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KulaVAC Foam Dressing Kit is intended to be used in conjunction with suction devices to deliver negative pressure wound therapy to the wound. KulaVAC Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

KulaVAC is wound dressing kit for Negative Pressure Wound Therapy (NPWT). The kit consists of individually reviewed medical components; polyurethane foam wound dressing, suction head, tubing, connectors, clamps and acrylic adhesive transparent film. Foam dressing is available in three sizes; small, medium and large, and the other accessories are used to connect to a suction device. The kit is supplied sterile and is single-use.

The KulaVAC Foam Dressing Kit, a negative pressure wound therapy (NPWT) device, underwent non-clinical testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

• Ability to deliver negative pressure: The system should consistently and effectively apply and maintain specified negative pressure levels to the wound bed.
• Fluid removal efficiency: The dressing and suction system should effectively remove exudates and infectious material from the wound.
• Seal integrity: The adhesive film should maintain a sufficient seal around the foam dressing to prevent air leaks and maintain negative pressure.
• Durability/Integrity of components: The foam, tubing, and connectors should withstand the pressures and conditions of NPWT without degradation or failure.
• Compatibility with suction devices: The kit should be compatible with standard suction devices used for NPWT. | All tests conducted for KulaVAC successfully met the acceptance criteria, demonstrating safety and effectiveness. Specifically, the bench testing using a mock wound model verified substantial equivalence to the predicate device in performance. The compatibility of the device with vacuum sources was also demonstrated. |
  | Wound Dressing Test (EN 13726-1) | Conformity to relevant sections of EN 13726-1, which typically covers:
• Fluid handling capacity: The ability of the dressing to absorb and retain wound exudate.
• Moisture vapor transmission rate (MVTR): The rate at which water vapor passes through the dressing.
• Adhesiveness: The ability of the dressing to adhere to the skin.
• Dimensional changes: Stability of the dressing's dimensions when wet or stretched. | All tests conducted for KulaVAC successfully met the acceptance criteria, demonstrating safety and effectiveness. Wound dressing tests were conducted in accordance with EN 13726-1. |
  | Biocompatibility Testing (ISO 10993-1) | Conformity to ISO 10993-1, indicating absence of unacceptable biological risks. This typically includes tests for:
• Cytotoxicity: No toxic effects on cells.
• Sensitization: No allergic reactions.
• Irritation: No skin or tissue irritation.
• Hemocompatibility: No adverse effects on blood components (if applicable). | All tests conducted for KulaVAC successfully met the acceptance criteria, demonstrating safety and effectiveness. Biocompatibility testing was conducted in accordance with ISO 10993-1. |

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify the exact sample size used for each "non-clinical test." It broadly states that "non-clinical testing was performed."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that CG Bio Co., Ltd. is based in Korea and the tests are described as "non-clinical testing," it is reasonable to infer the testing was conducted in a laboratory setting, likely in Korea.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• This information is not provided in the document. The non-clinical tests described (bench testing, wound dressing test, biocompatibility) are objective measurements and do not typically involve experts establishing a ground truth in the way clinical studies or diagnostic AI algorithms do. Instead, they rely on established industry standards and protocols.

4. Adjudication Method (Test Set)

• This information is not applicable as the tests are non-clinical and do not involve human interpretation or subjective assessment requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted. The provided text describes non-clinical bench, wound dressing, and biocompatibility tests, primarily focused on demonstrating substantial equivalence to predicate devices through technical performance. There is no mention of human readers or AI assistance in the context of comparative effectiveness.

6. Standalone Performance Study (Algorithm Only)

• Yes, in essence, the "non-clinical testing" described can be considered a standalone performance study of the device itself. The tests evaluate the physical and functional aspects of the KulaVAC Foam Dressing Kit (e.g., its ability to deliver negative pressure, remove fluid, biocompatibility) without human intervention in the evaluation process, other than to set up and monitor the tests according to protocols. There is no "algorithm" in the context of an AI device, but rather the performance of the physical medical device.

7. Type of Ground Truth Used

• The ground truth for the non-clinical tests was established through objective measurements and adherence to recognized industry standards and protocols.
  • For bench testing, the ground truth was the established performance characteristics of the predicate devices or engineering specifications.
  • For wound dressing tests, the ground truth was the performance requirements stipulated by the EN 13726-1 standard.
  • For biocompatibility testing, the ground truth was the safety criteria defined by the ISO 10993-1 standard.

8. Sample Size for the Training Set

• This information is not applicable. The KulaVAC Foam Dressing Kit is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

9. How Ground Truth for Training Set Was Established

• This information is not applicable as there is no training set for this type of medical device.

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