(270 days)
The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes
The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.
The Synthes Graphic Case & Tray System is a medical device intended for storing, organizing, and transporting orthopedic instruments and implants during sterilization and surgical procedures. It is designed to be used with an FDA-cleared sterile barrier. The device's performance was evaluated through non-clinical testing.
Here's a breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy with FDA cleared sterilization wrap | Validation for the efficacy of the dynamic air removal steam sterilization process in attaining a sterility assurance level (SAL) of 10-6 via the overkill method using a half cycle for the Synthes Graphic Case and Tray System when processed in two layers of blue sterilization wrap. | All biological indicator test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved. | Pass, all acceptance criteria met. Each product BI test location was negative for growth. Each positive control BI type was positive for growth. Each negative and environmental control BI type was negative for growth. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved. |
| Sterilization Efficacy with FDA cleared rigid sterilization container | Validation for the efficacy of the dynamic air removal steam sterilization process in attaining a sterility assurance level (SAL) of 10-6 via the overkill method using a half cycle for the Synthes Graphic Case and Tray System when processed in a rigid sterilization container. | All biological indicator (BI) test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved. | Pass, all acceptance criteria met. Each product BI test location was negative for growth. Each positive control BI type was positive for growth. Each negative and environmental control BI type was negative for growth. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved. |
| Dry Time and Thermal Profiling with FDA cleared sterilization wrap | Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in two layers of blue sterilization wrap. | The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle. | Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: -0.085%, Cycle 2: 0.093%, Cycle 3: 0.062%. No visible moisture was present. Temperature sensors remained in position. F0 results of >12.0 achieved for Cycle 1, 2, and 3 for all locations. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified cycle parameters. |
| Dry Time and Thermal Profiling with FDA cleared rigid sterilization container | Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in a rigid sterilization container. | The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle. | Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: 0.00%, Cycle 2: 0.00%, Cycle 3: 0.00%, Cycle 4: 0.00%, Cycle 5: 0.00%, Cycle 6: 0.00%. No visible moisture was present. Temperature sensors remained in position. F0 results of >12.0 achieved for all cycles and locations. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified cycle parameters. |
| Cleaning (Manual) | To validate the manual cleaning method for device challenge features, using clinically relevant soil and worst-case process parameters, and analyzed for protein and hemoglobin. | The extraction efficiency shall be greater than or equal to 70%. Test samples show no visible soil after cleaning. The overall result of the protein analyte test is a level of < 6.4µg / cm². The overall result of the hemoglobin analyte test is a level of < 2.2µg / cm². | The extraction efficiency was greater than or equal to 70% at each sample location. There was no visible soil after cleaning. For all cycles, the acceptance criteria were met with an observed protein analyte level of < 6.4µg/cm². For all cycles, the acceptance criteria were met with an observed hemoglobin analyte test level of < 2.2µg/cm². |
| Cleaning (Automated) | To validate the automated cleaning method for device challenge features, using clinically relevant soil and worst-case process parameters, and analyzed for protein and hemoglobin. | The extraction efficiency shall be greater than or equal to 70%. Test samples show no visible soil after cleaning. The overall result of the protein analyte test is a level of < 6.4µg / cm². The overall result of the hemoglobin analyte test is a level of < 2.2µg / cm². | The extraction efficiency was greater than or equal to 70% at each sample location. There was no visible soil after cleaning. For all cycles, the acceptance criteria was met with an observed protein analyte level of < 6.4µg/cm². For all cycles, the acceptance criteria were met with an observed hemoglobin analyte test level of < 2.2µg/cm². |
| Biocompatibility assessment (ANSI/AAMI/ISO 10993-5:2009 – Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity) | The biocompatibility testing evaluated the materials of construction (aluminum, stainless steel and silicone) as well as the silkscreen inks and anodization dyes to ensure no cell toxic substances will be transferred to medical devices. | Pass is a score of less than 2. | There was no cytotoxic reaction observed (Grade 0) in any of the sample extracts. |
| Durability (Limits of Reuse) | To verify the limits of reuse (durability) of the subject device, demonstrating it can withstand repeated clinical reprocessing cycles without unacceptable effects to material, function, or safety. | After 100 cycles of clinical processing, the subject device should show no signs of damage (corrosion, fading, scratches, flaking, cracks, bent corners, burs or sharp edges) and continue to function properly (bending of flexible devices, movement of hinges/joints, sticky/jammed latch/handles). | All acceptance criteria were met, and the results demonstrate that the subject devices continue to function as intended after 104 clinical reprocessing cycles. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes (number of devices, number of tests for each criterion) for each test. For many tests (e.g., Sterilization Efficacy, Dry Time, Cleaning), the results often refer to "Each product BI test location" or "For all cycles," suggesting that multiple test units or cycles were performed to represent the device.
The data provenance is not explicitly mentioned as a country of origin. The sponsor is "Synthes GmbH Luzernstrasse 21 Zuchwil, Switzerland," indicating the device manufacturer is based in Switzerland, but the location where the non-clinical testing was conducted is not specified. The study is non-clinical testing, which implies it's laboratory-based and not involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The tests performed are non-clinical, laboratory-based evaluations against objective, measurable criteria (e.g., absence of microbial growth, weight difference, concentration levels of analytes, visual inspection for damage, cytotoxicity scores). There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. As noted above, the tests are objective, measurable non-clinical evaluations, not interpretive assessments that would require adjudication.
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:
Not applicable. This is a non-clinical evaluation of a sterilization case and tray system, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these non-clinical tests is based on established scientific and regulatory standards and methods appropriate for sterilization and cleaning efficacy, biocompatibility, and durability. For example:
* Sterilization Efficacy: Negative growth of biological indicators, steam penetration verification (objective measurements).
* Dry Time and Thermal Profiling: Weight difference percentage, absence of visible moisture, F0 values, temperature sensor stability (objective measurements).
* Cleaning: Extraction efficiency percentage, absence of visible soil, quantifiable levels of protein and hemoglobin (objective measurements).
* Biocompatibility: Cytotoxicity score (objective, laboratory-derived evaluation).
* Durability: Absence of specific types of damage (visual inspection against defined criteria) and continued proper function (functional testing).
8. The sample size for the training set:
Not applicable. This is a physical medical device undergoing non-clinical validation, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
March 28, 2025
Synthes GmbH Thomas Shea Manger, Regulatory Affiars Luzernstrasse 21 Zuchwil, SO 4528 Switzerland
Re: K241927
Trade/Device Name: Synthes Graphic Case & Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 26, 2025 Received: February 26, 2025
Dear Thomas Shea:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Digitally signed by Stephen A. Digitally signed by
Stephen A. Anisko -S Anisko -S Date: 2025.03.28 16:08:45 -04'00'
for: Christopher Dugard Director DHT4C: Division of Infection Control 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) K241927
Device Name Synthes Graphic Case & Tray System
Indications for Use (Describe)
The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterlity; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Synthes Graphic Case & Tray System - Description and Dimensions | ||||
|---|---|---|---|---|
| Part Number | Part Description | Volume to VentRatio (in³/in²)(with Lid) | Weight(lbs.) | Dimensions (in)(L x W x H) Case/Tray(L x W) Lids |
| Outer Cases | ||||
| 60.133.181 | 1 High, 1/3 width outer case | 5.62 | 1.62 | 7.1 x 9.7 x 1.9 |
| 60.133.182 | 1 High, 2/3 width outer case | 4.84 | 2.19 | 13.6 x 9.7 x 1.9 |
| 60.133.183 | 1 High, 3/3 width outer case | 4.72 | 2.73 | 20 x 9.7 x 1.9 |
| 60.133.213 | 2 High, 1/3 width outer case | 8.11 | 2.10 | 7.1 x 9.7 x 3.4 |
| 60.133.223 | 2 High, 2/3 width outer case | 7.35 | 2.78 | 13.6 x 9.7 x 3.4 |
| 60.133.200 | 2 High, 3/3 width outer case | 6.12 | 3.41 | 20 x 9.7 x 3.4 |
| 60.133.313 | 3 High, 1/3 width outer case | 9.34 | 2.51 | 7.1 x 9.7 x 5 |
| 60.133.323 | 3 High, 2/3 width outer case | 8.81 | 3.31 | 13.6 x 9.7 x 5 |
| 60.133.300 | 3 High, 3/3 width outer case | 8.30 | 4.04 | 20 x 9.7 x 5 |
| 60.133.413 | 4 High, 1/3 width outer case | 10.05 | 2.92 | 7.1 x 9.7 x 6.6 |
| 60.133.423 | 4 High, 2/3 width outer case | 9.69 | 3.83 | 13.6 x 9.7 x 6.6 |
| 60.133.400 | 4 High, 3/3 width outer case | 9.19 | 4.65 | 20 x 9.7 x 6.6 |
| Case Lids | ||||
| Synthes Graphic Case & Tray System - Description and Dimensions | ||||
| Part Number | Part Description | Volume to VentRatio (in³/in²)(with Lid) | Weight(lbs.) | Dimensions (in)(L x W x H) Case/Tray(L x W) Lids |
| 60.133.013 | 1/3 width lid | n/a | .60 | 7.1 x 9.7 |
| 60.133.023 | 2/3 width lid | n/a | 1.01 | 13.6 x 9.7 |
| 60.133.000 | 3/3 width lid | n/a | 1.59 | 20 x 9.7 |
| Auxiliary Trays * Representative for all 1 high Tray size | ||||
| 60.133.103 | Auxiliary Tray 1/3 width | 5.62 | 0.89 | 6.34 x 9.25 x 1.77 |
| 60.133.169 | Auxiliary Tray, 1 High, 2/3 Width | 4.84 | 1.80 | 12.80 x 9.25 x 1.77 |
| 60.133.171 | Auxiliary Tray, 1 High, 3/3 Width | 4.72 | 2.70 | 19.25 x 9.25 x 1.77 |
| Auxiliary Tray Lids | ||||
| 60.133.111 | Lid (1/3 Width), Aluminium Tray | n/a | 0.81 | 6.61 x 9.65 |
| 60.133.110 | Lid (2/3 Width), Aluminium Tray | n/a | 1.33 | 13.07 x 9.65 |
| 60.133.109 | Lid 3/3 Aluminium Tray | n/a | 1.79 | 19.53 x 9.65 |
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510(k) Summary K241927
| Sponsor | Synthes GmbHLuzernstrasse 214528 Zuchwil, Switzerland |
|---|---|
| Contact | Thomas SheaManager, Regulatory AffairsT: +1 610-719-5679E: tshea@its.jnj.com |
| Alternate Contact | Damon LeesDirector, Regulatory AffairsT: +1 610-719-5608E: dlees@its.jnj.com |
| Date Prepared | March 25, 2025 |
| Proprietary Name | Synthes Graphic Case & Tray System |
| ClassificationName | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification | Class IIRegulation Number: 21 CFR 880.6850Product Code: KCT |
| Predicate /Referencedevices | Predicate Device: CrossRoads Tray System (K202268)Reference Device: DePuy Synthes Sterilization Container System (K181933) |
| DeviceDescription | The Synthes Graphic Case and Tray System is a modular, reusable case and traysystem intended for use in health care facilities for the purpose of containingmedical devices for sterilization. It is composed of multiple pieces, designed to beintegrated into a single unit that contains and protects instruments and implantsduring sterilization and transport. All components are perforated for steampenetration. |
| Indications forUse | The Synthes Graphic Case & Tray System are used in healthcare facilities tostore, organize, and transport DePuy Synthes orthopedic instruments andimplants during sterilization and surgical procedures. The Synthes Graphic Case& Tray System are not intended on their own to maintain sterility; they are intendedto be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g.,wraps or reusable rigid sterilization containers).The Synthes Graphic Case & Tray System is validated for use with orthopedicmedical devices including lumen (cannulated) devices and mated surface devices(devices or device configurations with conjoined surfaces which meet, touch orunite). Compatible instrument and implant materials include intrinsically stablemetals, composites, thermoplastics and thermosetting polymers with constant usetemperatures above 135°C. |
| The Synthes Graphic Case & Tray System were validated for a maximum load of25 lbs (case + contents+ lid+ weight of sterile barrier wrap). | |
| Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuumTemperature: 270 °F (132 °C)Exposure time: 4 minutesMinimum Drying time: 20 minutes |
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| Part Number | Part Description | Volume to Vent Ratio (in³/in²) (with Lid) | Weight (lbs.) | Dimensions (in) (L x W x H) Case/Tray (L x W) Lids |
|---|---|---|---|---|
| Outer Cases | ||||
| 60.133.181 | 1 High, 1/3 width outer case | 5.62 | 1.62 | 7.1 x 9.7 x 1.9 |
| 60.133.182 | 1 High, 2/3 width outer case | 4.84 | 2.19 | 13.6 x 9.7 x 1.9 |
| 60.133.183 | 1 High, 3/3 width outer case | 4.72 | 2.73 | 20 x 9.7 x 1.9 |
| 60.133.213 | 2 High, 1/3 width outer case | 8.11 | 2.10 | 7.1 x 9.7 x 3.4 |
| 60.133.223 | 2 High, 2/3 width outer case | 7.35 | 2.78 | 13.6 x 9.7 x 3.4 |
| 60.133.200 | 2 High, 3/3 width outer case | 6.12 | 3.41 | 20 x 9.7 x 3.4 |
| 60.133.313 | 3 High, 1/3 width outer case | 9.34 | 2.51 | 7.1 x 9.7 x 5 |
| 60.133.323 | 3 High, 2/3 width outer case | 8.81 | 3.31 | 13.6 x 9.7 x 5 |
| 60.133.300 | 3 High, 3/3 width outer case | 8.30 | 4.04 | 20 x 9.7 x 5 |
| 60.133.413 | 4 High, 1/3 width outer case | 10.05 | 2.92 | 7.1 x 9.7 x 6.6 |
| 60.133.423 | 4 High, 2/3 width outer case | 9.69 | 3.83 | 13.6 x 9.7 x 6.6 |
| 60.133.400 | 4 High, 3/3 width outer case | 9.19 | 4.65 | 20 x 9.7 x 6.6 |
| Case Lids | ||||
| Part Number | Part Description | Volume to Vent Ratio (in³/in²) (with Lid) | Weight (lbs.) | Dimensions (in) (L x W x H) Case/Tray (L x W) Lids |
| 60.133.013 | 1/3 width lid | n/a | .60 | 7.1 x 9.7 |
| 60.133.023 | 2/3 width lid | n/a | 1.01 | 13.6 x 9.7 |
| 60.133.000 | 3/3 width lid | n/a | 1.59 | 20 x 9.7 |
| Auxiliary Trays * Representative for all 1 high Tray size | ||||
| 60.133.103 | Auxiliary Tray 1/3 width | 5.62 | .89 | 6.34 x 9.25 x 1.77 |
| 60.133.169 | Auxiliary Tray, 1 High, 2/3 Width | 4.84 | 1.80 | 12.80 x 9.25 x 1.77 |
| 60.133.171 | Auxiliary Tray, 1 High, 3/3 Width | 4.72 | 2.70 | 19.25 x 9.25 x 1.77 |
| Auxiliary Tray Lids | ||||
| 60.133.111 | Lid (1/3 Width), Aluminium Tray | n/a | 0.81 | 6.61 x 9.65 |
| 60.133.110 | Lid (2/3 Width), Aluminium Tray | n/a | 1.33 | 13.07 x 9.65 |
| 60.133.109 | Lid 3/3 Aluminium Tray | n/a | 1.79 | 19.53 x 9.65' |
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Technological Comparison
Presented below is a Technological Comparison covering the design and performance specifications of the subject device and the predicate.
| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
|---|---|---|---|
| Device Name | Synthes Graphic Case and TraySystem | CrossRoads Tray System | |
| Device Image | Image: Synthes Graphic Case and Tray System | Image: CrossRoads Tray System | |
| Product Code | KCT | KCT | Same |
| Intended Use | The Synthes Graphic Case andTray System is designed tohold surgical implants andinstruments in order toorganize, steam sterilize andtransport the devices betweenuses. The cases and trays areintended to be wrapped with anFDA-cleared sterilization wrapor placed within a reusablesterilization container during thepre-vacuum autoclavesterilization process. | The CrossRoads Tray Systemis designed to hold varioussurgical instruments in order toorganize, steam sterilize andtransport the instrumentsbetween uses. The trays arewrapped with an FDA-clearedsterilization wrap during thepre-vacuum autoclavesterilization process. | Similar |
| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
| Indications forUse | The Synthes Graphic Case &Tray System is used inhealthcare facilities to store,organize, and transport DePuySynthes orthopedic instrumentsand implants during sterilizationand surgical procedures. TheSynthes Graphic Case & TraySystem are not intended ontheir own to maintain sterility;they are intended to be used inconjunction with a legallymarketed, FDA-cleared sterilebarrier (e.g., wraps or reusablerigid sterilization containers).The Synthes Graphic Case &Tray System is validated foruse with orthopedic medicaldevices including lumen(cannulated) devices andmated surface devices (devicesor device configurations withconjoined surfaces which meet,touch or unite). Compatibleinstrument and implantmaterials include intrinsicallystable metals, composites,thermoplastics andthermosetting polymers withconstant use temperaturesabove 135°C.The Synthes Graphic Case &Tray System were validated for | The CrossRoads Tray Systemis used in healthcare facilities tostore and organize CrossRoadssurgical instruments andcomponents duringcleaning/sterilization and duringimplant/prosthetic treatment.The CrossRoads Tray Systemare not intended on their own tomaintain sterility; it is intendedto be used in conjunction with alegally marketed, validated,FDA-cleared sterilization pouchor sterilization wrap.Sterilization validations for theworst-case CrossRoads TraySystem included surgicalinstruments such as drills,inserters, reamers, fixation pin,benders, and ratchetinghandles. The CrossRoads TraySystem is validated for amaximum load of 8.5 lbs (tray +instruments).Method: Steam Sterilization(Moist Heat Sterilization) CyclePre-vacuumTemperature: 270 °F (132 °C)Exposure time: 4 minutesDrying time: 20 minutesThe tray is 20.60" length x 9.80"width x 2.00" depth. | Different,subjectdeviceincludesindicationsfor devicetypes andmaterialsvalidated foruse with thesystem. |
| a maximum load of 25 lbs (case+ contents+ lid+ weight ofsterile barrier wrap).Method: Steam Sterilization(Moist Heat Sterilization) CyclePre-vacuumTemperature: 270 °F (132 °C)Exposure time: 4 minutesMinimum Drying time: 20 | |||
| IntendedDevice Load | minutesImplants and instruments | Implants and instruments | Same |
| Max Weight | 25 lbs (case + contents+ lid +weight of sterile barrier) | 8.5 lbs (tray + instruments) | Different,subjectsystem isvalidated fora greatermax load |
| Materials | Lid/base— AluminumInserts - Silicone, Aluminum,Stainless SteelLatch - Stainless Steel | Lid/base/Lift out tray -Aluminum Inserts - Silicone,aluminum, stainless steelLatch - Stainless steel | Similar |
| Design | Outer case, inner tray, lids | Base and lid | Similar |
| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
| Dimensions | Cases and trays ranging in sizefrom 7.2 – 20.1 length x 9.8width x 1.8 – 6.5 inches depthSee Table in IFU for completelist of cases and trays withdimensions. | 20.60 length x 9.80 width x2.00 inches depth | Different,subjectsystem offersa range ofsizes |
| Sterilization Parameters | |||
| SterilizationMethod | Pre-vacuum (steam) | Pre-vacuum (steam) | Same |
| CycleTemperature | 270°F (132°C) | 270°F (132°C) | Same |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Dry Time | 20 minutes | 20 minutes | Same |
| Sterile Barrier | FDA cleared sterilization wrap orrigid container | FDA cleared sterilization wrapor pouch | Similar |
| Performance Testing | |||
| Non-clinicalperformancetesting | Sterilization EfficacyDry TimeCleaningBiocompatibilityDurability (Limits of Reuse) | Sterilization EfficacyDry TimeCleaningBiocompatibility | Similar |
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Non-clinical Testing Summary
Nonclinical testing included Sterilization Efficacy, Dry Time and Thermal Profiling, Manual and Automated Cleaning Validation, Biocompatibility, and Durability (Limits of Reuse). Testing demonstrates that the Synthes Graphic Case and Tray System is summarized in the table below.
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| Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| SterilizationEfficacy with FDAclearedsterilization wrap | Validation for the efficacy ofthe dynamic air removal steamsterilization process inattaining a sterility assurancelevel (SAL) of 10-6 via theoverkill method using a halfcycle for the Synthes GraphicCase and Tray System whenprocessed in two layers ofblue sterilization wrap. | All biological indicator test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved. | Pass, all acceptance criteria met.Each product BI test location was negative for growth Each positive control BI type was positive for growth Each negative and environmental control BI type was negative for growth All integrators demonstrated steam penetration The sterilizer cycle tapes verified that the cycle parameters were achieved |
| SterilizationEfficacy with FDAcleared rigidsterilizationcontainer | Validation for the efficacy ofthe dynamic air removal steamsterilization process inattaining a sterility assurancelevel (SAL) of 10-6 via theoverkill method using a halfcycle for the Synthes GraphicCase and Tray System whenprocessed in a rigidsterilization container. | All biological indicator (BI) test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved. | Pass, all acceptance criteria met.Each product BI test location was negative for growth Each positive control BI type was positive for growth Each negative and environmental control BI type was negative for growth All integrators demonstrated steam penetration The sterilizer cycle tapes verified that the cycle parameters were achieved |
| Test | Purpose | Acceptance Criteria | Results |
| Dry Time and Thermal Profiling with FDA cleared sterilization wrap | Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in a two layers of blue sterilization wrap. | The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle. | Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: -0.085% Cycle 2: 0.093% Cycle 3: 0.062% For Autoclave Parameter of 20 Minute Dry Time: No Visible Moisture At the end of the cycle, the temperature sensors were found to have remained in position. $F_0$ results of >12.0 achieved for Cycle 1,2 and 3 for all locations All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved: |
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| Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dry Time andThermal Profilingwith FDA clearedrigid sterilizationcontainer | Validation of the efficacy ofthermal profile and dry time forthe Synthes Graphic Case andTray System when processedin a rigid sterilizationcontainer. | The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle. | Pass, all acceptance criteria met.Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time:Cycle 1: 0.00%Cycle 2: 0.00%Cycle 3: 0.00%Cycle 4: 0.00%Cycle 5: 0.00%Cycle 6: 0.00% For Autoclave Parameter of 20 Minute Dry Time: No Visible Moisture At the end of the cycle, the temperature sensors were found to have remained in position. F0 results of >12.0 achieved for all cycles and for all locations All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved |
| Test | Purpose | Acceptance Criteria | Results |
| Cleaning(Manual) | To validate the manualcleaning method, the devicechallenge features present inthe Case and Tray Systemwere soiled with a clinicallyrelevant soil for orthopedicsurgery, cleaned using worstcase process parameters (e.g.times, water temperature,and/or cleaning solutionconcentration) and analyzedfor the presence of twoclinically relevant analytes,protein and hemoglobin. | ● The extraction efficiencyshall be greater than orequal to 70%.● Test samples show novisible soil after cleaning.● The overall result of theprotein analyte test is alevel of < 6.4µg / cm².This is calculated byadding the standarddeviation of the sampleresults to the highestindividual result.● The overall result of thehemoglobin analyte testis a level of < 2.2µg/cm².This is calculated byadding the standarddeviation of the sampleresults to the highestindividual result. | ● The extractionefficiency wasgreater than orequal to 70% ateach samplelocation.● There was novisible soil aftercleaning.● For all cycles theacceptancecriteria were metwith an observedprotein analytelevel of < 6.4µg/cm².● For all cycles theacceptancecriteria were metwith an observedhemoglobinanalyte test is alevel of < 2.2µg/cm². |
| Cleaning(Automated) | To validate the automatedcleaning method, the devicechallenge features present inthe Case and Tray Systemwere soiled with a clinicallyrelevant soil for orthopedicsurgery, cleaned using worstcase process parameters (e.g.times, water temperature,and/or cleaning solutionconcentration) and analyzedfor the presence of twoclinically relevant analytes,protein and hemoglobin. | ● The extraction efficiencyshall be greater than orequal to 70%.● Test samples show novisible soil after cleaning.● The overall result of theprotein analyte test is alevel of < 6.4µg / cm².This is calculated byadding the standarddeviation of the sampleresults to the highestindividual result.● The overall result of thehemoglobin analyte testis a level of < 2.2µg / cm².This is calculated byadding the standarddeviation of the sampleresults to the highestindividual result. | ● The extractionefficiency wasgreater than orequal to 70% ateach samplelocation.● There was novisible soil aftercleaning.● For all cycles theacceptancecriteria was metwith an observedprotein analytelevel of < 6.4µg/cm².● For all cycles theacceptancecriteria were metwith an observedhemoglobinanalyte test is alevel of < 2.2µg/cm².? |
| Test | Purpose | Acceptance Criteria | Results |
| Biocompatibilityassessment(ANSI/AAMI/ISO10993-5:2009 –BiologicalEvaluation ofMedical Devices -Part 5: Tests forIn VitroCytotoxicity) | The biocompatibility testingevaluated the materials ofconstruction (aluminum,stainless steel and silicone) aswell as the silkscreen inks andanodization dyes used to printgraphics and text on the casesand trays, to ensure no celltoxicsubstances will be transferredto the medical devicescontained within the case ortray during processing. | Pass is a score of less than 2. | There was nocytotoxic reactionobserved (Grade 0)any of the sampleextracts. |
| Durability (Limitsof Reuse) | The objective of thisevaluation was to verify thelimits of reuse (durability) ofthe subject device, SynthesGraphic Case and TraySystem. The testing wasintended to demonstrate thatthe subject devices canwithstand repeated clinicalreprocessing cycles (i.e.,mechanical washer cycles andsteam pre-vacuum sterilizationcycles) without unacceptableeffects occurring to thematerial, joints, surfaces,color, labeling, function, etc.which could compromisepatient / user safety orproduct's function during itsintended lifetime. | After 100 cycles of clinicalprocessing the subject deviceshould show no signs ofdamage and continue tofunction properly.Damage, including but notlimited to:• Corrosion (e.g. rust,pitting),• Fading or discoloration ofartwork or labeling thatwhich product cannot beidentified• Scratches• Flaking of anodizedsurfaces• Cracks and wear• Bent lid corners near thelatching features• Burs or sharp edgesaround the perimeter thatmay tear sterile barriermaterialsProper function, including butnot limited to:• Bending of flexibledevices,• Movement of hinges /joint / box locks andmoveable features suchas handles, ratchetingand couplings.• Sticky or jammed latch orhandles when openingand closing | All acceptancecriteria were met andthe resultsdemonstrate that thesubject devicescontinue to functionas intended and after104 clinicalreprocessing cycles. |
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Clinical testing was not necessary for the determination of substantial equivalence.
Conclusion:
The conclusions drawn from the nonclinical testing demonstrate that the subject device, Synthes Graphic Case and Tray System, is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).