Who is the manufacturer of KARL STORZ Metal Sterilization Trays?

Karl Storz Endoscopy America, Inc. filed the 510(k) submission for KARL STORZ Metal Sterilization Trays (K203198).

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

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

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

K203198 · Karl Storz Endoscopy America, Inc. · KCT · Jul 6, 2021 · General Hospital

Device Facts

Record ID	K203198
Device Name	KARL STORZ Metal Sterilization Trays
Applicant	Karl Storz Endoscopy America, Inc.
Product Code	KCT · General Hospital
Decision Date	Jul 6, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time). When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used.

Device Story

Device consists of stainless steel metal mesh trays and lids designed to hold and protect KARL STORZ reusable medical instruments during steam sterilization. Trays feature silicone instrument holders and mesh construction to facilitate sterilant penetration and air removal. Used in clinical settings by healthcare personnel. Trays are not self-contained sterile barriers; must be double-wrapped with FDA-cleared sterilization wrap to maintain sterility post-process. Output is a sterilized, protected instrument set ready for clinical use. Benefits include organized, secure transport and effective sterilization of delicate surgical instruments.

Clinical Evidence

Bench testing only. Testing included pre-vacuum sterilization efficacy (AAMI ST77, ISO 17665-1) achieving 10^-6 SAL, dry time validation (20 minutes), manual and mechanical cleaning validation (AAMI TIR 30) for protein (< 6.4 µg/cm²) and hemoglobin (< 2.2 µg/cm²) residues, and in vitro cytotoxicity (ISO 10993-5).

Technological Characteristics

Stainless steel metal mesh construction. Dimensions range from 7"x5.31"x1.46" to 26.3"x3.1"x2". Features silicone instrument holders. Sterilization via pre-vacuum steam (132ºC). No software or electronic components.

Indications for Use

Indicated for use to encase and protect specific KARL STORZ reusable medical devices (probes, dilators, telescopes, light cables, laryngoscope blades) during pre-vacuum steam sterilization (132ºC, 4 min, 20 min dry time). Validated for devices with working channels ≥ 0.2mm and max length 240mm.

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

Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105)

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Submission Summary (Full Text)

{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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. July 6, 2021 Karl Storz Endoscopy America Inc % David Furr Consultant Toscano Consulting 8708 Capehart Cove Austin, Texas 78733 Re: K203198 Trade/Device Name: KARL STORZ Metal Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 26, 2021 Received: June 1, 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, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203198 Device Name KARL STORZ Metal Sterilization Trays #### Indications for Use (Describe) The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time). When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used. The system has been validated with devices with working channels ≥ 0.2mm and a maximum length of 240mm. Intended Load & Maximum Weight Trav Catalog Number Dimensions | 11580A | 7"x5.31"x1.46" | Sterilization of probes and dilators 1lb. (Karl Storz Instruments Only) | |----------|-------------------|-------------------------------------------------------------------------| | 11580B | 10.8"x6.9"x1.46" | Telescope sterilization tray 2.4lbs. | | 11580C | 13.5"x7"x1.38" | Telescope sterilization tray 5lbs. | | 11580D | 10.8"x6.9"x1.46" | Telescope sterilization tray 2.75lbs. | | 39501A1 | 11.4"x2.36"x2" | Cleaning/sterilization basket: Rigid scope 1.25lbs. | | 39501A2 | 13.9"x4.92"x2.13" | Cleaning/sterilization basket: 2 rigid scopes and LT cable 3.75lbs. | | 39501B2 | 19"x4.9"x2.1" | Cleaning/Sterilization basket; 2 rigid scopes/1 LT cable 5lbs. | | 39501BEC | 18.9"x4.9"x2.1" | Cleaning/sterilization basket: Scope & LT cable 3lbs | | 39501C | 26.3"x3.1"x2" | Cleaning/sterilization basket for telescopes up to 670mm 2.5lbs | | 39501CEC | 23.8"x4.9"x2.1" | Cleaning/sterilization basket: Scope & LT cable 3lbs | | 39501F | 22.4"x3.15x2.05" | Cleaning/sterilization basket: Rigid endoscope 3.5lbs. | | 39501LC2 | 10.24"x4.72"x6.7" | Cleaning/sterilization basket: Laryngoscope blades and module 3.2lbs | | 39501X | 25.3"x5.9"x3.1" | Cleaning/sterilization basket for telescopes up to 43cm 2.4lbs | | 39501XK | 18.11"x5.9"x3.15" | Cleaning/sterilization basket: telescopes 2.4lbs | | 39501XP | 18.11"x5.9"x3.15" | Cleaning/Sterilization basket for telescopes 2.4lbs | | 39550A | 18.9"x9.84"x2.36" | Cleaning/Sterilization basket: shaver and cable 3.25lbs. | l ype of Use elect 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary Pursuant to 21 CFR 807.92 K203198 ### Date: May 26, 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 8708 Capehart Cove Austin, Texas 78733 512-906-9654 | | 3. | Product: | KARL STORZ Sterilization Trays- Metal K203198 Product code: KCT - Class II (21 CFR 880.6850) | | 4. | Common/Classification Name: Predicate devices: | Sterilization wrap/container Symmetry Medical Polyvac Surgical Instrument Delivery System K012105 | Description: The KARL STORZ-ENDOSCOPE Metal 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 are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware. The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray. {5}------------------------------------------------ #### 510(k) Premarket Notification KARL STORZ Sterilization Travs- Metal #### Intended Use: The KARL STORZ Metal Sterilization Trays are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. KARL STORZ has validated the KARL STORZ Metal Sterilization Trays for use in steam sterilizers. Most of the metal sterilization trays are used with rigid telescopes, instruments and cables that do not have lumens. The system was validated with a miniature scope with an irrigation channel lumen diameter of 0.2mm and a length of 240mm. #### Comparison of Technological Characteristics: The KARL STORZ Metal Sterilization Trays are comparable to Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105). The Symmetry Medical system also includes plastic and hybrid trays however only the Symmetry Medical metal tray are considered as a predicate. Steam enters the KARL STORZ metal sterilization trays through mesh openings in the tray base and lid. After sterilization, sterility is maintained by the FDA cleared sterilization wrap. All of these characteristics are the same as the predicate device. The devices and the predicate have essentially the same indications for use and perform in a similar manner. | Element of Comparison | 510(k) Device: KARL STORZ Metal Sterilization Trays | 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 | None | | Indications for Use | The KARL STORZ Metal 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 for four minutes with a 20 minute dry time). When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. | 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 | Similar | {6}------------------------------------------------ # | | The system has been validated with devices with working channels $\geq$ 0.2mm and a maximum length of 240mm. (See IFU for table of part numbers & contents) | 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 132°C 30 minutes minimum and gravity steam 121°C 55 minutes minimum. | | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Principal Material of Construction | Stainless steel metal mesh | Thermoformed Radel Polyphenylsulfone, stainless steel or aluminum | Different | {7}------------------------------------------------ # | KARL STORZ Model Numbers | 16 models 11580A 11580B 11580C 11580D 39501A1 39501A2 39501B2 39501BEC 39501C 39501CEC 39501F 39501LC2 39501X 39501XK 39501XP 39550A | N/A | Different | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Dimensional Configuration Range | Sizes available in inches: 7"x5.31"x1.46" 10.8"x6.9"x1.46" 13.5"x7"x1.38" 10.8"x6.9"x1.46" 11.4"x2.36"x2" 13.9"x4.92"x2.13" 19"x4.9"x2.1" 18.9"x4.9"x2.1" 26.3"x3.1"x2" 23.8"x4.9"x2.1" 22.4"x3.15x2.05" 10.24"x4.72"x6.7" 25.3"x5.9"x3.1" 18.11"x5.9"x3.15" 18.11"x5.9"x3.15" 18.9"x9.84"x2.36" | Approximate sizes available in inches: 7x2x1 7x3x1 8x4x1 11x7x1 21x10x4 17x10x4 17x8x2 15x10x1.5 20.5x9.7x5 20x10x3 26x9x6 17x3.5x1.5 And others | Similar | | Device Manufacturer | Contract manufactured for KARL STORZ by Helmut Zepf Medizintechnik GmbH and HUPFER Metallwerke GmbH | Manufactured by Tecomet (formerly Symmetry Medical) | Different | | Sterilization Cycles | Prevacuum Steam 4 minute cycle 132°C Drying time 20 minutes | Prevacuum Steam 4 minute cycle 132°C 20- 40 minutes drying time; gravity steam 132°C for 30 minutes or 121°C for 55 minutes 20-50 minutes drying time | Similiar | | Load | Trays are to be loaded with KARL STORZ instruments | Various loads up to 25 lbs. | KARL STORZ trays are used with KARL STORZ instruments with a total load of <5 lbs. | {8}------------------------------------------------ #### 5 10(k) Premarket Notification KARL STORZ Sterilization Trays- Metal ## 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 | Acceptance Criteria | Result | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------|-------------------------------| | 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 | Demonstrate sterilization capabilities. | 10-6 SAL | PASSED | | 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 | To establish minimum dry time. | Pre and Post Sterilization weight difference <3% after drying | PASSED 20 minutes dry time | {9}------------------------------------------------ #### 5 10(k) Premarket Notification KARL STORZ Sterilization Trays- Metal | Manual Cleaning - Protein, Hemoglobin AAMI TIR 30 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices | To demonstrate manual cleaning | < 6.4 $\mu g/cm^2$ protein and < 2.2 $\mu g/cm^2$ 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 | To demonstrate mechanical cleaning | < 6.4 $\mu g/cm^2$ protein and < 2.2 $\mu g/cm^2$ hemoglobin on device after cleaning | PASS | | Material biocompatibility ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity | To demonstrate no Cytotoxic properties | Cytotoxicity No evidence of lysis | PASS | ## Conclusion: The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performed as well as or better than the legally marketed predicate devices.