Who is the manufacturer of OTOSILK OTOLOGICAL GRAFT DRESSING?

Boston Medical Products, Inc. filed the 510(k) submission for OTOSILK OTOLOGICAL GRAFT DRESSING (K964534).

What is the FDA product code for OTOSILK OTOLOGICAL GRAFT DRESSING?

NAD. It is classified under 21 CFR 878.4020 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for OTOSILK OTOLOGICAL GRAFT DRESSING?

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

What are the predicate devices for OTOSILK OTOLOGICAL GRAFT DRESSING?

Xomed Product No. XO-2904 / Xomed-Treace Product No. 14-28010.

Who can help prepare an FDA 510(k) submission like OTOSILK OTOLOGICAL GRAFT 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.

OTOSILK OTOLOGICAL GRAFT DRESSING

K964534 · Boston Medical Products, Inc. · NAD · Apr 9, 1997 · General, Plastic Surgery

Device Facts

Record ID	K964534
Device Name	OTOSILK OTOLOGICAL GRAFT DRESSING
Applicant	Boston Medical Products, Inc.
Product Code	NAD · General, Plastic Surgery
Decision Date	Apr 9, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4020
Device Class	Class 1
Attributes	Therapeutic

Intended Use

To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures.

Device Story

OTOSILK™ Otological Graft Dressing; sterile, disposable, non-adherent material. Used as carrier for split-thickness skin grafts in ear canal procedures (tympanoplasty, canalplasty, mastoid tympanoplasty, congenital aural atresia correction, canal exostoses removal). Graft placed dermis-side up on dressing; trimmed; applied to canal. Blue color aids visualization for complete removal 1-2 weeks post-operatively. Used by surgeons in clinical/OR settings. Benefits: facilitates graft placement; ensures total dressing removal without disturbing graft.

Clinical Evidence

Bench testing only. Sterile finished device samples passed biocompatibility testing; determined to be non-reactive and non-cytotoxic.

Technological Characteristics

Sterile, disposable, non-adherent material. Blue-colored for visualization. Form factor designed for ear canal application.

Indications for Use

Indicated for use as a temporary dressing in the external auditory canal for patients undergoing tympanoplasty or stapedectomy procedures.

Regulatory Classification

Identification

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

Xomed Product No. XO-2904 / Xomed-Treace Product No. 14-28010

Related Devices

K033796 — KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS · Heinz Kurz GmbH Medizintechnik · Jan 30, 2004
K150594 — Biodesign Otologic Repair Graft · Cook Biotech Incorprated · Sep 16, 2015
K972700 — EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) · Exmoor Plastics , Ltd. · Jul 16, 1998
K121360 — BIODESIGN ENT REPAIR GRAFT · Cook Biotech Incorprated · Feb 27, 2013
K982870 — EPIFILM OTOLOGIC LAMINA · Xomed, Inc. · Nov 3, 1998

Submission Summary (Full Text)

{0} APR - 9 1997 K964534 # SMDA Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## Product: OTOSILK™ Otological Graft Dressing ## Description: The OTOSILK™ Graft Dressing is a sterile, disposable graft dressing constructed of non-adherent material, designed for use with split thickness skin grafts used in procedures such as tympanoplasty, canalplasty, mastoid tympanoplasty, correction of congenital aural atresia, and removal of canal exostoses. Split thickness skin grafts may be taken from several sites, using either a razor blade or dermatome. The OTOSILK dressing will be used as a carrier for this skin graft to the ear canal. The graft is placed dermis side up on the dressing and the uncovered material is trimmed away. The skin graft and dressing are then applied to the canal. The dressing is removed from the canal one to two weeks post-operatively. The blue color of the OTOSILK Graft Dressing increases visualization of the dressing, ensuring total removal from the ear canal without disturbing the graft. ## Indication For Use: To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures. ## Predicate Device: Product No. XO-2904 originally marketed by Xomed (8641 Baypine Rd., Jacksonville, FL 32216) and subsequently marketed as Product No. 14-28010 by Xomed-Treace (6743 Southpoint Drive North, Jacksonville, FL 32216). ## Testing: Sterile finished device samples passed biocompatibility testing and were determined to be non-reactive and non-cytotoxic. Submitted by: Stuart K. Montgomery, President Date: