(250 days)
HYDROPERMEATE™ Topical Emulsion is indicated for use in:
- Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers
- Superficial wounds
- 1st and 2nd degree burns, including sunburns
- Dermal donor and graft site management
- Radiation dermatitis
- Minor abrasions
ANSWER2SKIN™ SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns.
ANSWER2SKIN™ FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.
HYDROPERMEATE™ Topical Emulsion consists of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. HYDROPERMEATE™ is a prescription product.
ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are topical emulsions consisting of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are over-the-counter products.
The provided text describes Dermal Life LLC's HYDROPERMEATE™ Topical Emulsion and ANSWER2SKIN™ SUNBURN RELIEF Cream / FIRST AID Cream. It focuses on demonstrating substantial equivalence to a predicate device (BIAFINE™ Wound Dressing Emulsion K964240) rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.
Therefore, an acceptance criteria table and a detailed study description as requested cannot be fully generated from this document because the submission method relies on substantial equivalence to a predicate device for regulatory clearance, not on meeting specific, de novo performance metrics with a dedicated clinical trial to prove efficacy against acceptance criteria.
The document states:
- "The Dermal Life product was tested for performance criteria (physical parameters, biocompatibility, human dermal studies for irritation and dermal sensitization)."
- "Performance data support that the Dermal Life wound dressing meets its specified criteria."
- "Functional and performance testing has been conducted to assess the safety and efficacy of HYDROPERMEATE™ Topical Emulsion and the results support the substantial equivalence to the predicate device."
This indicates that internal performance testing was done to support the substantial equivalence claim, but the details of the acceptance criteria, the specific study design (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance), and the resulting data are not provided in this 510(k) summary. These types of detailed studies are more common for novel devices or those seeking a De Novo classification, where specific performance targets must be met.
Summary based on available information:
| Acceptance Criteria (Inferred from regulatory pathway) | Reported Device Performance (Inferred from submission) |
|---|---|
| Technological Similarities: Device must be technologically similar to the predicate device (BIAFINE™ Wound Dressing Emulsion K964240) in composition and mechanism. | HYDROPERMEATE™ Topical Emulsion, ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are described as "technologically similar" to the predicate device, consisting of approximately 75% purified water, 20% wax (oily) ingredients, and 5% dissolved ingredients like triethanolamine sodium alginate. |
| Performance Criteria (Safety & Efficacy): The device must demonstrate equivalent safety and efficacy to the predicate device through performance testing. This includes: |
- Physical parameters
- Biocompatibility
- Human dermal studies for irritation
- Human dermal studies for dermal sensitization | "The Dermal Life product was tested for performance criteria (physical parameters, biocompatibility, human dermal studies for irritation and dermal sensitization). Performance data support that the Dermal Life wound dressing meets its specified criteria."
"Functional and performance testing has been conducted to assess the safety and efficacy... and the results support the substantial equivalence to the predicate device." Specific results are not detailed. |
| Indications for Use: The device's intended use must align with, or be comparable to, the predicate device. | HYDROPERMEATE™'s indications for use align with those commonly found for wound dressings (full thickness wounds, superficial wounds, burns, donor/graft sites, radiation dermatitis, minor abrasions).
ANSWER2SKIN™ products have indications for minor burns/sunburns, and minor superficial wounds/abrasions (cuts/scrapes). This aligns with the predicate's general wound dressing utility. |
Missing Information (Not available in the provided document):
- Sample size used for the test set and the data provenance: Not specified. The document only generically mentions "performance data" and "human dermal studies."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified for this type of submission. Ground truth, in this context, would likely refer to clinical outcomes in the dermal studies, which are not detailed.
- Adjudication method for the test set: Not applicable/not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is more common for diagnostic imaging devices, not topical emulsions.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is not an AI/algorithm-based device.
- The type of ground truth used: For the dermal studies, the "ground truth" would be the observed biological response (e.g., presence/absence of irritation or sensitization) as evaluated by dermatological assessment. Details are not provided.
- The sample size for the training set: Not applicable. This device is not an AI/machine learning device that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
In conclusion, the device's acceptance criteria are framed within the context of substantial equivalence to an existing predicate device. The "study" proving this involves performance testing (physical, biocompatibility, dermal irritation/sensitization) to show that the new device performs comparably to the predicate. However, detailed results, sample sizes, and specific methodologies of these supporting studies are not elaborated in this 510(k) summary.
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