(139 days)
Not Found
No
The document describes a negative pressure wound therapy system with an instillation option. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing described is focused on mechanical properties, fluid distribution, and biological response, not algorithmic performance.
Yes
The device is described as an "integrated wound management system that provides Negative Pressure Wound Therapy" and is intended to "promote wound healing." These are clear therapeutic objectives.
No
The device is intended for wound treatment and healing, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "dressing component of a negative pressure wound therapy system with an instillation feature," indicating it is a physical hardware component. The performance studies also describe bench tests and animal models, which are typical for evaluating physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The V.A.C.Ulta Negative Pressure Wound Therapy System is a therapeutic device that applies negative pressure and potentially instillation directly to a wound on the body. It is used to promote wound healing, not to analyze samples taken from the body.
- Intended Use: The intended use clearly describes treating wounds on a patient's body, not performing diagnostic tests on biological samples.
- Device Description: The description focuses on the dressing component and its function in applying negative pressure and instillation to the wound bed.
- Performance Studies: The performance studies described involve bench tests with simulated wound models, an acute swine model, and biocompatibility testing. These are typical for a therapeutic device, not an IVD which would involve clinical studies analyzing patient samples.
Therefore, the V.A.C.Ulta Negative Pressure Wound Therapy System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation 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.
The instillation option 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.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
A dressing component of a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions
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
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The V.A.C. VeraFlo Cleanse System was evaluated under a number of design verification and validation tests that assure conformance to design specifications.
The following tests were conducted on the V.A.C. VeraFlo Cleanse System: Negative pressure distribution measurements (bench test with simulated wound model). Visual observation of fluid distribution in the dressing and simulated wound bed (bench test with simulated wound model). Mechanical properties (tensile and tear strength per ASTM 3574-08 tests) Granulation tissue formation and wound fill response in an acute swine model. Cytotoxicity, irritation, and sensitization testing was performed in accordance to ISO 10993-1 standards, and results demonstrated that the device is biocompatible according to these standards. The device was shown to meet all performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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K103156
p. 1/3
510(k) SUMMARY
MAR 1 4 2011
| Date prepared | February 16, 2011 |
|---|---|
| 510(k) owner | KCI, Inc. |
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| Fax number | 210 255-6727 |
| Name of contact person | Margaret Marsh |
| Contact telephone number | 1 800 275-4524; Request Regulatory Affairs. |
| Name of the device | |
| Trade or proprietary name | V.A.C. VeraFlo Cleanse Dressing System |
| Common or usual name | Negative pressure wound therapy dressing |
| Classification name | Dressing component for use with a Negative Pressure Wound Therapy |
| Powered Suction Pump | |
| Legally marketed device(s) to which equivalence is claimed | V.A.C. VeraFlo Dressing, a component of the V.A.C.Ulta Negative |
| Pressure Wound Therapy System (K100657) | |
| Device description | A dressing component of a negative pressure wound therapy system with |
| an instillation feature which allows controlled delivery and drainage of | |
| topical wound treatment solutions and suspensions | |
| Device design | Negative pressure wound therapy system, in which instillation of topical |
| wound treatment solutions and suspensions and negative pressure | |
| wound therapy is provided via software controlled pumps. Instillation | |
| solutions and negative pressure are delivered through tubing to foam | |
| dressings in the wound covered by an occlusive drape. Software | |
| provides controls for both negative pressure wound therapy and delivery | |
| of instillation therapy. Software also provides controls for help and alarm | |
| functions. |
1
KIO3I56
P.243
| Intended use of the
device | The V.A.C.Ulta Negative Pressure Wound Therapy System is an
integrated wound management system that provides Negative Pressure
Wound Therapy with an instillation option. | | |
|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Negative Pressure Wound Therapy in the absence of instillation 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. | | |
| | The instillation option 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.Ulta Negative Pressure Wound Therapy System with and
without instillation is indicated for patients with chronic, acute, traumatic,
sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as
diabetic, pressure and venous insufficiency), flaps and grafts. | | |
| Summary of the
technological
characteristics of
the device,
compared to the
predicate device. | Feature | VeraFlo Cleanse
Dressing | VeraFlo Dressing
(predicate) |
| | Dressing
system
components | Same as predicate | Foam based dressing with
occlusive drape and
negative pressure/
instillation tubing |
| | Patient
contact
materials of
construction | Same as predicate, except
for slightly less colorant | Polyurethane ester foam
with polyurethane drape |
2
| Summary of tests
conducted | The V.A.C. VeraFlo Cleanse System was evaluated under a number of
design verification and validation tests that assure conformance to design
specifications.
The following tests were conducted on the V.A.C. VeraFlo Cleanse
System: Negative pressure distribution measurements (bench test with
simulated wound model). Visual observation of fluid distribution in the dressing and
simulated wound bed (bench test with simulated wound model). Mechanical properties (tensile and tear strength per ASTM 3574-
08 tests) Granulation tissue formation and wound fill response in an acute
swine model. Cytotoxicity, irritation, and sensitization testing was performed in
accordance to ISO 10993-1 standards, and results demonstrated
that the device is biocompatible according to these standards. The device was shown to meet all performance requirements. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions drawn | Testing demonstrates that the V.A.C. VeraFlo Cleanse System is
substantially equivalent in terms of both indications for use and
technology to the predicate product. |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
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
MAR 1 4 201
Re: K103156
Trade/Device Name: V.A.C. VeraFlo Cleanse Dressing System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: February 16, 2011 Received: February 17, 2011
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. Ilsting 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
4
Page 2 - Ms. Margaret Marsh
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 Pat 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/Safcty/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Alig 13. R. h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: V.A.C. VeraFlo Cleanse Dressing System
Indications for Use:
(Posted November 13, 2003)
The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation 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.
The instillation option 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.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Over-The-Counter Use Prescription Use X 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)
David Krosky MXM
(Division Sign-Off) Page _ of _
Division of Surgical, Othopedic, and Restorative Devices
510(k) Number K03156