(69 days)
No
The description focuses on the physical properties and clinical performance of wound dressings, with no mention of AI or ML technologies.
Yes
The device is intended for the management and healing of wounds, which are therapeutic functions.
No
The device is described as a wound dressing intended for the management of wounds. Its function is to treat and manage wounds, not to diagnose medical conditions or provide diagnostic information.
No
The device is described as a wound dressing, which is a physical product (hydrogel or freeze-dried preparation), 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.
- Device Description: The description focuses on the physical form and intended use for wound management.
- Performance Studies: The studies described evaluate the effectiveness of the dressings in treating wounds and reducing discomfort, not in diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is applied directly to the wound for treatment and management.
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 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.
Two clinical trials have been conducted to date using The Carrington Patch™. The first clinical trial was a randomized, double-blind, active-controlled study involved 60 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. The patients were randomly assigned to two groups where one group of 30 patients were treated with The Carrington™ Patch and one group of 30 patients treated with a control. The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the ulcers were healed. The Carrington Patch™ was found to reduce discomfort and no adverse events were reported in association with its use.
The second clinical study was an open-label, uncontrolled study involving 30 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. All patients were treated The Carrington™. Patch The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the ulcers were healed. The Carrington Patch™ was found to significantly reduce discomfort within 2 minutes and no adverse events were reported in association with its use.
The above studies demonstrate that Carrasyn® wound dressings are safe for their intended use and have not been associated with adverse events. These products are concluded to be a safe and effective dressings in the management of wounds.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K915001, K925002, K933741, K944427
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JU 11 1996
CARRINGTON
Device Name:
| Classification Name: | Dressings, wound and burns, hydrogel |
|---|---|
| Common Name: | Hydrogel Wound Dressings |
| Proprietary Names: | Carrasyn® Hydrogel Wound Dressing |
| CarraGauze® Pads | |
| CarraGauze® Strips | |
| The Carrington™ Patch | |
| CarraSorb™ M Freeze-Dried Wound Dressing | |
| 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), The Carrington™ Patch (K933741) and CarraSorb™ M Freeze-Dried Wound Dressing (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 intended for the management of wounds.
Since the products are for use in wounds, 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. Corporate Office & Manufacturing: 2001 Walnut Hill Lane Irving. Texas 75038 (214) 518-1300 (214) 518-1020 Fax
· Post Office Box 168128
Distribution Center& AccCE
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
· Irving. TX 75016-8128 · (800) 527-5216
**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.
Two clinical trials have been conducted to date using The Carrington Patch™ . The first clinical trial was a randomized, double-blind, active-controlled study involved 60 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. The patients were randomly assigned to two groups where one group of 30 patients were treated with The Carrington™ Patch and one group of 30 patients treated with a control. The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the ulcers were healed. The Carrington Patch™ was found to reduce discomfort and no adverse events were reported in association with its use.
The second clinical study was an open-label, uncontrolled study involving 30 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. All patients were treated The Carrington™. Patch The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the ulcers were healed. The Carrington Patch™ was found to significantly reduce discomfort within 2 minutes and no adverse events were reported in association with its use.
The above studies demonstrate that Carrasyn® wound dressings are safe for their intended use and have not been associated with adverse events. These products are concluded to be a safe and effective dressings in the management of wounds.