Who is the manufacturer of KARL STORZ UDEL Sterilization Trays?

Karl Storz Endoscopy America, Inc. filed the 510(k) submission for KARL STORZ UDEL Sterilization Trays (K201945).

What is the FDA product code for KARL STORZ UDEL Sterilization Trays?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for KARL STORZ UDEL Sterilization Trays?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KARL STORZ UDEL Sterilization Trays?

KARL STORZ Endoscope Sterilization Trays (K090818); Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105).

Who can help prepare an FDA 510(k) submission like KARL STORZ UDEL Sterilization Trays?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KARL STORZ UDEL Sterilization Trays

K201945 · Karl Storz Endoscopy America, Inc. · KCT · Feb 25, 2021 · General Hospital

Device Facts

Record ID	K201945
Device Name	KARL STORZ UDEL Sterilization Trays
Applicant	Karl Storz Endoscopy America, Inc.
Product Code	KCT · General Hospital
Decision Date	Feb 25, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated in the attached table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.

Device Story

UDEL Sterilization Trays are rigid, perforated containers designed to organize and protect specific KARL STORZ reusable medical instruments during sterilization. Trays consist of a Udel polysulfone base and lid, often featuring silicone mats or holders to secure instruments. The device is used in clinical settings by healthcare staff. Instruments are placed inside the tray, which is then double-wrapped in an FDA-cleared sterilization wrap to maintain a microbial barrier. The tray design allows for sterilant penetration (steam or STERRAD) through perforations. The device does not maintain sterility independently; it serves as a containment system to facilitate sterilization and protect instruments from damage during handling and processing. Benefits include organized instrument storage and protection of delicate endoscopes and camera heads during the sterilization cycle.

Clinical Evidence

Bench testing only. Efficacy validated for STERRAD (100S, NX, 100NX) and steam (pre-vacuum, gravity) cycles achieving 10^-6 SAL. Cleaning efficacy validated for protein (< 6.4 µg/cm²) and hemoglobin (< 2.2 µg/cm²) removal. Biocompatibility confirmed per ISO 10993. Material integrity verified after 200 STERRAD cycles and 2100 steam cycles.

Technological Characteristics

Materials: Udel polysulfone polymer (base/lid), silicone (holders/mats). Construction: Thermoformed or injection-molded perforated trays with latches. Sterilization: Steam (pre-vacuum/gravity) and STERRAD (100S, NX, 100NX). Standards: AAMI ST77, ISO 14937, ISO 17665-1, AAMI TIR 30, ISO 10993. Connectivity: None (mechanical device).

Indications for Use

Indicated for encasing and protecting specific KARL STORZ reusable medical devices (flexible endoscopes, rigid telescopes, camera heads, light cables) during sterilization in STERRAD and steam systems. Compatible with flexible endoscopes with lumen diameters ≥ 1.2mm and max length 845mm. Must be used with FDA-cleared sterilization wrap.

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

KARL STORZ Endoscope Sterilization Trays (K090818)
Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105)

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K102103 — SKELETAL DYNAMICS STERILIZATION TRAYS · Skeletal Dynamics, LLC · Dec 7, 2010
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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. February 25, 2021 Karl Storz EndoscopyAmerica Inc % David Furr Consultant Toscano Consulting 8708 Capehart Cove Austin, Texas 78733 Re: K201945 Trade/Device Name: KARL STORZ UDEL Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 26, 2021 Received: January 28, 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 {1}------------------------------------------------ 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, for 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) K201945 Device Name KARL STORZ UDEL Sterilization Trays #### Indications for Use (Describe) The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container. | 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}------------------------------------------------ | Tray Name | Intended Content KARL STORZ Instruments Only | STERRAD® 100S | STERRAD® NX Standard Cycle | STERRAD® NX Advanced Cycle | STERRAD® 100NX Standard Cycle | STERRAD® 100NX Flex Cycle | Steam Pre-vacuum 132°C 4 minutes See Dry Time in Table | Steam Gravity Cycle 121°C 30 minutes See Dry Time in Table | Product Load and Maximum Weight | |----------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------|-------------------------------|---------------------------------|----------------------------------|------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Flexible Endoscope Tray, P/N 39401AS | Flexible Endoscope | Non-Lumen Only | | Note: Tray does not fit chamber | | | Note: Flexible endoscopes cannot be autoclaved | Note: Flexible endoscopes cannot be autoclaved | 1 flexible fiberscope 5.76 lbs. | | Flexible Endoscope Tray, P/N 39402AS | Flexible Endoscope | Non-Lumen Only | | ✓ | | ✓ | Note: Flexible endoscopes cannot be autoclaved | Note: Flexible endoscopes cannot be autoclaved | 1 flexible fiberscope 1 fiber optic light cable 8.18 lbs. | | Flexible Video Endoscope Tray, P/N 39403AS | Flexible CCD Video Endoscope | Non-Lumen Only | | ✓ | | ✓ | Note: Flexible video endoscopes cannot be autoclaved | Note: Flexible video endoscopes cannot be autoclaved | 1 flexible CCD video endoscope 5.28 lbs. | | Flexible Endoscope Tray, P/N 39406AS | Flexible CMOS Video Endoscope | Non-Lumen Only | | ✓ | | ✓ | Note: Flexible video endoscopes cannot be autoclaved | Note: Flexible video endoscopes cannot be autoclaved | 1 flexible CMOS video endoscope 5.23 lbs. | | Camera Trays P/N 39301HCTS P/N 39301PHTS P/N 39301BCTS | Non-autoclave-able camera heads | | ✓ | ✓ | | ✓ | Note: Steam is not indicated when used with non-autoclavable camera heads | Note: Steam is not indicated when used with non-autoclavable camera heads | 1 camera head 2.82 lbs. (HCTS) 2.64 lbs. (PHTS) 4.32 lbs. (BCTS) | | Camera Trays P/N 39301HCTS P/N 39301ACTS P/N 39301PHTS | Autoclave-able camera heads | | ✓ | ✓ | | ✓ | Minimum Dry Time 50 minutes | Minimum Dry Time 80 minutes | 1 camera head 2.82 lbs. (HCTS) 3.08 lbs. (ACTS) 2.64 lbs. (PHTS) | | Rigid Telescope Trays P/N 39301AS P/N 39301BS P/N 39301CS P/N 39301DS | Rigid Telescopes (Non-Lumen only) | | ✓ | ✓ | | ✓ | Minimum Dry Time 30 minutes | Minimum Dry Time 80 minutes | 2 Telescopes 2.71 lbs. (AS) 3.21 lbs. (CS) 3.71 lbs. (DS) 4 Telescopes 6.86 lbs. (BS) | | Rigid Telescope Tray P/N 39301C1S | Rigid Telescopes (Non-Lumen only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 1 rigid telescope 1 fiber optic cable 3.17 lbs. | | Rigid Telescope Trays P/N 39311AS P/N 39314FS | Rigid Telescopes (Non-Lumen only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 4 rigid telescopes 1 fiber optic cable 6.86 lbs. (AS) 8.12 lbs. (FS) | | Rigid Telescope Tray, P/N 39311BS | Rigid Telescopes (Non-Lumen Only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 2 rigid telescopes 1 fiber optic cable 4.9 lbs. | | Basket-Style Rigid Telescope Trays P/N 39305C1S P/N 39305C2S P/N 39305L1S P/N 39305L2S | Rigid Telescopes (Non-Lumen only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 1 rigid telescope 1.58 lbs (C1S) 1.58 lbs (L1S) 2 rigid telescopes 2.56 lbs. (C2S) 2.56 lbs. (L2S) | {4}------------------------------------------------ # 510(k) Summary - K201945 ## Date: February 24, 2021 | 1. | Submitted By: | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Ave. El Segundo, California 90245 424-218-8376 | |----|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | Contact: | David C. Furr Toscano Consulting Group, Inc. 8708 Capehart Cove Austin, Texas 78733 512-906-9654 | | 3. | Product: | KARL STORZ UDEL Sterilization Trays Product code: KCT - Class II (21 CFR 880.6850) | | 4. | Common/Classification Name: Predicate devices: | Sterilization wrap/container KARL STORZ- Endoscope Sterilization Trays K090818 Symmetry Medical Polyvac Surgical Instrument Delivery System K012105 | ## Description: The KARL STORZ UDEL Sterilization Trays are intended only for use to encase specific KARL STORZ reusable medical devices for sterilization in steam and specified STERRAD Sterilization System 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 specific KARL STORZ medical devices, such as fiber optic light cable, flexible endoscopes, and camera heads. Some of the trays are specifically molded to fit and accommodate KARL STORZ light cables, flexible endoscopes, camera heads and rigid telescopes, allowing the instruments to be arranged in an organized manner when placed in the tray. All systems consist of a Udel plastic base and Udel plastic lid. Lids are attached to the trays with assembled hardware. Baskets are injection molded and trays are thermoformed from Udel polysulfone polymer (sourced from Solvay Specialty Polymers), which is compatible with all indicated sterilization modes. The sterilization trays are constructed with a perforated lid and base to allow for permeation of sterilant during sterilization. Some of the tray configurations are simply molded into the form of a mesh. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone holders and mats (depending on the tray type) to secure instruments and provide protection of the medical devices in the sterilization tray. The holders and mats are manufactured from silicone material, which is also compatible with all sterilization modes. {5}------------------------------------------------ # Intended Use: The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated in the attached table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container. | Tray Name | Intended Content | STERRAD® 100S | STERRAD® NX | | STERRAD® 100NX | | Steam Pre-vacuum 132°C 4 minutes See Dry Time in Table | Steam Gravity Cycle 121°C 30 minutes See Dry Time in Table | Product Load and Maximum Weight | |-------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | | KARL STORZ Instruments Only | | Standard Cycle | Advanced Cycle | Standard Cycle | Flex Cycle | | | | | Flexible Endoscope Tray, P/N 39401AS | Flexible Endoscope | ✓ Non-Lumen Only | | Note: Tray does not fit chamber | | ✓ | Note: Flexible endoscopes cannot be autoclaved | Note: Flexible endoscopes cannot be autoclaved | 1 flexible fiberscope 5.76 lbs. | | Flexible Endoscope Tray, P/N 39402AS | Flexible Endoscope | ✓ Non-Lumen Only | | ✓ | | ✓ | Note: Flexible endoscopes cannot be autoclaved | Note: Flexible endoscopes cannot be autoclaved | 1 flexible fiberscope 1 fiber optic light cable 8.18 lbs. | | Flexible Video Endoscope Tray, P/N 39403AS | Flexible CCD Video Endoscope | ✓ Non-Lumen Only | | ✓ | | ✓ | Note: Flexible video endoscopes cannot be autoclaved | Note: Flexible video endoscopes cannot be autoclaved | 1 flexible CCD video endoscope 5.28 lbs. | | Flexible Endoscope Tray, P/N 39406AS | Flexible CMOS Video Endoscope | ✓ Non-Lumen Only | | ✓ | | ✓ | Note: Flexible video endoscopes cannot be autoclaved | Note: Flexible video endoscopes cannot be autoclaved | 1 flexible CMOS video endoscope 5.23 lbs. | | Camera Trays P/N 39301HCTS P/N 39301PHTS P/N 39301BCTS | Non- autoclave-able camera heads | ✓ | ✓ | ✓ | ✓ | ✓ | Note: Steam is not indicated when used with non- autoclavable camera heads | Note: Steam is not indicated when used with non- autoclavable camera heads | 1 camera head 2.82 lbs (HCTS) 2.64 lbs. (PHTS) 4.32 lbs. (BCTS) | | Camera Trays P/N 39301HCTS P/N 39301ACTS P/N 39301PHTS | Autoclave-able camera heads | ✓ | ✓ | ✓ | ✓ | ✓ | Minimum Dry Time 50 minutes | Minimum Dry Time 80 minutes | 1 camera head 2.82 lbs (HCTS) 3.08 lbs. (ACTS) 2.64 lbs. (PHTS) | | Rigid Telescope Trays P/N 39301AS P/N 39301BS P/N 39301CS P/N 39301DS | Rigid Telescopes (Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Minimum Dry Time 30 minutes | Minimum Dry Time 80 minutes | 2 Telescopes 2.71 lbs. (AS) 3.21 lbs. (CS) 3.71 lbs. (DS) 4 Telescopes 6.86 lbs. (BS) | | Rigid Telescope Tray P/N 39301C1S | Rigid Telescopes (Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 1 rigid telescope 1 fiber optic cable 3.17 lbs. | | Rigid Telescope Trays P/N 39311AS P/N 39314FS | Rigid Telescopes (Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 4 rigid telescopes 1 fiber optic cable 6.86 lbs. (AS) 8.12 lbs. (FS) | | Rigid Telescope Tray, P/N 39311BS | Rigid Telescopes (Non-Lumen Only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 2 rigid telescopes 1 fiber optic cable 4.9 lbs. | | Basket-Style Rigid Telescope Trays P/N 39305C1S P/N 39305C2S P/N 39305L1S P/N 39305L2S | Rigid Telescopes (Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 1 rigid telescope 1.58 lbs (C1S) 1.58 lbs (L1S) 2 rigid telescopes 2.56 lbs. (C2S) 2.56 lbs. (L2S) | {6}------------------------------------------------ ## Comparison of Technological Characteristics: The KARL STORZ UDEL Sterilization Trays are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal. The KARL STORZ UDEL Sterilization Trays are predicated on the original KARL STORZ Endoskope Sterilization Trays (K090818). Three of the devices, 39301HCTC, 39402AS and 39301BS, are identical to this predicate with the exception of additional indications. In addition the Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105) is included as a predicate for steam applications. Tray configurations and loads are the same as the devices which were included in KARL STORZ previous 510(k) K090818. Additional tray configurations have been added and validated based on comparison of worst-case vent to volume factors and load. Sterilant enters the KARL STORZ UDEL sterilization trays through perforations in the tray base and lid. After sterilization, sterility is maintained by an FDA cleared sterilization wrap. All of these characteristics are the same as the predicate devices. All trays including all the predicate devices are manufactured by the same supplier using the same manufacturing processes. {7}------------------------------------------------ | Element of Comparison | 510(k) Device: KARL STORZ UDEL Sterilization Trays | Predicate Device: KARL STORZ Endoskope Sterilization Trays (K090818) | Predicate Device: Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105) | Explanation of Differences | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation and Product Classification Code | 21 CFR 880.6850 KCT | 21 CFR 880.6850 KCT | 21 CFR 880.6850 KCT | None | | Indications for Use | The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated in the attached table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container. | The KARL STORZ Endoskope Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX sterilization systems as indicated. STERRAD Sterilization Systems are pre-set and cycle parameters cannot be adjusted. Table 1 provides sterilization compatibility for STERRAD Sterilization Cycles and max load with KARL STORZ- Endoskope Sterilization Trays & Instruments. (Table provided in IFU) | Polyvac's Delivery Systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization processing by allowing steam penetration and air removal, when used in conjunction with an approved sterilization wrap. Sterility of the enclosed medical devices maintained until used. Polyvac's Delivery Systems are to be sterilized in one of the following cycles: pre vacuum steam, 132°C 4 minutes minimum, gravity steam 132ºC 30 minutes minimum and gravity steam 121°C 55 minutes minimum. | The new system can be used for any of the three sterilization methods cited in the predicates. The new indications for use includes all three methods. | | Principal Material of Construction | Thermoformed or injection molded Udel Polysulfone | Thermoformed or injection molded Udel Polysulfone | Thermoformed Radel Polyphenylsulfone or aluminum | Udel trays are made from the identical material as the KARL STORZ predicate; Most Symmetry Medical predicates are made from Radel, a similarly performing polymer in steam cycles | | Element of Comparison | 510(k) Device: KARL STORZ UDEL Sterilization Trays | Predicate Device: KARL STORZ Endoskope Sterilization Trays (K090818) | Predicate Device: Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105) | Explanation of Differences | | KARL STORZ Model Numbers | 20 models • 39301PHTS • 39301HCTS • 39301ACTS • 39301BCTS • 39401AS • 39402AS • 39403AS • 39406AS • 39311BS • 39301DS • 39314FS • 39311AS • 39301C1S • 39301CS • 39301AS • 39301BS • 39305C1S • 39305C2S • 39305L1S • 39305L2S | 3 models • 39301HCTS • 39402AS • 39301BS | N/A | Additional models have been added for this submission. Symmetry Medical model numbers from previous submissions are not related. | | Dimensional Configuration Range | Approximate sizes available in inches (see product description chart Section 4.2 for exact dimensions by catalog number): • 15x10x2.5 • 27x7x4 • 21x10x4 • 21x10x3 • 26x4x3 • 20x9x4 • 13x9x2 • 21x3.5x2 • 12x3.5x2 • 17x3.5x2 • 19x4x9 | Approximate sizes available in inches: • 15x10x2.5 • 22x10x4 • 17x3.5x2 | Approximate sizes available in inches: • 7x2x1 • 7x3x1 • 8x4x1 • 11x7x1 • 21x10x4 • 17x10x4 • 17x8x2 • 15x10x1.5 • 20.5x9.7x5 • 20x10x3 • 26x9x6 • 17x3.5x1.5 • And others | 3 of the KARL STORZ trays are identical to the KARL STORZ predicate and the others fall into very similar size ranges. | | Device Manufacturer | Contract manufactured for KARL STORZ by Tecomet | Contract manufactured for KARL STORZ by Tecomet | Manufactured by Tecomet (formerly Symmetry Medical) | None. All trays are manufactured in the same location by Tecomet | | Sterilization Cycles | Prevacuum Steam 4 minute cycle 132°C, Gravity Steam 30 mins 121 °C STERRAD 100S, NX, and 100NX cycles | STERRAD 100S, NX, and 100NX cycles | Prevacuum Steam and Gravity Steam Cycles | Subject device can be used in the predicate device cycles as specified in the Indications. | | Load | Trays are to be loaded with specific KARL STORZ instruments | Trays are to be loaded with specific KARL STORZ instruments | Various loads up to 25 lbs. | KARL STORZ trays are used with specific instruments and Symmetry predicates are general | {8}------------------------------------------------ # 510(k) Premarket Notification {9}------------------------------------------------ Summary of Non-Clinical Testing: The following testing was conducted or is referenced to establish efficacy. Worst case tray configurations were used to represent all trays. | Type of Testing | Primary Standard(s) Used (as applicable) | Test Criteria and Result | |----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | STERRAD 100S sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL PASSED | | STERRAD NX standard and advanced cycle sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL PASSED | | STERRAD 100NX flex cycle sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL PASSED | | Pre-vacuum sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL PASSED | | 510(k) Premarket Notification KARL STORZ UDEL Sterilization Trays | | | | Type of Testing | Primary Standard(s) Used (as applicable) | Test Result | | Pre-vacuum dry time | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | Establish Minimum Dry Time ESTABLISHED | | Gravity sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL PASSED | | Gravity dry time | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | Establish Minimum Dry Time ESTABLISHED | | Manual Cleaning – Protein, Hemoglobin | AAMI TIR 30 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices | < 6.4 µg/cm2 protein and < 2.2 µg/cm2 hemoglobin on device after cleaning PASS | | Mechanical Cleaning - Protein, Hemoglobin | AAMI TIR 30 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices | < 6.4 µg/cm2 protein and < 2.2 µg/cm2 hemoglobin on device after cleaning PASS | | Material biocompatibility | ISO 10993 Biological Evaluation of Medical Devices | Cytotoxicity – No evidence of lysis PASS | | Material stability 200 STERRAD Cycles and 2100 Steam Cycles | Internal Protocols and AAMI TIR 12 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities | Material Maintains Integrity PASS | {10}------------------------------------------------ {11}------------------------------------------------ ## Conclusion: The conclusions drawn from the non-clinical tests demonstrate substantial equivalence in that the proposed device is as safe, as effective, and performed as well as or better than the legally marketed predicate devices.