(148 days)
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No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also explicitly marked as "Not Found".
No.
The device is described as a temporary dressing/carrier for skin grafts after ear surgeries, which aids the healing process but does not directly treat a disease or condition itself.
No
The device description indicates it is a "graft dressing" used to carry and apply a skin graft, and not for identifying or diagnosing a condition. Its function is therapeutic, serving as a temporary dressing post-surgery.
No
The device description clearly states it is a "sterile, disposable graft dressing constructed of non-adherent material," indicating it is a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and genetic tests.
- This device is a surgical dressing. Its intended use is to be placed directly into the external auditory canal as a temporary dressing following surgical procedures. It is a physical device used in a surgical context, not for analyzing biological samples.
The description clearly states its function as a "temporary dressing" and a "carrier for this skin graft to the ear canal." This aligns with the definition of a medical device used for surgical support and wound management, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
external auditory canal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Sterile finished device samples passed biocompatibility testing and were determined to be non-reactive and non-cytotoxic.
Key Metrics
Not Found
Predicate Device(s)
Product No. XQ-2904
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4020 Occlusive wound dressing.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows a series of six black, abstract shapes against a white background. The shapes appear to be stylized representations of numbers, possibly handwritten or drawn with a thick brush. The numbers appear to be 2, 9, 6, 4, 5, and 4.
APR - 9 1997
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. XQ-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: