(222 days)
No
The summary describes a wound dressing with a silver coating and its use with negative pressure devices. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is indicated for promoting wound healing and reducing infection, which are therapeutic functions.
No
The device is a dressing designed to create a barrier to bacterial penetration and promote wound healing, not to diagnose a condition.
No
The device description clearly states it is a physical dressing (foam) with a silver coating, designed for use with negative pressure devices, indicating it is 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 wound dressing used in conjunction with negative pressure devices to promote wound healing and act as a barrier to bacterial penetration. This is a therapeutic and protective function applied directly to the patient's wound.
- Device Description: The description details a modified wound dressing with a silver coating.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is applied externally to a wound.
- Performance Studies: The performance studies focus on the barrier function, biocompatibility, and antimicrobial effectiveness of the dressing itself, not on analyzing biological samples.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (on the body) for wound treatment and protection.
N/A
Intended Use / Indications for Use
The V.A.C. GranuFoam Silver Dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C. family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial burns.
Product codes
OMP
Device Description
The V.A.C.® GranuFoam™ Silver dressing is a modification to the V.A.C. product line of black, reticulated, polyurethane foam dressings, designed specifically for use with the V.A.C. family of feedback-controlled devices, including the miniV.A.C. 9, V.A.C.® Freedom™ and V.A.C.® ATS™ systems, all currently marketed by KCI under 510(k) K032310. The modification is the addition of a silver containing coating to the GranuFoam™ dressing to allow for a silver option to the dressing line.
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
Comparative bench testing was conducted on V.A.C. GranuFoam Silver barrier. dressing and Acticoat 7 Antimicrobial dressing.
The gamma-irradiated V.A.C. GranuFoam Silver Dressing was tested under GLP studies in accordance with ISO-10993 for a surface device in contact with breached or compromised surface with prolonged duration. The dressing was shown to be nontoxic, non-irritating and non-sensitizing.
Antimicrobial effectiveness of the silver in the dressing was addressed in separate invitro laboratory evaluations using licensed commercial reference laboratories.
Key Metrics
Not Found
Predicate Device(s)
V.A.C.® GranuFoam™ dressing (K032310), Acticoat 7 Day Antimicrobial Dressing (K001519)
Reference Device(s)
Not Found
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
Qúze "1/2
510(k) Summary
V.A.C.® GranuFoam™ Silver Dressing
| 1. | Name/Address of Submitter: | Kinetic Concepts, Inc.
8023 Vantage Drive
San Antonio, TX 78265-9508 |
|----|----------------------------|------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Judith Harbour, Manager Regulatory Affairs |
| 3. | Date Summary Prepared: | June 16, 2004 |
| 4. | Name of Device: | V.A.C.® GranuFoam™ Silver Dressing |
| 5. | Classification Name: | Accessory to Powered Suction Pump
21 CFR 878.4780
Class II |
| 6. | Predicate Devices: | V.A.C.® GranuFoam™ dressing (K032310)
Acticoat 7 Day Antimicrobial Dressing (K001519) |
Description of Device 7.
The V.A.C.® GranuFoam™ Silver dressing is a modification to the V.A.C. product line of black, reticulated, polyurethane foam dressings, designed specifically for use with the V.A.C. family of feedback-controlled devices, including the miniV.A.C. 9, V.A.C.® Freedom™ and V.A.C.® ATS™ systems, all currently marketed by KCI under 510(k) K032310. The modification is the addition of a silver containing coating to the GranuFoam™ dressing to allow for a silver option to the dressing line.
8. Indication For Use
The V.A.C.® GranuFoam™ Silver dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C.® Family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.
9. Technological Characteristics and Substantial Equivalence
The substantial equivalence for the V.A.C®. GranuFoam™ Silver dressing is based on the indications, intended use and technological features. It is also substantially equivalent to Smith and Nephew's Acticoat 7 Antimicrobial dressing (K001519) and several other silver dressings currently on the market, in terms of an antimicrobial
1
K041642 page 2/2
Comparative bench testing was conducted on V.A.C. GranuFoam Silver barrier. dressing and Acticoat 7 Antimicrobial dressing.
The gamma-irradiated V.A.C. GranuFoam Silver Dressing was tested under GLP studies in accordance with ISO-10993 for a surface device in contact with breached or compromised surface with prolonged duration. The dressing was shown to be nontoxic, non-irritating and non-sensitizing.
Antimicrobial effectiveness of the silver in the dressing was addressed in separate invitro laboratory evaluations using licensed commercial reference laboratories.
10. Conclusion
Based on the information presented above it is concluded that the V.A.C.® GranuFoam™ Silver dressing can be marketed for its intended use and is substantially equivalent to the identified predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
APR -7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K041642
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: December 30, 2004 Received: January 3, 2005
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of January 25, 2005.
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 (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
3
Page 2 - Ms. Christy Oviatt
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
f/R Peter Humm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K041642
Device Name: V.A.C. GranuFoam Silver Dressing
Indications For Use: The V.A.C. GranuFoam Silver Dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C. family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial burns.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
| Page 1 of 1 |
|---|
| ------------- |
510(k) Number_________________________________________________________________________________________________________________________________________________________________