(85 days)
No
The summary describes a wound dressing with bacteriostatic properties and does not mention any computational or analytical functions, let alone AI/ML.
Yes
The device is described as a "wound dressing" intended for "local management of wounds" such as ulcers, abrasions, and lacerations, which are therapeutic applications.
No
Explanation: The device description states its purpose is for "local management of wounds" and mentions pigments added to make the material bacteriostatic, indicating a therapeutic or protective function, not a diagnostic one.
No
The device description clearly states it is a physical wound dressing made from a synthetic 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 states that the dressings are for the "local management of wounds" and are used as "external dressings." This indicates a direct application to the body for therapeutic or protective purposes.
- Device Description: The description focuses on the physical characteristics and bacteriostatic properties of the dressing material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body).
N/A
Intended Use / Indications for Use
Hydrofera Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.
Product codes
FRO
Device Description
Hydrofera Bacteriostatic Wound Dressings are blue in color and manufactured from a pure white synthetic material with absorbent sponge- like characteristics. The two pigments have been added to render the material bacteriostatic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, superficial hi post-surgical incisions, and other external wounds inflicted by trauma).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ultrafera wound dressing (K964614), Hydrofera Bacteriostatic Nasal Dressing (K983276)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JAN 11 2002
.
.
-510(K) SUMMARY
.
:
| A. Device Proprietary Name:
Device Common Name: | Hydrofera Bacteriostatic Wound Dressing
Wound dressing external use |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description: | Hydrofera Bacteriostatic Wound Dressings are
blue in color and manufactured from a pure
white synthetic material with absorbent sponge-
like characteristics. The two pigments have been
added to render the material bacteriostatic.
Please see Instructions for Use |
| B. Establishment Registration Number: | 1225532 |
| Establishment Name & Address: | Hydrofera LLC
322 Main Street
Willimantic CT 06226 |
| C. Device Classification of Category: | Unclassified |
| 1). Performance standards: | None |
| E. Proposed Labeling: | Draft Labeling is attached |
| F. Substantial Equivalence: | The subject wound dressing have the same
intended use as the predicate device:
Ultrafera wound dressing(K964614)
and Hydrofera Bacteriostatic Nasal Dressing
(K983276) |
| G. Materials: | Hydrofera Bacteriostatic Wound Dressings
are comprised of absorbent polyvinyl alcohol
PVA, free formaldehyde