(63 days)
The V.A.C. Therapy System 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
The components of the V.A.C.® Therapy System work as an integrated product to optimize both the delivery and the benefits of negative pressure. An open pore foam (reticulated polyurethane foam (GranuFoam®, GranuFoam® Silver, and Abdominal Dressings, etc.) or polyvinyl alcohol foam (Vers-Foam™ Dressing)] is cut to fit the wound, then covered with a semi-permeable adhesive drape. The software-controlled Therapy Unit applies negative pressure to the wound bed. The user can select continuous or intermittent therapy, depending upon wound type and the needs of each patient. The open cells of the foam enable equal distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. T.R.A.C.® (Therapeutic Regulated Accurate Care) technology monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.
Analysis of Acceptance Criteria and Study for K062227 (V.A.C.® Therapy System)
This 510(k) submission (K062227) by KCI USA, Inc. is for a modification to the V.A.C.® Therapy System, specifically a revision to the Indications for Use statement. It's crucial to note that this is not a submission for a new device, but rather an update to the labeling of an already legally marketed device. Therefore, the typical structure for a new device's performance study and acceptance criteria may not apply in the same way.
The submission states: "Because the V.A.C.® Therapy System has not been modified for the purposes of this submission, the predicate products are the V.A.C.® Therapy Family of Products (Therapy Units ATS, Freedom and Instill and their associated disposable components), which were most recently cleared under 510(k)s: K032310 (V.A.C.® ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (V.A.C.® GranuFoam® Silver Protection Dressing) and K022011 (V.A.C.® Abdominal Dressing)."
Furthermore, under the "Summary of nonclinical tests" and "Summary of clinical tests" sections, it explicitly states:
- "Not applicable; no new nonclinical tests were performed for the purposes of this submission."
- "Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature."
This indicates that no new performance studies with pre-defined acceptance criteria were conducted or are being presented in this specific 510(k) for the V.A.C. Therapy System. The basis for the revised Indications for Use relies entirely on published literature documenting the effective use of the V.A.C.® Therapy System.
Therefore, instead of a table of specific acceptance criteria and device performance from this submission, the "acceptance criteria" here is met by demonstrating that the proposed revised indications are consistent with existing scientific and clinical evidence from published literature.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) as an "Indications for Use" revision based on existing literature, a traditional table of acceptance criteria and reported device performance from new studies in this submission is not applicable.
Instead, the "acceptance criteria" here would be demonstrating that the proposed revised indications are supported by the body of existing clinical evidence available in published literature.
| Acceptance Criterion (Implicit for revised Indications for Use) | Basis for Meeting Criterion (from submission) |
|---|---|
| Proposed Indications for Use are supported by clinical evidence | "Published literature documenting the effective use of the V.A.C.® Therapy System in a variety of wound types and clinical situations support the following revision to the Indications for Use statement." |
Reported Device Performance (as inferred from the literature review context): The V.A.C.® Therapy System is reported to effectively:
- Create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention.
- Prepare the wound bed for closure.
- Reduce edema.
- Promote granulation tissue formation and perfusion.
- Remove exudate and infectious material.
- Be indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
- The V.A.C.® GranuFoam® Silver™ Dressing acts as an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
2. Sample Size Used for the Test Set and Data Provenance
As per the submission, "Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature."
Therefore, there is no specific test set or associated sample size detailed within this 510(k) document. The clinical evidence is derived from the broad existing body of published literature on the V.A.C.® Therapy System. Details of specific studies (sample size, provenance, retrospective/prospective nature) would be found within the referenced published literature, which is not provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new clinical study with a defined test set and ground truth establishment process was conducted for this submission. The "ground truth" for the expanded indications is implicitly established by the consensus and findings across the body of published medical literature.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical study with a defined test set requiring adjudication was conducted for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission is not evaluating human reader performance or the improvement with AI assistance. It's focused on the clinical indications for a wound therapy device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The V.A.C.® Therapy System is a physical medical device (negative pressure wound therapy system), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the updated indications is based on published clinical outcomes data and expert consensus as documented in the medical literature. The submission explicitly states: "Published literature documenting the effective use of the V.A.C.® Therapy System in a variety of wound types and clinical situations support the following revision to the Indications for Use statement."
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. If "training set" refers to the data that informed the original clearance of the device, that information would be in the predicate 510(k) submissions, not this one.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device in the context of this 510(k) notification.
In summary: This 510(k) notice is a request for a labeling change (expanded Indications for Use) for an existing medical device. The "study" that proves the device meets the acceptance criteria is explicitly stated as the body of published literature on the V.A.C.® Therapy System, rather than new, dedicated preclinical or clinical studies conducted for this specific submission. Therefore, many of the typical data points for AI/ML device evaluations (test set, training set, expert consensus for ground truth, MRMC studies) are not applicable to this particular 510(k) document.
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K062227 Page 1/2
Image /page/0/Picture/1 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 registered trademark symbol is located to the right of the "I".
OCT - 4 2006
| Date prepared | September 27, 2006 | |
|---|---|---|
| 510(k) Owner | ||
| Name | KCI USA, Inc. | |
| Address | 8023 Vantage Drive San Antonio, TX 78230 | |
| Fax number | 210 255-6727 | |
| Name of contactperson | Margaret Marsh; Senior Manager, Regulatory Affairs | |
| Name of the device | ||
| Trade orproprietary name | V.A.C.® Therapy System | |
| Common or usualname | Negative pressure wound therapy device | |
| Classificationname | Powered suction pump | |
| Legally marketeddevice to whichequivalence isclaimed | Because the V.A.C.® Therapy System has not been modifiedfor the purposes of this submission, the predicate productsare the V.A.C.® Therapy Family of Products (Therapy UnitsATS, Freedom and Instill and their associated disposablecomponents), which were most recently cleared under510(k)s: K032310 (V.A.C.® ATS and V.A.C.® Freedom®Therapy Units), K021501 (V.A.C.® Instill Therapy Unit),K053627 (V.A.C.® GranuFoam® Silver Protection Dressing)and K022011 (V.A.C.® Abdominal Dressing). | |
| Device description | The components of the V.A.C.® Therapy System work as anintegrated product to optimize both the delivery and thebenefits of negative pressure. An open pore foam (reticulatedpolyurethane foam (GranuFoam®, GranuFoam® Silver, andAbdominal Dressings, etc.) or polyvinyl alcohol foam (Vers-Foam™ Dressing)] is cut to fit the wound, then covered with asemi-permeable adhesive drape. The software-controlledTherapy Unit applies negative pressure to the wound bed.The user can select continuous or intermittent therapy,depending upon wound type and the needs of each patient.The open cells of the foam enable equal distribution of thenegative pressure across the surface of the wound, while thetubing transfers accumulated fluids to the canister. T.R.A.C.®(Therapeutic Regulated Accurate Care) technology monitorsand maintains target pressure and alarms as needed to helpassure target pressure is maintained and constant therapy isdelivered. The safety features of the system includeadditional alarms, such as those that signal for tubingblockages, a full or missing collection canister, inactivetherapy, low battery, and leaks in the seal of the dressing. | |
| Intended use of the device | The V.A.C. Therapy System is intended to create anenvironment that promotes wound healing by secondary ortertiary (delayed primary) intention by preparing the woundbed for closure, reducing edema, promoting granulation tissueformation and perfusion, and by removing exudate andinfectious material. It is indicated for patients with chronic,acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flapsand grafts.The V.A.C.® GranuFoam® Silver™ Dressing is an effectivebarrier to bacterial penetration and may help reduce infectionin the above wound types. | |
| Differences inintended use from thepredicate | The intended use of the device has not changed. | |
| Summary of thetechnologicalcharacteristics of thedevice compared tothe predicate device | Design | Same as predicates |
| Materials | Same as predicates | |
| EnergySource | Same as predicates | |
| Summary ofnonclinical tests | Not applicable; no new nonclinical tests were performed forthe purposes of this submission. | |
| Summary of clinicaltests | Not applicable; no new clinical tests were performed for thepurposes of this submission, except as described in thesubmitted literature. | |
| Conclusions | Published literature documenting the effective use of theV.A.C.® Therapy System in a variety of wound types andclinical situations support the following revision to theIndications for Use statement.The V.A.C.® Therapy System is intended to create anenvironment that promotes wound healing bysecondary or tertiary (delayed primary) intention bypreparing the wound bed for closure, reducingedema, promoting granulation tissue formation andperfusion, and by removing exudate and infectiousmaterial. It is indicated for patients with chronic,acute, traumatic, subacute and dehisced wounds,partial-thickness burns, ulcers (such as diabetic orpressure), flaps and grafts.The V.A.C.® GranuFoam® Silver™ Dressing is aneffective barrier to bacterial penetration and may helpreduce infection in the above wound types. |
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K062227 page 2/2
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ekci.
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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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
APR -7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K062227
Trade/Device Name: V.A.C.® Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: July 31, 2006 Received: August 2, 2006
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of October 4, 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 (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,
foe Dott
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: K062227 Device Name: V.A.C. ® Therapy System Indications for Use:
The V.A.C. Therapy System 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flans and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
| Prescription Use(Part 21 CFR 801 Subpart D) | |
|---|---|
| AND/OR | |
| Over-The-Counter Use(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)
(Division (Sign-Off))
Division of General, Restorative
and Neurological Services
(Posted November 13, 2003)
Page ___ of ___
510(k) Number L062227
§ 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.