(70 days)
lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.
lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound. lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing. lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.
The provided text describes a medical device called "lamin® Impregnated Gauze Dressing" and its substantial equivalence to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested in your prompt regarding AI/machine learning device performance.
This document describes a traditional medical device (a wound dressing) and its regulatory submission, which relies on demonstrating substantial equivalence to already-marketed predicate devices, primarily through biocompatibility testing. It is not an AI/ML powered device, and therefore the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, etc.) are not applicable here.
Therefore, I cannot populate the table or answer the specific questions as the input text does not contain the relevant information for an AI/ML device.
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FEB 2 4 1997
11.5 510(k) Summary
Submitter's Name and Address:
ProCyte Corporation 12040 115th Ave NE #210 Kirkland, Washington 98034
Contact person and telephone number: Paul Ketteridge Regulatory Affairs Officer Telephone: (206) 820-4548 Fax:
Date summary was prepared: December 12, 1996
Name of the Device:
| Proprietary name: | Iamin® Impregnated Gauze Dressing |
|---|---|
| Common name: | Hydrogel Dressing |
| Classification name: | Hydrogel and Burn Dressing |
Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:
lamin® Impregnated Gauze Dressing is substantially equivalent in function and intended use to the following non-classified commercially available noninteractive wound and burn dressings:
Dermagran Wound Dressing SteriCare Hydrogel Gauze Dressing CarraGauze Hydrogel Wound Dressing lamin Hydrating Gel
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ed Gauze Dressing Page 2 of 3
Device Description:
Explanation of how the device functions: lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound.
Basic scientific concepts that form the basis for the device: lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.
Statement of the Intended Use of the Device, Including General Description of the Conditions the Device Will Mitigate and the Patient Population for which the Device Is Intended: An impregnated hydrogel for the dressing and management lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.
These indication statements are not different from the predicate devices identified above.
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ProCvie Comoration 510(k) Summary lamin Impregnated Gauze Dressing December 13, 1996 Page 3 of 3
Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device: The technological characteristics of the device such as form, absorptive ability, occlusion, conformability, sterility, moist wound healing and appearance are not different from the predicate devices cited.
Assessment of Performance Data: Biocompatibility testing has been performed as recommended in the "Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing." These tests support the safe use of lamin® Impregnated Gauze Dressing as a temporary dressing in contact with breached or compromised skin.
N/A