(308 days)
No
The summary describes a negative pressure wound therapy system with software changes focused on reducing nuisance alerts, not AI/ML capabilities. Performance studies are bench tests and usability testing, not related to AI/ML model performance.
Yes
The device is described as a "Negative pressure wound therapy system" and is intended to "manage the environment of surgical incisions... by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy," which directly describes a therapeutic application to a patient's body.
No
The device is described as a "Negative pressure wound therapy system" intended to manage surgical incisions by removing exudate. Its function is to apply negative pressure for wound therapy, not to diagnose a condition or disease. The performance studies focus on engineering specifications and usability, not diagnostic accuracy.
No
The device description explicitly states it is a "Negative pressure wound therapy system," which is a hardware-based medical device. The performance studies also mention testing of a "Therapy Unit" and "Battery life," further indicating a physical device. While there are mentions of software changes and testing, the core device is not software-only.
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 and maintain a closed environment. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: It's described as a "Negative pressure wound therapy system," which is a type of medical device used for wound treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the Prevena Incision Management System is a therapeutic medical device, not an in vitro diagnostic device.
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 closed by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Product codes
OMP
Device Description
Negative pressure wound therapy system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
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:
The Prevena 125 Therapy Unit was evaluated to ensure conformance to design specifications following minor changes to software to reduce nuisance alerts.
The following bench tests were conducted:
- Performance testing to confirm therapy unit delivers negative pressure wound therapy within specification
- Software verification and validation testing to confirm that therapy unit performs as designed
- Battery life testing to demonstrate that changes do not affect battery life.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information:
No clinical tests were necessary. However:
- Usability testing was conducted with patient users to assess the impact of proposed labeling changes made as a result of software changes. The results demonstrated that all usability qoals were met, and recommended changes to the Patient Guide have been addressed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
KCI USA Incoprorated Ms. Melanie Avila Senior Manager, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K150006
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: October 12, 2015 Received: October 13, 2015
Dear Ms. Avila:
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
1
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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K150006
Device Name Prevena Incision Management System
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 by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 Peel & Place Dressing and Customizable Dressing
| Submitter Information [21 CFR 807.929(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-515-4059 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 3009897021 |
| Name of contact person | Melanie Avila, Senior Manager, Regulatory Affairs |
| Date prepared | October 12, 2015 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | Prevena™ Incision Management System |
| 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 |
| Product Code(s) | OMP |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | Prevena™ Incision Management System, cleared under 510(k) K121883 |
| Device description | |
| [21 CFR 807.92(a)(4)] | Negative pressure wound therapy system |
| 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. |
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Comparison of the Technological Characteristics with 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 nelps 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 technoloqical 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.g., visual and audible alarms indicating an air leak in the system or when the canister is full or when batteries are low).
The following technological differences exist between the subject and predicate devices:
- The volume and mute time has been chanqed for the Leak Alert and the mute time has been ● changed for the Low Battery Alert to minimize nuisance alerts under the new air leak threshold
- . The air leak threshold has been slightly increased to allow for more air in the system before therapy unit alarms
- The labeling has been updated to reflect the proposed change in mute times
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 Prevena 125 Therapy Unit was evaluated to ensure conformance to design specifications following minor changes to software to reduce nuisance alerts.
The following bench tests were conducted:
- . Performance testing to confirm therapy unit delivers negative pressure wound therapy within specification
- Software verification and validation testing to confirm that therapy unit performs as designed ●
- Battery life testing to demonstrate that changes do not affect battery life. .
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 was conducted with patient users to assess the impact of proposed labeling changes made as a result of software changes. The results demonstrated that all usability qoals were met, and recommended changes to the Patient Guide have been addressed.
Conclusions drawn [21 CFR 807.92(b)(3)]
The Prevena Incision Management System and its predicate (K121883) are substantially equivalent in terms of safety, function and indications for use.