The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132°C 4 minutes).

The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap.

KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.

Device Description

The KARL STORZ-ENDOSCOPE RADEL Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.

The tray configurations, available in various sizes, are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat.

The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to provide protection of the medical devices in the sterilization tray.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Karl Storz Radel Sterilization Trays and details non-clinical testing performed to demonstrate the device's safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents a "Summary of Non-Clinical Testing" which acts as the study proving the device meets the acceptance criteria. The table below excerpts the relevant information:

Table 1: Acceptance Criteria and Reported Device Performance

Type of Testing	Purpose	Acceptance Criteria	Reported Device Performance (Result)
Pre-vacuum sterilization efficacy (AAMI ST77, ISO 17665-1)	Demonstrate sterilization capabilities.	10^-6 Sterility Assurance Level (SAL)	PASSED
Pre-vacuum dry time (AAMI ST77, ISO 17665-1)	To establish minimum dry time.	Pre and Post Sterilization weight difference <3% after drying	PASSED (30 minutes dry time)
Manual Cleaning – Protein, Hemoglobin (AAMI TIR 30)	To demonstrate manual cleaning.	< 6.4 µg/cm² protein and < 2.2 µg/cm² hemoglobin on device after cleaning	PASS
Mechanical Cleaning - Protein, Hemoglobin (AAMI TIR 30)	To demonstrate mechanical cleaning.	< 6.4 µg/cm² protein and < 2.2 µg/cm² hemoglobin on device after cleaning	PASS
Material biocompatibility (ISO 10993-5)	To demonstrate no cytotoxic properties.	Cytotoxicity – No evidence of lysis	PASS

Study Details:

Based on the provided text, primarily the "Summary of Non-Clinical Testing" and related sections, here are the answers to the specific questions:

A table of acceptance criteria and the reported device performance
- See Table 1 above.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the numerical sample sizes (e.g., number of trays, number of cycles, number of cleaning tests) used for any of the non-clinical tests. It only states what was "validated" and with which instruments (e.g., "validated with a miniature scope with an irrigation channel lumen diameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm").
- Data Provenance: The document does not explicitly state the country of origin of the data. The submitting organization, KARL STORZ Endoscopy-America, Inc., is based in El Segundo, California, USA, and the consultant is in Austin, Texas, USA. Given this is an FDA 510(k) submission, it's presumed the studies were conducted to meet US regulatory requirements. The studies are non-clinical bench testing, not retrospective or prospective human clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this type of non-clinical device testing. The ground truth for performance (sterilization efficacy, dry time, cleaning effectiveness, biocompatibility) is established through adherence to recognized international and national standards (AAMI ST77, ISO 17665-1, AAMI TIR 30, ISO 10993-5) and standardized laboratory testing protocols, rather than expert consensus on medical images or clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the testing involves objective measurements against predefined acceptance criteria from standards, not subjective assessments requiring adjudication.
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
- This is not applicable. This document describes non-clinical performance testing of a sterilization tray, not an AI/imaging device requiring MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This document describes non-clinical performance testing of a sterilization tray, not an AI/imaging device. The "standalone" performance here relates to the device's ability to meet the specified performance criteria (e.g., achieving 10^-6 SAL), which is indeed what was tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on defined performance metrics and thresholds established by recognized national and international standards (e.g., 10^-6 SAL for sterilization, <3% weight difference for drying, specific µg/cm² limits for protein/hemoglobin, and no evidence of lysis for cytotoxicity). It's objective, quantitative data derived from laboratory testing, not subjective clinical or pathological assessments.
The sample size for the training set
- This is not applicable. The device is a medical device (sterilization tray), not an AI algorithm that requires a training set.
How the ground truth for the training set was established
- This is not applicable as there is no AI algorithm training set.

Summary

{0}------------------------------------------------

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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 7, 2021

Karl Storz Endoscopy America Inc % David Furr Consultant Toscano Consulting Group Inc. 8708 Capeheart Cove Austin, Texas 78733

Re: K203572

Trade/Device Name: Karl Storz Radel Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 15, 2021 Received: April 19, 2021

Dear David Furr:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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 mediation-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, Ph.D. Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203572

Device Name KARL STORZ RADEL Sterilization Trays

Indications for Use (Describe)

The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap.

Tray Catalog Number	Intended Load Maximum Weight(Karl Storz Instruments Only)
27717A	Trocar/Cannula 5.0 lbs.
27717B	Take-Apart Instruments 5.0 lbs.
39231XA	Karl Storz General Instruments 5.0 lbs.
39301A	Two Rigid Telescopes 2.71lbs.
39301C	Two Rigid Telescopes 3.21lbs.
39301C1	One Rigid Telescope/One Light Cable 3.17 lbs.
39311A	Four Telescopes/One Light Cable 6.86 lbs.
39317A	Three Telescopes/One Light Cable 6.86 lbs.

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.

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."

{3}------------------------------------------------

510(k) Summary K203572

Date: May 5, 2021

1.	Submitted By:	KARL STORZ Endoscopy-America, Inc.2151 E. Grand Ave.El Segundo, California 90245424-218-8376
2.	Contact:	David C. FurrToscano Consulting Group Inc.8708 Capehart CoveAustin, Texas 78733512-906-9654
3.	Product:	KARL STORZ RADEL Sterilization Trays (K203572)Product code: KCT - Class II (21 CFR 880.6850)
4.	Common/Classification Name:	Sterilization wrap/container
	Predicate devices:	Symmetry Medical Polyvac Surgical Instrument DeliverySystem K012105

Description:

{4}------------------------------------------------

Intended Use:

The trays are to be used in conjunction with an FDA cleared sterilization wrap.

KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation channel lumen diameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.

Tray Catalog Number	Intended Load Maximum Weight(Karl Storz Instruments Only)
27717A	Trocar/Cannula 5.0 lbs.
27717B	Take-Apart Instruments 5.0 lbs.
39231XA	Karl Storz General Instruments 5.0 lbs.
39301A	Two Rigid Telescopes 2.71lbs.
39301C	Two Rigid Telescopes 3.21lbs.
39301C1	One Rigid Telescope/One Light Cable 3.17 lbs.
39311A	Four Telescopes/One Light Cable 6.86 lbs.
39317A	Three Telescopes/One Light Cable 6.86 lbs.

Technological Characteristics Comparison Table:

Provided below is the comparison of the technological differences and similarities of the subject device and the predicate device.

{5}------------------------------------------------

Element ofComparison	510(k) Device:KARL STORZRADEL SterilizationTrays	Predicate Device:Symmetry MedicalPolyvac SurgicalInstrument DeliverySystem (K012105)	Comparison
Regulation andProduct ClassificationCode	21 CFR 880.6850KCT	21 CFR 880.6850KCT	Same
Indications for Use	The KARL STORZRADEL SterilizationTrays are intended onlyfor use to encase andprotect specific KARLSTORZ reusable medicaldevices for sterilization inpre-vacuum steamsterilization cycles (132°C4 minutes).When used in conjunctionwith an FDA clearedsterilization wrap, sterilityof the enclosed medicaldevice is maintained untilused.KARL STORZ hasvalidated the KARLSTORZ RADELSterilization Trays for usein pre-vacuum steamsterilizers. The systemwas validated with aminiature scope with anirrigation channel lumendiameter of 0.25mm and alength of 240mm and asemi-rigid ureteroscopewith a channel lumendiameter of 0.77mm and alength of 420mm.	Polyvac's DeliverySystems consist ofperforated trays withlids, which areintended to enclose andprotect medical deviceinstrumentation, and tofacilitate thesterilization processingby allowing steampenetration and airremoval, when used inconjunction with anapproved sterilizationwrap. Sterility of theenclosed medicaldevices maintaineduntil used. Polyvac'sDelivery Systems areto be sterilized in oneof the following cycles:pre vacuum steam,132ºC 4 minutesminimum, gravitysteam 132°C 30minutes minimum andgravity steam 121℃ 55minutes minimum.	Similar
Principal Material ofConstruction	Thermoformed RadelPolyphenylsulfone,	Thermoformed RadelPolyphenylsulfone,stainless steel oraluminum	Different
KARL STORZ ModelNumbers	8 models	N/A	Different
DimensionalConfiguration Range	Approximate sizesavailable in inches:21.2x9.8x4.3 21.2x9.8x1.9 19.8x8.9x1.8 12.18x3.22x1.2 21.48 x 3.53x 1.75 21.48 x 3.53x 1.75 13.36 x 9.31x 1.9 20.24x9.30x3.1	Approximate sizesavailable in inches:7x2x1 7x3x1 8x4x1 11x7x1 21x10x4 17x10x4 17x8x2 15x10x1.5 20.5x9.7x5 20x10x3 26x9x6 17x3.5x1.5 And others	Similar
Device Manufacturer	Manufactured byTecomet (formerlySymmetry Medical)	Manufactured byTecomet (formerlySymmetry Medical)	Same
Sterilization Cycles	Prevacuum Steam 4minute cycle 132°C	Prevacuum steam andgravity steam	Similiar
Load	Trays are to be loadedwith KARL STORZinstruments; maximumweights as indicated	Various loads up to 25lbs.	Similar

{6}------------------------------------------------

{7}------------------------------------------------

Summary of Non-Clinical Testing:

Shown below is the non-clinical testing performed with the subject device and the standards and test method used to demonstrate the subject device met the acceptance criteria of each standard..

Type of Testing	Purpose	AcceptanceCriteria	Result
Pre-vacuum sterilizationefficacyAAMI ST77 ContainmentDevices for Reusable MedicalDevice SterilizationISO 17665-1 Sterilization of HealthCare Products - Moist Heat - Part 1Requirements for the Development,Validation, and Routine Control of aSterilization Process for MedicalDevices	Demonstrate sterilizationcapabilities.	10-6 SAL	PASSED
Pre-vacuum dry timeAAMI ST77 Containment Devices forReusable Medical Device SterilizationISO 17665-1 Sterilization of HealthCare Products - Moist Heat - Part 1Requirements for the Development,Validation, and Routine Control of aSterilization Process for MedicalDevices	To establish minimum drytime.	Pre and PostSterilization weightdifference <3% afterdrying	PASSED30 minutes drytime
Manual Cleaning – Protein,HemoglobinAAMI TIR 30 ACompendium of Processes,Materials, Test Methods,and Acceptance Criteria forCleaning Reusable MedicalDevices	To demonstrate manual cleaning	< 6.4 µg/cm2protein and< 2.2 µg/cm2hemoglobin on deviceafter cleaning	PASS
Mechanical Cleaning - Protein,HemoglobinAAMI TIR 30 A Compendiumof Processes, Materials, TestMethods, and AcceptanceCriteria for Cleaning ReusableMedical Devices	To demonstrate mechanicalcleaning	< 6.4 µg/cm²protein and< 2.2 µg/cm²hemoglobin on deviceafter cleaning	PASS
Material biocompatibility	To demonstrate no	Cytotoxicity – No	PASS
ISO 10993-5 Biological Evaluationof Medical Devices – Part 5: Tests forin vitro cytotoxicity	Cytotoxic properties	evidence of lysis

{8}------------------------------------------------

Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performed as well as or better than the legally marketed predicate devices.

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).