(227 days)
Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), first and second degree burns.
Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin.
Hyaluronic Acid Topical Wound Cream 0.2%w/w is a white or light straw colored hydrophilic viscous cream containing hyaluronic acid for topical use on wounds.
This document is a 510(k) summary for the Hyaluronic Acid Topical Wound Cream 0.2%w/w, claiming substantial equivalence to a predicate device, Bionect® Cream (K963004). This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically involve comprehensive studies with specific acceptance criteria, sample sizes, and ground truth definitions as would be present in a de novo classification or premarket approval (PMA) application for novel, high-risk devices or software as a medical device (SaMD).
Instead, "acceptance criteria" here refers to demonstrating that the new device shares the same fundamental scientific technology, physical and performance characteristics, and indications for use as the predicate device, and that any differences do not raise new questions of safety or effectiveness. The study supporting this is primarily biocompatibility testing and comparative analysis rather than a clinical trial with specific performance metrics like sensitivity/specificity.
Let's break down the information provided in the context of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of specific performance metrics like sensitivity, specificity, or F1-score for the device. Instead, the acceptance criteria are implicitly that the new device (Hyaluronic Acid Topical Wound Cream 0.2%w/w) is as safe and effective as the predicate device (Bionect® Cream) and shares the same technological characteristics and intended use.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics: | The characteristics of Hyaluronic Acid Topical Wound Cream 0.2% w/w are not different from the predicate device (Bionect® Cream). The proposed device uses the same technology (Hyaluronic acid as a moisture-management component) and is a hydrophilic topical cream containing 0.2% w/w sodium hyaluronate. |
| Intended Use/Indications: | Prescription Use: Indicated for dressing and management of wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), first and second-degree burns. (Page 5) |
| Over-the-Counter Use: Indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin. (Page 7) (Both indications are stated to be similar to the predicate device.) | |
| Safety and Effectiveness: | "The performed studies demonstrated that Hyaluronic Acid Topical Wound Cream 0.2%w/w is as safe and effective as the predicate device (Bionect® Cream) for its intended use on breached and compromised skin as a moist wound dressing." (Page 5 and 7) This conclusion is based on biocompatibility testing and comparative studies. |
| Biocompatibility: | Testing conducted according to ISO 10993 'Biological Evaluation of Medical Devices'. (Page 5 and 7) |
| Physical/Performance Characteristics: | Described as a white or light straw colored hydrophilic viscous cream intended for moisture management on the wound bed to aid in providing a moist wound environment. It is a repeat use, preservative-protected non-sterile topical product. (Pages 5-7) (These characteristics are implied to be consistent with the predicate.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of clinical images or diagnostic performance. The evaluation performed was primarily biocompatibility testing and comparative studies against the predicate device. The sample size for these studies is not provided, nor is the country of origin of the data explicitly stated (other than the sponsor being in India). The nature of these "comparative studies" is not detailed enough to determine if they were retrospective or prospective, but typical biocompatibility testing would involve in-vitro and/or in-vivo animal models, which are prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to this 510(k) submission. There was no clinical ground truth established by experts for a test set, as this is a topical wound cream and not a diagnostic device involving expert interpretation of medical images or other clinical data for performance evaluation. The "ground truth" for demonstrating safety and effectiveness relied on standard biocompatibility tests and comparison to a known safe and effective predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Since there was no test set involving expert review or interpretation of cases, no adjudication method was used or needed.
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 information is not applicable. The device is a topical wound cream, not an AI or diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a topical wound cream, not an algorithm, so a standalone performance evaluation of an algorithm was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (Bionect® Cream), supported by regulatory standards for medical device safety. The studies performed were biocompatibility tests (according to ISO 10993) and comparative studies to show that the new device performed similarly to the predicate. This relies on the assumption that if the new device has identical technological characteristics, similar indications, and passes standard safety tests (biocompatibility), then its safety and effectiveness are "ground-truthed" by the predicate.
8. The sample size for the training set:
This information is not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The development of the cream would involve formulation and laboratory testing, but not in the sense of a data "training set."
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of medical device submission.
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