Prospera Spectruum Negative Pressure Wound Therapy System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. April 18, 2024 DeRoyal Industries, Inc. Mary Catherine Reeves Domestic Regulatory Affairs Manager 200 DeBusk Lane Powell, Tennessee 37849 Re: K230233 Trade/Device Name: Prospera Spectruum Negative Pressure Wound Therapy Unit (NP-7000) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 27, 2023 Received: January 27, 2023 Dear Mary Catherine Reeves: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K230233 Device Name Prospera Spectruum™ Negative Pressure Wound Therapy System ### Indications for Use (Describe) The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended for use in acute, extended and home care settings. When used on open wounds, 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it 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 exudates via the application of negative pressure wound therapy. The Prospera Spectruum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C. Drape components from the V.A.C. Therapy Wound Dressing kit. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | 510(k) #: K230233 | 510(k) Summary | Prepared on: 2024-04-18 | |-----------------------------------------------------------|------------------------------------------------------------|-------------------------| | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | DeRoyal Industries, Inc. | | | Applicant Address | 200 DeBusk Lane Powell TN 37849 United States | | | Applicant Contact Telephone | 865-362-6112 | | | Applicant Contact | Ms. Mary Catherine Reeves | | | Applicant Contact Email | mreeves@deroyal.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Prospera Spectruum™ Negative Pressure Wound Therapy System | | | Common Name | Powered suction pump | | | Classification Name | Negative Pressure Wound Therapy Powered Suction Pump | | | Regulation Number | 878.4780 | | | Product Code | OMP | | | Legally Marketed Predicate Devices<br>21 CFR 807.92(a)(3) | | | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K183543 | ACTIV.A.C. Therapy Unit | OMP | | K201571 | ACTIV.A.C.™ Negative Pressure Wound Therapy System | OMP | | K133276 | V.A.C. Therapy Wound Dressings | OMP | ## Device Description Summary The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) is a component of the Prospera Spectruum Negative Pressure Wound Therapy (NPWT) System. The Prospera Spectruum™ Negative Pressure Wound Therapy System consists of: - · Prospera Spectruum™ Negative Pressure Wound Therapy Unit - · Disposable canister which collects wound exudate - Prospera Spectruum™ Contour Dome The Prospera Spectrum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C.Drape components from the V.A.C. Therapy Wound Dressing kit. The Prospera Spectruum™ Negative Wound Therapy Unit (NP-7000) is a portable, rechargeable battery and mains powered, reusable, software-controlled unit used with a can provide continuous or variable applications of negative pressure to a wound in the user defined range between 25mmHg. The Prospera Spectruum™ Negative Pressure Wound Therapy System is designed for use in home, acute or extended care settings. The compatible dressing components include a wound interface dressing applied to the wound covered with a semi-occlusive drape and is connected to the canister of the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) via a dual lumen {5}------------------------------------------------ dressing connection. This connection allows for the distribution of negative pressure to the wound bed and removal of wound exudate which is transported to the collection canister via the lumen. The software within the Prospera Spectrum™ Negative Pressure Wound Therapy Unit (NP-7000) provides and maintains the prescribed pressure within the user defined range as well as alarming as neduced below the defined threshold. The alarms alert the user to conditions such as tubing blockages, a full canister, inactive therapy, low battery, and leaks in the system. Additional features include: - GPS for optional inventory management support - Therapy history report via USB data port - · Pre-set therapy options - Event Log - · User interface with flat buttons requiring depression for activation to reduce unintentional screen changes • Confirmation screen to provide a visual notification to the user prior to device shutdown. The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) will continue delivering therapy and will not power off until the user stops therapy and acknowledges via user interface that the intent is to power off the unit. # Intended Use/Indications for Use ### 21 CFR 807.92(a)(5) The Prospera Spectruum™ Negative Wound Therapy System is a wound management system intended for use in acute, extended and home care settings. When used on open wounds, 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, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and graph al incisions, it is intended to manage the enviral incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. The Prospera Spectrum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C. Drape components from the V.A.C. Therapy Wound Dressing kit. # Indications for Use Comparison 21 CFR 807.92(a)(5) 21 CFR 807.92(a)(6) The Indications for Use of the predicates and subject device are similar. The indicated wound types and care settings are identical. The inclusion of the wound dressing compatibility statement in the subject device's lintended Use statement indicating the use of the subject device with the legally marketed wound dressing components is supported by the tertiary predicate, K133276, which is the legally marketed NPWT Dressing Kit that is compatible with the primary and secondary predicates, K18543 and K201571, ACTV.A.C.™ Negative Pressure Wound Therapy System. The tertiary predicate includes a dressing connection (equivalent to the Prospera Spectrum™ Contour Dome), wound interface dressing (Granufoam) and secondary semi-occlusive wound drape (V.A.C.Drapel, These components work together to dress the wound and connect it to the prospera Spectrum™ system as described in this submission will work using the Prospera Spectruum™ Contour Dome to connect the wound dressed by the legally marketed wound dressing components cleared under K133276, Granufoam and V.A.C.Drapera Spectrum™ NPWT Unit (NP-7000) and canister to apply negative and remove exudate. Functional bench testing has been completed using these legally marketed wound dressing components with the Prospera Spectruum™ NP-7000), Canister, and Contour Dome to establish safe and effective performance when used together as a system and support substantial equivalence to the predicates. These differences in the Indication for Use statement between the subject and predicate devices have no impact on the intended therapeutic use of the device and do not constitute a new intended use of the device when used as labeled. # Technological Comparison Controlled delivery of negative pressure to the technological principle for both the subject and predicate devices. The software-controlled powered therapy unit applies negative pressure to the dual lumen tubing connected to compatible wound dressing components and exudate is removed from the wound is collected the attached canister. The subject and predicate device are based on the following same technological elements: • Intended use • Indicated wound types - · Negative pressure therapy specifications - Use environment (acute, extended and home care settings) - System components: powered NPWT unit, disposable canisters, dressing connection with lumen and compatible wound dressing {6}------------------------------------------------ #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The following testing has been conducted to support the conclusion that the proposed device is substantially equivalent to the predicate device: • Conformance to the most current General Requirements for Basic Safety and Essential Performance 60601-1 standards. v Software has been assessed in accordance for the Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005). • Prospera Spectruum™ bench testing demonstrates the unit maintains negative pressure within specifications and manages fluid exudate without unexpected alarms. • Usability Testing was performed per ISO 62366-1 and ANS/AAM HE 75. Testing was performed using lay users who represent patients and lay caregivers to support the use of the home environment and with clinicians to support the use of the device in the hospital. In all instances, Prospera Spectruum™ NPWT System functioned as intended and all test results observed were as expected. Clinical Tests Not Applicable The Prospera Spectrum™ NPWT system is as safe and effective as the predicates ACTIV.A.C.™ Therapy System (K201571) and V.A.C. Therapy Wound Dressings (K133276). The subject device's fundamental technology and principles of operation for the Prospera Spectruum™ NPWT System are the same compared to the predicate device's Indications for Use are the same as the predicate devices. The identified technological differences between the Prospera Spectruum™ NPWT System and its predicate devices could not significantly affectiveness of the device, nor did they represent a major change in intended use or safety. The performance data demonstrates that the Prospera Spectruum™ NPWT System is as the predicates. Thus, the Prospera Spectruum™ NPWT System is substantially equivalent to the predicates.