The instrument basket is intended to be used to enclose and protect one Olympus video telescope for sterilization in a prevacuum steam sterilizer or STERRAD® sterilizer using the following parameters or cycles:

• Prevacuum steam sterilization

- Exposure time at a temperature of 132 °C (269.6 °F:)
Wrapped instruments	4 min.
Immediate-use non-porous instruments	3 min.

- Exposure time at a temperature of 135 °C (275 °F:)
Wrapped instruments	3 min.
Immediate-use non-porous instruments	3 min.

- Drying time	30 min.
---------------	---------

After steam sterilization, let the instrument basket cool down at room temperature.

- Cool-down time	30 min.
------------------	---------

• STERRAD® sterilization

STERRAD® 100S cycle
STERRAD® 100NX™: standard cycle and express cycle

The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K cleared sterilization wrap to maintain sterility of the enclosed Olympus video telescope and accessories.

Validated worst-case load

The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 lb (3950 g).

Device Description

The instrument basket, for ENDOEYE is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization as well as enclosure during transport within the reprocessing cycle.

The Olympus instrument basket is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use.

Rigid containment device consisting of a base with lid which can be fastened by a latching mechanism. The device is perforated in order to enable reprocessing of enclosed medical devices held in place by silicone retainers.

AI/ML Overview

The provided text describes a medical device, an instrument basket, for which K171692 is a 510(k) premarket notification. The document outlines the device's indications for use, comparison to a predicate device, and performance data from various tests. However, it does not contain information on "acceptance criteria" for a diagnostic or AI device, nor does it present a study proving a device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

The device in question, an "Instrument basket, for ENDOEYE," is classified as a "Sterilization wrap" (21 CFR 880.6850, Product Code: KCT). It's a container designed to hold surgical instruments during sterilization processes. The performance data presented relates to the physical and material properties of the basket itself, ensuring it can withstand sterilization and is biocompatible, not to diagnostic performance or AI effectiveness.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: The document does not define such criteria for diagnostic performance. The "performance data" section focuses on biocompatibility and physical integrity during sterilization.
Sample size used for the test set and the data provenance: Not applicable, as no diagnostic test set is described.
Number of experts used to establish the ground truth and their qualifications: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI or diagnostic device.
Standalone (algorithm only without human-in-the-loop performance): Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (page 8) explicitly states that "Performance tests were carried out to ensure that the system functions as intended and meets design specifications." The listed tests are:

Biocompatibility testing: Conducted according to ISO 10993 standards (Biological Safety toxicology, Cytotoxicity, Chemical Analysis).
Performance Bench Testing: Focused on mechanical protection, enabling automated cleaning/disinfection, enabling use with sterilization wrap, and enabling sterilization of loaded video telescopes. These were conducted as required by AAMI / ANSI ST77:2013 (containment devices for reusable medical device sterilization).

These tests ensure the safety and functionality of the sterilization basket, not the diagnostic performance or AI capabilities of a medical image analysis tool.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are rendered in black and white. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2018

Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K171692

Trade/Device Name: Instrument basket, for ENDOEYE Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 01, 2018 Received: March 05, 2018

Dear Sheri L. Musgnung:

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 general 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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D.

Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171692

Device Name Instrument basket, for ENDOEYE

Indications for Use (Describe)

• Prevacuum steam sterilization

- Exposure time at a temperature of 132 °C (269.6 °F:)
Wrapped instruments	4 min.
Immediate-use non-porous instruments	3 min.

- Exposure time at a temperature of 135 °C (275 °F:)
Wrapped instruments	3 min.
Immediate-use non-porous instruments	3 min.

- Drying time	30 min.
---------------	---------

After steam sterilization, let the instrument basket cool down at room temperature.

- Cool-down time	30 min.
------------------	---------

• STERRAD® sterilization

STERRAD® 100S cycle
STERRAD® 100NX™: standard cycle and express cycle

The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K c

Validated worst-case load

The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 lb (3950 g).

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary K171692

1. General information

■

Manufacturer/Holder Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
트 Establishment Registration No.: 9610773
. Official Correspondent: Sheri L. Musqnung Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 484-896-3147 Phone: FAX: 484-896-7128 Email: sheri.musgnung@olympus.com Establishment Registration No.: 2429304

March 29, 2018

Submission Date:

2. Device identification

트 Proprietary name:
Common name:
트 Requlation Number:
I Regulation Description:
I Device Class:
Product Code:
Review Panel:

Instrument basket, for ENDOEYE Sterilization wrap containers, trays, cassettes & other accessories 21 CFR 880.6850 Sterilization wrap ll КСТ General Hospital

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3. Predicate device

K033222, Olympus Instrument Tray, for video telescopes

4. Description of device

5. Indications of use

Prevacuum steam sterilization

Exposure time at a temperature of 132 °C (269.6 °F): Wrapped instruments	4 min.
Immediate-use non-porous instruments	3 min.
Exposure time at a temperature of 135 °C (275 °F): Wrapped instruments	3 min.
Immediate-use non-porous instruments	3 min.
Drying time	30 min.
After steam sterilization, let the instrument basket cool down at room temperature.
Cool-down time	30 min.

STERRAD® sterilization

STERRAD® 100S cycle
STERRAD® 100NXTM: standard cycle and express cycle

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Validated worst-case load

The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 Ib (3950 g).

5.1 Comparison of Indications for Use statement to the predicate:

The subject device has a similar intended Use as the legally-marketed Instrument tray, for EndoEYE cleared via K033222 (August 2, 2004) since both are sterilization trays. Also the predicate device and new Instrument basket, for ENDOEYE can undergo steam sterilization with the same enclosed devices. The main difference between the subject device and the predicate is that the new Instrument basket, for ENDOEYE can also be used during STERRAD® sterilization.

Item ofComparison	PredicateDevice	Subject Device	Comparison
Generaltechnology	Perforated rigidenclosuredesigned toenclose Olympusvideo telescopesand accessorieswhile allowing forsufficientpenetration ofreprocessingagents.	Perforated rigidenclosuredesigned toenclose Olympusvideo telescopesand accessorieswhile allowing forsufficientpenetration ofreprocessingagents.	Identical
Intended to bereused	Yes	Yes	Identical
Design	Rigidcontainmentdevice consistingof a base with lidwhich can befastened by alatchingmechanism. Thedevice isperforated inorder to enablereprocessing ofenclosed medicaldevices held in	Rigid containmentdevice consistingof a base with lidwhich can befastened by alatchingmechanism. Thedevice isperforated inorder to enablereprocessing ofenclosed medicaldevices held inplace by silicone	Identical
	place by siliconeretainers.	retainers.
Percentage ofsurfaceperforation	About 3.3%	About 72%	The increased surfaceperforation does notintroduce anyadditional risks sincethe maincharacteristics (fitgeometry troughdesign, base withcloseable lid) remainidentical.
Microbial barrierproperties	To be used withFDA clearedsterilization wrap	To be used withFDA clearedsterilization wrap	Identical
Toxicologicalproperties	Materials arebiocompatible	Materials arebiocompatible	Identical
Material	Thermoplastic,silicone	Stainless steel,silicone	The materials usedare different. Allmaterials used in thesubject device havebeen validated to bebiocompatible andverified to becompatible with theintendedreprocessingmethods. Therefore,the use of differentmaterials in thesubject device doesnot raise differentquestions of safetyand effectivenesscompared to thepredicate device.
Autoclavability(steamsterilization) ofempty basket/tray	yes	yes	Identical
STERRAD®sterilization(gas plasma) ofempty basket/tray	no	STERRAD®100S cycleSTERRAD®100NXTM:standard cycleand expresscycle	STERRADsterilization wasadded as anadditionalsterilization optionfor the subjectdevice
Drying time(steamsterilization)	15-30 minutes	30 minutes	Identical

6. Comparison of technological characteristics

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7. Performance Data

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.

Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.

The testing included the following tests:

Biological Safety toxicology: AAMI ANSI ISO 10993-1:2009; Biological . Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
. Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials

Performance Bench Testing

The instrument basket is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization process.

Its main performance characteristics are:

The mechanical protection of the enclosed video telescopes ensured by adaptive holding retainers and closeable basket design
-Enabling automated cleaning/disinfection of loaded video telescopes (validated combinations only as outlined in the respective device IFU's)
Enabling use with sterilization wrap (maintaining sterility is secured by the sterilization wrap which is not part of this submission)
-Enabling sterilization of loaded video telescopes (validated combinations only as outlined in the respective device IFU's)

To outline that these performance characteristics have been met the submission contains the respective validations, tests and an outline of the design as required by the recognized standard AAMI / ANSI ST77:2013, containment devices for reusable medical device sterilization. (Sterility) (recognition number: 14-396) assigned to the product code KCT.

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The following standards have been applied to the Instrument Basket:

Rec. No. Standard

2-220	ISO 10993-1:2009
2-245	ISO 10993-5:2009
2-191	ISO 10993-12:2012
5-40	ISO 14971:2007
14-396	AAMI ANSI ST77:2013
5-96	AAMI ANSI IEC 62366-1:2015

For the above mentioned ISO standards, identical DIN EN ISO standards have been used by the recognized test laboratories.

8 Conclusion

Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, subject Instrument basket, for ENDOEYE is substantially equivalent to, and is as safe and as effective as, the legally marketed predicate device, Olympus sterilization trays cleared under K033222 under regulation 21 CFR 880.6850, product code KCT.

Regulation Number and Section

§ 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).