Who is the manufacturer of MITRAFLEX PIGMENTED WOUND DRESSING?

Polymedica Industries, Inc. filed the 510(k) submission for MITRAFLEX PIGMENTED WOUND DRESSING (K964701).

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

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

What is the regulatory pathway for MITRAFLEX PIGMENTED WOUND DRESSING?

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

What are the predicate devices for MITRAFLEX PIGMENTED WOUND DRESSING?

MITRAFLEX Wound Dressings; MITRAFLEX Wound Dressings, Wet-Stick.

Who can help prepare an FDA 510(k) submission like MITRAFLEX 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.

MITRAFLEX PIGMENTED WOUND DRESSING

K964701 · Polymedica Industries, Inc. · FRO · Feb 7, 1997 · SU

Device Facts

Record ID	K964701
Device Name	MITRAFLEX PIGMENTED WOUND DRESSING
Applicant	Polymedica Industries, Inc.
Product Code	FRO · SU
Decision Date	Feb 7, 1997
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

MITRAFLEX 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

Device Story

Sterile, absorptive, adhesive, conformable wound dressing; three-layer construction. Wound contact surface: porous adhesive for application. Second layer: microporous polyurethane membrane; absorbs/acts as reservoir for exudate; moisture vapor permeable; maintains moist environment; impermeable to microorganisms/liquids. Used in clinical/home settings for wound management; applied by healthcare providers or patients. Benefits: promotes optimal wound repair; protects wound site.

Clinical Evidence

Bench testing only. Laboratory tests demonstrated the device is nontoxic, nonirritating, and nonsensitizing.

Technological Characteristics

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

Indications for Use

Indicated for management of venous stasis ulcers, diabetic ulcers, pressure sores, donor sites, blisters, incisions, severe sunburn, poison ivy, dermabrasions, plastic surgery procedures (e.g., facelifts, laser resurfacing), partial/full-thickness wounds, superficial/thermal/minor chemical burns, abrasions, lacerations, skin tears, and dermal lesions.

Predicate Devices

MITRAFLEX Wound Dressings
MITRAFLEX Wound Dressings, Wet-Stick

Related Devices

K963623 — SPYROFLEX PIGMENTED WOUND DRESSING · Polymedica Industries, Inc. · Oct 25, 1996
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
K980209 — SIMPLICARE THIN FILM WOUND DRESSINGS · Hollister, Inc. · Feb 20, 1998
K982939 — BTF THIN FILM WOUND DRESSING · Bioderm, Inc. · Oct 13, 1998

Submission Summary (Full Text)

{0} k964701 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 - 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 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. 27