(52 days)
No
The device description and performance studies focus on the material properties and biological compatibility of a wound dressing, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is intended to provide a healing environment for wounds, which directly implies a therapeutic function.
No
The device is a wound dressing designed to prevent wound desiccation and promote healing, not to diagnose a condition.
No
The device description clearly states it is composed of "absorbent pads saturated with water based hydrogels," which are physical components, 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 to provide a moist packing/healing environment for wounds. This is a therapeutic function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a wound dressing, which is a medical device used for wound care.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
PanoGauze™ Non-Woven Hydrogel Dressing, like the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, is intended to provide a moist packing/healing environment which helps to prevent wound desiccation.
Product codes
878.4022
Device Description
Both are absorbent pads saturated with water based hydrogels packaged in sterile single-use poly/Mylar-laminate pouches.
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
In regards to safety, several studies were conducted by an independent testing laboratory that demonstrate the following with regard to PanoGauze™ Non-Woven Hydrogel Dressing:
- . Met the USP requirements for systemic toxicity.
- . Meets USP requirements for cytotoxicity,
- Is not considered a primary irritant to the skin per the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500. In fact, no irritation was observed.
- Showed no evidence of causing delayed dermal contact sensitization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JAN - 9 1997
Summary Basis of Substantial Equivalence. 510 (k) Summarv
PanoGauze™ Non-Woven Hydrogel Dressing is substantially equivalent in design, composition and function to the Carrington Laboratories, Inc. CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, 510(k) #K915001, authorized for marketing January 31, 1992.
This is a Class II, (21 CFR §878.4022) Hydrogel Wound & Burn Dressing. There are no established performance standards. PanoGauze™ Non-Woven Hydrogel Dressing, like the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, is intended to provide a moist packing/healing environment which helps to prevent wound desiccation. Both are absorbent pads saturated with water based hydrogels packaged in sterile single-use poly/Mylar-laminate pouches.
In regards to safety, several studies were conducted by an independent testing laboratory that demonstrate the following with regard to PanoGauze™ Non-Woven Hydrogel Dressing:
- . Met the USP requirements for systemic toxicity.
- . Meets USP requirements for cytotoxicity,
- Is not considered a primary irritant to the skin per the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500. In fact, no irritation was observed.
- � Showed no evidence of causing delayed dermal contact sensitization.
In summary. PanoGauze™ Non-Woven Hydrogel Dressing can be determined to be substantially equivalent to CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad on the basis that it maintains a moist environment in the wound bed, does not introduce microbial contamination, and is safe to use - as established by negative results when tested for toxicity.