(76 days)
The V.A.C. Simplicity™ Negative Pressure Wound 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, pressure or venous insufficiency), flaps and grafts.
Negative pressure wound therapy unit component of an integrated negative pressure wound therapy system
The provided text describes the V.A.C. Simplicity™ Negative Pressure Wound Therapy Unit. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily focused on the device's ability to deliver negative pressure wound therapy (NPWT) comparably to a predicate device and its compliance with relevant safety standards.
| Acceptance Criteria / Specification | Reported Device Performance |
|---|---|
| Functional Performance | |
| Deliver NPWT at -125 mmHg | "Testing demonstrated that the V.A.C. Simplicity™ Therapy Unit delivers equivalent negative pressure wound therapy at -125 mmHg" compared to the ActiV.A.C. Therapy Unit. |
| Software Performance | |
| Software Verification & Validation | "Software verification and validation testing confirms that the software meets the requirements of the software requirements specification." |
| Electrical Safety | |
| Compliance with Electrical Safety | "The therapy unit was tested to all applicable electrical safety and electromagnetic emissions standards and was found to be in compliance." |
| Electromagnetic Emissions | "The therapy unit was tested to all applicable electrical safety and electromagnetic emissions standards and was found to be in compliance." |
| Usability | |
| Ease of use in home environment | "Usability studies were performed with 30 subjects representing home care nurses and patients to assure that the product could easily be used in the home environment and that labeling can be understood and followed." "The home care nurse responses in the V.A.C. Simplicity™ Therapy Unit usability test are supportive of usability in the extended care environment" (based on previous testing showing equivalence between home care and extended care nurse responses for a similar product). |
2. Sample Size Used for the Test Set and Data Provenance
- Functional Performance, Software, Electrical Safety, Electromagnetic Emissions: No specific sample sizes for these bench tests are explicitly stated. The documentation indicates "testing demonstrated" for functional performance and "testing confirms" for software, implying sufficient testing was conducted to meet internal specifications.
- Usability Study Test Set: 30 subjects (home care nurses and patients).
- Data Provenance: The document does not explicitly state the country of origin for the usability study data. Given the address for KCI USA, Inc. in San Antonio, Texas, it is safe to assume the data is from the United States. The study was prospective for the V.A.C. Simplicity™ device, as it was conducted specifically for its submission, though it leveraged prior prospective data from a similar device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the functional, software, electrical safety, and electromagnetic emissions tests, the "ground truth" refers to established engineering specifications, industry standards, and regulatory requirements. The document does not specify the number or qualifications of experts who established these standards, as these are generally accepted benchmarks.
- For the usability study, the "ground truth" was established by the 30 subjects (home care nurses and patients) themselves, through their ability to understand labeling and easily use the product. These individuals are the end-users and their experience forms the basis of the usability assessment. No external "experts" were used to establish this specific ground truth beyond the subjects providing direct feedback.
4. Adjudication Method for the Test Set
- For the technical performance tests (functional, software, electrical safety, electromagnetic emissions), the adjudication method is implied to be adherence to objective pass/fail criteria based on specifications and standards. No human-expert adjudication process is described separately from the testing itself.
- For the usability study, no formal adjudication method (like 2+1 or 3+1) is mentioned. The study "assured that the product could easily be used... and that labeling can be understood and followed" by the 30 subjects. This suggests a direct assessment of their interaction and comprehension, likely relying on observed performance and feedback without further external adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a negative pressure wound therapy unit, not an AI-powered diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the typical sense of a MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical device (a pump) with embedded software. While "standalone" performance testing for the software was conducted ("Software verification and validation testing confirms that the software meets the requirements"), this is not in the context of a standalone algorithm in the way it's typically understood for AI/ML devices. The "algorithm" (software) runs intrinsically within the device to monitor and maintain pressure and alarms. Its standalone performance is assessed through its ability to meet the requirements of its specification, and its overall performance is inherently tied to the hardware it controls.
7. The Type of Ground Truth Used
- Functional Performance: Engineering specifications for negative pressure delivery (e.g., -125 mmHg).
- Software Performance: Requirements outlined in the "software requirements specification."
- Electrical Safety & Electromagnetic Emissions: Applicable electrical safety and electromagnetic emissions standards.
- Usability: User experience and comprehension (direct feedback from home care nurses and patients).
8. The Sample Size for the Training Set
This document describes a medical device clearance (510(k)) for a physical pump with embedded software, not an AI/ML device that typically involves distinct "training sets" for machine learning models. Therefore, the concept of a training set in that context is not applicable here, and no sample size for such a set is mentioned.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the context of AI/ML for this device. The ground truth for its various performance aspects (functional, safety, usability) was established through engineering specifications, regulatory standards, and direct user feedback, as detailed in point 7.
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JUL 2 1 2011
510(k) SUMMARY
V.A.C. Simplicity™ Negative Pressure Wound Therapy Unit
| Date prepared | July 20, 2011 |
|---|---|
| 510(k) owner | KCI, Inc. |
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| Fax number | 210 255-6727 |
| Name of contactperson | Margaret Marsh |
| Contact telephonenumber | 1 800 275-4524; Request Regulatory Affairs. |
| Name of the device | |
| Trade orproprietary name | V.A.C. Simplicity™ Negative Pressure Wound Therapy Unit |
| Common or usualname | Negative Pressure Wound Therapy Unit |
| Classificationname | Negative Pressure Wound Therapy Powered Suction Pump |
| Legally marketeddevice(s) to whichequivalence isclaimed | ActiV.A.C. ® Negative Pressure Wound Therapy Unit, cleared under510(k) K06369 |
| Device description | Negative pressure wound therapy unit component of an integratednegative pressure wound therapy system |
| Device design | The therapy unit is nearly identical to the predicate product, exceptfor the user interface, which is similar to that of the currentlymarketed V.A.C. Via Therapy Unit. The therapy unit deliversnegative pressure wound therapy to the wound bed through theV.A.C. ® Foam Dressing System; it also transfers wound exudatesinto a canister. Software monitors and maintains target pressureand alarms as needed to help assure target pressure is maintainedand constant therapy is delivered. The safety features of the systeminclude alarms, such as those that signal for blockages, low battery,and leaks in the system. |
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| Intended use of thedevice | The V.A.C. Simplicity™ Therapy System is an integrated woundmanagement system for use in acute, extended and home caresettings. It is intended to create an environment that promoteswound healing by secondary or tertiary (delayed primary) intentionby preparing the wound bed for closure, reducing edema, promotinggranulation tissue formation and perfusion, and by removingexudate and infectious material. It is indicated for patients withchronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venousinsufficiency), flaps and grafts | ||
|---|---|---|---|
| Differences inintended use from thepredicate(s) | The intended use is identical to that of the predicate. | ||
| Summary of thetechnologicalcharacteristics of thedevice compared tothe predicate device | Feature | V.A.C. Simplicity™Therapy System | ActiV.A.C.Therapy System |
| Therapy unit | Same as predicate | Software controlledpump for delivery ofnegative pressurewound therapy | |
| Therapy options | -125 mmHg only | Selectable negativepressure settings in therange of -25 to -200mmHg. | |
| Dressingsystem | Same as predicate | Foam based dressingwith occlusive drape | |
| Pressuresensing | Same as predicate | By means of a sensingpad in tubing line | |
| Summary ofnonclinical tests | The V.A.C. Simplicity™ Therapy Unit was evaluated to assureconformance to design specifications.The following bench tests were conducted:Ability to deliver NPWT at -125 mmHg in a comparablemanner to the ActiV.A.C. Therapy Unit. Testingdemonstrated that the V.A.C. Simplicity™ Therapy Unitdelivers equivalent negative pressure wound therapy at-125 mmHg. Software verification and validation testing confirms that thesoftware meets the requirements of the softwarerequirements specification. The therapy unit was tested to all applicable electrical safetyand electromagnetic emissions standards and was found tobe in compliance. | ||
| Summary of clinicaltests | Although human clinical studies were not required to be conducted,usability studies were performed with 30 subjects representing homecare nurses and patients to assure that the product could easily beused in the home environment and that labeling can be understoodand followed.KCI previously conducted simultaneous usability testing on home |
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| care and extended care nurses for a similar product, the V.A.C. ViaNegative Pressure Wound Therapy Unit. This testing validated thatthe results from home care nurses are equivalent to extended carenurses, in that they responded in an identical manner throughout theusability testing. Based on this experience, the home care nurseresponses in the V.A.C. Simplicity™ Therapy Unit usability test aresupportive of usability in the extended care environment. | |
|---|---|
| Conclusions drawnfrom the nonclinicaland clinical tests thatdemonstrate that thedevice is as safe, aseffective, andperforms as well as orbetter than thepredicate device | Testing demonstrates that the V.A.C. Simplicity™ Therapy Unit issubstantially equivalent in terms of both indications for use andtechnology to the predicate product |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
KCI USA, Inc. % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249-3441
JUL 2 1 2011
Re: K111280
Trade/Device Name: V.A.C. Simplicity™ Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: May 2, 2011 Received: May 6, 2011
Dear Ms. Marsh:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 limited to: registration and listing (21
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Page 2 - Ms. Margaret Marsh
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
iately yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number K111280 Device Name: V.A.C. Simplicity™ Negative Pressure Wound Therapy System
Indications for Use:
The V.A.C. Simplicity™ Negative Pressure Wound 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, pressure or venous insufficiency), flaps and grafts.
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)
Daniel Krone for MXM
(Division Sign-Off) Page _ of _
(Posted November 13, 2003)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111280
§ 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.