PREVENT Kit

K232379 · Clear Choice Therapeutics · OMP · Feb 5, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K232379
• Device Name: PREVENT Kit
• Applicant: Clear Choice Therapeutics
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Feb 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris. The PREVENT™ Kit is appropriate for use on the following wounds: Pressure Ulcers Diabetic/Neuropathic Ulcers Venous Insufficiency Ulcers Traumatic Wounds Post-Operative and Dehisced Surgical Wounds Skin Flaps and Grafts The system is for prescription use only.

Device Story

PREVENT™ Kit is a sterile, single-use dressing system for negative pressure wound therapy (NPWT). Components include a thermoplastic elastomer (TPE) wound contact barrier, adhesive film drapes, and a dome assembly with drainage tubing. Used with CCT1 or CCT Mini pumps; the pump creates a vacuum to remove exudate, infectious material, and tissue debris from the wound bed into a collection canister. Operated by healthcare professionals in clinical or home settings. The TPE barrier provides flow pathways for exudate removal. The system promotes wound healing by maintaining a closed, negative-pressure environment. Output is the physical removal of wound fluids; clinical decision-making is supported by visual monitoring of the wound bed through the transparent dressing and drape. Benefits include effective exudate management and wound healing support.

Clinical Evidence

No human clinical trials. Evidence includes bench testing (7-day simulated use, tensile strength, seal strength, alarm functionality), shelf-life testing (1-year real-time/accelerated), biocompatibility (ISO 10993-1), and a 35-day GLP animal study in swine comparing wound healing and histological response to a control. Usability testing (ISO 62366-1) with 15 participants showed 249/272 subtasks performed successfully with no serious use errors.

Technological Characteristics

Components: TPE (Medalist MD-10135) wound contact barrier, polyurethane film drape with acrylate adhesive. Principle: NPWT via vacuum pump. Dimensions: 20cm x 25cm barrier. Sterilization: Ethylene oxide (ISO 11135-1). Connectivity: Mechanical connection to external pump via Luer lock. Software: None (mechanical dressing kit).

Indications for Use

Indicated for adult patients requiring negative pressure wound therapy (NPWT) for pressure ulcers, diabetic/neuropathic ulcers, venous insufficiency ulcers, traumatic wounds, post-operative/dehisced surgical wounds, and skin flaps/grafts. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• Theia Foam Kit (K211277)

Submission Summary (Full Text)

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February 5, 2024

Clear Choice Therapeutics % Cynthia Pritchard CEO BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, North Carolina 27614

Re: K232379

Trade/Device Name: PREVENT™ Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: January 3, 2024 Received: January 5, 2024

Dear Cynthia Pritchard:

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 (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"

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(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).

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.

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For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known): K232379

Device Name PREVENT™ Kit

#### Indications for Use (Describe)

The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris.

The PREVENT™ Kit is appropriate for use on the following wounds:

- Pressure Ulcers
- Diabetic/Neuropathic Ulcers
- · Venous Insufficiency Ulcers
- · Traumatic Wounds
- Post-Operative and Dehisced Surgical Wounds
- · Skin Flaps and Grafts

The system is for prescription use only.

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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This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# Sponsor/Applicant Name and Address

| Company Name: | Clear Choice Therapeutics, Inc. |
|-----------------|--------------------------------------------------|
| Address: | 310 S. West Street, Suite 200, Raleigh, NC 27603 |
| Telephone: | [phone] (office) or 919-345-1836 (mobile) |
| Contact Person: | Bret A. Batchelder |
| Title: | CEO |

Date Summary Prepared: 2 February 2024

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### Device Name and Classification

| Trade Name: | PREVENTTM Kit | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21 CFR Section: | 21 CFR 878.4780 | |
| Regulation Name: | powered suction pump | |
| Product Code: | OMP | |
| Classification: | Class II | |
| Panel: | General and Plastic Surgery | |
| Parameter | Subject Device | Primary Predicate Device |
| | PREVENT™<br>Kit | Theia Foam Kit |
| Company<br>Name | Clear Choice Therapeutics (CCT) | Clear Choice Therapeutics (CCT) |
| 510(k) # | 232379 | K211277 |
| Classification<br>name | Negative Pressure Wound Therapy Powered<br>Suction Pump | Negative Pressure Wound Therapy Powered<br>Suction Pump |
| Classification<br>panel | General and Plastic Surgery Devices (DHT4B) | General and Plastic Surgery Devices (DHT4B) |
| Class | II | II |
| 21 CFR<br>number | 878.4780 | 878.4780 |
| Category | Powered suction pump and wound dressing<br>kit | Powered suction pump and wound dressing<br>kit |
| Product Code | OMP | OMP |
| Device<br>Description | The PREVENT™ Kits are composed of sterile, single-use, disposable components that are designed to be used with a pump to deliver NPWT to a wound surface as part of a negative pressure wound therapy (NPWT) system.<br>The dressing kit includes 1) a thermoplastic elastomer (TPE) dressing (Prevent™ barrier) used to contact the wound bed and allow the application of NPWT to the wound and to provide flow pathways for the removal of exudate, 2) occlusive drape(s) to create a seal around the wound, and 3) a dome assembly with drainage tubing that is connected to the suction tubing of the disposable canister of the negative pressure pump to create a closed system.<br>The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.<br>The wound contact layer is provided in a single size and thickness, so the kits are provided in a single size | The Theia Foam Kits are composed of sterile, single use, disposable components for use with negative pressure pumps as part of a negative pressure wound therapy (NPWT) system.<br>The dressing kit includes 1) a foam dressing used to contact the wound bed and allow the application of NPWT to the wound and to provide flow pathways for the removal of exudate, 2) occlusive drape(s) to create a seal around the wound, and 3) a dome assembly with drainage tubing that is connected to the suction tubing of the disposable canister of the negative pressure pump to create a closed system.<br>The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.<br>The kits are provided in small, medium, and large sizes (based on foam dressing length x width) with an additional option of foam thickness for wound packing and coverage. |
| Parameter | Subject Device | Primary Predicate Device |
| Kit Components | Prevent™ barrier, 20 cm x 25 cm Dome assembly consisting of ported dome with skirt and connection tube including clamp and Luer lock connection [2] Drapes | Foam Dressing (three sizes: large 25 x 16cm, medium 20 x 13cm, and small is 10 x 8cm. each available in 3 cm and 1.5 cm thickness) Dome assembly consisting of ported dome with skirt and connection tube including clamp and Luer lock connection [1 or 2] Drapes |
| Wound contact layer | The Prevent™ barrier is a flexible transparent component of thermoplastic elastomer (Medalist MD-10135 Natural). This component is intended for use as the primary contact layer, applied in direct contact with the wound surface. | The Theia foam is a black, reticulated flexible polyether-based polyurethane hydrophobic foam material with 60 pores per square inch. This component is intended for use as the primary contact layer, applied in direct contact with the wound surface. |
| Skin Contact Layer (Drape) | 2.5mil 3M 9836 Clear polyolefin carrier<br>1.0 mil 3M 9836 Polyurethane Film<br>3M 9836 Acrylate adhesive designed for medical / surgical use | 2.5mil 3M 9836 Clear polyolefin carrier<br>1.0 mil 3M 9836 Polyurethane Film<br>3M 9836 Acrylate adhesive designed for medical/surgical use |
| Intended Use / Indications for Use | The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris.<br><br>The PREVENT™ Kit is appropriate for use on the following wounds:<br>Pressure UlcersDiabetic/Neuropathic UlcersVenous Insufficiency UlcersTraumatic WoundsPost-Operative and Dehisced Surgical WoundsSkin Flaps and Grafts<br>The system is for prescription use only. | The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pump for the application of negative pressure wound therapy to the wound. The Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.<br><br>The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds:<br>Pressure UlcersDiabetic/Neuropathic UlcersVenous Insufficiency UlcersTraumatic WoundsPost-Operative and Dehisced Surgical WoundsSkin Flap and Grafts<br>The system is appropriate for use in acute, extended and homecare settings. |
| Parameter | Subject Device | Primary Predicate Device |
| Principles of<br>Operation | The wound bed is dressed, fitted with mode<br>of communication between the wound bed<br>and suction apparatus, and sealed (according<br>to labeling instructions). The suction<br>apparatus is engaged to create a vacuum<br>(negative pressure) within the wound bed<br>drives the wound exudate to be pumped<br>from the wound bed into a collection<br>canister. The device is designed to provide a<br>pre-set level of negative pressure to the<br>wound bed. | The wound bed is dressed, fitted with mode<br>of communication between the wound bed<br>and suction apparatus, and sealed (according<br>to labeling instructions). The suction<br>apparatus is engaged to create a vacuum<br>(negative pressure) within the wound bed<br>drives the wound exudate to be pumped<br>from the wound bed into a collection<br>canister. The device is designed to provide a<br>pre-set level of negative pressure to the<br>wound bed. |
| Maximum<br>Duration of a<br>single<br>dressing | 3 days | 3 days |
| Dressing<br>changes | • Follow hospital protocol, policy, and<br>procedure for using NPWT dressings and<br>pumps.<br>• With a heavily colonized or infected<br>wound, consider changing the dressing<br>every 12 to 24 hours. Regular monitoring<br>of the wound must be maintained to<br>check for signs of infection | • Follow hospital protocol, policy, and<br>procedure for using NPWT dressings and<br>pumps.<br>• With a heavily colonized or infected<br>wound, consider changing the dressing<br>every 12 to 24 hours. Regular monitoring<br>of the wound must be maintained to<br>check for signs of infection. |
| User<br>Population | Healthcare professionals | Healthcare professionals |
| Patient<br>Population | Adults | Adults |
| Use<br>Environment | Healthcare facilities and home care settings | Healthcare facilities and home care settings |
| Canister<br>Volume | 900 ml | 900 ml |
| Pump | Pump; Exsudex™ Negative Pressure Wound<br>Drainage Pump models XS and XL, privately<br>labeled as CCT Mini and CCT1 Negative<br>Pressure Wound Drainage Pumps,<br>respectively | Pump; Exsudex™ Negative Pressure Wound<br>Drainage Pump models XS and XL, privately<br>labeled as CCT Mini and CCT1 Negative<br>Pressure Wound Drainage Pumps,<br>respectively |
| Pump Type | Custom designed pump<br>controlled by a microprocessor | Custom designed pump<br>controlled by a microprocessor |
| Pump power<br>source | AC or battery | AC or battery |
| Pressure<br>intensity<br>(NPWT<br>operating<br>ranges) | Pump spec indicates range is -10 to -200<br>mmHg; nominal pressure at the wound<br>surface is 120 mmHg | Pump spec indicates range is -10 to -200<br>mmHg; nominal pressure at the wound<br>surface is 120 mmHg |
| Sterility | Kit components are supplied sterile; SAL 10-6 | Kit components are supplied sterile; SAL 10-6 |
| Parameter | Subject Device | Primary Predicate Device |
| <b>Sterilization method</b> | Ethylene oxide; validated to ISO / AAMI 11135-1 Medical Devices - Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and AAMI / ANSI / ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals…