(72 days)
No
The summary describes a wound dressing with a silver coating and its use with a negative pressure wound therapy system. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as "intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing" and "may help reduce infection," indicating a therapeutic purpose.
No
This device is a wound dressing designed to help promote wound healing and act as a bacterial barrier. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "polyurethane foam with a silver coating," indicating it is a physical dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help promote wound healing" and act as a "barrier to bacterial penetration" in various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a "polyurethane foam with a silver coating" used as a "component of the V.A.C. Therapy System" for "negative pressure wound management." This describes a physical dressing used in a treatment system.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting specific biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies mentioned focus on "antibacterial activity," which relates to the therapeutic function of the silver coating, not a diagnostic function.
IVD devices are used 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. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
Product codes
OMP
Device Description
The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C. Therapy System which is an integrated negative pressure wound management system. The dressing is polyurethane foam with a silver coating designed specifically for use with the V.A.C. family of negative pressure wound therapy devices.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies of the antibacterial activity of the predicate device were previously conducted against S. aureus, P. aeruginosa, and E. coli. In support of the proposed change to the product specification, testing has been conducted and the product has been shown to pass these tests with equivalent results.
No clinical tests were necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for KCI. The logo consists of a stylized graphic to the left of the letters "KCI". The graphic is made up of four curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows handwritten text. The first line reads "K102956". The second line reads "pg 1 of 2", indicating it is page 1 of 2.
510(k) SUMMARY V.A.C. GranuFoam Silver Protection Dressing
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 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 | 210.515.4126 |
| Fax number | 210.255.6727 |
| Establishment | |
| Registration Number | 1625774 |
| Name of contact | |
| person | Shannon Scott, Regulatory Affairs Manager |
| Date prepared | December 14, 2010 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | V.A.C. GranuFoam Silver® Protection Dressing |
| Common or usual | |
| name | Negative pressure wound therapy dressing |
| Classification name | Negative pressure wound therapy powered suction pump |
| Classification panel | General and Plastic Surgery |
| 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. GranuFoam Silver Protection Dressing (K053627) |
| Device description | |
| [21 CFR 807.92(a)(4)] | The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C. |
| Therapy System which is an integrated negative pressure wound management | |
| system. The dressing is polyurethane foam with a silver coating designed | |
| specifically for use with the V.A.C. family of negative pressure wound therapy | |
| devices. | |
| Indications for use | |
| [21 CFR 807.92(a)(5)] | The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the |
| V.A.C. family of negative pressure wound therapy systems to help promote wound | |
| healing. The dressing is an effective barrier to bacterial penetration and may help | |
| reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, | |
| partial thickness burns, ulcers (such as diabetic, pressure or venous | |
| insufficiency), flaps and grafts. |
DEC 1 5 2010
1
Image /page/1/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 small registered trademark symbol appears to the right of the "I".
K102956
pg 2082
510(k) SUMMARY V.A.C. GranuFoam Silver Protection Dressing
| Summary of the technological characteristics of the device compared to the predicate device
| [21 CFR 807.92(a)(6)] | ||
|---|---|---|
| Characteristic | New Device | |
| V.A.C. GranuFoam | ||
| Silver Protection Dressing | Predicate | |
| V.A.C. GranuFoam | ||
| Silver Protection Dressing | ||
| K053627 | ||
| Indications for use | Same as predicate with the | |
| addition of venous insufficiency | ||
| ulcers, cleared under 510(k) | ||
| K091585. |
The V.A.C. GranuFoam Silver
Protection Dressing is intended
for use with the V.A.C. family of
negative pressure wound therapy
systems to help promote wound
healing. The dressing is an
effective barrier to bacterial
penetration and may help reduce
infection in 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
Protection Dressing is intended
for use with the V.A.C. family of
negative pressure wound
therapy systems to help promote
wound healing. The dressing is
an effective barrier to bacterial
penetration and may help reduce
infection in chronic, acute,
traumatic, subacute, and
dehisced wounds, diabetic
ulcers, pressure ulcers, flaps,
grafts and partial thickness
burns. |
| Dressing composition | Same as predicate | Black, reticulated, polyurethane
foam with silver coating |
| Antibacterial activity | Same as predicate | Studies of antibacterial activity
against S. aureus, P.
aeruginosa, and E. coli. |
| Performance Data [21 CFR 807.92(b)] | | |
| [21 CFR 807.92(b)(1)]
Summary of non-clinical tests conducted for determination of substantial equivalence | Studies of the antibacterial activity of the predicate device were previously conducted against S. aureus, P.
aeruginosa, and E. coli. In support of the proposed change to the product specification, testing has been
conducted and the product has been shown to pass these tests with equivalent results. | |
| [21 CFR 807.92(b)(2)]
Summary of clinical tests conducted for determination of substantial equivalence or of clinical
information | No clinical tests were necessary. | |
| Conclusions drawn [21 CFR 807.92(b)(3)] | The V.A.C. GranuFoam Silver Protection Dressing and its predicate (K053627) are identical in product
design, composition and processing. V.A.C. GranuFoam Silver Protection Dressing is substantially
equivalent to its predicate (K053627) in terms of safety, function and indications for use. | |
2
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
KCI USA, Inc. % Shannon Scott Regulatory Affairs Manager 6203 Fairnon Drive San Antonio, Texas 78249
DEC 15 2019
Re: K102956
Trade/Device Name: V.A.C. GranuFoam Silver Protection Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: November 22, 2010 Received: November 23, 2010
Dear 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 misleding.
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
3
Page 2 - Shannon Scott
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 801); good manufacturing of medical
forth in the quality systems (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control (QD) regulation (21 CFR Part 820); and if applicable, the elections 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/AboutEDA/CentersOff go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/11/20/2019
the Center for Devices and Radiological Hoolth in ODE DRH/CDRHOffices/ucm/11/5809.htm for the Center for Devices and Radiological Health's (CDRH's) Offices/ucm1115809.html for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, p note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part and of the other chance, "Insolanding of Ference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regu 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 the many of the Act from the
(800) 638-2041 or (301) 796-7100 or at its International and (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Harvard Business Resources for You/industry/default.htm.
Sincerely yours,
Az 13-nt
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
102956
DEC 1 5 2010
INDICATIONS FOR USE
510(k) Number (if known): Device Name: V.A.C. GranuFoam Silver Protection Dressing Indications for Use:
The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
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)
David Kume for MXM
Division Sign-Off
Division of Surgical, Orthopedic, and Restorative Devices
Page of
(Posted November 13, 2003)
510(k) Number K102956
Page 1