(22 days)
No
The summary describes a hydrogel dressing for wound management and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for the "local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns," which indicates a therapeutic purpose.
No
The device is a hydrogel dressing used for local management of skin wounds, not for diagnosing conditions.
No
The device description explicitly states it is a hydrogel dressing supplied in tubes, spray bottles, and syringes, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management of skin wounds." This is a topical application for treating a physical condition on the body.
- Device Description: The description details a "hydrogel dressing" applied to the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimens.
The information provided clearly indicates this is a medical device for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K933495, K950934, K952276, K930560
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
-
- MPM GelPad (MPM Medical, Inc.); K933495
-
- MPM Sterile Hydrogel Dressing in pre-filled syringes (MPM Medical, Inc.); K950934
-
- MPM Sterile Hydrogel Dressing in plastic bottles and tubes (MPM Medical, Inc.); K952276
-
- 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.
1
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.