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Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.

Due to the nature of the device (a medicated wound gel), the provided documents (K020540) do not contain information about acceptance criteria and studies in the context of device performance as one would expect for an AI/software device. Instead, the "study" described is related to biocompatibility and a comparison to a predicate device for substantial equivalence.

Therefore, I cannot directly provide the requested table and detailed information as it pertains to AI/software performance criteria. However, I can extract the relevant information regarding the safety and equivalence arguments made for this specific product.

Here's a breakdown of what the document does provide, structured to address your points as much as possible within the context of a physical medical device submission for substantial equivalence:

Device: Regenecare™ Wound Gel (Medicated Hydrogel Wound and Burn Dressing)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are related to safety and substantial equivalence to a predicate device, rather than quantitative performance metrics like sensitivity/specificity for AI.

• Demonstrated by Sensitization Test in Guinea Pigs
• Demonstrated by In Vitro Cytotoxicity Test |
  | Safety (Lidocaine) | - Pre-established through long history of over-the-counter use of topical lidocaine (up to 4%).
• Conclusion: Addition of 2% lidocaine to the original formulation does not raise new biocompatibility issues. |
  | Substantial Equivalence | - Similar in composition to MPM Regenecare™ Wound Gel (K992074).
• Identical in function to MPM Regenecare™ Wound Gel (K992074).
• Identical in intended use to MPM Regenecare™ Wound Gel (K992074) and other legally marketed hydrogel wound dressing products.
• Conclusion: Safe and effective for intended use, performs at least as well as legally marketed predicate devices. |

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

• Biocompatibility Tests: The document mentions "rabbits" and "guinea pigs" for animal testing, and "in vitro" for cytotoxicity. Specific sample sizes (e.g., number of animals, number of replicates) are not provided in this summary.
• Safety of Lidocaine: This relies on the general historical use of lidocaine, not a specific "test set" in this submission.
• Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/animal study results and a comparison to existing market data.

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

This concept is not applicable here. The "ground truth" for biocompatibility is whether the biological response meets accepted safety standards, determined by standard laboratory protocols and expert interpretation of those results. The primary "experts" involved would be toxicologists and regulatory reviewers.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader interpretation or clinical endpoints requiring 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 is a physical wound gel, not an AI or software device.

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

Not applicable. This is a physical wound gel, not an AI or software device.

7. The Type of Ground Truth Used

• Biocompatibility: Laboratory test results (irritation, sensitization, cytotoxicity) against established physiological endpoints and safety thresholds.
• Safety of Lidocaine: Historical clinical use and accepted pharmacological profiles.
• Substantial Equivalence: Comparison of device characteristics (composition, function, intended use) to an already cleared (predicate) device.

8. The Sample Size for the Training Set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary of the "Study" (Biocompatibility & Comparison to Predicate):

The "study" or evidence presented for K020540 relates entirely to establishing the safety and substantial equivalence of the Regenecare™ Wound Gel, particularly with the addition of 2% lidocaine, to an already approved predicate device (MPM Regenecare™ Wound Gel; K992074).

• Biocompatibility: The original predicate device's biocompatibility was established through:
  • A primary dermal irritation test in rabbits.
  • A sensitization test in guinea pigs.
  • An in vitro cytotoxicity test.
• Lidocaine Safety: The submission leverages the well-established long history of over-the-counter use for topical lidocaine (up to 4%) to argue that the 2% concentration does not introduce new biocompatibility issues.
• Substantial Equivalence Argument: The new device (Regenecare™ Wound Gel with lidocaine) is stated to be similar in composition and identical in function and intended use to the predicate device. This comparison forms the basis for demonstrating that the new device is "safe and effective for its intended use, and performs at least as well as legally marketed predicate devices."

In essence, for this traditional medical device, the "acceptance criteria" were that the device be biocompatible and substantially equivalent in safety and efficacy to a previously cleared device, a benchmark they met by referring to prior testing and established safety profiles.

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Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes.

Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.

This document is a 510(k) premarket notification for a medical device called "MPM Regenecare™ Wound Gel". A 510(k) is a submission made to the FDA by medical device manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison to an existing device, rather than new extensive clinical studies that would establish acceptance criteria and device performance in the way clinical trials do for new drugs.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training) generally comes from performance studies, which are not typically part of a 510(k) summary focused on substantial equivalence.

Based on the provided text, the following can be extracted:

• Device Name: MPM Regenecare™ Wound Gel
• Intended Use: Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
• Predicate Device: MPM Hydrogel™ Dressing (K952276)
• Studies Mentioned (for biocompatibility, not performance of wound healing efficacy):
  • Primary dermal irritation test in rabbits
  • Sensitization test in guinea pigs
  • In vitro cytotoxicity test

The 510(k) process focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness information, often without the need for new clinical data, especially for devices like wound dressings that have well-established predicates. The biocompatibility tests listed are to ensure the material itself is safe, not to prove the clinical efficacy of wound healing according to specific performance metrics.

In summary, there are no acceptance criteria or studies providing performance metrics for the wound healing efficacy of the device within this 510(k) summary.

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