(148 days)
The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.
When used on open wounds, 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. 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, they are also 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.
Negative pressure wound therapy system for application to surgically closed incisions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the K120033 device:
Based on the provided K120033 510(k) Summary, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with explicit acceptance criteria.
The 510(k) Summary for K120033 states that the "V.A.C. Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use." The primary purpose of this submission is to expand the existing indications for use of the V.A.C. Therapy Systems to include closed surgical incisions, which is an indication already cleared for the predicate device, Prevena Incision Management System.
Therefore, the "acceptance criteria" discussed are centered around demonstrating equivalence to the predicate device's performance for this specific extended indication, rather than quantitative performance metrics for the device itself.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an equivalence submission, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device for the extended indication. There are no explicit quantitative performance metrics or acceptance criteria stated for the device's performance that are typically seen in a de novo study.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Delivery of negative pressure to indicated wound type (closed incisions) | "The subject device was found to be equivalent to the predicate device in delivery of negative pressure to the indicated wound type." |
| Safety, function, and indications for use (for closed incisions) | "Equivalency testing... demonstrated that the systems are equivalent under all test conditions. The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states:
- "Non-clinical tests were not necessary to demonstrate substantial equivalence."
- "Clinical tests were not necessary to demonstrate substantial equivalence."
This indicates that no test set (clinical or non-clinical) with a sample size was used or reported in this 510(k) submission to directly evaluate the device's performance against specific acceptance criteria. The equivalence was established based on existing knowledge of the device's functionality and the predicate's cleared indications. Therefore, there is no information on data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no test set (clinical or non-clinical) was used, no experts were utilized to establish ground truth for a test set within this submission.
4. Adjudication Method for the Test Set
As no test set was used, there was no adjudication method employed or reported in this submission.
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
This device is not an AI-powered diagnostic or assistive tool. It is a negative pressure wound therapy system. Therefore, no MRMC comparative effectiveness study was done and the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (negative pressure wound therapy system), not an algorithm or AI. Therefore, a standalone performance study in this context is not applicable. The "performance data" section states that non-clinical and clinical tests were not necessary to demonstrate substantial equivalence.
7. The Type of Ground Truth Used
Given that no clinical or non-clinical tests were conducted for this specific submission to demonstrate performance, no "ground truth" was established or used in the context of validating a device's performance against a reference standard. The claim is based on the equivalence of the subject device's known functionalities to the predicate device's cleared indications.
8. The Sample Size for the Training Set
This submission is not for an AI model or a device that requires a training set. Therefore, there is no training set or associated sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is not applicable.
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MAY 31 20晚
510(k) SUMMARY
.
| Submitter Information [21 CFR 807.929(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon DriveSan Antonio, TX 78249 |
| Phone number | 210-515-4368 |
| Fax number | 210-255-6727 |
| EstablishmentRegistration Number | 1625774 |
| Name of contact person | Shannon Scott, Regulatory Affairs Senior Manager |
| Date prepared | March 30, 2012 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietaryname | V.A.C. Therapy System, ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom,V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems |
| Common or usual name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and components) |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4780 |
| Product Code(s) | OMP |
| Legally marketeddevice(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)] | Prevena Incision Management System (K100821) |
| Device description[21 CFR 807.92(a)(4)] | Negative pressure wound therapy system for application to surgically closedincisions. |
| Indications for use[21 CFR 807.92(a)(5)] | The ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, andV.A.C. Simplicity Negative Pressure Wound Therapy Systems are integratedwound management systems for use in acute, extended and home caresettings.When used on open wounds, they are intended to create an environment thatpromotes wound healing by secondary or tertiary (delayed primary) intentionby preparing the wound bed for closure, reducing edema, promotinggranulation tissue formation and perfusion, and by removing exudate andinfectious material. Open wound types include: chronic, acute, traumatic,subacute and dehisced wounds, partial-thickness burns, ulcers (such asdiabetic, pressure or venous insufficiency), flaps and grafts.When used on closed surgical incisions, they are also intended to manage theenvironment of surgical incisions that continue to drain following sutured orstapled closure by maintaining a closed environment and removing exudatesvia the application of negative pressure wound therapy. |
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Differences in intended use from the " _ _ _ " " = predicate(s) - - -
The intended use for the subject devices has been expanded to include closed surgical incisions. This use is consistent with the indications for use cleared for the Prevena Incision Management System under 510(k) K100821.
Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]
The subject device was found to be equivalent to the predicate device in delivery of negative pressure to the indicated wound type. The devices are equivalent in terms of functional components.
| Characteristic | New DeviceV.A.C. Therapy Systems | PredicatePrevena™ Incision Management SystemK100821 |
|---|---|---|
| Indicated wound types | Chronic, acute, traumatic,subacute and dehisced wounds,partial-thickness burns, ulcers(such as diabetic, pressure orvenous insufficiency), flaps, graftsand surgical incisions. | Closed surgical incisions |
| Dressing | Multiple dressing components | Single, one size, multi-layer dressing. |
| Therapy unit | Multiple patient use; battery andAC powered | Single patient use only; battery powered |
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)] [
Non-clinical tests were not necessary to demonstrate substantial equivalence.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]» بين تريب الانتراب بين ت
Clinical tests were not necessary to demonstrate substantial equivalence.
Conclusions drawn [21 CFR 807.92(b)(3)]
Equivalency testing of the V.A.C. Therapy Systems to the Prevena Incision Management System with respect to delivery of negative pressure wound therapy demonstrated that the systems are equivalent under all test conditions. The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the organization's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
MAY 3 1 2012
KCI USA, Inc. % Ms. Shannon Scott Regulatory Affairs Senior Manager 6203 Farinon Drive San Antonio, Texas 78249
Re: K120033
Trade/Device Name: Activac Therapy Unit and Infovac Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered sunction pump Regulatory Class: Class II Product Code: OMP Dated: May 25, 2012 Received: May 29, 2012
Dear Ms. Shannon Scott:
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
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Page 2 - Ms. Scott
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 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/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,
For
Mark N. Melkerson
Dep Clin Dir
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ki20033
INDICATIONS FOR USE
510(k) Number (if known): K120033
Device Name: ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Neqative Pressure Wound Therapy Systems
Indications for Use:
The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.
When used on open wounds, 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. 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, they are also 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.
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 Knaefler MM
(Division Sign-Off)
Page _ of _
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120033
(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.