(227 days)
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.
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.
The provided text describes the acceptance criteria and a summary of non-clinical testing for the KARL STORZ UDEL Sterilization Trays. The device is a medical device sterilization tray, and the testing focuses on its efficacy in various sterilization methods and its material stability.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Type of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (STERRAD 100S, STERRAD NX Standard & Advanced, STERRAD 100NX Flex, Pre-vacuum Steam, Gravity Steam) | 10^-6 Sterility Assurance Level (SAL) | PASSED |
| Pre-vacuum Dry Time | Establish Minimum Dry Time | ESTABLISHED |
| Gravity Dry Time | Establish Minimum Dry Time | ESTABLISHED |
| Manual Cleaning – Protein, Hemoglobin | < 6.4 µg/cm² protein and < 2.2 µg/cm² hemoglobin on device after cleaning | PASS |
| Mechanical Cleaning - Protein, Hemoglobin | < 6.4 µg/cm² protein and < 2.2 µg/cm² hemoglobin on device after cleaning | PASS |
| Material Biocompatibility | No evidence of lysis (Cytotoxicity) | PASS |
| Material Stability (200 STERRAD Cycles and 2100 Steam Cycles) | Material Maintains Integrity | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document generally refers to "worst case tray configurations" being used for testing. However, specific sample sizes for individual tests are not provided in the summary. The data provenance is not specified (e.g., country of origin, retrospective/prospective). The studies are "non-clinical testing" conducted to establish efficacy.
3. 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 information is not applicable to this type of device and study. The "ground truth" for sterilization efficacy is typically established through standardized biological indicators and laboratory analysis to determine the Sterility Assurance Level (SAL), not by human expert consensus in the way clinical diagnostic devices are evaluated. Similarly, for cleaning and material stability, the "ground truth" is determined by objective measurements against established chemical and physical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The testing described here involves objective laboratory measurements and adherence to standards.
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
An MRMC comparative effectiveness study is not applicable to this device. This device is a sterilization tray, not an AI-powered diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is not an algorithm or an AI system. Its performance is evaluated through its physical properties and interaction with sterilization processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests is derived from:
- Sterilization efficacy: Achieved Sterility Assurance Level (SAL) of 10^-6, which is an industry standard based on the inactivation of biological indicators. This is determined through microbiological testing.
- Cleaning efficacy: Quantitative measurements of residual protein and hemoglobin on the device surface after cleaning, compared against established limits in standards like AAMI TIR 30.
- Material stability: Assessment of the material's physical integrity after a specified number of sterilization cycles, likely through visual inspection, mechanical testing, or other material science methods, against an internal protocol and AAMI TIR 12.
- Dry time: Objective measurement of the time required for the device to be completely dry after sterilization.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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
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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)
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| Tray Name | Intended ContentKARL STORZ Instruments Only | STERRAD® 100S | STERRAD® NXStandard Cycle | STERRAD® NXAdvanced Cycle | STERRAD® 100NXStandard Cycle | STERRAD® 100NXFlex Cycle | SteamPre-vacuum 132°C 4 minutesSee Dry Time in Table | SteamGravity Cycle 121°C 30 minutesSee 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 fiberscope5.76 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 fiberscope1 fiber optic light cable8.18 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 endoscope5.28 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 endoscope5.23 lbs. | ||
| Camera TraysP/N 39301HCTSP/N 39301PHTSP/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 head2.82 lbs. (HCTS)2.64 lbs. (PHTS)4.32 lbs. (BCTS) | ||
| Camera TraysP/N 39301HCTSP/N 39301ACTSP/N 39301PHTS | Autoclave-able camera heads | ✓ | ✓ | ✓ | Minimum Dry Time 50 minutes | Minimum Dry Time 80 minutes | 1 camera head2.82 lbs. (HCTS)3.08 lbs. (ACTS)2.64 lbs. (PHTS) | ||
| Rigid Telescope TraysP/N 39301ASP/N 39301BSP/N 39301CSP/N 39301DS | Rigid Telescopes(Non-Lumen only) | ✓ | ✓ | ✓ | Minimum Dry Time 30 minutes | Minimum Dry Time 80 minutes | 2 Telescopes2.71 lbs. (AS)3.21 lbs. (CS)3.71 lbs. (DS)4 Telescopes6.86 lbs. (BS) | ||
| Rigid Telescope TrayP/N 39301C1S | Rigid Telescopes(Non-Lumen only) | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | 1 rigid telescope1 fiber optic cable3.17 lbs. | |||
| Rigid Telescope TraysP/N 39311ASP/N 39314FS | Rigid Telescopes(Non-Lumen only) | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | 4 rigid telescopes1 fiber optic cable6.86 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 telescopes1 fiber optic cable4.9 lbs. | |||
| Basket-Style Rigid Telescope TraysP/N 39305C1SP/N 39305C2SP/N 39305L1SP/N 39305L2S | Rigid Telescopes(Non-Lumen only) | ✓ | ✓ | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | 1 rigid telescope1.58 lbs (C1S)1.58 lbs (L1S)2 rigid telescopes2.56 lbs. (C2S)2.56 lbs. (L2S) |
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510(k) Summary - K201945
Date: February 24, 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 UDEL Sterilization TraysProduct code: KCT - Class II (21 CFR 880.6850) |
| 4. | Common/ClassificationName:Predicate devices: | Sterilization wrap/containerKARL STORZ- Endoscope Sterilization Trays K090818Symmetry 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.
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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 | IntendedContent | STERRAD®100S | STERRAD® NX | STERRAD®100NX | SteamPre-vacuum132°C 4 minutesSee Dry Time inTable | SteamGravity Cycle121°C 30minutesSee Dry Time inTable | Product Load andMaximum Weight | ||
|---|---|---|---|---|---|---|---|---|---|
| KARL STORZInstrumentsOnly | StandardCycle | AdvancedCycle | StandardCycle | FlexCycle | |||||
| Flexible EndoscopeTray,P/N 39401AS | FlexibleEndoscope | ✓Non-LumenOnly | Note: Traydoes not fitchamber | ✓ | Note:Flexible endoscopescannot be autoclaved | Note:Flexible endoscopescannot be autoclaved | 1 flexible fiberscope5.76 lbs. | ||
| Flexible EndoscopeTray, P/N 39402AS | FlexibleEndoscope | ✓Non-LumenOnly | ✓ | ✓ | Note:Flexible endoscopescannot be autoclaved | Note:Flexible endoscopescannot be autoclaved | 1 flexible fiberscope1 fiber optic lightcable8.18 lbs. | ||
| Flexible VideoEndoscope Tray,P/N 39403AS | Flexible CCDVideoEndoscope | ✓Non-LumenOnly | ✓ | ✓ | Note:Flexible videoendoscopes cannotbe autoclaved | Note:Flexible videoendoscopes cannotbe autoclaved | 1 flexible CCD videoendoscope5.28 lbs. | ||
| Flexible EndoscopeTray,P/N 39406AS | FlexibleCMOS VideoEndoscope | ✓Non-LumenOnly | ✓ | ✓ | Note:Flexible videoendoscopes cannotbe autoclaved | Note:Flexible videoendoscopes cannotbe autoclaved | 1 flexible CMOSvideo endoscope5.23 lbs. | ||
| Camera TraysP/N 39301HCTSP/N 39301PHTSP/N 39301BCTS | Non-autoclave-ablecamera heads | ✓ | ✓ | ✓ | ✓ | ✓ | Note: Steam is notindicated when usedwith non-autoclavable cameraheads | Note: Steam is notindicated when usedwith non-autoclavable cameraheads | 1 camera head2.82 lbs (HCTS)2.64 lbs. (PHTS)4.32 lbs. (BCTS) |
| Camera TraysP/N 39301HCTSP/N 39301ACTSP/N 39301PHTS | Autoclave-ablecamera heads | ✓ | ✓ | ✓ | ✓ | ✓ | Minimum Dry Time50 minutes | Minimum Dry Time 80minutes | 1 camera head2.82 lbs (HCTS)3.08 lbs. (ACTS)2.64 lbs. (PHTS) |
| Rigid TelescopeTraysP/N39301ASP/N39301BSP/N39301CSP/N 39301DS | RigidTelescopes(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Minimum Dry Time30 minutes | Minimum Dry Time 80minutes | 2 Telescopes2.71 lbs. (AS)3.21 lbs. (CS)3.71 lbs. (DS) 4Telescopes6.86 lbs. (BS) |
| Rigid TelescopeTrayP/N39301C1S | RigidTelescopes(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum OnlyMinimum Dry Time30 minutes | 1 rigid telescope 1fiber optic cable3.17 lbs. | |
| Rigid TelescopeTraysP/N 39311ASP/N 39314FS | RigidTelescopes(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum OnlyMinimum Dry Time30 minutes | 4 rigid telescopes 1fiber optic cable6.86 lbs. (AS)8.12 lbs. (FS) | |
| Rigid TelescopeTray,P/N 39311BS | RigidTelescopes(Non-LumenOnly) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum OnlyMinimum Dry Time30 minutes | 2 rigid telescopes1 fiber optic cable4.9 lbs. | |
| Basket-Style RigidTelescope TraysP/N 39305C1SP/N39305C2SP/N39305L1SP/N 39305L2S | RigidTelescopes(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum OnlyMinimum Dry Time30 minutes | 1 rigid telescope1.58 lbs (C1S)1.58 lbs (L1S)2 rigid telescopes2.56 lbs. (C2S)2.56 lbs. (L2S) |
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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.
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| Element ofComparison | 510(k) Device:KARL STORZ UDELSterilization Trays | Predicate Device:KARL STORZEndoskope SterilizationTrays (K090818) | Predicate Device:Symmetry Medical PolyvacSurgical InstrumentDelivery System(K012105) | Explanation of Differences |
|---|---|---|---|---|
| Regulationand ProductClassificationCode | 21 CFR 880.6850KCT | 21 CFR 880.6850KCT | 21 CFR 880.6850KCT | None |
| Indicationsfor Use | The KARL STORZUDEL Sterilization Traysare intended only for useto encase and protectspecific KARL STORZreusable medical devicesfor sterilization inSTERRAD and steamsterilization systems asindicated in the attachedtable. The system may beused with flexibleendoscopes with lumendiameters ≥ 1.2mm and amaximum length of845mm.KARL STORZ UDELSterilization Trays mustbe used in conjunctionwith an FDA clearedsterilization wrap orcontainer. | The KARL STORZEndoskope SterilizationTrays are intended onlyfor use to encase andprotect specific KARLSTORZ reusable medicaldevices for sterilization inSTERRAD 100S and NXsterilization systems asindicated. STERRADSterilization Systems arepre-set and cycleparameters cannot beadjusted. Table 1provides sterilizationcompatibility forSTERRAD SterilizationCycles and max load withKARL STORZ-Endoskope SterilizationTrays & Instruments.(Table provided in IFU) | Polyvac's Delivery Systemsconsist of perforated trayswith lids, which areintended to enclose andprotect medical deviceinstrumentation, and tofacilitate the sterilizationprocessing by allowingsteam penetration and airremoval, when used inconjunction with anapproved sterilization wrap.Sterility of the enclosedmedical devices maintaineduntil used. Polyvac'sDelivery Systems are to besterilized in one of thefollowing cycles: prevacuum steam, 132°C 4minutes minimum, gravitysteam 132ºC 30 minutesminimum and gravity steam121°C 55 minutesminimum. | The new system can be used forany of the three sterilizationmethods cited in the predicates.The new indications for useincludes all three methods. |
| PrincipalMaterial ofConstruction | Thermoformed orinjection molded UdelPolysulfone | Thermoformed orinjection molded UdelPolysulfone | Thermoformed RadelPolyphenylsulfone oraluminum | Udel trays are made from theidentical material as the KARLSTORZ predicate; MostSymmetry Medical predicates aremade from Radel, a similarlyperforming polymer in steamcycles |
| Element ofComparison | 510(k) Device:KARL STORZUDELSterilization Trays | Predicate Device:KARL STORZEndoskope SterilizationTrays (K090818) | Predicate Device:Symmetry Medical PolyvacSurgical InstrumentDelivery System(K012105) | Explanation of Differences |
| KARLSTORZModelNumbers | 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 beenadded for this submission.Symmetry Medical modelnumbers from previoussubmissions are not related. |
| DimensionalConfigurationRange | Approximate sizesavailable in inches (seeproduct description chartSection 4.2 for exactdimensions by catalognumber):• 15x10x2.5• 27x7x4• 21x10x4• 21x10x3• 26x4x3• 20x9x4• 13x9x2• 21x3.5x2• 12x3.5x2• 17x3.5x2• 19x4x9 | Approximate sizesavailable in inches:• 15x10x2.5• 22x10x4• 17x3.5x2 | Approximate sizesavailable 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 areidentical to the KARL STORZpredicate and the others fall intovery similar size ranges. |
| DeviceManufacturer | Contract manufacturedfor KARL STORZ byTecomet | Contract manufacturedfor KARL STORZ byTecomet | Manufactured by Tecomet(formerly SymmetryMedical) | None. All trays are manufacturedin the same location by Tecomet |
| SterilizationCycles | Prevacuum Steam4 minute cycle 132°C,Gravity Steam 30 mins121 °CSTERRAD 100S, NX,and 100NX cycles | STERRAD 100S, NX,and 100NX cycles | Prevacuum Steam andGravity Steam Cycles | Subject device can be used in thepredicate device cycles asspecified in the Indications. |
| Load | Trays are to be loadedwith specific KARLSTORZ instruments | Trays are to be loadedwith specific KARLSTORZ instruments | Various loads up to 25 lbs. | KARL STORZ trays are used withspecific instruments andSymmetry predicates are general |
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510(k) Premarket Notification
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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 Criteriaand Result |
|---|---|---|
| STERRAD 100S sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device SterilizationISO 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 SALPASSED |
| STERRAD NX standard and advanced cycle sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device SterilizationISO 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 SALPASSED |
| STERRAD 100NX flex cycle sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device SterilizationISO 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 SALPASSED |
| Pre-vacuum sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device SterilizationISO 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 SALPASSED |
| 510(k) Premarket NotificationKARL STORZ UDEL Sterilization Trays | ||
| Type of Testing | Primary Standard(s) Used(as applicable) | Test Result |
| Pre-vacuum dry time | AAMI 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 | EstablishMinimum DryTimeESTABLISHED |
| Gravity sterilization efficacy | AAMI 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 | 10-6 SALPASSED |
| Gravity dry time | AAMI 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 | EstablishMinimum DryTimeESTABLISHED |
| Manual Cleaning – Protein,Hemoglobin | AAMI TIR 30 A Compendium ofProcesses, Materials, Test Methods, andAcceptance Criteria for CleaningReusable Medical Devices | < 6.4 µg/cm2protein and< 2.2 µg/cm2hemoglobin ondevice aftercleaningPASS |
| Mechanical Cleaning - Protein,Hemoglobin | AAMI TIR 30 A Compendium ofProcesses, Materials, Test Methods, andAcceptance Criteria for CleaningReusable Medical Devices | < 6.4 µg/cm2protein and< 2.2 µg/cm2hemoglobin ondevice aftercleaningPASS |
| Material biocompatibility | ISO 10993 Biological Evaluation ofMedical Devices | Cytotoxicity –No evidence oflysisPASS |
| Material stability 200 STERRADCycles and 2100 Steam Cycles | Internal Protocols and AAMI TIR 12Designing, Testing, and LabelingReusable Medical Devices forReprocessing in Health Care Facilities | MaterialMaintainsIntegrityPASS |
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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.
§ 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).