Search Results

Rx

Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.

OTC

Management of minor wounds including minor cuts, abrasions, lacerations and burns.

The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.

The provided document describes the KeriCure Inc.'s Field Shield Wound Dressing, an unclassified device. The information focuses on demonstrating its substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the Field Shield Wound Dressing. Instead, the document focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices, particularly through various types of testing. The reported device performance is outlined in the "Summary of Performance Testing" table.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Study (Pain Relief): The document states "Subjects were asked to complete an assessment prior to use of the device and within 30 minutes after application of the device." However, the sample size for this clinical study is not explicitly stated.
• Data Provenance: Not specified, but generally, clinical studies for FDA submissions are prospective. Given the medical device context, it's likely originating from a regulated clinical trial, but country of origin is not mentioned.
• Other Performance Tests (Biocompatibility, Antimicrobial, Endotoxin): These are laboratory tests typically performed on device samples. The specific number of samples for each test is not provided, but they represent a "test set" of the device material. Data provenance for these lab tests would typically be from a certified testing laboratory.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• For the Clinical Study (Pain Relief): The "ground truth" for pain reduction is based on subjects' self-assessment using a VAS pain score scale. No external experts are mentioned for establishing this ground truth, as it's a self-reported outcome.
• For other performance tests (e.g., biocompatibility, antimicrobial activity), the "ground truth" is established by the accepted standards and protocols of the respective laboratory tests. The experts involved would be the qualified laboratory personnel conducting these standardized tests. Their specific numbers and qualifications (e.g., toxicologists, microbiologists) are not detailed in this summary.

4. Adjudication Method for the Test Set

• For the Clinical Study (Pain Relief): There is no mention of an adjudication process for the VAS pain scores. Scores were directly collected from subjects. Since it's a subjective measure, individual responses constitute the data.
• For other performance tests: Adjudication is typically not applicable in the same way as expert consensus reviews. The results are determined by objective laboratory measurements against defined standards.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed for this device. This type of study is more common for diagnostic imaging devices where different readers interpret cases. The Field Shield Wound Dressing is a therapeutic wound dressing, so a different type of clinical evaluation is more appropriate.
• The clinical study focused on the effectiveness of lidocaine for pain relief, not on reader interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• This concept is not applicable to the Field Shield Wound Dressing. This is a physical wound dressing and not a software algorithm or AI device. Therefore, there is no "algorithm only" performance to evaluate. The device's performance is intrinsically linked to its physical application and biological interaction with the wound.

7. Type of Ground Truth Used

• Clinical Study (Pain Relief): Self-reported patient outcomes (VAS pain scores).
• Other Performance Tests (Biocompatibility, Antimicrobial, Endotoxin): Established according to recognized scientific and regulatory standards (e.g., ISO, USP, FDA guidance). This includes various in vitro and in vivo laboratory test results.
• Nonclinical Wound Healing Study: Observation of device-related adverse events and comparison to standard of care in a wound healing model (likely animal model, though not specified).

8. Sample Size for the Training Set

• Not Applicable. As a physical medical device, there is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are inherently defined by its composition and manufacturing process, not by a dataset it was trained on.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. Since there is no training set for this device, there is no ground truth to establish for it.

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KeriCure™ Liquid Bandage and KeriCure Natural Seal™ Liquid Bandage: To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

KeriCure™ Advanced Liquid Bandage: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

The KeriCure™ Liquid Bandage family of products is comprised of a protective, elastic polymer film (proprietary polyacrylate polymer). As applied to the skin, the liquid bandage is slightly more viscous than water and sets within minutes to form a clear, breathable and completely transparent film. The Liquid Bandage is capable of adhering to both intact and compromised body tissue. The device is available with either a dropper or spray applicator.

The provided text describes information about the KeriCure™ Advanced Liquid Bandage, a medical device, and its substantial equivalence to predicate devices, focusing on performance and biocompatibility testing. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, human expert involvement, or AI-related effectiveness.

Here's an analysis of what is available vs. what is not:

Information Present in the Document:

• Device Name: KeriCure™ Advanced Liquid Bandage, KeriCure™ Liquid Bandage, KeriCure Natural Seal™ Liquid Bandage.
• Intended Use: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions (for Advanced version).
• Product Code: KMF (Liquid bandage)
• Regulatory Class: Class I
• Predicate Devices: K083913 – NUVADERM – Chesson Labs; K991920 – Dermaphylyx Hydrophilic Wound Dressing, Dermaphylyx, Inc.
• Biocompatibility Testing: Passed ISO 10993-10 for irritation and skin sensitization. Cytotoxicity testing performed according to 10993-5, with spray applicator scoring 1.
• Shelf Life Testing: Performed according to ISO11737-1, ASTM F1980, USP-51 and USP-35, indicating a 12-month shelf life.
• Performance Testing (General): "Performance testing for KeriCure™ Liquid Bandages was performed according to the following standards: ASTM 570, ASTM D638-10, ASTM D789, E96/ E96M-10. The applicant device passed all testing requirements with results similar to the predicate devices in terms of performance capabilities."
• Substantial Equivalence: Claimed based on similar fundamental technological characteristics (flexible wound management, moisture barrier, absorptive qualities, infection protection) and verified by test results in design, materials, and intended use.

Information NOT present in the Document (that you requested):

1. A table of acceptance criteria and the reported device performance: While general statements about "passing all testing requirements" are made, specific numerical acceptance criteria (e.g., "tear strength must be > X N/mm") and the device's exact reported performance values are not provided.
2. Sample size used for the test set and the data provenance: The document mentions "testing requirements" and "test results" but does not specify the sample sizes (e.g., number of bandages tested, number of subjects in a trial) or the origin of the data (e.g., country, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This device is a liquid bandage, not typically an AI-driven diagnostic tool that relies on expert interpretation of images or other data for ground truth establishment. Therefore, this information is not relevant or present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device testing.
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 explicitly for AI-assisted diagnostic or interpretative devices. The KeriCure™ Advanced Liquid Bandage is a physical wound dressing; it does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance characteristics mentioned (e.g., elasticity, water vapor transmission), the "ground truth" would be established by the defined parameters within the ASTM/ISO standards themselves, rather than expert consensus or pathology data. For biocompatibility, the ground truth is the absence of irritation, sensitization, or cytotoxicity as defined by the ISO standards.
8. The sample size for the training set: Not applicable, as this is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary: The provided text details the regulatory clearance for a liquid bandage, including its intended use, predicate devices, and general statements about biocompatibility and performance testing against established standards. However, it lacks the specific quantitative data, study designs, and human expert involvement details that would be found in a submission for an AI-powered diagnostic device or a study designed to evaluate human performance with and without AI assistance.

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