Who is the manufacturer of SPYROFLEX PIGMENTED WOUND DRESSING?

Polymedica Industries, Inc. filed the 510(k) submission for SPYROFLEX PIGMENTED WOUND DRESSING (K963623).

What is the FDA product code for SPYROFLEX PIGMENTED WOUND DRESSING?

MGP. as a Class U device in the SU panel.

What is the regulatory pathway for SPYROFLEX PIGMENTED WOUND DRESSING?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPYROFLEX PIGMENTED WOUND DRESSING?

SPYROFLEX Wound Dressings; Wet-Stick; SPYROFLEX Wound Dressings; Flexzan Topical Wound Dressings.

Who can help prepare an FDA 510(k) submission like SPYROFLEX PIGMENTED WOUND DRESSING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPYROFLEX PIGMENTED WOUND DRESSING

K963623 · Polymedica Industries, Inc. · MGP · Oct 25, 1996 · SU

Device Facts

Record ID	K963623
Device Name	SPYROFLEX PIGMENTED WOUND DRESSING
Applicant	Polymedica Industries, Inc.
Product Code	MGP · SU
Decision Date	Oct 25, 1996
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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).

Device Story

Sterile, absorptive, adhesive, conformable wound dressing; two-layer construction. Wound contact surface: porous adhesive for application. Second layer: microporous polyurethane membrane; absorbs/stores exudate; moisture vapor permeable; maintains moist environment; impermeable to microorganisms/liquids. Used in clinical/home settings for wound management; applied by clinicians or patients. Provides moist healing environment; protects wound from external contaminants; manages exudate; promotes optimal repair.

Clinical Evidence

Bench testing only; laboratory tests demonstrate device is nontoxic, nonirritating, and nonsensitizing.

Technological Characteristics

Two-layer construction; wound contact surface is porous adhesive; outer layer is microporous polyurethane membrane. Moisture vapor permeable; impermeable to microorganisms and liquids. Sterile.

Indications for Use

Indicated for management of various dermal lesions and injuries including venous stasis ulcers, diabetic ulcers, pressure sores, partial/full-thickness wounds, burns (thermal, chemical, sunburn), abrasions, lacerations, donor sites, blisters, skin tears, incisions, and post-surgical sites (dermatologic, plastic surgery).

Predicate Devices

SPYROFLEX Wound Dressings
Wet-Stick
SPYROFLEX Wound Dressings
Flexzan Topical Wound Dressings

Related Devices

K964701 — MITRAFLEX PIGMENTED WOUND DRESSING · Polymedica Industries, Inc. · Feb 7, 1997
K974520 — SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM · Innovative Technologies (Us), Inc. · Feb 6, 1998
K971126 — HYDROCOLLOID WOUND DRESSINGS · Innovative Technologies , Ltd. · Jun 24, 1997
K982939 — BTF THIN FILM WOUND DRESSING · Bioderm, Inc. · Oct 13, 1998
K980209 — SIMPLICARE THIN FILM WOUND DRESSINGS · Hollister, Inc. · Feb 20, 1998

Submission Summary (Full Text)

{0} OCT 25 1996 K963623 # 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. 43