(69 days)
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No
The device description and performance studies focus on the physical properties and clinical efficacy of a hydrogel wound dressing, with no mention of AI or ML technology.
Yes
The device is a wound dressing intended for the management of wounds, which is a therapeutic purpose. The performance studies also indicate its use in treating diabetic ulcers and radiation dermatitis, further supporting its therapeutic nature.
No
Explanation: The device is a wound dressing used for the management of wounds, not for diagnosing any condition.
No
The device description explicitly states it is a wound dressing, which is a physical product, not software.
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 wounds." This describes a therapeutic or treatment purpose, not a diagnostic one.
- Device Description: The description details a wound dressing, which is a topical application for wound care. This is consistent with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) or providing information about a patient's health status or disease. IVDs are designed to perform such analyses.
- Performance Studies: The performance studies focus on the safety and effectiveness of the dressing in treating wounds, not on the accuracy of a diagnostic test.
Therefore, based on the provided text, the Carrasyn™ wound dressing is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes
MGO
Device Description
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.
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
Not Found
Intended User / Care Setting
Not Found
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
Clinical experience to date has been gained during the course of two studies that involved four patients with radiation dermatitis and 30 with diabetic ulcers. Grades III or IV diabetic ulcers of the foot were treated with Carrasyn™ Hydrogel Wound Dressing for 10 weeks. Acute and subacute radiation dermatitis was treated for various times with Carrasyn™ Hydrogel Wound Dressing. These studies evaluated the acceptability of Carrasyn™ Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment. These studies concluded that Carrasyn™ wound dressings are safe and effective for their intended use.
Key Metrics
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Predicate Device(s)
K902345, K915001, K925002, K944427
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAR 2 1 1996
Device Name:
| Classification Name: | Dressings, wound and burns, hydrogel |
|---|---|
| Common Name: | Hydrogel Wound Dressings |
| Proprietary Names: | Carrasyn™ Hydrogel Wound Dressing |
| CarraGauze™ Pads | |
| CarraGauze™ Strips | |
| Carrasyn™ FDG Pads | |
| Device Sponsor: | Carrington Laboratories, Inc. |
| 2001 Walnut Hill Lane | |
| Irving, TX 75038-4404 | |
| Registration No: 162544 |
Regulatory Classification: Unclassified. (Product code MGO)
Summary of Safety and Effectiveness:
This 510 (k) Premarket Notification provides for the standardization and clarification of previously cleared indications for the labeling of Carrasyn™ wound dressings. Carrasyn™ Hydrogel Wound Dressing was originally marketed pursuant to 510 (k) Number K902345. The additional wound dressings that are included in this labeling standardization and clarification include CarraGauze™ pads (K915001), CarraGauze™strips (K925002) and Carrasyn™ FDG pads (K944427).
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.
Since the products are for topical use, the safety of these wound gels was established through standard biocompatibility tests. These biocompatibility tests were conducted in standard animal models with preparations of the Carrasyn™ wound dressings. These tests included Primary Dermal Irritation testing and Primary Eye Irritation testing. These studies demonstrated that Carrasyn™ wound dressings are not primary dermal irritants or primary eye irritants. These studies were conducted in conformance with Good Laboratory Practices (GLP) regulations of the United States Food and Drug Administration (21 CFR, Part 58).
0 004
1
Clinical experience to date has been gained during the course of two studies that involved four patients with radiation dermatitis and 30 with diabetic ulcers. Grades III or IV diabetic ulcers of the foot were treated with Carrasyn™ Hydrogel Wound Dressing for 10 weeks. Acute and subacute radiation dermatitis was treated for various times with Carrasyn™ Hydrogel Wound Dressing. These studies evaluated the acceptability of Carrasyn™ Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment. These studies concluded that Carrasyn™ wound dressings are safe and effective for their intended use.