(171 days)
The V.A.C.® Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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 InfoV.A.C.® Therapy System is designed for the application of V.A.C.® Therapy in the acute, extended and home care settings. The software-controlled therapy unit applies negative pressure to the wound bed. The open cells of the V.A.C.® foam dressing to which the therapy unit is connected enable distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. The software 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. Optional features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a Screen Guard feature that prevents unintentional screen changes, an exportable Therapy History Report, and a Log Tool for recording canister changes, dressing changes and dressing pieces used. Another new optional feature is the ability to receive and store digital images of the patient's wound throughout the healing process. By tracing the wound perimeter on the digital image, wound area can be calculated by the software. If the user inputs a wound depth value, wound volume can also be calculated. Wound images and area/volume calculations can be electronically transferred via a Patient History Report.
The provided text describes the InfoV.A.C.® Therapy Unit, a negative pressure wound therapy device. It does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria in a quantitative manner as typically requested for AI/ML device evaluations. Instead, the document focuses on demonstrating substantial equivalence to predicate devices and detailing the new optional features.
However, I can extract information related to the device's performance assertions and the general nature of the studies conducted.
Here's a breakdown of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria (e.g., specific sensitivity, specificity, or AUC targets) nor does it report specific numerical performance metrics for the InfoV.A.C.® Therapy Unit in the context of wound analysis. The performance is primarily assessed through verification and validation testing to assure "performance and conformance to design specifications" for its new features, and through a comparative analysis to predicate devices for its core function.
| Feature/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Negative pressure delivery | Equivalent to predicate devices (V.A.C.® ATS and V.A.C. Freedom®) | "Same technology and performance specifications for the delivery of negative pressure wound therapy." |
| Alarms (tubing blockages, full/missing canister, inactive therapy, low battery, leaks) | Functionality as designed to assure target pressure and constant therapy, and to signal issues. | "additional alarms... help assure target pressure is maintained and constant therapy is delivered." |
| Seal Check™ (optional) | Ability to identify dressing leaks. | Designed to identify dressing leaks. |
| Therapy Settings Guide (optional) | Provides options based on KCI Clinical Guidelines. | Provides options for therapy settings. |
| Screen Guard feature (optional) | Prevents unintentional screen changes. | Prevents unintentional screen changes. |
| Exportable Therapy History Report (optional) | Generates a report of therapy history. | Generates an exportable report. |
| Log Tool (optional) | Records canister changes, dressing changes, and dressing pieces used. | Records specified events. |
| Digital image storage and wound analysis (area/volume calculation) (optional) | Ability to receive and store digital images, calculate wound area, and optionally wound volume. | "ability to receive and store digital images...By tracing the wound perimeter...wound area can be calculated...If the user inputs a wound depth value, wound volume can also be calculated." |
| Electronic transfer of wound data (optional) | Ability to transfer images and calculations via Patient History Report. | Wound images and area/volume calculations can be electronically transferred. |
| Safety and Usability (Home Care) | Equivalent to or improved over V.A.C. Freedom® in elements affecting safety and usability. | "InfoV.A.C.® improves upon V.A.C. Freedom® in the elements that affect safety and usability in the home care setting." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of evaluating an AI/ML algorithm with a specific sample size. The "non-clinical tests" involved "verification and validation tests," but no sample sizes for these tests (e.g., number of wound images or wound measurements) are provided.
For the clinical context, the document states: "A review of a large body of clinical data from prospective randomized controlled trials, comparative and retrospective studies, payor/provider data, and retrospective review of independent electronic medical record data documents the safe use of the V.A.C. Freedom® Therapy Unit in the home care setting." This refers to clinical data for the predicate device, which is then extrapolated to the new device based on equivalence in core function and improved features. The provenance of this large body of clinical data is not specified beyond being "clinical data." Given the manufacturer, it is likely to include data from the USA, but no specific countries are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The document outlines that the wound area is calculated by the software by "tracing the wound perimeter on the digital image," which implies a user-inputted tracing rather than an automated algorithm establishing a ground truth that needs expert validation. If wound depth is input, wound volume is calculated. The clinical data referenced is for the predicate device's overall safety and effectiveness, not for validating the accuracy of the new wound measurement feature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned for any "test set" related to the wound measurement capabilities.
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 such MRMC comparative effectiveness study is mentioned. The AI-like functionality (wound measurement) in this device is presented as a tool for the user (caregiver/patient), not as an assistive AI for human readers/clinicians, nor is its impact on human performance quantified.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's wound measurement capability described involves human input ("By tracing the wound perimeter on the digital image, wound area can be calculated by the software. If the user inputs a wound depth value, wound volume can also be calculated."). This indicates a human-in-the-loop process, not a standalone algorithm that automatically detects and measures wounds without user interaction. Therefore, a standalone performance study as typically understood for an AI algorithm was not applicable or performed according to the provided text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the wound measurement features, the ground truth is established by the user's tracing of the wound perimeter and input of wound depth. This is not an external, independent ground truth like pathology or expert consensus on image analysis. For the broader clinical effectiveness, the "large body of clinical data" for the predicate device likely relied on clinical outcome data as ground truth.
8. The sample size for the training set
The document does not describe the use of a "training set" in the context of an AI/ML algorithm. The wound measurement function appears to be based on geometric calculations performed after user input (tracing and depth).
9. How the ground truth for the training set was established
As there is no mention of an algorithm training set, this information is not applicable.
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Image /page/0/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 bold, sans-serif font. A small registered trademark symbol is located to the lower right of the letter "I".
K063740 page 1/3
JUN - 7 2007
| Date prepared | June 1, 2007 |
|---|---|
| 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 | InfoV.A.C.® Therapy Unit |
| Common or usualname | Negative pressure wound therapy device |
| Classificationname | Powered suction pump |
| Legally marketeddevice to whichequivalence isclaimed | InfoV.A.C.® Therapy Unit and its associated canisters representdesign modifications of the V.A.C.® ATS Therapy Unit andassociated canister(s). The V.A.C. Freedom® Therapy Unit alsoserves as a predicate in terms of the indication for home use. TheV.A.C.® ATS Therapy Unit and the V.A.C. Freedom® Therapy Unitare described in the following 510(k)s:K032310 for the V.A.C.® Family of Products (cleared October10, 2003) K062227 for the V.A.C.® Therapy System that provided textrelating to the mechanism of action for inclusion into theIndications for Use statement (cleared October 4, 2006) In addition, K063426 covers the V.A.C.® ATS 1000 ml canister(cleared December 13. 2006). |
| Device description | The InfoV.A.C.® Therapy System is designed for the application ofV.A.C.® Therapy in the acute, extended and home care settings.The software-controlled therapy unit applies negative pressure tothe wound bed. The open cells of the V.A.C.® foam dressing towhich the therapy unit is connected enable distribution of thenegative pressure across the surface of the wound, while thetubing transfers accumulated fluids to the canister. The softwaremonitors and maintains target pressure and alarms as needed tohelp assure target pressure is maintained and constant therapy isdelivered. The safety features of the system include additionalalarms, such as those that signal for tubing blockages, a full ormissing collection canister, inactive therapy, low battery, and leaksin the seal of the dressing.Optional features include: Seal Check™ for identifying dressingleaks, a Therapy Settings Guide that provides options for therapysettings based on the recommendations in the KCI ClinicalGuidelines, a Screen Guard feature that prevents unintentionalscreen changes, an exportable Therapy History Report, and a LogTool for recording canister changes, dressing changes anddressing pieces used.Another new optional feature is the ability to receive and storedigital images of the patient's wound throughout the healingprocess. By tracing the wound perimeter on the digital image,wound area can be calculated by the software. If the user inputs awound depth value, wound volume can also be calculated. Woundimages and area/volume calculations can be electronicallytransferred via a Patient History Report. |
| Intended use of thedevice | The V.A.C.® Therapy System is an integrated wound managementsystem for use in acute, extended and home care settings. It isintended to create an environment that promotes wound healingby secondary or tertiary (delayed primary) intention by preparingthe wound bed for closure, reducing edema, promoting granulationtissue formation 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), flaps and grafts.The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrierto bacterial penetration and may help reduce infection in the abovewound types. |
| Differences inintended use from thepredicate | The intended use of the device has not changed from thepredicate devices. |
| Summary of thetechnologicalcharacteristics of thedevice compared tothe predicate device | The InfoV.A.C.® Therapy Unit and the predicates V.A.C.® ATS andV.A.C. Freedom® Therapy Units have the same technology andperformance specifications for the delivery of negative pressurewound therapy. The InfoV.A.C.® Therapy Unit differs only inoptional ancillary features that make the InfoV.A.C.® Therapy Uniteasier to use by the caregiver and patient, and by the addition ofcapability for wound image storage and analysis. |
| Summary of non-clinical tests | The new optional ancillary features were evaluated under anumber of verification and validation tests in order to assureperformance and conformance to design specifications. |
| Summary of clinicaltests | A review of a large body of clinical data from prospectiverandomized controlled trials, comparative and retrospectivestudies, payor/provider data, and retrospective review ofindependent electronic medical record data documents the safeuse of the V.A.C. Freedom® Therapy Unit in the home care setting.An engineering analysis of device performance establishes thatthe InfoV.A.C.® and V.A.C. Freedom® are equivalent in the deliveryof negative pressure wound therapy, and that InfoV.A.C.®improves upon V.A.C. Freedom® in the elements that affect safetyand usability in the home care setting. The existing clinical datacan therefore be used to predict the safety of the InfoV.A.C.®Therapy System in the home care setting. |
| Conclusions drawnfrom the non-clinicaland clinical tests thatdemonstrate that thedevice is as safe, aseffective, andperforms as well as orbetter than thepredicate device | Verification and validation testing conducted under design controlrequirements document that the InfoV.A.C.® Therapy Unit and thepredicates V.A.C.® ATS and V.A.C. Freedom® Therapy Units areequivalent in terms of technology and performance specificationsfor the delivery of negative pressure wound therapy. Newoptional, ancillary features have been determined to meetperformance specifications.Clinical data supporting the safe use of the V.A.C. Freedom®Therapy Unit in the home care setting are also applicable to theInfoV.A.C.® Therapy Unit. |
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KO63740 page 2/3
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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: K063740
Trade/Device Name: Info V.A.C.® Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: May 1, 2007 Received: May 2, 2007
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of June 7, 2007.
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,
For Peter Rummell
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): K063740 Device Name: InfoV,A.C. ® Therapy Unit
Indications for Use:
The V.A.C. Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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, partialthickness 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.
S.O.m
(Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of General Devices
and Neurological Devices and Neurological 1.663140
510(k) I
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)
Page of
(Posted November 13, 2003)
§ 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.