K Number
K110748Device Name
OLYMPUS INSTRUMENT TRAY
Manufacturer
Date Cleared
2012-02-15
(335 days)
Product Code
Regulation Number
880.6850AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
The Olympus Instrument Tray is comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage.
More Information
Not Found
No
The device is a physical instrument tray for sterilization, with no mention of software, data processing, or AI/ML terms.
No
This device is an instrument tray designed to protect endoscopes during sterilization, not to provide therapy itself.
No
Explanation: The device is an instrument tray designed to enclose and protect Olympus flexible endoscopes during sterilization. Its purpose is to facilitate the sterilization process and protect the endoscopes, not to diagnose medical conditions or analyze biological data.
No
The device description clearly states it is comprised of plastic lids and bottoms, indicating it is a physical hardware device used for sterilization, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose and protect flexible endoscopes during sterilization using ethylene oxide. This is a process related to the sterilization of medical devices, not the diagnosis of diseases or conditions using in vitro methods.
- Device Description: The device is described as a tray with holes for gas penetration, designed for physical protection during sterilization and storage. This aligns with a device used in the sterilization process, not for analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening
- Use of reagents or assays
The device is an accessory used in the sterilization process of medical devices (endoscopes).
N/A
Intended Use / Indications for 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".
Compatible Olympus Endoscopes are:
CHF-CB30L, CHF-CB30S, CHF-P20, CHF-P60, CHF-XP20, CHF-V, CYF-5, CYF-5A, CYF-V2, CYF-V2R, CYF-VA2, CYF-VH, CYF-VHA, CYF-VHR, ENF-GP, ENF-P4, ENF-T3, ENF-V2, ENF-V3, ENF-VQ, ENF-VT2, ENF-XP, ENF-VH, HYF-1T, HYF-V, HYF-XP, LF-2, LF-DP, LF-GP, LF-P, LF-TP, LF-V, URF-P5, URF-V
Product codes
KCT
Device Description
The Olympus Instrument Tray is comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage.
Material: The trays are constructed of biocompatible RADEL-R. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with EtO sterilization.
Dimensions: 531mm (L) x 255mm (W) x 86mm (D)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation of "Worst-Case" Challenges of the Instrument Tray: Validation was performed to assess the worst case component load and the ability of ethylene oxide to penetrate and aerate from the surfaces and silicon holders of the instrument Trav. The PCDs (process challenge devices) were placed in the trays and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. The trays were wrapped with two layers of FDA approved sterilization wrap (Kimguard KC600; K082554) and placed into ethylene oxide sterilizer for processing. The system was sterilized successfully in a 30 minute half cycle demonstrating 6 log reduction capability ( SAL of 10-6). Test systems were exposed to 60 minute full cycles and ethylene oxide residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations of EO and ECH were all within acceptable limits. Therefore the instrument tray is effectively sterilized when the worst case components are loaded and the level of remaining residuals was found to be acceptable.
Validation of 'Worst-Case" Endoscope in the Instrument Trav: Validation was also performed to assess the worst case endoscope (URF-P5) loaded into the instrument tray. This testing assessed the ability of ethylene oxide to penetrate the worst case endoscope features (lumen length and diameter) and the level of residuals remaining. Validation was performed with FDA cleared accessories, including biological indication wrap (Kimguard KC600; K082554) and ethylene oxide sterilizer. The endoscopes were sterilized successfully in a 30 minute half cycle demonstrating 6 log reduction capability ( SAL of 10-6). The endoscopes were exposed for full cycles and all ethylene oxide residual concentrations of EO and ECG were all within acceptable limits. Therefore, the Instrument Tray was found to not hinder sterilization and aeration of the worst-case endoscope.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Other standards applied to the design of this device include ANSI/AMMI ST33-1996, AAMI / ANSI / ISO 11135-1, AAMI / ANSI / ISO 10993-1, AAMI / ANSI / ISO 10993-7, and AAMI/ ANSI ST77:2006.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).
0
| 510(k) Summary of Safety and Effectiveness
| February 1, 2012 | FEB 15 2012 | ||
|---|---|---|---|
| Applicant | Olympus Winter & Ibe GmbH | ||
| Kuehnstrasse 61 * 22045 Hamburg * Germany | |||
| Establishment Registration No: 9610773 | |||
| Official Correspondent | Stacy Abbatiello Kluesner, M.S., RAC | ||
| Regulatory Affairs & Quality Assurance | |||
| Olympus America Inc. | |||
| 3500 Corporate Parkway | |||
| PO Box 610 | |||
| Center Valley, PA 18034-0610 | |||
| Phone: 484-896-5405 | |||
| FAX: 484-896-7128 | |||
| Email: Stacy.Kluesner@Olympus.com | |||
| Establishment Registration No.: 2429304 | |||
| Manufacturer | Olympus Winter and Ibe GmbH | ||
| Kuehnstrasse 61 * 22045 Hamburg * Germany | |||
| Establishment Registration No.: 9610773 | |||
| Device Trade Name: | Olympus Winter & Ibe Instrument Tray WA05991A; | ||
| abbreviated hereinafter as Olympus Instrument Tray | |||
| Common Name: | Sterilization Wrap Container, Tray, Cassette & other | ||
| 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".
1
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 | |
|---|---|
| Temperature.............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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the list of the table is not complete. I will add the missing values and dots. ```json { |
2
Product Description:
| Tray | Item no. | Compatible endoscopes |
|---|---|---|
| Olympus Instrument | ||
| Tray | WA05991A | Olympus Flexible Endoscopes of the CHF, |
| CYF, ENF, HYF, LF, and URF series | ||
| Feature | The Olympus Instrument Tray is comprised of plastic lids and bottoms | |
| that contain numerous large holes (approximately 7mm in diameter) that | ||
| permit ready ingress and egress of sterilization gases. | ||
| The trays are designed to provide protection from physical damage to the | ||
| flexible endoscope during sterilization and storage. | ||
| Intended Use | Provided above. | |
| Material | The trays are constructed of biocompatible RADEL-R. Radel-R is a | |
| polyphenylsulfone plastic that is widely used in medical devices. Radel-R | ||
| meets the requirements for biocompatibility pursuant to ISO-10993 and is | ||
| compatible with EtO sterilization. | ||
| Patient Contact | The trays do not contact the patient | |
| Sterilization | ||
| modality | EtO | |
| Dimensions | 531mm (L) x 255mm (W) x 86mm (D) |
Performance Data:
Validation of "Worst-Case" Challenges of the Instrument Tray:
Validation was performed to assess the worst case component load and the ability of ethylene oxide to penetrate and aerate from the surfaces and silicon holders of the instrument Trav. The PCDs (process challenge devices) were placed in the trays and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. The trays were wrapped with two layers of FDA approved sterilization wrap (Kimguard KC600; K082554) and placed into ethylene oxide sterilizer for processing. The system was sterilized successfully in a 30 minute half cycle demonstrating 6 log reduction capability ( SAL of 10-6). Test systems were exposed to 60 minute full cycles and ethylene oxide residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations of EO and ECH were all within acceptable limits. Therefore the instrument tray is effectively sterilized when the worst case components are loaded and the level of remaining residuals was found to be acceptable.
Validation of 'Worst-Case" Endoscope in the Instrument Trav:
Validation was also performed to assess the worst case endoscope (URF-P5) loaded into the instrument tray. This testing assessed the ability of ethylene oxide to penetrate the worst case endoscope features (lumen length and diameter) and the level of residuals remaining. Validation was performed with FDA cleared accessories, including biological indication wrap (Kimguard KC600; K082554) and ethylene oxide sterilizer. The endoscopes were sterilized successfully in a 30 minute half cycle demonstrating 6 log reduction capability ( SAL of 10-6). The endoscopes were exposed for full cycles and all ethylene oxide residual concentrations of EO and ECG were all within acceptable limits. Therefore, the Instrument Tray was found to not hinder sterilization and aeration of the worst-case endoscope.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Other standards applied to the design of this device include ANSI/AMMI ST33-1996, AAMI / ANSI / ISO 11135-1, AAMI / ANSI / ISO 10993-1, AAMI / ANSI / ISO 10993-7, and AAMI/ ANSI ST77:2006.
Technological Characteristics and Substantial Equivalence:
3
The Olympus Winter & Ibe GmbH Instrument Tray is composed of the same materials, constructed the same and uses the same design philosophy as the general hospital trays sold by Gyrus ACMI FGT Endoscopes Storage/Sterilization trays (K092682) and Olympus (K033222). In contrast to the Olympus Sterilization Trays (K033222), the Olympus Instrument Tray is only indicated for EtO sterilization as is the Gyrus ACMI FGT Storage/Sterilization Tray (K092686).
■ Conclusion:
In summary, the Olympus Instrument Tray is substantially equivalent to the predicate devices and raises no new concerns of safety or efficacy when compared to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Olympus Winter & Ibe GmbH C/O Stacy A. Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway Center Valley, Pennsylvania 18034
FEB 1 5 2012
Re: K110748
Trade/Device Name: Olympus Instrument tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 3, 2012 Received: February 8, 2012
Dear Ms. Kluesner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the gencral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 -- Ms. Kluesner
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Anthony J. Watson
Anthony D. Watson, B.S., M.S., M.B.A. · Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
| 510(k) Number: | K110748 |
|---|---|
| Device Name: | Olympus Instrument tray |
| Model Numbers: | WA05991A |
Indications For 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".
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 |
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | ✓ |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
es fa Antary Dudrim
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 2
510(k) Number: K110748
7
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 Temperature................................................................................................................................................................... Humidity ... ... ... ......................................................................................................................................................... Vacuum set point.............................................................................................................................................................. Time ......................................................................................................................................................................... Exposure Temperature................................................................................................................................................................... Humidity ... ... ... ......................................................................................................................................................... Sterilization gas ............................................................................................................................................................ Ethylene oxide gas concentration............................................................................................................................ 735 mg/l Exposure time................................................................................................................................................................. Aeration Temperature................................................................................................................................................................... Time .........................................................................................................................................................................
Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clamin-Will
Division of Anesthesiology, General Hospital Infection Control, Dental Device
Page 2 of 2
510(k) Number: K110748