(210 days)
The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. They are 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. They are 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. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
The V.A.C. Instill® Therapy System is indicated for patients who would benefit from V.A.C.® Therapy coupled with controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It is intended 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 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 provided text describes a 510(k) summary for the V.A.C.® Therapy Systems, focusing on an expanded indication for use to include venous insufficiency ulcers. However, it explicitly states that no clinical or non-clinical studies were required for this change in indication, and therefore, no performance metrics or detailed study results are provided to define or prove acceptance criteria.
The submission relies on existing medical literature to document acceptable clinical experience with the V.A.C.® Therapy System for treating venous insufficiency ulcers. This means the acceptance criteria are implicitly those established by prior regulatory approvals and clinical use of the V.A.C.® Therapy System for its previously approved indications, and the "proof" is the existing body of medical literature.
Therefore, many of the requested details about acceptance criteria and studies cannot be extracted directly from this document.
Here's what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for clinical performance. The implicit acceptance criterion for the expanded indication is that the device's performance for venous insufficiency ulcers is "acceptable" and equivalent to its performance for previously approved indications, as supported by existing medical literature.
- Reported Device Performance: No specific performance metrics (e.g., wound healing rates, reduction in edema, granulation tissue formation rates) are reported in this document related to venous insufficiency ulcers from a new study. The document only references "acceptable clinical experience using the V.A.C.® Therapy System to treat venous insufficiency ulcers" in medical literature.
2. Sample size used for the test set and the data provenance:
- Not applicable. No new test set or clinical study was conducted for this submission. The "data provenance" is "Medical literature."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new test set or ground truth establishment process is described.
4. Adjudication method for the test set:
- Not applicable. No new test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not a study involving AI or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a negative pressure wound therapy system, not an algorithm.
7. The type of ground truth used:
- Medical Literature / Existing Clinical Experience: The "ground truth" for the expanded indication of venous insufficiency ulcers is based on the established clinical effectiveness and safety of the V.A.C.® Therapy System as documented in medical literature over time for wound healing, which is considered sufficient evidence for this 510(k) submission.
8. The sample size for the training set:
- Not applicable. No new training set was used for a device modification of this nature (expanded indication based on existing literature).
9. How the ground truth for the training set was established:
- Not applicable. No new training set or ground truth establishment process is described.
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K091585
pg 1 of 2
510(k) SUMMARY
DEC 2 9 2009
| Date prepared | December 23, 2009 |
|---|---|
| 510(k) owner | |
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| Fax number | 210 255-6727 |
| Name of contactperson | Margaret Marsh |
| Name of thedevice | |
| Trade orproprietaryname | V.A.C.® Therapy Systems |
| Common orusual name | Negative Pressure Wound Therapy Systems |
| Classificationname | Negative Pressure Wound Therapy Powered Suction Pump (andcomponents) |
| Legally marketeddevice(s) to whichequivalence isclaimed | V.A.C.® Therapy System Family of Products |
| Device description | The software-controlled therapy unit applies negative pressure to thewound bed. The open cells of the V.A.C.® Foam Dressing to which thetherapy unit is connected enable distribution of the negative pressureacross the surface of the wound, while the tubing transfers accumulatedfluids to the canister. The software monitors and maintains target pressureand alarms as needed to help assure target pressure is maintained andconstant therapy is delivered. |
V.A.C.® Therapy Systems
{1}------------------------------------------------
| Intended use ofthe device | The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® TherapySystems are integrated wound management systems for use in acute,extended and home care settings. They are intended to create anenvironment 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. They are indicated forpatients with chronic, acute, traumatic, subacute and dehisced wounds,partial-thickness burns, ulcers (such as diabetic, pressure or venousinsufficiency), flaps and grafts.The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterialpenetration and may help reduce infection in the above wound types. |
|---|---|
| The V.A.C. Instill® Therapy System is indicated for patients who wouldbenefit from V.A.C.® Therapy coupled with controlled delivery of topicalwound treatment solutions and suspensions over the wound bed. It isintended for patients with chronic acute, traumatic, subacute and dehiscedwounds, partial thickness burns, ulcers (such as diabetic, pressure, orvenous insufficiency), flaps and grafts. | |
| Differences inintended usefrom thepredicate(s) | The only difference between the current and the predicate products is inthe addition of venous insufficiency ulcers to the Indications for Usestatement. |
| Summary of thetechnologicalcharacteristics ofthe devicecompared to thepredicate device | The technological characteristics of the V.A.C.® Therapy System Family ofProducts is unchanged. |
| Summary ofnonclinical tests | None required for the change in indication |
| Summary ofclinical tests | Medical literature documents acceptable clinical experience using theV.A.C.® Therapy System to treat venous insufficiency ulcers. |
:
. . . . . . . . .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
KCI USA % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249
DEC 2 9 2009
Re: K091585
Trade/Device Name: V.A.C. Therapy System; V.A.C. Instillamet (V.A.C. 9 Instill) Regulation Number: 21 CFR 878-4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 12, 2009 Received: October 13, 2009
Dear Ms. Marsh:
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.
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
{3}------------------------------------------------
Page 2 - Ms. Margaret Marsh
device-related adverse events) (21 CFR 803); 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.
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/CDRH0ffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
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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K091585
pg 1 of 2
INDICATIONS FOR USE
510(k) Number (if known): K091585
Device Name: V.A.C.® Therapy System
Indications for Use:
The ActiV.A.C.®, InfoV.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. They are 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. They are 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. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
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)
Daniel Kramer for MXM Page 1 of 1
(Posted November 13, 2003)
Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091585
{5}------------------------------------------------
K09 1585
pg 2 of 2
INDICATIONS FOR USE
510(k) Number (if known):
KOGISSS
Device Name: V.A.C. Instillamat (V.A.C.® Instill)
Indications for Use:
The V.A.C. Instill device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. Instill is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (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)
Daniel Krone for UXM
Division of Surgical, Orthopedic. and Restorative Devices
Page ⊥ of ⊥
(Posted November 13, 2003)
510(k) Number
§ 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.