The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam 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.
Unwrapped non-porous instruments	3 min.

Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................ 3 min.
Drying time.........................................................................................................................30 min.

After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time...............................................................................................................................30 min.

The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes.

The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.

Worst case load:

The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.

Device Description

The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices.

The Olympus instrument tray 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.

AI/ML Overview

The provided text describes the acceptance criteria and study results for the "Instrument tray, for semi-rigid ureteroscope" (K203492).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Name of Test	Purpose	Acceptance Criteria	Reported Device Performance (Results)
ISO 10993-5:2009 (Biocompatibility)	Demonstration of biocompatibility for materials that contact the loaded devices	Non-cytotoxic under the conditions of the study	Pass
ISO 10993-12:2012 (Chemical analysis, sample preparation)	Not explicitly stated as a separate purpose in the table, but related to biocompatibility evaluation.	Non-cytotoxic under the conditions of the study	Pass
Cleaning validation	Demonstration of the efficacy of the cleaning procedure	Visibly cleanResidual protein content less than 3 microgram/cm²Residual TOC less than 12 microgram/cm²	Pass
Half-cycle sterilization validation	Demonstration of 6 log reduction of stearothermophilus Geobacillus under half cycle conditions	No viable growth	Pass
Verification of tray durability after repeated sterilization cycles	Demonstration of tray durability over 400 sterilization cycles	No visible degradationNo corrosionLegibility of markings	Pass
Evaluation of residual moisture	Demonstrate adequate drying time	No visible condensation or pooling on the wrap and contents free of visible condensation	Pass

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test within the "Summary of Non-clinical Testing" section. It refers to "the study" or "400 sterilization cycles" for the durability test.

Sample Size: Not explicitly stated for most tests, except for "400 sterilization cycles" for the durability test.
Data Provenance: The studies were conducted in support of a 510(k) premarket notification for a medical device. This indicates the data is likely prospective and generated specifically for regulatory submission, rather than retrospective analysis of existing data. The manufacturer is Olympus Winter & Ibe GmbH, located in Hamburg, Germany, so the origin of the data would be associated with their testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily engineering and microbiology validation tests (e.g., biocompatibility, cleaning efficacy, sterilization efficacy, durability, moisture evaluation). These types of tests typically rely on standardized protocols and objective measurements rather than expert consensus on subjective interpretations.

4. Adjudication method for the test set

This information is not applicable/not provided as the tests are objective performance evaluations with defined criteria, not requiring adjudication in the context of expert review or consensus building.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance. This device is an instrument tray for sterilization, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable as the device is a physical instrument tray, not an algorithm, and does not involve AI or software performance.

7. The type of ground truth used

The ground truth for these performance tests is based on:

Objective measurement against pre-defined thresholds: For cleaning validation (residual protein/TOC), sterilization validation (6 log reduction, no viable growth), and residual moisture (no visible condensation).
Visual inspection and observation against criteria: For cleaning validation (visibly clean), durability (no visible degradation, no corrosion, legibility of markings).
Standardized biological assays: For biocompatibility (non-cytotoxic).

These are all empirical and objective measures, not pathology, outcomes data, or expert consensus in the typical sense of diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

September 15, 2021

Olympus Winter & Ibe GmbH % Dolan Mills Principal Specialist. Regulatory Affairs Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772

Re: K203492

Trade/Device Name: Instrument tray, for semi-rigid ureteroscope Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 9, 2021 Received: August 10, 2021

Dear Dolan Mills:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray III -S

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203492

Device Name Instrument tray, for semi-rigid ureteroscope

Indications for Use (Describe)

Prevacuum steam sterilization

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

Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................................ 3 min.
Drying time.........................................................................................................................30 min.

The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.

Worst case load:

The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.

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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2 510(k) Summary, K203492

2.1 General Information

Manufacturer:	Olympus Winter & Ibe GmbHKuehnstr. 6122045 HamburgGermany
	Establishment Registration Number: 9610773
Official Correspondent:	Dolan MillsProgram Manager, Regulatory AffairsGyrus ACMI, Inc.800 West Park DriveWestborough, MA 01581Phone: (901) 373-0236Email: dolan.mills@olympus.com
	Establishment Registration Number: 3003790304
Date Prepared:	Sept 15, 2021

2.2 Device Identification

Proprietary name:	Instrument tray, for semi-rigid ureteroscope
Device Classification name:	Sterilization Wrap Containers, Trays, Cassettes &Other Accessories
Regulation Medical Specialty:	General Hospital
Regulation Number; Name:	21CFR 880.6850; Sterilization wrap.
Product code; name; class:	KCT; Sterilization Wrap Containers, Trays, Cassettes& Other Accessories; class II

2.3 Predicate Device

The applicant device, Instrument tray, for semi-rigid ureteroscope, is considered substantially equivalent to legally marketed device of K171692, KCT, 21CFR 880.6850:

Instrument basket, for ENDOEYE

No reference devices were used in this submission.

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2.4 Product Description

2.5 Indications for Use

The instrument tray is intended to be used to enclose and protect one Olympus semirigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles:

Prevacuum steam sterilization - Exposure time at a temperature of 132 °C (269.6 °F:) Wrapped instruments ..........................................................................................................................................................

Unwrapped non-porous instruments ......................................3 min.

Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ..................................3 min.
Drying time..........................................................................................................................30 min.

The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.

Worst case load:

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The instrument tray containing a ureteroscope, attachments, light-guide cable, lightguide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.

2.6 Technological Characteristic Comparison with Predicate

Provided below is a technological comparison of the subject device with the predicate device.

Item ofComparison	Subject Device,K203492	Predicate Device,K171692	Evaluation of Differences
Generaltechnology	Perforated rigidenclosure designed toenclose Olympustelescopes andaccessories whileallowing for sufficientpenetration ofreprocessing agents.	Perforated rigidenclosure designed toenclose Olympus videotelescopes andaccessories whileallowing for sufficientpenetration ofreprocessing agents.	Same
Indications forUse	The instrument tray isintended to be used toenclose and protect oneOlympus semi-rigidureteroscope, modelsWA2UR11A,WA2UR12A,WA2UR13A,WA2UR14A,WA2UR21A,WA2UR22A,WA2UR23A,WA2UR31A, andWA2UR32A(K200369), andaccessories duringsterilization in aprevacuum steamsterilizer using thefollowing parameters orcycles:Prevacuum steamsterilization- Exposure time at atemperature of 132 °C(269.6 °F:)Wrapped instruments....................4 min.	The instrument basket isintended to be used toenclose and protect oneOlympus video telescopefor sterilization in aprevacuum steamsterilizer or STERRAD®sterilizer using thefollowing parameters orcycles:• Prevacuum steamsterilization- Exposure time at atemperature of 132 °C(269.6 °F:)Wrapped instruments....................4 min.Immediate-use non-porous instruments........3 min.- Exposure time at atemperature of 135 °C(275 °F:)Wrapped instruments........3 min.Immediate-use non-porous instruments3 min	Similar
Item ofComparison	Subject Device,K203492	Predicate Device,K171692	Evaluation of Differences
	Unwrapped non-porousinstruments .............3min.- Exposure time at atemperature of 135 °C(275 °F:)Wrapped instruments............3min.Unwrapped non-porousinstruments ............3min.- Dryingtime............30 min.After steam sterilization,let the instrument traycool down at roomtemperature.- Cool-downtime............30 min.The instrument tray isalso intended for theenclosure of Olympussemi-rigid ureteroscopesand accessories duringtransport and storagewithin the reprocessingcycle. The instrumenttray is not compatiblewith flexibleureteroscopes.The instrument tray is tobe used in conjunctionwith a FDA clearedsterilization wrap.Maintenance of sterilitydepends on thesterilization wrap.Worst case load: Theinstrument traycontaining aureteroscope,attachments, light-guidecable, light-guide cable	- Drying time............30 min.After steam sterilization,let the instrument basketcool down at roomtemperature.- Cool-down time............30 min.• STERRAD®sterilization- STERRAD® 100Scycle- STERRAD®100NX™: standard cycleand express cycleThe instrument basket isnot intended to maintainsterility. It is intended tobe used in conjunctionwith a 510K clearedsterilization wrap tomaintain sterility of theenclosed Olympus videotelescope andaccessories.Validated worst-caseloadThe instrument basketwhich is double-wrappedin a sterilization wrapwith one enclosedOlympus video telescopeand accessories must notexceed 8.708 lb (3950 g).
Item of	Subject Device,	Predicate Device,	Evaluation of Differences
Comparison	K203492	K171692
	and stopcocks must notexceed a weight of 3300grams (7.27 lb)altogether.
Intended to bereused	Yes	Yes	Same
Device Setup	Consists of base with lid(lid can be fastened by alatching mechanism)	Consists of base with lid,lid can be fastened by alatching mechanism	Same
Percentage ofsurfaceperforation	About 39%	About 72%	Different
Microbialbarrierproperties	To be used with FDAcleared sterilizationwrap	To be used with FDAcleared sterilizationwrap	Same
Toxicologicalproperties	Under conditions ofthe study, thematerials are non-cytotoxic	Under conditions ofthe study, thematerials are non-cytotoxic	Same
Autoclavability(steamsterilization) ofemptybasket/tray	yes	yes	Same
ValidatedDrying time(steamsterilization)	30 minutes	30 minutes	Same
Material	Stainless steel,Silicone	Stainless steel,Silicone	Same

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2.7 Summary of Non-clinical Testing

The following performance data were provided in support of the equivalence determination. All standards applied are FDA recognized international standards.

Name	Purpose	Acceptance Criteria	Results
ISO 10993-5:2009	Demonstration of biocompatibility for materials that contact the loaded devices	Non-cytotoxic under the conditions of the study	Pass
ISO 10993-12:2012	Chemical analysis, and sample preparation	Non-cytotoxic under the conditions of the study	Pass
Cleaning validation	Demonstration of the efficacy of the cleaning procedure	Visibly cleanResidual protein content less than 3 microgram/cm2Residual TOC less than 12 microgram/cm2	Pass

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Name	Purpose	Acceptance Criteria	Results
Half-cyclesterilizationvalidation	Demonstration of 6 logreduction ofstearothermophilusGeobacillus under half cycleconditions	No viable growth	Pass
Verification of traydurability afterrepeated sterilizationcycles	Demonstration of traydurability over 400sterilization cycles	No visible degradationNo corrosionLegibility of markings	Pass
Evaluation of residualmoisture	Demonstrate adequate dryingtime	No visible condensation orpooling on the wrap andcontents free of visiblecondensation	Pass

2.7.1 Applied standards

Standard No.	Standard Title	FDA-Recognitionno + date
ISO10993-1Fourth Edition2009	Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process[Including: Technical Corrigendum 1 (2010)]	2-22007/26/2016
ISO10993-5Third Edition2009	Biological evaluation of medical devices -- Part 5: Testsfor In Vitro cytotoxicity	2-24512/23/2016
ISO10993-12Fourth Edition2012	Biological evaluation of medical devices - Part 12:Sample preparation and reference materials	2-19107/26/2016
IEC62366-1Edition 1.02015-02	Medical devices - Part 1: Application of usabilityengineering to medical devices [IncludingCORRIGENDUM 1 (2016)]	5-11412/23/2016
ANSI AAMIST772013/(R)2018	Containment devices for reusable medical devicesterilization	14-39601/14/2019
ISO14971Second edition2007	Medical devices - Application of risk management tomedical devices	5-4006/27/2016

Table 2.1: Applied standards

2.8 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject Instrument tray, for semi-rigid ureteroscope, is as safe, as effective and performs as

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well as or better than the legally marketed predicate device, Instrument basket, for ENDOEYE (K171692).

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).