(486 days)
Not Found
No
The summary describes a negative pressure wound therapy system with different dressing and therapy unit options. There is no mention of AI, ML, or any related technologies like image processing or algorithms that would suggest AI/ML is incorporated. The performance studies focus on pressure distribution and usability, not AI/ML performance metrics.
Yes
The device is described as a "Negative Pressure Wound Therapy System" intended to "manage the environment of surgical incisions" and remove exudate, which are therapeutic functions.
No
The device is described as an incision management system that applies negative pressure to a surgical incision, rather than gathering information or diagnosing a condition.
No
The device description explicitly lists physical components like dressings and therapy units, which are hardware. The usability and performance studies also involve physical interaction with these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage surgical incisions by applying negative pressure wound therapy to remove exudate. This is a therapeutic and wound management function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for applying negative pressure to a wound site. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the wound site.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Prevena Incision Management System does not fit this description.
N/A
Intended Use / Indications for Use
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Prevena Incision Management System provides surgical incision management via the application of negative pressure wound therapy over an incision site that has been surgically closed with sutures or staples. The Prevena System is applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference.
The Prevena Incision Management System consists of:
A Prevena Dressing (Prevena Peel & Place Dressing or Prevena Customizable Dressing and A source of negative pressure wound therapy, which may be one of the following KCI therapy units with its associated canisters: Prevena 125 Therapy UnitActiV.A.C. Therapy UnitV.A.C. Freedom Therapy UnitInfoV.A.C. Therapy Unit
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical incisions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, OR surgical nurse, patient
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Usability testing of the Prevena Clinician Guide and the V.A.C. Ulta Instructions for Use was conducted with both 15 surgeon and 15 OR surgical nurse participants. The testing assessed labeling revised to add instructions for using the V.A.C.Ulta Therapy Unit with the Prevena Dressings. In summary, participants were asked to select the appropriate components from a storage area, apply the Prevena Dressing to a simulated incision model in the OR, connect the dressing to a V.A.C.Ulta Therapy Unit and then select the appropriate therapy settings and confirm patient discharge restrictions. Subjects had the opportunity to use product labeling in completing usability tasks.
Usability testing was also conducted with 15 patient user participants on a revised Prevena Patient Guide. The testing assessed the ability of the patient user to read the revised Prevena Patient Guide, to understand that the V.A.C.Ulta Therapy Unit should not be in the home and to know what to do should this occur.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of non-clinical tests conducted for determination of substantial equivalence:
Prevena Dressing Pressure Manifold Test with V.A.C.Ulta Therapy Unit: The average distribution of negative pressure across the full length of the Prevena Dressing on a simulated wound bed under both wet and dry conditions demonstrated that the V.A.C.Ulta Therapy Unit provides an acceptable source of negative pressure at -125 mmHg.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information:
No clinical tests were necessary. Usability testing for the Prevena Clinician Guide and V.A.C. Ulta Instructions for Use was conducted with 15 surgeon and 15 OR surgical nurse participants. All of the new and critical tasks relating to usability of the V.A.C.Ulta Therapy Unit with the Prevena Dressings were safely completed. Usability test results did not require changes to the user interface or product labeling.
Usability testing was also conducted with 15 patient user participants on a revised Prevena Patient Guide. The testing confirmed that patients were able to recognize the V.A.C.Ulta Therapy Unit should not be in their home and to call their clinician for the appropriate therapy unit for use at home. Usability test results did not require changes to the user interface or product labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Kinetic Concepts Incorporated USA Ms. Margaret Marsh Technical Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K141017
Trade/Device Name: Prevena Incision Management with Peel & Place Dressing Prevena Incision Management with Customizable Dressing Systems Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 3. 2015 Received: August 5, 2015
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141017
Device Name
Prevena Incision Management System with Peel and Place Dressing Prevena incision Management System with Customizable Dressing
Indications for Use (Describe)
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate yia the application of negative pressure wound therapy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY Prevena Incision Management with Peel & Place Dressing and Customizable Dressing
| Submitter Information [21 CFR 807.92(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-255-6481 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 3005178245 |
| Name of contact | |
| person | Margaret Marsh, Technical Director, Regulatory Affairs |
| Date prepared | August 18, 2015 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | Prevena Incision Management with Peel & Place Dressing and Customizable |
| Dressing Systems | |
| SKUs: PRE 1055US; PRE 2055US; PRE1001US; PRE2001US | |
| Common or usual | |
| name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and components) |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4780 |
| Regulatory Class | II |
| Product Code(s) | OMP |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | Prevena Incision Management System with Peel & Place Dressing (K100821) |
| Prevena Incision Management System with Customizable Dressing (K123878) | |
| V.A.C.Ulta Negative Pressure Wound Therapy System (K100657) | |
| Device description | |
| [21 CFR 807.92(a)(4)] | The Prevena Incision Management System provides surgical incision |
| management via the application of negative pressure wound therapy over an | |
| incision site that has been surgically closed with sutures or staples. The | |
| Prevena System is applied to the incision site immediately after surgery for a | |
| minimum of 2 days up to a maximum of 7 days depending on the surgeon's | |
| preference. | |
| The Prevena Incision Management System consists of: | |
| A Prevena Dressing (Prevena Peel & Place Dressing or Prevena | |
| Customizable Dressing and A source of negative pressure wound therapy, which may be one of the | |
| following KCI therapy units with its associated canisters: Prevena 125 Therapy UnitActiV.A.C. Therapy UnitV.A.C. Freedom Therapy UnitInfoV.A.C. Therapy Unit |
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Indications for use [21 CFR 807.92(a)(5)]
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]
Neqative Pressure Wound Therapy is the technological principal for both the subject and predicate devices. Application of negative pressure to an incision site that is closed via staples or sutures helps draw the incision edges together and removes fluid from the incision site. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination.
At a high level, the subject device and predicate device are based on the following same technological elements:
- . The dressings that are applied over the incision site in the operating room are identical. One of the following dressings may be selected by the surgeon, based on incision length and geometry:
- A negative pressure pump (therapy unit) is required that can provide -125 mmHg of negative pressure continuously to the dressing for a maximum of 7 days.
- The dressings are connected to the therapy unit via a disposable canister.
- Incision fluid is collected into the disposable canister
- . The therapy unit provides alarms that indicate when negative pressure wound therapy may be compromised (e.q., visual and audible alarms indicating blockage in the tubing line, an air leak in the system, when the canister is full or batteries are low).
The following technological differences exist between the subject and predicate devices:
- The V.A.C.Ulta Therapy System offers the option of topical wound treatment ● solutions and suspensions over the wound bed (V.A.C. VeraFlo Therapy). However, the Prevena Peel & Place and Prevena Customizable Dressings cannot and should not be used with VeraFlo Therapy, as instillation is not indicated for use over closed incisions.
- V.A.C.Ulta Therapy system is not intended for home use, and cannot transition home with the patient.
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
The following performance data were provided in support of the substantial equivalence determination.
Prevena Dressing Pressure Manifold Test with V.A.C.Ulta Therapy Unit:
The average distribution of negative pressure across the full length of the Prevena Dressing on a simulated wound bed under both wet and dry conditions demonstrated that the V.A.C.Ulta Therapy Unit provides an acceptable source of negative pressure at -125 mmHg.
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Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
No clinical tests were necessary. However:
- Usability testing of the Prevena Clinician Guide and the V.A.C. Ulta Instructions for Use was ● conducted with both 15 surgeon and 15 OR surgical nurse participants. The testing assessed labeling revised to add instructions for using the V.A.C.Ulta Therapy Unit with the Prevena Dressings. In summary, participants were asked to select the appropriate components from a storage area, apply the Prevena Dressing to a simulated incision model in the OR, connect the dressing to a V.A.C.Ulta Therapy Unit and then select the appropriate therapy settings and confirm patient discharge restrictions. Subjects had the opportunity to use product labeling in completing usability tasks. All of the new and critical tasks relating to usability of the V.A.C.Ulta Therapy Unit with the Prevena Dressings were safely completed. Usability test results did not require changes to the user interface or product labeling.
- o Usability testing was also conducted with 15 patient user participants on a revised Prevena Patient Guide. The testing assessed the ability of the patient user to read the revised Prevena Patient Guide, to understand that the V.A.C.Ulta Therapy Unit should not be in the home and to know what to do should this occur. The testing confirmed that patients were able to recognize the V.A.C.Ulta Therapy Unit should not be in their home and to call their clinician for the appropriate therapy unit for use at home. Usability test results did not require changes to the user interface or product labeling.
Conclusions drawn [21 CFR 807.92(b)(3)]
The Prevena Incision Management System and its predicate (K100821 and K123878) are substantially equivalent in terms of safety, function and indications for use.