(181 days)
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.
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.
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.
The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.
The wound contact layer is provided in a single size and thickness, so the kits are provided in a single size.
This FDA 510(k) summary describes the PREVENT™ Kit, a negative pressure wound therapy (NPWT) dressing. The primary focus of the provided text is on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a diagnostic study for an AI/ML powered device. As such, information regarding AI/ML specific aspects like acceptance criteria for algorithmic performance, independent test sets, expert ground truth establishment, MRMC studies, or training set details for AI are not present in this document.
The document discusses various performance and safety tests for the PREVENT™ Kit, which is a physical medical device, not an AI/ML algorithm.
Here's an attempt to answer the questions based on the provided text, highlighting what is not applicable or not provided for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
The document states acceptance criteria were "pre-determined" and that the device "met the pre-determined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria for most tests, nor does it provide the exact numerical performance results beyond general statements of success.
| Acceptance Criteria Category (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| Bench Testing (e.g., 7-day Glass Top Simulated Use, Tensile Testing, Seal Strength, Bubble Emission, System Alarm Functionality) | "All tests of the device met the pre-determined acceptance criteria." |
| Shelf-Life (Accelerated Aging, Real-time Long-term) | "The data from all three sets of accelerated aging tests confirm that the PREVENT™ Kit device meets the requirements as tested and reported within the document series. Real-time, long-term shelf life testing on the PREVENT™ Kit was completed for one year and confirmed the acceptable results of one year accelerated aging. Real-time testing will continue to a minimum of two years to confirm acceptable results to support the targeted two-year shelf-life." |
| Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Systemic Toxicity, Implantation, EO residuals, Bacterial Endotoxin) | "All tests of the device met the pre-determined acceptance criteria." |
| GLP Animal Testing (Animal health, wound healing, local histological effects compared to control) | "All endpoints were evaluated per protocol for this study and met the pre-determined acceptance criteria. Based on evaluation of overall animal healing performance and local tissue response to the study articles, there were no concerns identified regarding the safety and effectiveness of CCT PREVENT™ Kit." |
| Usability Testing (Successful completion of subtasks, absence of harmful use errors) | "Only 10 use errors were observed and none of these would cause harm of a serious nature." (Out of 272 individual subtasks, 249 were successful without UEs, difficulties, or close calls.) |
2. Sample size(s) used for the test set and the data provenance
- Bench Testing: Sample sizes are not explicitly stated for individual bench tests.
- Shelf-Life: Not specified.
- Biocompatibility Testing: Not specified.
- GLP Animal Testing: Sample size is not explicitly stated. The study involved swine.
- Usability Testing: 15 participants. Data provenance is implied to be from a controlled, prospective validation study conducted to ISO/IEC 62366-1:2015 standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a physical medical device approval, not an AI/ML diagnostic algorithm. The "ground truth" equivalent here would be the physical and biological test results, which are objectively measured/observed, not established by expert consensus. For usability testing, the "truth" is the observed performance of the participants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no diagnostic image interpretation or similar expert-driven assessment described.
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
This is not applicable. This document details the clearance of a negative pressure wound therapy kit, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as it is not an algorithm. The device's performance is inherently "standalone" in mechanical/biological terms (e.g., flow rate, seal integrity, biocompatibility, wound healing in animals).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Mechanical measurements, physical properties, alarm function validation.
- Shelf-Life: Stability data (e.g., material degradation, sterility maintenance).
- Biocompatibility Testing: Lab results from standardized tests (e.g., cytotoxicity assays, irritation tests, analytical chemistry for residuals, LAL test for endotoxins).
- GLP Animal Testing: Direct observation of animal health, gross and histological evaluation of wound healing and tissue response (e.g., pathology findings). This is a form of outcomes data in a controlled animal model.
- Usability Testing: Observed user performance against pre-defined task success criteria and identification of use errors.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (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
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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: | (919) 743-2500 (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™Kit | Theia Foam Kit | |
| CompanyName | Clear Choice Therapeutics (CCT) | Clear Choice Therapeutics (CCT) |
| 510(k) # | 232379 | K211277 |
| Classificationname | Negative Pressure Wound Therapy PoweredSuction Pump | Negative Pressure Wound Therapy PoweredSuction Pump |
| Classificationpanel | General and Plastic Surgery Devices (DHT4B) | General and Plastic Surgery Devices (DHT4B) |
| Class | II | II |
| 21 CFRnumber | 878.4780 | 878.4780 |
| Category | Powered suction pump and wound dressingkit | Powered suction pump and wound dressingkit |
| Product Code | OMP | OMP |
| DeviceDescription | 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.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.The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.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.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.The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.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 carrier1.0 mil 3M 9836 Polyurethane Film3M 9836 Acrylate adhesive designed for medical / surgical use | 2.5mil 3M 9836 Clear polyolefin carrier1.0 mil 3M 9836 Polyurethane Film3M 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.The PREVENT™ Kit is appropriate for use on the following wounds:Pressure UlcersDiabetic/Neuropathic UlcersVenous Insufficiency UlcersTraumatic WoundsPost-Operative and Dehisced Surgical WoundsSkin Flaps and GraftsThe 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.The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds:Pressure UlcersDiabetic/Neuropathic UlcersVenous Insufficiency UlcersTraumatic WoundsPost-Operative and Dehisced Surgical WoundsSkin Flap and GraftsThe system is appropriate for use in acute, extended and homecare settings. |
| Parameter | Subject Device | Primary Predicate Device |
| Principles ofOperation | The wound bed is dressed, fitted with modeof communication between the wound bedand suction apparatus, and sealed (accordingto labeling instructions). The suctionapparatus is engaged to create a vacuum(negative pressure) within the wound beddrives the wound exudate to be pumpedfrom the wound bed into a collectioncanister. The device is designed to provide apre-set level of negative pressure to thewound bed. | The wound bed is dressed, fitted with modeof communication between the wound bedand suction apparatus, and sealed (accordingto labeling instructions). The suctionapparatus is engaged to create a vacuum(negative pressure) within the wound beddrives the wound exudate to be pumpedfrom the wound bed into a collectioncanister. The device is designed to provide apre-set level of negative pressure to thewound bed. |
| MaximumDuration of asingledressing | 3 days | 3 days |
| Dressingchanges | • Follow hospital protocol, policy, andprocedure for using NPWT dressings andpumps.• With a heavily colonized or infectedwound, consider changing the dressingevery 12 to 24 hours. Regular monitoringof the wound must be maintained tocheck for signs of infection | • Follow hospital protocol, policy, andprocedure for using NPWT dressings andpumps.• With a heavily colonized or infectedwound, consider changing the dressingevery 12 to 24 hours. Regular monitoringof the wound must be maintained tocheck for signs of infection. |
| UserPopulation | Healthcare professionals | Healthcare professionals |
| PatientPopulation | Adults | Adults |
| UseEnvironment | Healthcare facilities and home care settings | Healthcare facilities and home care settings |
| CanisterVolume | 900 ml | 900 ml |
| Pump | Pump; Exsudex™ Negative Pressure WoundDrainage Pump models XS and XL, privatelylabeled as CCT Mini and CCT1 NegativePressure Wound Drainage Pumps,respectively | Pump; Exsudex™ Negative Pressure WoundDrainage Pump models XS and XL, privatelylabeled as CCT Mini and CCT1 NegativePressure Wound Drainage Pumps,respectively |
| Pump Type | Custom designed pumpcontrolled by a microprocessor | Custom designed pumpcontrolled by a microprocessor |
| Pump powersource | AC or battery | AC or battery |
| Pressureintensity(NPWToperatingranges) | Pump spec indicates range is -10 to -200mmHg; nominal pressure at the woundsurface is 120 mmHg | Pump spec indicates range is -10 to -200mmHg; nominal pressure at the woundsurface 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 |
| Sterilization method | 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 | Gamma irradiation |
Predicate Device
THEIA NPWT Wound Foam Dressing Kit, K211277
Device Description
The PREVENT™ Kit is used with the CCT1 and CCT Mini NPWT Drainage Pumps for negative pressure wound therapy (NPWT). NPWT uses a closed drainage system to apply controlled suction (vacuum) to a wound bed. The wound is first dressed with a single layer Prevent™ barrier (dressing) to allow pressure to be distributed evenly to the wound bed. The wound is then sealed with an adhesive film drape. A dome drainage tube is connected to the dressing through an opening of the film drape. The drainage tube is connected to a canister on the side of the vacuum pump. The vacuum may be applied continuously or intermittently, depending on the type of wound being managed and the clinical objectives.
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 CCT 1 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.
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Kit Contents
-
- (2) 10x12 in. transparent adhesive film drapes
-
- (1) Dome Assembly consisting of ported dome with skirt and connection tube including clamp and Luer lock connection
-
- (1) Prevent™ barrier, 20 cm X 25 cm
-
- Instructions for Use (IFU)
The CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps are not provided with the PREVENT™ Kit. Please refer to the CCT1 and CCT Mini Negative Pressure Wound Drainage Pump User Manual and follow the recommendations for use.
Device Comparison Table
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Comparison Summary
The kits are composed of sterile, single-use components to be used for NPWT, and each component of both kits has the same function. The main difference between the two devices is that the wound contact layers are of different formats, sizes and materials.
Each side of the Prevent™ barrier (wound contact layer) has a unique geometry to allow for efficient flow of fluids and negative pressure.). The transparent Prevent™ barrier, drape and dome assembly allow visibility of the wound bed, and the TPE dressing is hydrophobic.
The PREVENT™ Kit is sterilized with EO, whereas the Theia Foam Kit is gamma irradiated, but both have been validated to meet the SAL requirements.
Performance Summary
Bench Testing
Performance testing included 7-day Glass Top Simulated Use, Tensile Testing |Dome assembly to Tubing Connection], Tensile Strength of the Prevent™ barrier, Seal Strength and Bubble Emission tests of the primary sterile barrier, and System Alarm Functionality. All tests of the device met the pre-determined acceptance criteria.
Shelf-Life
The data from all three sets of accelerated aging tests confirm that the PREVENT™ Kit device meets the requirements as tested and reported within the document series. Real-time, longterm shelf life testing on the PREVENT™ Kit was completed for one year and confirmed the acceptable results of one year accelerated aging. Real-time testing will continue to a minimum of two years to confirm acceptable results to support the targeted two-year shelf-life.
Safety Summary
Biocompatibility Testing
GLP (21 CFR Part 58) biocompatibility testing of the PREVENT™ Kit included cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute / subchronic systemic toxicity, and implantation, per ISO 10993-1:2018. EO residuals ( ISO 10993-7:2008) and bacterial endotoxin tests ( Limulus Amoebocyte Lysate (LAL) Test) are done on each lot of sterilized devices. All tests of the device met the pre-determined acceptance criteria.
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GLP Animal Testing
A new GLP (21 CFR Part 58) study was completed to compare the wound healing and tissue response of the CCT PREVENT™ Kit to a marketed control article and to show that the CCT PREVENT™ Kit is as safe and effective as a marketed control article over the course of 35 +/- 1 days in swine. The following endpoints were considered: animal health, wound healing, and local histological effects.
All endpoints were evaluated per protocol for this study and met the pre-determined acceptance criteria. Based on evaluation of overall animal healing performance and local tissue response to the study articles, there were no concerns identified regarding the safety and effectiveness of CCT PREVENT™ Kit.
Usability Testing
A Human Factors / Usability Validation study was done per ISO / IEC 62366-1:2015. Results indicate that the CCT PREVENT™ Kit is appropriate for use by the intended users in the intended use environments. Fifteen enrolled participants performed a simulated use scenario of applying the Prevent™ barrier, draping the wound, connecting the dome assembly and tubing to the drape, initiating NPWT, pausing NPWT, and removing and disposing of the wound materials. None of the participants were trained, and had to perform the tasks relying only on the user interfaces of the system and the IFU.
The study population collectively performed 272 individual subtasks that were evaluated for performance. Of those individual subtasks, 249 were classified as being performed successfully, without UEs, difficulties, or close calls. Only 10 use errors were observed and none of these would cause harm of a serious nature.
Conclusion
The differences between the subject and predicate devices do not raise any new issues of safety or effectiveness. The subject device performed as well as the control device in the 35-day GLP study. Therefore, we conclude that the PREVENT™ Kit is substantially equivalent to the predicate devices.
§ 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.