(89 days)
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Not Found
No
The summary describes a simple hydrogel dressing and does not mention any AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the management of various wounds and skin conditions, provides a moist wound environment, absorbs exudate, and protects against contamination, all of which are therapeutic actions.
No
This device is a wound dressing designed to cover and manage various skin injuries and conditions. Its intended use is therapeutic (wound care) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "sterile saturated cotton-blend non-woven gauze," which is a physical material, 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 device applied externally to the skin for wound management. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health status.
- Device Description: The device is a sterile saturated gauze, which is a physical dressing applied to a wound. This is consistent with a topical medical device, not an IVD.
- No mention of analyzing biological samples: There is no indication that this device is used to analyze any biological specimens from the patient.
- Predicate Devices: The predicate devices listed are all wound dressings, further supporting that this device falls under the category of wound care products, not IVDs.
Therefore, based on the provided text, this device is a wound dressing and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, 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, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.
Product codes
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Device Description
lamin® Wet Dressing (Copper-Saline) acts to provide a moist wound environment and protect the wound. lamin® Wet Dressing (Copper-Saline) was designed to provide a soothing, moist environment for each application to various types of wounds as saturated gauze dressina. lamin® Wet Dressing (Copper-Saline) is sterile saturated cotton-blend non-woven gauze.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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® Wet Dressing (Copper-Saline) as a temporary dressing in contact with breached or compromised skin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
11.5 510(k) Summary
FEB -3 1997
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: (206) 820-7611
Date summary was prepared: October 31, 1996
Name of the Device:
| Proprietary name: | lamin® Wet Dressing (Copper-Saline |
|---|---|
| Common name: | Hydrogel Dressing |
| Classification name: | Hydrogel and Burn Dressing |
Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:
lamin® Wet Dressing (Copper-Saline) is substantially equivalent in function and intended use to the following non-classified commercially available noninteractive wound and burn dressings:
Dermagran Wet Dressing (Zinc-Saline) MPM Wet Dressings (Saline) lamin Hydrating Gel CarraGauze Hydrogel Wound Dressing
26
1
ProCyte Corporation
510(k) Summary
lamin° Wet Dressing
November 5, 1996
Page 2 of 3
Device Description:
Explanation of how the device functions: lamin® Wet Dressing (Copper-Saline) acts to provide a moist wound environment and protect the wound.
Basic scientific concepts that form the basis for the device: lamin® Wet Dressing (Copper-Saline) was designed to provide a soothing, moist environment for each application to various types of wounds as saturated gauze dressina.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: lamin® Wet Dressing (Copper-Saline) is sterile saturated 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: A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, 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, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.
These indication statements are not different from the predicate devices identified above.
2
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® Wet Dressing (Copper-Saline) as a temporary dressing in contact with breached or compromised skin.