(39 days)
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.
The V.A.C.® GranuFoam® Silver Protection dressing is one of the V.A.C.® product line of dressings designed specifically for use with the V.A.C.® Family of negative pressure devices. The V.A.C.® GranuFoam® Silver Protection dressing is comprised of black, reticulated, polyurethane foam covered with a silver coating.
Acceptance Criteria and Study for V.A.C.® GranuFoam® Silver Protection Dressing
This device, the V.A.C.® GranuFoam® Silver Protection Dressing, received 510(k) clearance based on its substantial equivalence to a previously cleared predicate device, the V.A.C.® GranuFoam™ Silver Protection Dressing (K050260). The primary change in the current submission was labeling modifications, specifically the removal of a contraindication for use in magnetic resonance environments and the inclusion of labeling for conditions of safe use in such environments.
Therefore, the "acceptance criteria" and "study" are not based on the device's diagnostic performance or clinical effectiveness in the traditional sense, but rather on its safety and compatibility in a specific environment.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and compatibility in a magnetic resonance (MR) environment: The device must demonstrate safe operation and not pose undue risks to the patient or interfere with the MR imaging process when used within a magnetic resonance environment. (Implied requirement for label change) | Verification of safe use in MR environment: "Verification of the conditions for safe use of the V.A.C.® GranuFoam® Silver Protection dressing in a magnetic resonance environment is based on testing in accordance with international performance standards and peer-reviewed published literature." |
| Substantial Equivalence: The device must be shown to be as safe and effective as a legally marketed predicate device for its intended use. | Substantial Equivalence Achieved: The device is concluded to be "substantially equivalent to the V.A.C.® GranuFoam™ Silver Protection dressing (K050260)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a new clinical study. The evaluation focused on testing in accordance with international performance standards and review of peer-reviewed published literature regarding MR safety of similar materials/devices. The document does not specify a "test set" of patients or data in the typical sense of a clinical trial.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The evaluation relies on international performance standards (which are typically defined guidelines and test methods) and peer-reviewed published literature (which could be derived from various sources, but the origin is not specified here).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for MR compatibility is established through adherence to international performance standards and scientific evidence from peer-reviewed published literature, not through expert consensus on a test set of cases. These standards and literature would have been reviewed by individuals with expertise in regulatory affairs, engineering, and medical device safety (likely within the FDA and KCI).
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication. The evaluation was based on demonstrating compliance with technical standards and scientific literature for MR compatibility.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this submission. This type of study is typically used to evaluate the diagnostic performance of software or imaging modalities with and without AI assistance. This device is a wound dressing, not a diagnostic tool requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical wound dressing, not an algorithm, so a standalone performance evaluation in this context is not relevant.
7. The Type of Ground Truth Used
The "ground truth" here is the established scientific and regulatory understanding of magnetic resonance compatibility for medical devices. This is derived from:
- International performance standards: Standards specifically designed to test and assess device safety within MR environments (e.g., ASTM standards for MR safety).
- Peer-reviewed published literature: Existing scientific publications and research related to materials, device designs, and their interactions with MR fields.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for this device, as it is a physical wound dressing and not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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FEB € 2006
510(k) Summary V.A.C.® GranuFoam® Silver Protection Dressing
| 1. Submitter: | KCI USA, Inc (Kinetic Concepts, Inc.)8023 Vantage DriveSan Antonio, TX 78230 |
|---|---|
| 2. Contact Person: | Christy OviattSr. Regulatory Affairs Specialist |
| 3. Date Summary Prepared: | December 2, 2005 |
| 4. Name of Device: | V.A.C.® GranuFoam® Silver ProtectionDressing |
| 5. Classification Name: | Accessory to Powered Suction Pump21 CFR 878.4780Class II |
| 6. Predicate Devices: | V.A.C.® GranuFoam® Silver Protection Dressing(K050261) |
7. Description of Device
The V.A.C.® GranuFoam® Silver Protection dressing is one of the V.A.C.® product line of dressings designed specifically for use with the V.A.C.® Family of negative pressure devices.
8. Indication 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, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.
9. Technological Characteristics and Substantial Equivalence
The V.A.C.® GranuFoam® Silver Protection dressing is comprised of black, reticulated, polyurethane foam covered with a silver coating.
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KCI USA, Inc V.A.C.® GranuFoam® Silver Protection Dressing
The V.A.C.® GranuFoam® Silver Protection dressing is considered substantially equivalent to the V.A.C.® GranuFoam™ Silver Protection dressing (K050260). The only change is to the labeling for the dressing. A contraindication for use in magnetic resonance environments has been removed and labeling has been included for conditions of safe use in the magnetic resonance environment.
Verification of the conditions for safe use of the V.A.C.® GranuFoam® Silver Protection dressing in a magnetic resonance environment is based on testing in accordance with international performance standards and peer reviewed published literature.
10. Conclusion
Based on the information presented above it is concluded that the V.A.C.® GranuFoam® Silver Protection dressing can be marketed for its intended use and is substantially equivalent to the identified predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2009
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K053627
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 28, 2005 Received: December 29, 2005
Dear Ms. Oviatt:
.
This letter corrects our substantially equivalent letter of February 6, 2006.
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
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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 (OS) 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. Pretz
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubare Muchup ofri mkm
(Division Si: Off)
Division of ( eneral, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K053621
§ 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.