(144 days)
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No
The device description focuses on the physical properties and mechanism of action of an absorptive wound dressing, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for the management of exudating wounds, which is a therapeutic purpose.
No
Explanation: The device is described as an "absorptive pillow dressing for the management of exudating wounds" and it functions by absorbing wound exudate. It does not perform any diagnostic function.
No
The device description clearly describes a physical wound dressing made of polymer granules and mesh fabric, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of exudating wounds by absorbing wound exudate. This is a therapeutic function, not a diagnostic one.
- Device Description: The device description focuses on the physical properties and mechanism of action related to absorbing wound exudate. It does not describe any components or processes for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids, tissues, or other samples to provide information about a patient's health status, disease, or condition.
- Predicate Devices: The listed predicate devices are all wound dressings, which are therapeutic devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to manage wound exudate, which is a treatment for the wound itself, not a diagnostic test.
N/A
Intended Use / Indications for Use
An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
Product codes
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Device Description
OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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 "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of OsmoCyte™ Ultra/PE Pillow Wound Dressing as a wound dressing temporary 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
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§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
510(k) Number K962623 Summary September 6, 1996
ATTACHMENT 8
NOV 26 1996
510(k) Summary
Submitter's Name and Address:
ProCyte Corporation 12040 115th Ave NE #210 Kirkland, Washington 98034-6900
Contact person and telephone number:
Paul Ketteridge Regulatory Affairs Officer (206) 820-4548 Telephone: (206) 820-7611 Fax:
Date summary was prepared: September 4, 1996
Name of the Device:
| Proprietary name: | OsmoCyte™ Ultra/PE Pillow Wound Dressing |
|---|---|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |
ldentification of Predicate Devices to which Substantial Equivalence is Being Claimed:
OsmoCyte™ Ultra/PE Pillow Wound Dressing is substantially equivalent in function and intended use to the following non-classified commercially available or 510(k) cleared non-interactive wound and burn dressings:
- HyQ Wound Dressing (Kingston Technologies) .
- Allevyn Cavity Dressing (Smith + Nephew) .
- . Kaltostat Wound Packing (Calgon Vestal)
- . Aquacel (Convatec)
- Sorbsan Topical Wound Dressing (Dow Hickam)
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Device Description:
Explanation of how the device functions: OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels.
Basic scientific concepts that form the basis for the device: OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight in wound exudate.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: OsmoCyte™ Ultra/PE Pillow Wound Dressing contains highly absorptive polymer granules able to absorb many times their weight in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
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 absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
These indication statements are not different from the predicate devices identified above.
Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device:
The technological characteristics of the device are similar to the predicate devices. The ability to absorb large amounts of wound exudate, coupled with the ability to be used safely in deep cavity or tunnel wounds is comparable to several the predicate devices. In addition, OsmoCyte™
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Ultra/PE Pillow Wound Dressing has the advantage, by using an inert LDPE mesh, containing the absorbent granules, to assuring its complete removal from the wound.
Assessment of Performance Data:
Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of OsmoCyte™ Ultra/PE Pillow Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.