(94 days)
No
The summary describes a wound dressing product and its clinical studies, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes.
The device is intended for the "management of wounds" and is used to "treat" conditions like diabetic ulcers and radiation dermatitis, indicating a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is for the "management of wounds," indicating a treatment function, not a diagnostic one. There is no mention of the device identifying diseases or conditions.
No
The device description clearly states it is a hydrogel or freeze-dried preparation, which are physical substances, 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 is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing, which is a topical application for wound care.
- Performance Studies: The studies described focus on the safety and effectiveness of the dressing in treating wounds (radiation dermatitis and diabetic ulcers), not on diagnostic accuracy.
Therefore, the information clearly indicates that this device is a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
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
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
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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
CARRINGTO
SEP 12 1998
Device Name:
ﻟﺴﻴﺴﺎ
Classification Name: Dressings, wound and burns, hydrogel
Common Name: Hydrogel Wound Dressings
Carrasyn® Hydrogel Wound Dressing Proprietary Names: CarraGauze®Pads CarraGauze® Strips CarraSorb M ™ Freeze-Dried Gel
- 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®trips (K925002) and CarraSorb M ™ Freeze-Dried Gel (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), Carrington Laboratories, Inc. · Post Office Box 168128 (800) 527-5216 Irving. TX 75016-8128
Comorate Office & Manufacturing 2001 Walnut HIll Land Inving, Texas 75038 (214) 518-1300 (214) 518-1020 Fax
Research & Development:
1300 E. Rochelle Boulevard
Irving, Texas 75062
(214) 717-5009
(214) 717-0997 Fax
Distribution Center& Ac
1909 Hereford Drive
Irving, Texas 75038
(214) 518-1300
(214) 756-0108 Fax
Sulte SJO-2632 - Unit C-101 1601 N.W. 97th Avenue Mlaml, Florida 33102-5216 011-506-666-0100
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.