Who is the manufacturer of PANOGAUZE NON-WOVEN HYDROGEL DRESSING?

Sage Pharmaceuticals, Inc. filed the 510(k) submission for PANOGAUZE NON-WOVEN HYDROGEL DRESSING (K964620).

What is the FDA product code for PANOGAUZE NON-WOVEN HYDROGEL DRESSING?

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

What is the regulatory pathway for PANOGAUZE NON-WOVEN HYDROGEL DRESSING?

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

Who can help prepare an FDA 510(k) submission like PANOGAUZE NON-WOVEN HYDROGEL 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.

PANOGAUZE NON-WOVEN HYDROGEL DRESSING

K964620 · Sage Pharmaceuticals, Inc. · MGQ · Jan 9, 1997 · SU

Device Facts

Record ID	K964620
Device Name	PANOGAUZE NON-WOVEN HYDROGEL DRESSING
Applicant	Sage Pharmaceuticals, Inc.
Product Code	MGQ · SU
Decision Date	Jan 9, 1997
Decision	SN
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

PanoGauze™ Non-Woven Hydrogel Dressing is intended to provide a moist packing/healing environment which helps to prevent wound desiccation.

Device Story

PanoGauze™ is a sterile, single-use, absorbent non-woven pad saturated with water-based hydrogel; packaged in poly/Mylar-laminate pouches. Used in clinical or home settings for wound and burn management. Provides moist environment to prevent wound desiccation. Healthcare provider applies dressing to wound bed; maintains moist environment to facilitate healing. Benefits include protection of wound bed and prevention of desiccation.

Clinical Evidence

Bench testing only. Independent laboratory studies confirmed USP compliance for systemic toxicity and cytotoxicity. Testing per 16 CFR 1500 (FHSA) showed no primary skin irritation and no evidence of delayed dermal contact sensitization.

Technological Characteristics

Non-woven absorbent pad saturated with water-based hydrogel. Sterile, single-use. Packaging: poly/Mylar-laminate pouches. Class II device (21 CFR 878.4022).

Indications for Use

Indicated for use as a hydrogel wound and burn dressing to maintain a moist wound environment and prevent desiccation.

Predicate Devices

Carrington Laboratories, Inc. CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad (K915001)

Related Devices

K964468 — IAMIN WET DRESSING (COPPER-SALINE) · Procyte Corp. · Feb 3, 1997
K965005 — IAMIN IMPREGNATED GAUZE DRESSING · Procyte Corp. · Feb 24, 1997
K984262 — MODIFICATION OF BIONECT HYDROGEL GAUZE PADS · Fidia Pharmaceutical Corp. · Feb 10, 1999
K072068 — BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS · Bioartificial Gel Technologies (Bagtech), Inc. · Dec 21, 2007
K983362 — NU-GEL * WOUND DRESSING · Johnson & Johnson Medical, Inc. · Dec 16, 1998

Submission Summary (Full Text)

{0} JAN - 9 1997 K964620 # Summary Basis of Substantial Equivalence. 510 (k) Summary PanoGauze™ Non-Woven Hydrogel Dressing is substantially equivalent in design, composition and function to the Carrington Laboratories, Inc. CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, 510(k) #K915001, authorized for marketing January 31, 1992. This is a Class II, (21 CFR §878.4022) Hydrogel Wound & Burn Dressing. There are no established performance standards. PanoGauze™ Non-Woven Hydrogel Dressing, like the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, is intended to provide a moist packing/healing environment which helps to prevent wound desiccation. Both are absorbent pads saturated with water based hydrogels packaged in sterile single-use poly/Mylar-laminate pouches. In regards to safety, several studies were conducted by an independent testing laboratory that demonstrate the following with regard to PanoGauze™ Non-Woven Hydrogel Dressing: - Met the USP requirements for systemic toxicity, - Meets USP requirements for cytotoxicity, - Is not considered a primary irritant to the skin per the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500. In fact, no irritation was observed, - Showed no evidence of causing delayed dermal contact sensitization. In summary, PanoGauze™ Non-Woven Hydrogel Dressing can be determined to be substantially equivalent to CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad on the basis that it maintains a moist environment in the wound bed, does not introduce microbial contamination, and is safe to use - as established by negative results when tested for toxicity. 510 (k) PREMARKET NOTIFICATION Page 2