(190 days)
The following indications for use of the product should be managed under the supervision of a health care professional:
Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds.
The following conditions are considered appropriate for OTC use by the lay person:
- · Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.
Coreleader Algi-Fiber wound dressing is composed of calcium alginate fiber. It is softness and therefore Coreleader Algi-Fiber wound dressing is suitable for wound surface regardless the location, size, sinus and depth of a patient. Due to its highly hydrophilic property, the Coreleader Algi-Fiber wound dressing absorbs the wound exudates to form a hydrogel protection layer. The Coreleader Algi-Fiber wound dressing is biocompatibility. It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant. Coreleader Algi-Fiber is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 10° SAL.
The provided text describes a wound dressing device and its substantial equivalence to predicate devices, focusing on its physical properties, intended use, and biocompatibility. However, it does not include acceptance criteria for a device's performance that would typically be evaluated through a clinical study (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific functional outcome for a therapeutic device).
Therefore, a table of acceptance criteria and reported device performance, information about sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth types cannot be extracted from this document. This document is a 510(k) Summary for a medical device (Coreleader Algi-Fiber Wound Dressing), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria as one would find for an AI-powered diagnostic or similar complex device.
Here's an analysis of what can be extracted:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Comparison):
The table provided in the document compares the proposed device (Coreleader Algi-Fiber Wound Dressing) with a predicate device (Comfeel SeaSorb Dressing) across several attributes to establish substantial equivalence.
| Acceptance Criteria (Predicate) | Reported Device Performance (Coreleader Algi-Fiber) |
|---|---|
| Device Description: Highly absorbent material composed of a Xerogel of calcium sodium alginate cast into a high density polyethylene net. | Device Description: Highly absorbent wound dressing consisting of an calcium alginate fiber. (Further described as made of non-woven from calcium alginate fiber, absorbing exudates to form a hydrogel, and suitable for various wound surfaces.) |
| Use: Single | Use: Single |
| Biocompatibility: Non-hypersensitivity, non-cytotoxicity, and non-irritant | Biocompatibility: Non-hypersensitivity, non-cytotoxicity, and non-irritant. (Explicitly stated: "It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant.") |
| Intended Use: For management of (under the guidance of a health care professional) moderate to heavily exudating wounds, including leg ulcers and pressure sores, etc. | Intended Use: For management of (under the guidance of a health care professional) moderate to heavily exudating wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds. (Also includes OTC use for minor exuding wounds.) |
| Precautions: (Extensive list including arterial insufficiency, complicated diabetic wounds, high infection risk, syphilis, tuberculosis, leprosy, cancer, removal for radiation/ultrasonic/diathermy/microwaves, clinical infection signs, not for dry wounds or third degree burns, no known hypersensitivity ingredients.) | Precautions: (Extensive list including hypersensitivity, not for surgical implant, high risk infected wounds only under physician care, not left permanently, not for dry wounds or third degree burns, single-use only, no re-sterilization.) Many precautions are similar to the predicate, demonstrating alignment in safety considerations. |
| Sterilization: Sterile | Sterilization: Sterile (Further specified as "sterilized by γ-ray radiation to a 10⁻⁶ SAL.") |
| Packaging: Polyester pouches laminated with peelable polyethylene prior to sterilization | Packaging: Sterilization pouch: Top material: Medical grade paper pouches. Bottom material: Transparent see-through film (made of PET). (This differs slightly in material but serves the same sterile packaging function.) |
Study Details (Limited Information for this Type of Device Submission):
- Sample Size for the Test Set and Data Provenance: Not applicable/not provided for performance evaluation in this 510(k) summary. The submission focuses on substantial equivalence based on product characteristics and previous testing data (e.g., biocompatibility testing).
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable/not provided. Biocompatibility testing results are typically from laboratory analyses, not expert consensus on clinical cases.
- Adjudication Method: Not applicable/not provided.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study is not mentioned as it's not relevant for this class of wound dressing.
- Standalone Performance (Algorithm Only): Not applicable. This is a physical wound dressing, not an algorithm.
- Type of Ground Truth Used: For biocompatibility, the "ground truth" would be established by standardized in vitro and in vivo biological tests (e.g., ISO 10993 series for cytotoxicity, irritation, sensitization). The document states the device "has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant."
- Sample Size for the Training Set: Not applicable/not provided.
- How the Ground Truth for the Training Set Was Established: Not applicable/not provided.
Summary of Device and Evidence Presented:
The Coreleader Algi-Fiber Wound Dressing gained acceptance by demonstrating substantial equivalence to legally marketed predicate devices (CALGON VESTAL DIV., K910059, KALTOSTAT WOUND DRESSING and COLOPLAST CORP., K983519, COMFEEL SEASORB DRESSING). The evidence for this equivalence relies on direct comparison of material composition (calcium alginate fiber vs. calcium sodium alginate xerogel), intended use, single-use nature, sterilization methods, packaging, and critically, biocompatibility.
The biocompatibility of the Coreleader Algi-Fiber Wound Dressing was tested and shown to meet the standards of being non-hypersensitive, non-cytotoxic, and non-irritant. While no specific study names or detailed results are provided in this summary, the statement "It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant" confirms that the necessary biological evaluation tests were performed and passed. This type of submission does not typically include detailed clinical trial data or performance metrics beyond the basic safety and functional comparisons required to demonstrate substantial equivalence to an existing device.
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