(433 days)
The Sterisystem Dry-Base Instrument Tray is intended to protect surgical instruments 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.
The alone trays are not intended to maintain sterlity; they are intended to be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature: 132C (270F) Sterilization Time: 4 minutes Drying time: 30 minutes Maximum Weight: Up to 25lbs depending on the weight limit of the cleared sterilization wrap used.
Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.
The Sterisystem Dry-Base Instrument Trays are reusable sterilization trays. The trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be 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 trays and lids, available in various sizes. All trays are constructed of stainless steel metal meshbase and the lid are constructed of stainless steel and silicone. The tray and lid designs have a higher percentage of open cells than metal mesh allowing for complete permeation of sterilant. The trays have latches designed to fasten the lid onto the base.
This document describes the validation of the Sterisystem Dry-Base Instrument Tray for its intended use, which is to protect surgical instruments and facilitate sterilization when used with an FDA-cleared sterilization wrap.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Effectiveness: Destruction of Geobacillus stearothermophilus spores on biological indicators (BIs) with 100 spores after a 132°C pre-vacuum steam autoclave half cycle exposure. | All biological indicator test samples were negative for growth following the incubation period. Positive controls showed growth, and negative/environmental controls were negative for growth. Integrators demonstrated steam penetration. |
| Drying Time: Device should be dry after the specified drying period. | Drying time was evaluated after sterilization and determined to be 30 minutes. |
| Sterility Maintenance (with wrap): Maintain sterility of enclosed medical devices with an FDA-cleared sterilization wrap for a specified duration. | Maintenance of sterility was evaluated on the subject device with a cleared sterilization wrap for 30 days. (Specific results beyond "evaluated" are not detailed in the provided text, but the conclusion states "perform as well as or better than the legally marketed predicate device"). |
| Cleaning Effectiveness: Manual and automated cleaning methods remove soil from all designated surfaces. | The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the subject device. |
| Biocompatibility: Materials used in construction meet acceptable cytotoxicity levels. | Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels per ISO 10993. |
| Life Cycle Performance: Device maintains functional quality, material integrity, and traceability after repeated sterilization, washing, and simulated use. | All results of performance testing met acceptance criteria (after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles, and simulated functional use of the components). |
| Maximum Weight Capacity | Up to 25lbs (validated, depending on the weight limit of the cleared sterilization wrap used). |
2. Sample Size for the Test Set and Data Provenance:
-
Sterilization Effectiveness: The study evaluated "Each sterilization wrap and tray tested." This implies a sample size of at least one of each configuration of the Sterisystem Dry-Base Instrument Tray in conjunction with a sterilization wrap. The precise number of trays and wraps tested is not explicitly stated as a single numeric value in the provided text.
-
30 Day Storage: "Maintenance of sterility was however evaluated on the subject device with a cleared sterilization for 30 days." Similar to sterilization effectiveness, the precise number of samples is not explicitly given.
-
Cleaning Validation: "A manual and automated cleaning validation was performed." The number of devices subjected to this validation is not specified.
-
Biocompatibility: "Biocompatibility testing was conducted on all materials used in construction of the subject device." The number of test articles or samples is not specified beyond "all materials."
-
Life Cycle Testing: "Life cycle testing was performed." The number of cycles and devices tested is not specified.
-
Data Provenance: The document does not specify the country of origin but implies that the tests were conducted by or on behalf of O&M Halyard, Inc. (Alpharetta, Georgia, USA). The studies appear to be prospective as they are specifically conducted to validate the performance of the device before market clearance.
3. Number of Experts and Qualifications:
The document does not mention the use of human experts to establish ground truth for the performance tests conducted (sterilization, cleaning, biocompatibility, life cycle). These tests typically rely on laboratory-based, objective measurements and established standards (e.g., Geobacillus stearothermophilus growth, chemical residue levels, cell lysis).
4. Adjudication Method:
Not applicable, as the evaluation methods are laboratory-based and objective, rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation of images or data is involved and the intent is to show how the device aids human readers. The Sterisystem Dry-Base Instrument Tray is a sterilization accessory, not a diagnostic device.
6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was effectively done for the critical functions of the device. The various tests (sterilization efficacy, drying time, cleaning, biocompatibility, life cycle) determined the inherent performance characteristics of the physical device itself. The device's function is mechanical and chemical (facilitating sterilization), not based on an algorithm or human-in-the-loop diagnostic process.
7. Type of Ground Truth Used:
The ground truth used for the acceptance criteria and performance evaluation is primarily objective laboratory measurements and established scientific standards:
- Microbiological assays: For sterilization effectiveness (e.g., absence of Geobacillus stearothermophilus growth).
- Physical measurements/observations: For drying time, material integrity (life cycle testing), visual cleanliness (cleaning validation).
- Chemical/biological assays: For cleaning validation (residue levels) and biocompatibility (cell lysis, reactivity).
- Pre-defined acceptance limits: For all quantitative measures based on regulatory standards (e.g., ISO 10993 for biocompatibility) and industry best practices for sterilization.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product (a sterilization tray), not an artificial intelligence or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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.
January 2, 2021
O&M Halyard, Inc Steven Dowdley Associate Director of Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K203177
Trade/Device Name: Sterisystem Dry-Base Instrument Tray Regulation Number: 21 CFR 880.6250 Regulation Name: Sterilization Tray Regulatory Class: Class II Product Code: KCT Dated: November 12, 2021 Received: November 12, 2021
Dear Steven Dowdley:
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
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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, 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
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Indications for Use
510(k) Number (if known) K203177
Device Name
Sterisystem Dry-Base Instrument Tray
Indications for Use (Describe)
The Sterisystem Dry-Base Instrument Tray is intended to protect surgical instruments 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.
The alone trays are not intended to maintain sterlity; they are intended to be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature: 132C (270F) Sterilization Time: 4 minutes Drying time: 30 minutes Maximum Weight: Up to 25lbs depending on the weight limit of the cleared sterilization wrap used.
Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.
| Code | Configuration Description | Dimension Description (inches) | Quantity |
|---|---|---|---|
| 47413 | Low/Small Size Tray only | (4 3/4 x 9 13/16 x 2 1/2) | 12 |
| 47414 | Low/Mid Size Tray only | (9 7/16 x 9 13/16 x 2 1/2) | 12 |
| 47914 | Low/Small Size Lid & Tray | (5 3/4 x 10 1/8 x 2 7/8) | 1 |
| 47915 | Low/Full Size Lid & Tray | (19 11/64 x 10 1/8 x 2 7/8) | 1 |
| 47916 | High/Full Size Lid & Tray | (19 11/64 x 10 1/8 x 4 3/8) | 1 |
| 47416 | Low/Full Size Tray only | (18 7/8 x 9 13/16 x 2 1/2) | 6 |
| 47917 | Low/Small Size Lid & Tray | (5 3/64 x 12 3/12 x 2 7/8) | 1 |
| 47417 | High/Mid Size Tray only | (9 7/16 x 9 13/16 x 3 15/16) | 6 |
| 47918 | Low/Mid Size Lid & Tray | (9 49/64 x 12 3/12 x 2 7/8) | 1 |
| 47418 | High/Full Size Tray only | (18 7/8 x 9 13/16 x 3 15/16) | 6 |
| 47919 | Low/Full Size Lid & Tray | (19 11/64 x 12 3/12 x 2 7/8) | 1 |
| 47419 | Low/Small Size Tray only | (4 3/4 x 11 13/16 x 2 1/2) | 12 |
| 47920 | Low/Mid Size Lid & Tray | (9 49/64 x 10 1/8 x 2 7/8) | 1 |
| 47921 | High/Mid Size Lid & Tray | (9 49/64 x 10 1/8 x 4 3/8) | 1 |
| 47922 | Low/Large Size Lid & Tray | (14 31/64 x 10 1/8 x 2 7/8) | 1 |
| 47426 | Low/Full Size Tray only | (18 7/8 x 11 13/16 x 2 1/2) | 6 |
| 47425 | Low/Mid Size Tray only | (9 7/16 x 11 13/16 x 2 1/2) | 12 |
| 47428 | Small Size Lid | (4 3/4 x 9 13/16 x 13/16) | 6 |
| 47429 | Full Size Lid | (18 7/8 x 9 13/16 x 13/16) | 6 |
| 47430 | Small Size Lid | (4 3/4 x 11 13/16 x 13/16) | 6 |
| 47431 | Mid Size Lid | (9 7/16 x 11 13/16 x 13/16) | 6 |
| 47432 | Full Size Lid | (18 7/8 x 11 13/16 x 13/16) | 6 |
| 47442 | Mid Size Lid | (9 7/16 x 9 13/16 x 13/16) | 6 |
FORM FDA 3881 (7/17)
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Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K203177
510(k) Summary - Sterisystem Dry-Base Instrument Tray
In accordance with 21 CFR 807.92, the following 510(k) summary is provided:
| Date Summary was Prepared | November 5, 2021 |
|---|---|
| 510(k) Submitter: | O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 |
| Primary Contact forthis 510(k) Submission: | Steven Dowdley, RACTel: 678-451-8062Email: steven.dowdley@hyh.com |
| Device Trade Name: | Sterisystem Dry-Base Instrument Tray |
| Device Common Name: | Sterilization Tray |
| Device Product Codeand Classification Name: | KCTClass II, 21 CFR §880.6850 |
| Predicate Device: | Smith & Nephew Multi Purpose Instrument Tray (K102122) |
| Subject Device Description: | The Sterisystem Dry-Base Instrument Trays are reusable sterilization trays.The trays are not intended to maintain sterility by themselves. Priorto sterilization, the trays must be wrapped with an appropriate FDA-clearedsterilization wrap to provide a microbial barrier which allows sterilant topermeate throughout the interior of the loaded tray.The tray configurations are all trays and lids, available in various sizes. Alltrays are constructed of stainless steel metal meshbase and the lid areconstructed of stainless steel and silicone. The tray and lid designs have ahigher percentage of open cells than metal mesh allowing for completepermeation of sterilant. The trays have latches designed to fasten the lid ontothe base. |
| Indications for Use: | The Sterisystem Dry-Base Instrument Tray are intended to protect medicaldevice instrumentation and facilitate the sterilization process by sterilantpenetration and air removal. When used in conjunction with an FDA clearedsterilization wrap, sterility of the enclosed medical device is maintained untilused.The system has been validated for the use in the following sterilization cycle:Pre-Vacuum SteamTemperature132°C (270°F)Sterilization Time4 minutesDrying time30Maximum Tray WeightUp to 25lbs depending on theweight limit of the clearedsterilization wrap used. |
| Pre-Vacuum sterilized devices may be stored in a protective storage for up to30 days provided integrity of the container is not comprised. |
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Technological Characteristics
Shown below is a comparison of the technological and performance characteristics of the subject and predicate device.
| Subject Device | Predicate Device K102122 | Comparison | |
|---|---|---|---|
| FDA Product Code: | KCT | KCT | Same |
| FDA Classification: | Class II | Class II | Same |
| RegulationNumber: | 880.6250 | 880.6250 | Same |
| Common Name: | Sterilization Tray | Sterilization Tray | Same |
| Intended Use | The Sterisystem Dry-Base InstrumentTray are intended to protect medicaldevice instrumentation and facilitate thesterilization process by sterilantpenetration and air removal. When usedin conjunction with an FDA clearedsterilization wrap, sterility of the enclosedmedical device is maintained until used.The system has been validated for theuse in the following pre-vacuum steamsterilization cycle:Pre-Vacuum SteamTemperature 132°C (270°F)Sterilization Time 4 minutesDrying time 30 minutesMaximum Weight 25lbsPre-Vacuum sterilized devices may bestored in a protective storage for up to 30days provided integrity of the container isnot comprised. The maximum weightload is 25lbs.(See IFU for table of part numbers &contents) | Smith & Nephew Multi-Purpose Sterilization trays areintended to contain Smith &Nephew reusable surgicalinstruments for convenientorganized storage, sterilizationand transport between usages.The subject instrument traysare suitable for use in aprevacuum steamsterilization method.The subject instrument traysare not intended to maintainsterility; they are intended tobe used in conjunction with anFDA cleared sterilization wrapin order tomaintain sterility of theenclosed devicesMethod: Pre-vacuum steamTemp: 132 - 135CExposure 4 minutesDrying Time: 30 minutes | Same |
| Models | 47413 Low/Small Size Tray only(4 3/4 x 9 13/16 x 2 1/2)47414 Low/Mid Size Tray only(9 7/16 x 9 13/16 x 2 1/2)47914 Low/Small Size Lid & Tray(5 3/4 x 10 1/8 x 2 7/8)47915 Low/Full Size Lid & Tray | Not listed | Different |
| Composition: | Stainless steel, Silicone | Stainless steel/ Silicone | Similar |
| 47916 High/Full Size Lid & Tray(19 11/64 x 10 1/8 x 4 3/8) | |||
| 47416 Low/Full Size Tray only(18 7/8 x 9 13/16 x 2 1/2) | |||
| 47917 Low/Small Size Lid & Tray(5 3/64 x 12 3/12 x 2 7/8) | |||
| 47417 High/Mid Size Tray only(9 7/16 x 9 13/16 x 3 15/16) | |||
| 47918 Low/Mid Size Lid & Tray(9 49/64 x 12 3/12 x 2 7/8) | |||
| 47418 High/Full Size Tray only(18 7/8 x 9 13/16 x 3 15/16) | |||
| 47919 Low/Full Size Lid & Tray(19 11/64 x 12 3/12 x 2 7/8) | |||
| 47419 Low/Small Size Tray only(4 3/4 x 11 13/16 x 2 1/2) | |||
| 47920 Low/Mid Size Lid & Tray(9 49/64 x 10 1/8 x 2 7/8) | |||
| 47921 High/Mid Size Lid & Tray(9 49/64 x 10 1/8 x 4 3/8) | |||
| 47922 Low/Large Size Lid & Tray(14 31/64 x 10 1/8 x 2 7/8) | |||
| 47426 Low/Full Size Tray only(18 7/8 x 11 13/16 x 2 1/2) | |||
| 47425 Low/Mid Size Tray only(9 7/16 x 11 13/16 x 2 1/2) | |||
| 47428 Small Size Lid(4 3/4 x 9 13/16 x 13/16) | |||
| 47429 Full Size Lid(18 7/8 x 9 13/16 x 13/16) | |||
| 47430 Small Size Lid(4 3/4 x 11 13/16 x 13/16) | |||
| 47431 Mid Size Lid(9 7/16 x 11 13/16 x 13/16) | |||
| 47432 Full Size Lid(18 7/8 x 11 13/16 x 13/16) | |||
| 47442 Mid Size Lid(9 7/16 x 9 13/16 x 13/16) | |||
| Image: Stainless steel tray with green silicone corners | |||
| Image: Stainless steel tray with holes and orange writing | |||
| Reuse | Reusable device | Reusable device | Same |
| Sterilization: | Steam Sterilization | Steam Sterilization | Same |
| Material ofconstruction | Stainless Steel and silicone | Stainless Steel and silicone | Same |
| Design: | Perforated design | Perforated design | Same |
| Re-useable: | Reusable | Reusable | Same |
| Drying time: | 30 minutes | 30 minutes | Same |
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Non-Clinical Performance Testing:
Sterilization Effectiveness
Sterilization validations were performed to verify the effectiveness of steam sterilization of the Sterisystem Dry-Base Instrument Tray using a pre-vacuum cycle. The study evaluated the resistance of biological indicators (Bls) with 100 Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half cycle exposures.
For each sterilization wrap and tray tested:
- All biological indicator test samples were negative for growth following the incubation period. .
- The positive controls were positive for growth. ●
- . The negative and environmental controls were neqative for growth.
- The integrators demonstrated steam penetration. .
Dry time was also evaluated after sterilization and determined to be 30 minutes.
30 Dav Storage
The subject device is not intended to maintain sterilization tray is intended to be used in conjunction with an FDA cleared sterlization wrap in order to maintain sterility of the enclosed device. Maintenance of sterility was however evaluated on the subject device with a cleared sterilization for 30 days.
Cleaning Validation
A manual and automated cleaning validation was performed to validate the cleaning instructions. The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the of the subject device.
Biocompatibility
Biocompatibility testing was conducted on all materials used in construction of the subject device per ISO 10993. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels.
Life Cycle Testing
Life cycle testing was performed to verify that the device maintained functional quality requirements, material integrity, and traceability after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use of the components. All results of performance testing met acceptance criteria
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Sterisystem Dry-Base Instrument Tray is as safe, as effective and perform as well as or better than the legally marketed predicate device cleared under K102122
§ 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).