(154 days)
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.
Negative pressure wound therapy system for application to surgically closed incisions.
This K133232 510(k) summary describes the Prevena Incision Management System, a negative pressure wound therapy device.
Here's an analysis of the provided text regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain explicit acceptance criteria or a direct table comparing them to reported device performance. This 510(k) is a submission for a labeling change for an existing device, and it relies on substantial equivalence to previously cleared predicate devices (K123878 and K100821). The submission states: "There have been no technological changes to the predicate device for the purpose of the proposed labeling change."
Instead of performance criteria, the document asserts:
- "The Prevena Incision Management System and its predicate are substantially equivalent in terms of safety, function and indications for use."
- "The safety and effectiveness of the Prevena Incision Management System is adequately supported by the substantial equivalent information and data provided in this Premarket Notification."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No new clinical or non-clinical tests were performed for this particular 510(k) submission.
- Data Provenance: The document states that KCI conducted a systematic literature review of studies involving the Prevena Incision Management System and is adding a bibliography of published studies to the labeling. This suggests the data provenance is from retrospective, published clinical studies potentially from various countries, but specific details on the countries of origin are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was created for this submission. The systematic literature review might have reviewed studies where expert consensus was used, but this is not detailed in the provided text.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No new test set required adjudication for this submission.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device in question is a medical device (Negative Pressure Wound Therapy System), not an AI diagnostic tool that would involve human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not an AI algorithm. It's a medical device that provides negative pressure wound therapy.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the systematic literature review, the "ground truth" would implicitly refer to the outcomes reported in the published clinical studies. These outcomes would likely include measures relevant to wound healing, infection rates, drainage management, and patient safety, which are typically derived from clinical observation, patient records, and potentially pathology reports depending on the specific study designs. The document states the system "is intended to manage the environment of surgical incisions that continue to drain... by maintaining a closed environment and removing exudate," implying ground truth would relate to these aspects.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document pertains to a resubmission for a labeling change for an existing medical device, not a new device requiring a training set or an AI algorithm.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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K133232
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510(k) SUMMARY Prevena Incision Management System
.
| Submitter information [21 CFR 807.929(a)(1)] | ||
|---|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | |
| Address | 6203 Farinon DriveSan Antonio, TX 78249 | |
| Phone number | 210-255-6137 | |
| Fax number | 210-255-6727 | |
| EstablishmentRegistrationNumber | 1625774 | |
| Name of contactperson | Brian Young, VP Global Regulatory & Clinical Affairs | |
| Date prepared | March 21, 2014 | |
| Name of the device [21 CFR 807.92(a)(2)] | ||
| Trade or proprietaryname | • Prevena Incision Management System with Peel & Place Dressing• Prevena Incision Management System with Customizable Dressing | |
| Common or usualname | 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 | |
| Product Code(s) | OMP | |
| Legally marketeddevice(s) to whichequivalence isclaimed[21 CFR 807.92(a)(3)] | Prevena Incision Management System with Customizable Dressing (K123878)Prevena Incision Management System with Peel & Place Dressing (K100821) | |
| Device description[21 CFR 807.92(a)(4)] | Negative pressure wound therapy system for application to surgically closedincisions. | |
| Indications for use[21 CFR 807.92(a)(5)] | The Prevena Incision Management System is intended to manage theenvironment of surgical incisions that continue to drain following sutured orstapled closure by maintaining a closed environment and removing exudate viathe application of negative pressure wound therapy. | |
| Summary of thetechnologicalcharacteristics of thedevice compared tothe predicate device[21 CFR 807.92(a)(6)] | There have been no technological changes to the predicate device for thepurpose of the proposed labeling change. | |
| Dressing systems: | Same as predicate: One composite dressing or multipledressing components | |
| Therapy unit: | Same as predicate: Software controlled pump for deliveryof negative pressure wound therapy and removal ofwound fluid |
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Performance Data [21 CFR 807.92(b)]
KCI conducted a systematic literature review of studies involving the Prevena Incision Management System (Prevena Therapy), and is adding a bibliography of published studies to the labeling.
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
No non-clinical tests were necessary.
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. A systematic literature review of published clinical studies was conducted.
Conclusions drawn [21 CFR 807.92(b)(3)]
The Prevena Incision Management System and its predicate are substantially equivalent in terms of safety, function and indications for use. The safety and effectiveness of the Prevena Incision Management System is adequately supported by the substantial equivalent information and data provided in this Premarket Notification.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2014
Kinetic Concepts Incorporated Mr. Brian Young Vice President, Global Regulatory & Clinical Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K133232/S003
Trade/Device Name: Prevena Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 19, 2014 Received: February 21, 2014
Dear Mr. Young:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Brian Young
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): _K133232 Device Name: Prevena Incision Management System 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.
Over-The-Counter Use Prescription Use X 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)
Jiyoung Dang -S
Page _1 of _1
(Posted November 13, 2003)
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§ 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.