(74 days)
MITRAFLEX Wound Dressings, Wet-Stick, MITRAFLEX Wound Dressings
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is intended for the management of various wounds and skin conditions, indicating a therapeutic purpose.
No
The device is a wound dressing intended for healing, not for diagnosing medical conditions.
No
The device description clearly describes a physical, multi-layered wound dressing, not a software product.
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 device is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the physical structure and function of a wound dressing, focusing on absorption, moisture management, and protection. This aligns with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide information about a patient's health status, disease, or condition.
- No Mention of Diagnostic Performance: The performance studies mentioned focus on safety (nontoxic, nonirritating, nonsensitizing), which is relevant for a therapeutic device, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a wound dressing, which is a therapeutic product applied to the body to aid in healing.
N/A
Intended Use / Indications for Use
MITRAFLEX Pigmented Wound Dressings are intended for use in the management of:
- Venous stasis ulcers
- Partial-thickness wounds
- Diabetic ulcers
- Superficial burns
- Pressure sores
- Abrasions and lacerations
- Donor sites
- Full-thickness wounds
- Blisters
- Skin tears
- Incisions
- Dermal lesions
- Severe sunburn
- Minor chemical burns
- Poison Ivy
- Thermal burns
- Dermabrasions and other dermatologic procedures
- Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
Product codes
Not Found
Device Description
MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings.
MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.
MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.
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
MITRAFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.
Key Metrics
Not Found
Predicate Device(s)
MITRAFLEX Wound Dressings, Wet-Stick, MITRAFLEX Wound Dressings
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
FEB - 7 1997
510(k) Summary
| Proprietary Name: | MITRAFLEX® Pigmented Wound Dressing |
|---|---|
| Common Name: | Dressing |
| Classification: | Unclassified |
| Submitter's Details: | PolyMedica Industries, Inc. |
| 581 Conference Place | |
| Golden, CO 80401 | |
| Tel: (303)271-0300 | |
| FAX: (303)271-0397 | |
| Contacts: Andrew M. Reed, Ph.D., Julie Chaffee |
Description:
MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings.
MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.
MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.
MITRAFLEX Pigmented Wound Dressings are intended for use in the management of:
| Venous stasis ulcers | Partial-thickness wounds |
|---|---|
| Diabetic ulcers | Superficial burns |
| Pressure sores | Abrasions and lacerations |
| Donor sites | Full-thickness wounds |
| Blisters | Skin tears |
| Incisions | Dermal lesions |
| Severe sunburn | Minor chemical burns |
| Poison Ivy | Thermal burns |
| Dermabrasions and other dermatologic procedures | Facelifts and other plastic surgery procedures (e.g. laser resurfacing) |
MITRAFLEX Pigmented Wound Dressings are substantially equivalent to MITRAFLEX Wound Dressings, Wet-Stick, and MITRAFLEX Wound Dressings. These devices are all self-adhesive wound dressings which provide a degree of absorption and breathability. They are all intended for use in the management of a wide variety of dermal lesions and injuries.
MITRAFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.