OLYMPUS INSTRUMENT TRAY

K110748 · Olympus Winter & Ibe GmbH · KCT · Feb 15, 2012 · General Hospital

Device Facts

• Record ID: K110748
• Device Name: OLYMPUS INSTRUMENT TRAY
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: KCT · General Hospital
• Decision Date: Feb 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

This instrument tray is intended to be used to enclose and protect Olympus flexible endoscopes during sterilization. The instrument tray is designed to hold one endoscope at a time and is to be used in conjunction with an FDA cleared sterilization wrap for ethylene oxide sterilization. The instrument tray is an optional accessory to the Olympus endoscopes for which it is designed. Maintenance of sterility depends on the sterilization wrap, not on the instrument tray. This instrument tray is indicated for ethylene oxide sterilization of only compatible Olympus endoscopes. For compatible endoscopes, refer to the table below "Compatible Olympus Endoscopes".

Device Story

Plastic instrument tray (WA05991A) designed to house and protect single flexible endoscopes during ethylene oxide (EtO) sterilization. Tray features numerous 7mm diameter holes to facilitate gas ingress/egress. Used in clinical settings; operated by healthcare staff. Device is an accessory; sterility maintenance relies on external FDA-cleared sterilization wrap (e.g., Kimguard KC600). Tray protects endoscopes from physical damage during processing and storage. Benefits include safe, effective sterilization of complex endoscope geometries without hindering gas penetration or aeration.

Clinical Evidence

Bench testing only. Validation performed using worst-case component loads and worst-case endoscope (URF-P5). Successful 30-minute half-cycle sterilization demonstrated 6-log reduction (SAL 10^-6). Residual EO/ECH concentrations after 60-minute full cycles and 12-hour aeration met ISO 10993-7 limits.

Technological Characteristics

Constructed of biocompatible RADEL-R (polyphenylsulfone). Dimensions: 531mm x 255mm x 86mm. Features 7mm diameter perforations for gas exchange. Compatible with EtO sterilization. Complies with ISO 10993, ISO 14971:2007, ANSI/AAMI ST33-1996, AAMI/ANSI/ISO 11135-1, and AAMI/ANSI ST77:2006.

Indications for Use

Indicated for ethylene oxide sterilization of specific compatible Olympus flexible endoscopes (CHF, CYF, ENF, HYF, LF, and URF series). Designed to hold one endoscope per tray.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays (K092682)
• Olympus Sterilization Trays (K033222)

Submission Summary (Full Text)

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K110748

| 510(k) Summary of Safety and Effectiveness<br>February 1, 2012 | | | FEB 15 2012 |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Applicant | Olympus Winter & Ibe GmbH<br>Kuehnstrasse 61 * 22045 Hamburg * Germany<br>Establishment Registration No: 9610773 | | |
| Official Correspondent | Stacy Abbatiello Kluesner, M.S., RAC<br>Regulatory Affairs & Quality Assurance<br>Olympus America Inc.<br>3500 Corporate Parkway<br>PO Box 610<br>Center Valley, PA 18034-0610<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail]<br>Establishment Registration No.: 2429304 | | |
| Manufacturer | Olympus Winter and Ibe GmbH<br>Kuehnstrasse 61 * 22045 Hamburg * Germany<br>Establishment Registration No.: 9610773 | | |
| Device Trade Name: | Olympus Winter & Ibe Instrument Tray WA05991A;<br>abbreviated hereinafter as Olympus Instrument Tray | | |
| Common Name: | Sterilization Wrap Container, Tray, Cassette & other<br>Accessories | | |
| Regulation Number: | 21 CFR 880.6850 | | |
| Regulation Name: | Sterilization Wrap | | |
| Regulatory Class: | II | | |
| Product Code: | KCT | | |
| Classification Panel: | General Hospital | | |
| Performance Standards: | None established | | |
| Predicate Devices: | K092682 Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays K033222 Olympus Sterilization Trays | | |

#### Intended Use:

This instrument tray is intended to be used to enclose and protect Olympus flexible endoscopes during sterilization. The instrument tray is designed to hold one endoscope at a time and is to be used in conjunction with an FDA cleared sterilization wrap for ethylene oxide sterilization. The instrument tray is an optional accessory to the Olympus endoscopes for which it is designed. Maintenance of sterility depends on the sterilization wrap, not on the instrument tray.

This instrument tray is indicated for ethylene oxide sterilization of only compatible Olympus endoscopes. For compatible endoscopes, refer to the table below "Compatible Olympus Endoscopes".

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## Compatible Olympus Endoscopes are:

| CHF-CB30L | CYF-V2R | ENF-V3 | LF-DP |
|-----------|---------|---------|--------|
| CHF-CB30S | CYF-VA2 | ENF-VQ | LF-GP |
| CHF-P20 | CYF-VH | ENF-VT2 | LF-P |
| CHF-P60 | CYF-VHA | ENF-XP | LF-TP |
| CHF-XP20 | CYF-VHR | ENF-VH | LF-V |
| CHF-V | ENF-GP | HYF-1T | URF-P5 |
| CYF-5 | ENF-P4 | HYF-V | URF-V |
| CYF-5A | ENF-T3 | HYF-XP | |
| CYF-V2 | ENF-V2 | LF-2 | |

# Worst case dimension:

The endoscope URF-P5 offers the most challenging dimensions in regards to maximum length (835 mm), minimum inner diameter (1.2 mm) and number of lumen (1).

Ethylene oxide sterilization parameters:

| In chamber conditioning | |
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