(111 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 an addition to the V.A.C. 9 product line of dressings designed specifically for use with the V.A.C. 0 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.
The provided text describes the V.A.C. GranuFoam Silver Protection Dressing and its substantial equivalence to predicate devices, focusing on its use as an antimicrobial barrier and for negative pressure wound therapy. However, the details required to fill out a comprehensive table of acceptance criteria and a detailed study description for a typical AI/device performance evaluation are not fully present in the document.
Here's an attempt to extract and infer information based on the provided text, and point out where information is missing for a complete response:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Performance Threshold) | Reported Device Performance |
|---|---|
| Antimicrobial Barrier Effectiveness: Substantially equivalent to predicate devices (V.A.C. GranuFoam™ Silver dressing, Johnson & Johnson Silvercel™ Wound dressing) in terms of antibacterial effectiveness. | "Comparative in vitro testing to demonstrate antibacterial effectiveness was conducted on the V.A.C. GranuFoam® Silver Protection dressing, the V.A.C. GranuFoam® Silver dressing and the Johnson & Johnson Silvercel™ Wound dressing." (The specific results or a quantitative comparison demonstrating "equivalence" are not provided.) |
| Compatibility with V.A.C. Negative Pressure Systems: Substantially equivalent to predicate devices (V.A.C. GranuFoam® Silver dressing, V.A.C. GranuFoam® dressing) for use with V.A.C. family of negative pressure devices to promote wound healing including fluid removal. | "Comparative bench testing was conducted to provide evidence of equivalence in physical properties of the three dressings." (Specific physical properties and the results demonstrating "equivalence" are not detailed.) |
| Biocompatibility: Meets GLP testing standards in accordance with ISO-10993. | "Verification of the biocompatibility of the V.A.C. GranuFoam® Silver Protection dressing is based on GLP testing of the gamma-irradiated dressing in accordance with ISO-10993." (Specific test results or a quantitative statement of compliance are not provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the comparative in vitro or bench testing. The document refers to "testing" and "conducted on the dressings," but doesn't provide numbers of samples or experimental runs.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described appears to be laboratory-based ("in vitro testing", "bench testing") rather than involving human subjects. Therefore, a "retrospective or prospective" classification isn't directly applicable in the typical clinical study sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The studies mentioned (in vitro, bench testing) are not clinical studies involving expert interpretation or "ground truth" establishment in a diagnostic context. They assess material properties and antimicrobial activity.
4. Adjudication method for the test set
- Not applicable. As per point 3, this is not a study where expert adjudication would be relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device (dressing) submission, not an AI/diagnostic software submission. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used
- For Antimicrobial Barrier Effectiveness: The "ground truth" would be established by microbiological laboratory standards and comparison to the known antibacterial performance of the predicate devices. The specific metrics (e.g., zone of inhibition, bacterial log reduction) are not detailed.
- For Compatibility with V.A.C. Negative Pressure Systems: The "ground truth" would be established by engineering specifications and performance characteristics (e.g., fluid handling capacity, tensile strength, pore size) of the predicate devices.
- For Biocompatibility: The "ground truth" is established by the international standard ISO-10993, which outlines methods for evaluating biological responses to medical devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. As per point 8, this is not an AI/machine learning device.
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K0T0261
1/2
MAY 2 6 2005
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: | February 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 Dressing (K041642)V.A.C.® GranuFoam® Dressing (K032310)Johnson & Johnson Silvercel™ Wound Dressing(K024298) |
7. Description of Device
The V.A.C. Granufoam Silver Protection dressing is an addition to the V.A.C. 9 product line of dressings designed specifically for use with the V.A.C. 0 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. 8 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.
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Keror261
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KCI USA, Inc V.A.C.® GranuFoam® Silver Protection Dressing
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. The substantial equivalence for the V.A.C. GranuFoam Silver Protection dressing is based on the indications, intended use and technological features.
The V.A.C. GranuFoam® Silver Protection dressing is considered substantially equivalent to the V.A.C. GranuFoam™ Silver dressing (K.041642) and the Johnson & Johnson Silvercel Wound Dressing (K024298) in terms of an antimicrobial barrier. Comparative in vitro testing to demonstrate antibacterial effectiveness was conducted on the V.A.C. GranuFoam® Silver Protection dressing, the V.A.C. GranuFoam® Silver dressing and the Johnson & Johnson Silvercel™ Wound dressing.
The V.A.C. GranuFoam® Silver Protection dressing is considered substantially equivalent to the V.A.C. GranuFoam® Silver dressing (K041642) and the V.A.C. GranuFoam® dressing (K032310) in terms of use with the V.A.C. family of negative pressure devices used to help promote wound healing through means including drainage and removal of infectious material or other fluids. Comparative bench testing was conducted to provide evidence of equivalence in physical properties of the three dressings.
Verification of the biocompatibility of the V.A.C. GranuFoam® Silver Protection dressing is based on GLP testing of the gamma-irradiated dressing in accordance with ISO-10993.
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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the caduceus symbol.
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: K050261
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: April 25, 2005 Received: April 26, 2005
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of May 26, 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
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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 (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,
Fok Dottor
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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KOTO261
Indications for Use
510 (k) Number (if known): K050261
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)
(vision Sign-Off)
Division of General, Restorative
and Neurological Devices
Page 1 of 1
§ 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.