(26 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or methodologies.
Yes
The device is described as an "integrated wound management system" intended to "create an environment that promotes wound healing" by various mechanisms, which directly aligns with a therapeutic purpose.
No
The device is described as an integrated wound management system intended to promote wound healing by creating an environment for closure, reducing edema, promoting granulation tissue formation, and removing exudate and infectious material, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states "V.A.C. Therapy Wound Dressings," which are physical components (dressings) used with a Negative Pressure Wound Therapy System. The performance studies also focus on physical properties like peel adhesion and MVTR, and biocompatibility, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for managing and promoting the healing of wounds by applying negative pressure. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is described as "V.A.C. Therapy Wound Dressings for use with KCI's V.A.C. NPWT System." This refers to components used in the wound therapy system, not a device designed to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening. The focus is entirely on treating the wound itself.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device operates in vivo (on the body) to treat a wound.
N/A
Intended Use / Indications for Use
The 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
V.A.C. Therapy Wound Dressings for use with KCI's V.A.C. NPWT System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed, surgical incisions
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)
The V.A.C. ® Dressing System was evaluated to ensure conformance to the design specifications.
The following tests were conducted:
- Peel adhesion testing
- Moisture vapor transmission rate (MVTR) testing
- Biocompatibility testing according to ISO10993-1
- Study conducted on healthy human volunteers, under design validation (210 CFR 820.30(g)), to ensure that the proposed modified device meets user requirements
There was no clinical study conducted, however, a study was conducted on healthy human volunteers, under design validation (210 CFR 820.30(g)), to ensure that the proposed modified device meets user requirements as there is no reliable method for measuring these requirements on the bench.
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.
Not Found
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.
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510(k) SUMMARY
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NOV 1 9 2013
-K133276.page 1.of 2
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V.A.C. ® Therapy Wound Dressings
| Submitter Information [21 CFR 807.929(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-515-4059 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 1625774 |
| Name of contact person | Melanie Avila |
| Date prepared | 10/23/2013 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary name | V.A.C. ® Negative Pressure Wound Therapy System |
| Common or usual name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and components) |
| Regulation | 878.4780 |
| Product Code(s) | OMP |
| Legally marketed device(s) to which | |
| equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | V.A.C. Therapy Wound Dressings cleared for use under multiple 510(k)s for |
| the KCI V.A.C. Therapy Negative Pressure Wound Therapy Systems. The | |
| most recent 510(k) was K120033. | |
| Device description | |
| [21 CFR 807.92(a)(4)] | V.A.C. Therapy Wound Dressings for use with KCI's V.A.C. NPWT System. |
| 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, 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. |
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- ਸ਼ਾਪੂ
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510(k) SUMMARY
V.A.C. ® Therapy Wound Dressings
Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]
| Characteristic | V.A.C. ® Therapy Wound Dressing System (Modified Device) | V.A.C. ® Therapy Wound Dressing System (Predicate) |
|---|---|---|
| Indicated Wound Type | Same as predicate | Chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts |
| Dressing | Same as predicate | Multiple dressing components |
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
The V.A.C. ® Dressing System was evaluated to ensure conformance to the design specifications.
The following tests were conducted:
- Peel adhesion testing
- Moisture vapor transmission rate (MVTR) testing
- Biocompatibility testing according to ISO10993-1
- Study conducted on healthy human volunteers, under design validation (210 CFR 820.30(g)), to ensure that the proposed modified device meets user requirements
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
There was no clinical study conducted, however, a study was conducted on healthy human volunteers, under design validation (210 CFR 820.30(g)), to ensure that the proposed modified device meets user requirements as there is no reliable method for measuring these requirements on the bench.
Conclusions drawn [21 CFR 807.92(b)(3)]
Testing indicates that the modified V.A.C. ® Therapy Wound Dressing System is substantially equivalent in terms of both indications for use and fundamental scientific technology to the predicate product.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol that resembles an abstract human figure with three curved lines representing arms or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
KCI USA, Incorporated Ms. Melanie Avila Regulatory Affairs Project Manager 6203 Fairnon Drive San Antonio, Texas 78249
November 19, 2013
Re: K133276
Trade/Device Name: V.A.C. Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 23, 2013 Received: October 24, 2013
Dear Ms. Avila:
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 - Ms. Melanie Avila
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ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/Industrv/default.htm.
Sincerely vours.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): __ K.133276 Device Name: _ V.A.C. ® Drape Indications for Use:
The 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 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 Over-The-Counter Use ਮ 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)
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