(253 days)
No
The description focuses on standard negative pressure wound therapy technology and does not mention any AI or ML components.
Yes.
The device is intended to manage surgical incisions by applying negative pressure wound therapy to remove exudate and maintain a closed environment, which are therapeutic actions.
No
The device is described as an "Incision Management System" intended to manage surgical incisions by maintaining a closed environment and removing exudate via negative pressure wound therapy. There is no mention of it being used to identify, diagnose, or monitor a medical condition or disease.
No
The device description clearly outlines hardware components such as a pump, tubing, dressing, and canister, which are integral to the device's function of applying negative pressure wound therapy.
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 to remove exudate and maintain a closed environment. This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of applying negative pressure and collecting fluid. There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Lack of Diagnostic Elements: There are no mentions of analyzing biomarkers, detecting pathogens, or providing any kind of diagnostic result based on the collected exudate.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the physical management of a surgical incision.
N/A
Intended Use / Indications for Use
The PREVENA RESTOR(TM) 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
OMP
Device Description
The negative pressure technology for the subject device is the same as that for the predicate device systems.
The PREVENA RESTOR™ dressing is a component of the PREVENA RESTOR™ Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference.
The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing connected to a PREVENA RESTOR™ dressing placed over the incision site. The integrated one-piece dressing, which includes an occlusive film, provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together and removes fluid from the incision site into a canister fitted to the therapy unit.
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)
Bench testing demonstrated that the subject PREVENA RESTOR™ dressing is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue.
February 15, 2019
KCI USA, Inc. Shannon Scott Sr. Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K181507
Trade/Device Name: PREVENA RESTOR™ Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: January 16, 2019 Received: January 17, 2019
Dear Shannon Scott:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly Ferlin -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
Indications for Use
510(k) Number (if known) K181507
Device Name
PREVENA RESTOR(TM) Incision Management System
Indications for Use (Describe)
The PREVENA RESTOR(TM) 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.
| 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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Image /page/3/Picture/1 description: The image shows the KCI logo, which features a stylized sphere with a purple and white gradient on the left side. To the right of the sphere are the letters "KCI" in a sans-serif font. Below the letters is the text "AN ACELITY COMPANY" in a smaller font size. The logo appears to be for a company called KCI, which is part of the Acelity company.
510(k) SUMMARY
PREVENA RESTOR™ Incision Management System
| Submitter Information [21 CFR 807.92(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-255-7433 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 3005178245 |
| Name of contact | |
| person | Shannon Scott |
| Date prepared | February 15, 2019 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | PREVENA RESTOR™ Incision Management System |
| Common or usual | |
| name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump |
| Classification panel | General and Plastic Surgery |
| Regulation | 21 CFR 878.4780 |
| Regulatory Class | II |
| Product Code(s) | OMP |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | |
| [21 CFR 807.92(a)(3)] | Predicate 510(k) Number(s): |
| K180855 | |
| K161897 | |
| K153199 | |
| Device description | |
| [21 CFR 807.92(a)(4)] | The negative pressure technology for the subject device is the same as |
| that for the predicate device systems. | |
| The PREVENA RESTOR™ dressing is a component of the PREVENA | |
| RESTOR™ Incision Management System. The systems provide | |
| surgical incision management via the application of negative pressure | |
| wound therapy over an incision site that has been closed with sutures | |
| or staples. The systems are applied to the incision site immediately | |
| after surgery for up to seven (7) days depending on the surgeon's | |
| preference. | |
| The pump in the therapy unit delivers continuous negative pressure at | |
| -125 mmHg through tubing connected to a PREVENA RESTOR™ | |
| dressing placed over the incision site. The integrated one-piece | |
| dressing, which includes an occlusive film, provides | |
| a negative pressure environment and protects the incision from | |
| external contamination. The application of negative pressure draws the | |
| incision edges together and removes fluid from the incision site into a | |
| canister fitted to the therapy unit. | |
| Indications for use | |
| [21 CFR 807.92(a)(5)] | The PREVENA RESTORTM 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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Image /page/4/Picture/1 description: The image is a logo for KCI, an Acelity company. The logo features a sphere on the left side, with a purple design on the bottom. To the right of the sphere, the letters "KCI" are displayed in a sans-serif font. Below the letters, the words "AN ACELITY COMPANY" are written in a smaller font.
510(k) SUMMARY
PREVENA RESTOR™ Incision Management System
Comparison of the Technological Characteristics (i.e., design, material, chemical composition, energy source) with the Predicate Device [21 CFR 807.92(a)(6)]
Negative 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 film 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 systems are based on the following same technological elements:
- Both device systems contain the same Indications for Use. ●
- . The choice of therapy unit has not changed from the predicate systems.
- The dressing is connected to the PREVENA PLUS™ 125 Therapy Unit, ACTIV.A.C.™ . Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit via a disposable canister and appropriate tubing connections.
- . The dressings are constructed from the same materials and are sterilized in the same type of packaging.
- The dressings are applied over the same types of incisions on the same anatomical ● locations.
The following design difference exists between the subject and predicate device:
- The PREVENA RESTOR™ dressings include precision designed pre-cut foam. ●
- The PREVENA RESTOR™ dressing are presented in various shapes and sizes. ●
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
Bench testing demonstrated that the subject PREVENA RESTOR™ dressing is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.
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Image /page/5/Picture/1 description: The image shows the logo for KCI, an Acelity company. The logo features a stylized sphere on the left, with a purple and white gradient. To the right of the sphere are the letters "KCI" in a sans-serif font. Below the letters is the text "AN ACELITY COMPANY" in a smaller font.
510(k) SUMMARY
PREVENA RESTOR™ Incision Management System
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. No usability testing was required as there has been only minor changes to the user interface and to the Instructions for Use.
Conclusions drawn [21 CFR 807.92(b)(3)]
The subject PREVENA RESTOR™ Incision Management System and its identified predicate are substantially equivalent in terms of basal design, utilized materials, principles of operation, mode-of-action, safety, performance, type of packaging, and indications for use.