(508 days)
"OTC": IPM Wound Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx: Under the supervision of a health care professional; • IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (postoperative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
IPM Wound Gel Bio is a clear viscous, odorless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%. Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid is an extracellular matrix component of human skin. The Hyaluronic acid used in IPM Wound Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. Other ingredients in IPM Wound Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%). IPM Wound Gel Bio is presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
The provided text describes a 510(k) premarket notification for a medical device called "IPM Wound Gel Bio", which is a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove meeting those criteria.
Therefore, the input does not contain the specific information requested about acceptance criteria and a study to prove the device meets these criteria. It focuses on comparing the new device's characteristics and intended use to already legally marketed predicate devices to establish substantial equivalence.
Here's a breakdown of why many of your questions cannot be answered from the provided text:
- Acceptance Criteria Table: No specific performance acceptance criteria are listed for the IPM Wound Gel Bio. The submission relies on establishing similarity to predicate devices.
- Device Performance: The document states that the device is "comparable to the predicates" in terms of quality, safety, and effectiveness due to similar indications and technological characteristics (except for the source of hyaluronic acid). However, no specific performance metrics of the IPM Wound Gel Bio are reported.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Training Set Ground Truth: These questions relate to clinical or performance studies that would typically involve a test set, expert evaluation, etc. The provided 510(k) summary does not describe such a study for the IPM Wound Gel Bio itself. Instead, it refers to biocompatibility evaluations and a histological study done on one of its predicate devices (L.A.M. IPM Wound Gel).
Information that can be extracted related to the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993 and USP | Met (for Bio fermented HA): "Bio fermented HA passed biocompatibility evaluations and thus demonstrated substantial equivalence to the predicate device in this respect, i.e., biocompatibility." |
| Effectiveness (Wound Healing): Maintain a moist wound environment, contribute to wound healing process. | Implied substantially equivalent to predicates: "Considering that the only difference is the source of HA and that proposed indications are similar to already approved to the predicates indicated by Glyco, it is fair to understand that quality, safety and effectiveness are demonstrated and are comparable to the predicates." (Note: The histological study mentioned was for a predicate device, not the new device directly). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a test set or clinical study for "IPM Wound Gel Bio." It references biocompatibility tests conducted for the "bio fermented HA" (the new type of HA used in IPM Wound Gel Bio), which likely involved in vitro or in vivo animal testing. It also references a "Histological Study in Porcine" for the predicate device, L.A.M. IPM Wound Gel, which "demonstrated the effectiveness... on partial thickness wound healing." No sample sizes for these tests are provided, nor is the country of origin of the data or whether they were retrospective/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 provided. The document does not detail any expert consensus or ground truth establishment process for the IPM Wound Gel Bio in a clinical study context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as there is no described test set with human adjudication.
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:
No MRMC comparative effectiveness study was done. This device is a hydrogel dressing, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is a physical medical device (wound gel), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth would be established through standard test methods and their interpretation against ISO and USP guidelines. For the histological study on the predicate device, it would involve pathological examination of tissue samples from porcine wounds. No ground truth is specified for a clinical study of "IPM Wound Gel Bio."
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
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