(22 days)
Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.
This document is a 510(k) summary for a medical device (MPM Hydrogel Dressing) and details the "Substantial Equivalence" to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CADe device. The provided text focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices, primarily through comparison of composition and biocompatibility testing, rather than performance metrics against specific acceptance criteria.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxic | Non-cytotoxic |
Explanation: The primary "acceptance criterion" mentioned is non-cytotoxicity. The study performed confirms this.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The "test" here refers to a cytotoxicity test of the device material itself, not a clinical study on patients.
- Data provenance: Not specified, but likely laboratory-based (in vitro) testing.
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)
Not applicable. This was a laboratory test (cytotoxicity), not an expert-driven ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a laboratory test.
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 not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the cytotoxicity test would be the established scientific method for determining cell toxicity.
8. The sample size for the training set
Not applicable. This device does not use a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not use a "training set."
In summary: The provided text describes a 510(k) submission for a hydrogel wound dressing, focusing on its substantial equivalence to predicate devices based on composition and a single biocompatibility test (cytotoxicity). It does not involve AI, image analysis, or clinical performance studies with human readers, and therefore, most of your requested information elements are not relevant to this type of device and submission.
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K 62160 P.5
Jun 26 Koos 510 (k) SUMMARY
l. ADMINISTRATIVE
MPM Medical, Inc. Submitter: P.O. Box 151335 Arlington, Texas 76015
Contact Person: Paul Miller
Date of Preparation: June 21, 1996
11. DEVICE NAME
Proprietary Name: MPM Hydrogel " Dressing (Non-Sterile)
Common Name: Wound Dressing
Classification Name: Hydrogel wound and burn dressing
PREDICATE DEVICES 111.
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- MPM GelPad (MPM Medical, Inc.); K933495
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- MPM Sterile Hydrogel Dressing in pre-filled syringes (MPM Medical, Inc.); K950934
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- MPM Sterile Hydrogel Dressing in plastic bottles and tubes (MPM Medical, Inc.); K952276
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- MPM Hydrogel Saturated Dressing (MPM Medical, Inc), K930560
IV. DEVICE DESCRIPTION
The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.
V. INTENDED USE
Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
VI. COMPARISON TO PREDICATE DEVICES
he MPM Hydrogel Dressing is similar in composition, function and intended use o the MPM GelPad (K933495) and the MPM Sterile Hydrogel Dressing (K950934 and K952276). The only difference between these products is that the hydrogel formulation has been suitably preserved in lieu of terminal sterilization. In addition, the MPM Hydrogel Dressing is similar to the MPM Saturated Hydrogel Dressng which is also supplied non-sterile.
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A cytotoxicity test (USP Agarose Diffusion) performed with the MPM Hydrogel Dressing showed the product to be non-cytotoxic with a reactivity profile similar to that of the MPM GelPad and the MPM Sterile Hydrogel Dressing. Since the composition of the two hydrogels is otherwise identical, biocompatibility data submitted for the MPM GelPad (K933495) remain applicable, and no additional biocompatibility tests have been performed with the product.
Accordingly, MPM Medical, Inc. concluded that the MPM Hydrogel Dressing is as safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the MPM GelPad, MPM Sterile Hydrogel Dressing and MPM Saturated Hydrogel Dressing.
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