(70 days)
Not Found
Not Found
No
The 510(k) summary describes a simple wound dressing and does not mention any AI or ML capabilities.
No
The device is a wound dressing that provides a moist environment and protection for skin wounds and burns, which are supportive functions, but it does not actively treat or cure a disease or condition in a therapeutic sense.
No
Explanation: The device is a dressing intended for wound management and protection, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical gauze dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wound dressing applied to the skin for managing various types of wounds and burns. This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a sterile impregnated gauze dressing designed to provide a moist wound environment and protection. This aligns with the function of a wound dressing, not an in vitro diagnostic test.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies mentioned are biocompatibility tests, which are relevant for devices that come into contact with the body, not for diagnostic tests.
- Predicate Devices: The predicate devices listed are all wound dressings or gels, further supporting that this device falls under the category of wound care products, not IVDs.
In vitro diagnostics are tests performed outside of the body on samples to detect diseases, conditions, or infections. This device is applied directly to the body for therapeutic and protective purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Dermagran Wound Dressing, SteriCare Hydrogel Gauze Dressing, CarraGauze Hydrogel Wound Dressing, lamin Hydrating Gel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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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2
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.