(44 days)
SPYROFLEX Pigmented Wound Dressings are intended for use in the management of.
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Blisters
Incisions
Severe sunburn
Poison Ivy
Dermabrasions and other dermatologic procedures
Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
Partial-thickness wounds
Superficial burns
Abrasions and lacerations
Full-thickness wounds
Skin tears
Dermal lesions
Minor chemical burns
Thermal burns
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.
The provided text describes a medical device, SPYROFLEX® Pigmented Wound Dressing, and its intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.
The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided document.
To summarize the parts that cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not provided.
- If a standalone performance (algorithm only) was done: Not applicable, as this is a physical wound dressing, not an algorithm.
- The type of ground truth used: Not applicable, as this is a physical wound dressing.
- The sample size for the training set: Not applicable, as this is a physical wound dressing, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
The document states that "SPYROFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing." However, no details on these "laboratory tests" (e.g., methodology, sample sizes, specific criteria, results) are provided to form acceptance criteria or their fulfillment.
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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 PlaceGolden, CO 80401Tel: (303)271-0300FAX: (303)271-0397Contacts: 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.
N/A