MPM HYDROGEL DRESSING (NON-STERILE)

K962160 · Mpm Medical., Inc. · MGQ · Jun 26, 1996 · SU

Device Facts

• Record ID: K962160
• Device Name: MPM HYDROGEL DRESSING (NON-STERILE)
• Applicant: Mpm Medical., Inc.
• Product Code: MGQ · SU
• Decision Date: Jun 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.

Device Story

Clear, viscous hydrogel dressing; non-sterile; supplied in tubes, spray bottles, and syringes. Intended for local management of skin wounds. Applied topically by clinicians or patients to pressure ulcers, stasis ulcers, and burns. Provides moist wound environment. Preserved formulation replaces terminal sterilization. Biocompatibility established via USP Agarose Diffusion testing and comparison to predicate hydrogel products.

Clinical Evidence

Bench testing only. Biocompatibility evaluated via USP Agarose Diffusion test; product determined to be non-cytotoxic. Performance data relies on established biocompatibility of identical hydrogel formulations from predicate devices.

Technological Characteristics

Clear, viscous hydrogel; non-sterile; meets USP requirements for Antimicrobial Preservative Effectiveness. Supplied in 4 oz tubes, 8 oz spray bottles, 0.5 oz and 1 oz syringes.

Indications for Use

Indicated for local management of skin wounds, including Stage I-IV pressure ulcers, stasis ulcers, and first and second degree burns in patients requiring wound care.

Predicate Devices

• MPM GelPad (K933495)
• MPM Sterile Hydrogel Dressing in pre-filled syringes (K950934)
• MPM Sterile Hydrogel Dressing in plastic bottles and tubes (K952276)
• MPM Hydrogel Saturated Dressing (K930560)

Submission Summary (Full Text)

{0}

JUN 21 '96 15:54 R HAMER ASSOC
K962160 P.5

# 510 (k) SUMMARY
JUN 26 1996

## I. ADMINISTRATIVE

Submitter: MPM Medical, Inc.
P.O. Box 151335
Arlington, Texas 76015

Contact Person: Paul Miller

Date of Preparation: June 21, 1996

## II. DEVICE NAME

Proprietary Name: MPM Hydrogel™ Dressing (Non-Sterile)
Common Name: Wound Dressing
Classification Name: Hydrogel wound and burn dressing

## III. PREDICATE DEVICES

1. MPM GelPad (MPM Medical, Inc.); K933495
2. MPM Sterile Hydrogel Dressing in pre-filled syringes (MPM Medical, Inc.); K950934
3. MPM Sterile Hydrogel Dressing in plastic bottles and tubes (MPM Medical, Inc.); K952276
4. 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.oz. 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

The MPM Hydrogel Dressing is similar in composition, function and intended use to 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 Dressing which is also supplied non-sterile.

Premarket Notification: MPM HYDROGEL WOUND DRESSING

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JUN 21 '96 15:54 R HAMER ASSOC P.6

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.

Premarket Notification: MPM HYDROGEL WOUND DRESSING