(44 days)
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No
The document describes a passive wound dressing with no mention of computational or analytical capabilities, let alone AI/ML.
Yes
The device is a wound dressing designed to promote healing and manage various types of wounds, which falls under the definition of a therapeutic device.
No
The device is a wound dressing intended for management and healing of various wound types, not for diagnosing medical conditions.
No
The device description clearly describes a physical wound dressing made of multiple layers and materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that SPYROFLEX Pigmented Wound Dressings are "sterile, absorptive dressings" applied directly to wounds.
- Intended Use: The intended uses listed are all related to the management and healing of various types of wounds and skin conditions. This involves direct application to the body surface, not testing of samples taken from the body.
Therefore, SPYROFLEX Pigmented Wound Dressings are a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SPYROFLEX 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
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Device Description
SPYROFLEX Pigmented Wound Dressings are sterile, absorptive dressings.
SPYROFLEX 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.
SPYROFLEX dressings are constructed of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of SPYROFLEX 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. SPYROFLEX is impermeable to microorganisms and liquids.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
SPYROFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.
Key Metrics
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Predicate Device(s)
SPYROFLEX Wound Dressings, Wet-Stick, SPYROFLEX Wound Dressings, and Flexzan Topical Wound Dressings
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
OCT 25 1996
510(k) Summary
| Proprietary Name: | SPYROFLEX® 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:
SPYROFLEX Pigmented Wound Dressings are sterile, absorptive dressings.
SPYROFLEX 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.
SPYROFLEX dressings are constructed of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of SPYROFLEX 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. SPYROFLEX is impermeable to microorganisms and liquids.
SPYROFLEX 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) |
SPYROFLEX Pigmented Wound Dressings are substantially equivalent to SPYROFLEX Wound Dressings, Wet-Stick, SPYROFLEX Wound Dressings, and Flexzan Topical 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.
SPYROFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.