary name | ActiV.A.C.® Therapy Unit |
| Common or usual | |
| name | Negative pressure wound therapy device |
| Classification | |
| name | Powered suction pump |
| Legally marketed | |
| device to which | |
| equivalence is | |
| claimed | The predicate device is the V.A.C. Freedom® Therapy Unit, |
| which was cleared for market entry in the V.A.C.® Family of | |
| Products 510(k) K032310. It was also included in the V.A.C.® | |
| Therapy System 510(k) K062227 which provided text relating | |
| to the mechanism of action for inclusion into the Indications | |
| for Use statement. | |
| Device description | 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. | |
| Intended use of the | |
| device | 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. | |
| Differences in | |
| intended use from the | |
| predicate | The intended use of the device has not changed from the |
| predicate. | |
| Summary of the | |
| technological | |
| characteristics of the | |
| device compared to | |
| the predicate device | 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. | |
| Summary of | |
| nonclinical tests | The new optional, ancillary features were evaluated under a |
| number of verification and validation tests in order to assure | |
| conformance to design specifications. | |
| Summary of clinical | |
| tests | A review of a large body of clinical data from randomized |
| controlled trials, literature reports, and registry/MDR | |
| databases documents the safe use of the predicate V.A.C.® | |
| Freedom® Therapy Unit in the home care setting. | |
| An engineering analysis of device performance documents | |
| that the ActiV.A.C.® and V.A.C. Freedom® are equivalent in | |
| the delivery of negative pressure wound therapy, and that | |
| ActiV.A.C.® improves upon V.A.C. Freedom® in the elements | |
| that affect safety and usability in the home care setting. This | |
| analysis concludes that the existing clinical data can be used | |
| to predict the safety of the ActiV.A.C.® Therapy System in the | |
| home care setting. | |
| Conclusions drawn | |
| from the nonclinical | |
| and clinical tests that | |
| demonstrate that the | |
| device is as safe, as | |
| effective, and | |
| performs as well as or | |
| better than the | |
| predicate device | Verification and validation testing conducted under design |
| control requirements document that the ActiV.A.C.® Therapy | |
| Unit and the predicate V.A.C. Freedom® Therapy Unit are | |
| equivalent in terms of technology and performance | |
| specifications for the delivery of negative pressure wound | |
| therapy. New optional ancillary features have been | |
| determined to meet performance specifications. Clinical data | |
| supporting the safe use of the V.A.C. Freedom® Therapy Unit | |
| in the home care setting are also applicable to the ActiV.A.C.® | |
| Therapy Unit. |
1
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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, with each line slightly offset from the others, creating a sense of depth. The letters "KCI" are large and prominent, making the logo easily recognizable.
2
Image /page/2/Picture/0 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 bold, sans-serif font. A small registered trademark symbol is located to the lower right of the "I".
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design. The text is also in black and arranged to follow the circular shape of the logo.
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
4
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
5
Image /page/5/Picture/0 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. A registered trademark symbol is present to the right of the "I". The logo is black and white.
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.
Petro
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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)