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Over-the-Counter Use: Medline Burn and Wound Dressing is intended to moisten the management of minor cuts, minor abrasions, minor lacerations and minor burns.

Medline Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to moisten the wound. The dressing protects the wound and provides a moist wound environment conducive to healing. Medline Burn and Wound Dressing (OTC) contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes. Medline Burn and Wound Dressing (OTC) is provided non-sterile for single patient use. The subject device is comprised of the following ingredients: Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, and Polyhexanide (PHMB). The Medline Burn and Wound Dressing (OTC) contains a concentration of 0.1% w/w of PHMB, which acts as a preservative to inhibit the growth of microorganisms within the product.

The provided text is a 510(k) premarket notification for a medical device called "Medline Burn and Wound Dressing (OTC)". This document primarily focuses on demonstrating substantial equivalence to a predicate device for a change in intended use from prescription to over-the-counter.

Because this is a submission for an over-the-counter wound dressing, and not an AI-powered diagnostic device, many of the typical acceptance criteria and study details related to AI performance (like sensitivity, specificity, MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets for AI models) are not applicable to this document. The submission is about safety and effectiveness for a physical medical product, not an AI algorithm.

Here's an analysis based on the information available, addressing the relevant points and noting where information is not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are related to the safety and effectiveness of the wound dressing for its intended OTC use, primarily demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical testing already completed for the primary predicate device.

2. Sample Size for the Test Set and Data Provenance

• Test Set (for performance testing): Not applicable in the context of an "AI test set" here. The testing was non-clinical and performed on materials/animals for the primary predicate device (K173911).
• Data Provenance: The study (non-clinical performance testing, e.g., wound healing study) that supports the current device's performance was conducted under GLP (21 CFR 58) for the primary predicate device K173911. The origin of the animal study data (e.g., country) is not specified in this document. It was retrospective to this particular 510(k) but prospective for the original K173911 application.

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

• This information is not provided as the evaluation relies on non-clinical (biocompatibility, shelf-life, animal wound healing) studies rather than expert-adjudicated clinical data for an AI algorithm. The "ground truth" for these tests would be the measured scientific outcomes (e.g., tissue reaction, microbial growth, wound closure rates).

4. Adjudication Method for the Test Set

• Not applicable, as there isn't a "test set" requiring expert adjudication in the context of an AI device.

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

• Not applicable. This device is a wound dressing, not an AI diagnostic or assistance tool, so no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a wound dressing, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for the device's safety and effectiveness is derived from non-clinical testing results:
  • Biocompatibility: Measured biological reactions per ISO 10993-1.
  • Shelf Life: Product stability and retention of specifications over time.
  • Antimicrobial Effectiveness: Measured reduction in microbial load.
  • Microbial Limits/Examination: Measured absence or presence of specific microorganisms.
  • Wound Healing Study: Measured physiological endpoints of wound repair in an animal model (e.g., wound closure, tissue regeneration).

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set for an AI model was used.

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Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.

Medline Burn and Wound Dressing is a translucent, biocompatible, odorless, semisolid gel intended to cleanse and moisten the wound bed. The dressing maintains moisture in the wound and protects the wound from dessication to provide an optimal moist wound environment conducive to wound healing. Medline Burn and Wound Dressing contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes. Medline Burn and Wound Dressing is provided non-sterile for single patient use. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.

The provided document is a 510(k) summary for the Medline Burn and Wound Dressing, which is a medical device. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not involve a clinical study to prove device performance against acceptance criteria in the manner that AI/ML devices do.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for proving device performance cannot be extracted from this document because the device is a wound dressing, not an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Prontosan Wound Gel and Manuka Fill) through a comparison of technological characteristics and non-clinical testing.

Here's a breakdown of what can be extracted, and why the other requested points are not applicable:

1. Table of acceptance criteria and reported device performance: Not applicable. This document performs a comparison for substantial equivalence, not a direct performance study against criteria for an AI/ML output. Instead, it compares characteristics and non-clinical test results to predicate devices.

   DEVICE CHARACTERISTIC	PROPOSED DEVICE PERFORMANCE / CHARACTERISTICS	PREDICATE DEVICE PERFORMANCE / CHARACTERISTICS	COMPARISON ANALYSIS
   Product Code	FRO	FRO (Primary & Secondary Predicates)	Same as Predicates
   Intended Use	Cleanses and moistens wound bed; manages ulcers, 1st & 2nd degree burns, partial & full thickness wounds, surgical incisions; supports autolytic debridement.	Cleanses & moistens wound bed; manages ulcers, 1st & 2nd degree burns, partial & full thickness wounds, surgical incisions; softens encrusted dressings (Primary); manages leg/pressure/diabetic foot ulcers, 1st & 2nd degree burns, surgical/trauma wounds; provides moist environment for autolytic debridement (Secondary).	Same as Primary Predicate; Same as Secondary Predicate
   Regulation Number	Unclassified	Unclassified (Primary & Secondary Predicates)	Same as Predicates
   Configurations	1.75 oz tube	30 ml tube (Primary); Individual tubes in a variety of sizes (Secondary)	Similar to Predicates
   Design Features	Clear to translucent, water soluble, virtually odorless, amorphous wound gel with a surfactant and PHMB as a preservative.	Clear, colorless, virtually odorless aqueous wound gel with a surfactant and PHMB as a preservative (Primary); Wound gel with honey, helps maintain a moist wound environment (Secondary)	Similar to Predicates
   Materials	Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, PHMB	Purified Water, Glycerol, Hydroxyethylcellulose, Undecylenamidopropyl Betaine, PHMB (Primary); 100% Leptospermum scoparium honey from New Zealand (Secondary)	Similar to Primary Predicate
   Non-Clinical Testing Conducted	- Biocompatibility in accordance to ISO 10993-1

• Shelf Life
• USP Antimicrobial Effectiveness
• Wound Healing Study (GLP) | - Biocompatibility in accordance to ISO 10993-1
• Shelf Life
• USP Antimicrobial Effectiveness
• USP Bacterial Endotoxin Testing (Primary);
• Biocompatibility in accordance to ISO 10993-1
• Sterilization Validation
• Packaging Validation
• Shelf Life
• Wound Healing Study (Secondary) | Similar to Predicates|
  | Sterile vs. Non-Sterile | Non-sterile | Sterile by aseptic filtration until first opened (Primary); Sterile by gamma irradiation (Secondary) | Different than Predicates |
  | Reusable vs. Single Use | Single patient, multiple use | Single patient, multiple use (Primary); Single use (Secondary) | Same as Primary Predicate; Similar to Secondary Predicate |

2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "non-clinical testing" including a "Wound Healing Study" (animal study, conducted under GLP - 21 CFR 58), but does not specify a "test set" in the context of an AI/ML algorithm or provide sample sizes for such. Data provenance (country, retrospective/prospective) is also not relevant here for an AI/ML "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept applies to AI/ML devices where human experts label data. For a wound dressing, "ground truth" would relate to the outcome of biological or chemical tests, or healing observed in the animal study, not expert consensus on image interpretation or similar.

4. Adjudication method: Not applicable. No "adjudication" of expert opinions for a test set is required for this type of device.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are specific to imaging and AI/ML devices where the performance of human readers, with and without AI assistance, is evaluated. This is not relevant for a wound dressing.

6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used: For the non-clinical "Wound Healing Study," the ground truth would be the observed biological outcome of wound healing in the animal model. For biocompatibility and antimicrobial effectiveness, the ground truth would be the results of standard laboratory tests against established criteria (e.g., ISO 10993-1, USP ).

8. The sample size for the training set: Not applicable. There is no AI/ML algorithm, and therefore no "training set."

9. How the ground truth for the training set was established: Not applicable. No training set exists.

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