(113 days)
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
Cycle: Dynamic Air Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes
Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
- . Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.)
- . No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
- Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon Containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:
Brand Name: EZ-TRAX™ Model: BASE.ASSY.AL.24.12.2.4 Dimensions: L) 22.97" (W) 11.18" (H) 2.44"
Brand Name: EZ-TRAX™ Model: BASE.ASSY.AL.21.12.4 Dimensions: (L) 19.97" (W) 11.18" (H) 4.187"
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Stryker Mako Total Knee with Triathlon Devices between surgical uses.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.
The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids.
The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.
The provided text contains details about the regulatory approval (510(k) clearance) of a medical device, the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device. It outlines testing performed to demonstrate the device's safety and effectiveness, specifically for sterilization and material compatibility.
However, the request asks for information typically associated with the development and validation of an AI/machine learning-based medical device where "acceptance criteria" and "study that proves the device meets the acceptance criteria" would refer to performance metrics like sensitivity, specificity, AUC, or reader studies. The provided document concerns a physical medical device (a sterilization containment system), not an AI or software device. Therefore, many of the requested items, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "training set," and "type of ground truth (pathology, outcomes data)," are not applicable to this type of device and are not present in the document.
The "acceptance criteria" in this context refer to engineering and functional performance thresholds for sterilization, cleaning, and material integrity, as outlined in the "Summary of Nonclinical Testing" section.
Below is an attempt to answer the questions based on the provided document, where applicable. For questions that are not relevant to this type of medical device (physical containment system) or not explicitly stated in the document, it will be noted as "Not Applicable (N/A)" or "Not specified."
Acceptance Criteria and Study for EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device
This device is a sterilization containment system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to physical, chemical, and microbiological performance standards for sterilization, cleaning, and material compatibility, not AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Test / Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Compatibility (AAMI TIR12:2010, AAMI ST81:2004/R2016, ISO 17665-1:2006/R2013) | Verify no degradation or lack of functionality after repetitive cleaning and sterilization processing for 25 cycles. | Verify no degradation or lack of functionality after repetitive cleaning and sterilization processing for 25 cycles. | Material compatibility pre-vacuum 132C for 4 minutes - Mechanical Washing and Steam Sterilization. The testing subjected the device to repetitive cleaning and sterilization processing for 25 reprocessing cycles at parameters that represented the worst-case conditions. Chemical indicators were utilized to demonstrate steam penetration. The study found no degradation or lack of functionality after 25 cycles. |
| Mechanical Cleaning Validation - Hemoglobin (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18) | Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 µg/cm2 per device. | Hemoglobin level less than 2.2 µg/cm2 per device. | The mechanical cleaning validation of the EZ-TRAX™ containment system concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a hemoglobin level less than 2.2 µg/cm2 per device. |
| Mechanical Cleaning Validation - Protein Analysis (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18) | Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a protein level less than 6.4 µg/cm2 per device. | Protein level less than 6.4 µg/cm2 per device. | The mechanical cleaning validation of the EZ-TRAX™ containment system protein concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a protein level less than 6.4 ug/cm2 per device. |
| MEM Elution Cytotoxicity (ISO 10993-5:2009 / R2014) | Verify the device does not have a cytotoxic potential. | No cytotoxic potential. | The cytotoxicity testing was conducted per ISO 10993-5:2009/(R)2014 and concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential. |
| Sterilization Validation (AAMI ST77:2013, ISO 14937:2009, AAMI ST8:2013) | Verify the device and cycle parameters achieve a Sterility Assurance Level (SAL) of 10-6. | Sterility Assurance Level (SAL) of 10-6. | The sterilization validation of the EZ-TRAX™ containment system included pre-vacuum steam 132C for 4 minutes. The conclusion could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the following pre-vacuum steam sterilization cycle 132C for 4 minutes. |
| Thermal Profile Study (AAMI ST77:2013) | Verify the device and cycle parameters demonstrate that adequate sterilant penetration is achieved. | Adequate sterilant penetration is achieved. | The thermal profile study of the EZ-TRAX™ Containment Device included pre-vacuum steam 132C for 4 minutes. The study demonstrated that adequate sterilant penetration can be achieved. The EZ-TRAX™ Containment Device can reach and maintain a steady-state thermal conditions throughout the exposure phase when processed in the following pre-vacuum steam sterilization cycle 132C for 4 minutes. |
| Drying Time Test (AAMI ST77:2013, ISO 17665-1:2006/R 2013) | Verify the device is properly dried using the specified cycle parameters. | Device is properly dried. | The results demonstrate EZ-TRAX™ meets or exceeds the minimum acceptance criteria for dry time. The EZ-TRAX™ is considered properly dried following processing in the steam pre-vacuum sterilization cycle of 132 C / 270F, Exposure Time 4.0 minutes, and Dry Time 10.0 minimum. |
| Handle 100 lbs force test (AAMI ST77:2013) | Verify the handles do not show evidence of permanent distortion, cracking, or other evidence of failure when tested with a force of 50 lbs. | No permanent distortion, cracking, or other evidence of failure when tested with a force of 50 lbs. | None of the tray handles broke loose, showed evidence of permanent distortion, cracking, or other evidence of failure when tested with force of 50 lbs. |
| Sterilization Validation of Stryker Mako Triathlon Instrument Set #1 with MICS with EZ-TRAX™ (AAMI ST8:2013, TIR12:2010, ST77:2013/R2018, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013) | Verify that the device with instrument set specific to device and specified cycle parameters achieve a Sterility Assurance Level of 10-6. | Sterility Assurance Level (SAL) of 10-6. | The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing Stryker Mako Triathlon Instrument Set #1 with MICS in a steam pre-vacuum cycle at 132C and 4 minutes. |
| Sterilization validation of Stryker Mako Triathlon Universal TKA with EZ-TRAX™ (AAMI ST77:2013, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013) | Verify that the device with implants specific to device and specified cycle parameters achieve a Sterility Assurance Level of 10-6. | Sterility Assurance Level (SAL) of 10-6. | The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing Stryker Mako Triathlon Universal TKA01 and TKA03 in a steam pre-vacuum cycle at 132C and 4 minutes. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical laboratory testing (e.g., repeating sterilization cycles, cleaning efficacy tests). It does not explicitly state the "sample size" in terms of number of patient cases or specific devices tested for each test, beyond mentioning "25 cycles" for material compatibility. The nature of these tests is typically to test a representative number of devices or components to demonstrate compliance with standards.
- Sample Size for Test Set:
- Material compatibility, cleaning, sterilization validation, thermal profile, and drying time tests were performed for "25 cycles" (for material compatibility) or against specific instrument load configurations. The exact number of containment devices subjected to each specific test (e.g., how many trays were cytotoxic tested) is not specified beyond "test articles."
- Data Provenance: Not specified, but standard safety/performance testing for FDA clearance is typically conducted in a controlled laboratory environment conforming to relevant ISO/AAMI standards. It is not patient or country-specific data in the way an AI/ML study would be. This is pre-clinical/non-clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A). This is a physical device, not an AI/ML device that requires human expert review to establish "ground truth" for diagnostic or predictive performance. The "ground truth" for these tests comes from established international and national standards (e.g., AAMI, ISO, ASTM) and laboratory testing protocols (e.g., sterilization validation using biological indicators to confirm SAL, chemical assays for cleaning efficacy).
4. Adjudication method for the test set
- Not Applicable (N/A). (See point 3).
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 (N/A). This type of study is relevant for AI-assisted diagnostic devices, not for a physical sterilization containment system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this physical device, the "ground truth" is based on:
- Validated microbiological endpoints: e.g., achieving a Sterility Assurance Level (SAL) of 10^-6, which is confirmed using biological indicators.
- Chemical and Physical Measurements: e.g., quantifiable levels of residual protein/hemoglobin after cleaning, stable material properties after repeated cycles, achievement and maintenance of specified temperatures during sterilization.
- Industry Standards: Compliance with recognized international and national standards (AAMI, ISO, ASTM) for sterilization, cleaning, and biocompatibility.
8. The sample size for the training set
- Not Applicable (N/A). This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable (N/A). (See point 8).
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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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 2, 2020
K1 Medical LLC % Joseph Azary Regulatory Consultant / Application Correspondent Joseph Azary 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K202270
Trade/Device Name: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 30, 2020 Received: November 6, 2020
Dear Joseph Azary:
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 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 Quality Center for Devices and Radiological Health
Enclosure
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| 510(k) Number ( if known ) | K202270 |
|---|---|
| ----------------------------------- | --------- |
Device Name
EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device
Indications for Use (Describe)
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |
Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
- . Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.)
- . No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
- Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier
system + Stryker Mako Total Knee with Triathlon Containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
K1 Medical LLC's EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270
Submitter
K1 Medical LLC 56 Newton Road Woodbridge, CT 06525
Contact Person: Joseph Azary, Requlatory Consultant
Phone: 203-242-6670 Date Prepared: November 24, 2020
Name of Device: EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device
Common or Usual Name: Sterilization Cassette
Classification Name: Sterilization Wrap Regulatory Class: Class II, 21 CFR 880.6850
Product Code: KCT
Predicate Device:
EZ-TRAX™ Containment Device, K1 Medical, K192487
Device Description
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Stryker Mako Total Knee with Triathlon Devices between surgical uses.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.
The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids.
The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.
510(k) Summary Page 1 of 8
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Intended Use / Indications for Use
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |
Sterilization validations included the worst case load configurations of the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
- -Contents in the validation configuration include: reusable surgical instruments (impactors, trials, MICS, sagittal saws, arrays, etc).
- -No lumended devices were validated within the tray system as part of the product load. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims.
- Healthcare facilities should not exceed 25 pounds (EZ-TRAX™) Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes: .
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |
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Summary of Technological Characteristics
Provided below is a comparison of the subject device to the predicate device.
Technological Characteristics Comparison Table
| TRADENAME | K1 Medical LLCEZ-TRAX™ StrykerMako Total Knee withTriathlon ContainmentDeviceK202270 | K1 Medical LLCEZ-TRAX™Containment DeviceK192487 | Comparison |
|---|---|---|---|
| FundamentalScientificTechnology | Sterilization Cassette | Sterilization Cassette | Identical |
| Product Code | KCT | KCT | Identical |
| MaterialComposition | Thermoplastic polymers,Aluminum, and stainlesssteel | Thermoplasticpolymers, Aluminum,and stainless steel | Identical |
| Design | Base, lid with locking latchand individual inserts | Base, lid with lockinglatch and individualinserts | Identical |
| Dimensions | Worst case 24 x 12 x 4" | Worst case 24 x 12 x 4" | Identical |
| Configuration | Perforated bases, lidsand inserts | Perforated bases, lidsand inserts | Identical |
| Air Permeance | Yes | Yes | Identical |
| PercentPerforation | Evenly distributed holepattern | Evenly distributed holepattern | Identical |
| SterilizationMethod | Dynamic Air Removal | Dynamic Air Removal | Identical |
| SterilizationParameters | Dynamic Air RemovalTemperature: 270FExposure Time: 4 minutesDrying Time: 10 minutes | Dynamic Air RemovalTemperature: 270FExposure Time: 4 minutesDrying Time: 10 minutes | Identical |
| Reusable | Yes | Yes | Identical |
| MicrobialBarrierProperties | Used with FDA approvedsterile barrier system | Used with FDAapproved sterile barriersystem | Identical |
| MaterialCompatibility | Materials compatible withsterilization method | Materials compatiblewith sterilizationmethod | Identical |
| Toxicological | Biocompatible | Biocompatible | Identical |
| Intended Use/Indications forUse | The EZ-TRAXTM StrykerMako Total Knee withTriathlon ContainmentDevice is intended for useas an accessory inhealthcare facilities toorganize, enclose,reprocess, transport, andstore Stryker Mako TotalKnee with Triathlondevices between surgicaluses. The EZ-TRAXTMStryker Mako Total Kneewith TriathlonContainment Device is notintended on its own tomaintain sterility; it isintended to be used inconjunction with a legallymarketed, validated, FDA-cleared sterile barriersystem. | The EZ-TRAXTMContainment Device isintended for use as anaccessory in healthcarefacilities to organize,enclose, reprocess,transport, and storemedical devices betweensurgical and othermedical uses. The EZ-TRAXTM ContainmentDevice is not intendedon its own to maintainsterility; it is intended tobe used in conjunctionwith a legally marketed,validated, FDA-clearedsterile barrier system.Cycle: Dynamic AirRemovalTemperature: 270F /132CExposure Time: 4minutesDrying Time: 10 minutesSterilization validationsincluded a worst caseEZ-TRAXTMContainment Device anda medical devicechallenge set comprisingof:- Lumendimensions (3)1mm x 500mm- Conjoined/matedsurfaces:forceps, clamps,bending pliers,ratchet handles,retractors- Cannulated: drillbits, taps,guides,screwdrivers,cannulatedscrews- A total weight of42 lbscomprising of(EZ-TRAXTMContainment | The subject device has specificindications for use with theStryker Mako Total Knee withTriathlon Containment device.The parameters including cycle,temperature, exposure time, anddrying time are identical with nodifference.The contents and loadconfigurations of the subjectdevice are different because theyare specific to the Stryker MakoTotal Knee with TriathlonContainment device. |
| Cycle: Dynamic AirRemovalTemperature: 270F/132CExposure Time: 4minutesDrying Time: 10 minutesThe validated worst caseload configurations of theEZ- TRAXTM StrykerMako Total Knee withTriathlon ContainmentDevice were utilized. | |||
| Brand NameModelDimensions | |||
| EZ-TRAXTM (L) 22.97"BASE.ASSY. (W) 11.18"AL.24.12.2.4 (H) 2.44" | |||
| EZ-TRAXTM (L) 19.97"BASE.ASSY. (W) 11.18"AL.21.12.4 (H) 4.187" |
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| - Contents in thevalidated configurationinclude: reusable surgicalinstruments (impactors,trials, , MICS, sagitalsaws,.arrays, etc.)- No lumened deviceswere validated within thetray system as part of theproduct load. The EZ-TRAX™ Stryker MakoTotal Knee with TriathlonContainment Device doesnot have any lumenclaims. | Device + sterilebarrier system +medical deviceload) as a worstcase challengeto the system.Healthcarefacilities shouldnot exceed 25pounds (EZ-TRAX™ContainmentDevice + sterilebarrier system +medical deviceload).The EZ-TRAX™ isoffered in the followingsizes:Brand ModelName DimensionsEZ-TRAX™ (L) 22.97"BASE.ASSY (W) 11.18"AL.12.12.2 (H) 2.04"EZ-TRAX™ (L) 22.97" |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Summary of Nonclinical Testing
Provided below is a summary table of the non-clinical testing that were performed using the subject device. The result demonstrated that the subject device nonclinical test results met the acceptance criteria of the standards.
| Test / | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Methodology | |||
| AAMI TIR12:2010AAMIST81:2004/R2016ISO 17665-1:2006/R2013 | MaterialCompatibility | Verify no degradation or lackof functionality after repetitivecleaning and sterilizationprocessing for 25 cycles. | Material compatibilitypre-vacuum 132C for 4minutes - MechanicalWashing and SteamSterilizationThe testing subjectedthe device to repetitivecleaning andsterilization processingfor 25 reprocessingcycles at parametersthat represented theworst case conditions. |
| AAMI TIR12:2010AAMIST81:2004/R2016ISO 17665-1:2006/R2013 | Chemical indicatorswere utilized todemonstrate steampenetration. The studyfound no degradationor lack of functionalityafter 25 cycles. | ||
| AAMI TIR30:2011ASTM F32018-18ASTM F3293-18 | MechanicalCleaning Validation- Hemoglobin | Verify cleaning instructionsprovided are efficacious forremoving gross amounts ofsoil to a hemoglobin levelless than 2.2 µg/cm2 perdevice. | The mechanical cleaningvalidation of the EZ-TRAX™ containmentsystem concluded that themanufacturer's cleaninginstructions areefficacious for removinggross amounts of soil fromthe EZ-TRAX™containment system to ahemoglobin level lessthan 2.2 µg/cm2 perdevice. |
| AAMI TIR30:2011ASTM F32018-18ASTM F3293-18 | MechanicalCleaning Validation- Protein Analysis | Verify cleaning instructionsprovided are efficacious forremoving gross amounts ofsoil to a protein level lessthan 6.4 µg/cm2 per device. | The mechanical cleaningvalidation of the EZ-TRAX™ containmentsystem protein concludedthat the manufacturer'scleaning instructions are |
| efficacious for removinggross amounts of soil fromthe EZ-TRAX™containment system to aprotein level less than 6.4ug/cm2 per device. | |||
| ISO 10993-5:2009/ R2014 | MEM ElutionCytotoxicity | Verify the device does nothave a cytotoxic potential. | The cytotoxicity testingwas conducted per ISO10993-5:2009/(R)2014and concluded that testarticles met therequirements of the testand are NOT consideredto have a cytotoxicpotential. |
| AAMI ST77:2013ISO 14937:2009AAMI ST8:2013 | SterilizationValidation | Verify the device and cycleparameters achieve aSterility Assurance Level of10-6. | The sterilization validationof the EZ-TRAX™containment systemincluded pre-vacuumsteam 132C for 4 minutes.The conclusion couldachieve a SterilityAssurance Level (SAL) of10-6 after processing inthe following pre-vacuumsteam sterilization cycle132C for 4 minutes. |
| AAMI ST77:2013 | Thermal ProfileStudy | Verify the device and cycleparameters demonstrate thatadequate sterilantpenetration is achieved. | The thermal profile studyof the EZ-TRAX™Containment Deviceincluded pre-vacuumsteam 132C for 4 minutes.The study demonstratedthat adequate sterilantpenetration can beachieved. The EZ-TRAX™ ContainmentDevice can reach andmaintain a steady statethermal conditionsthroughout the exposurephase when processed inthe following pre-vacuumsteam sterilization cycle132C for 4 minutes. |
| AAMI ST77:2013ISO 17665-1:2006/R 2013 | Drying Time Test | Verify the device is properlydried using the specifiedcycle parameters. | The results demonstrateEZ-TRAX™ meets orexceeds the minimumacceptance criteria for drytime. The EZ-TRAX™ isconsidered properly driedfollowing processing in thesteam pre-vacuumsterilization cycle of 132 C/ 270F, Exposure Time4.0 minutes, and Dry Time10.0 minimum. |
| AAMI ST77:2013 | Handle 100 lbsforce test | Verify the handles do notshow evidence of permanentdistortion, cracking, or otherevidence of failure whentested with a force of 50 lbs. | None of the tray handlesbroke loose showedevidence of permanentdistortion, cracking, orother evidence of failurewhen tested with force of50 lbs. |
| AAMI ST8:2013TIR12:2010ST77:2013/R2018ISO14937:2009/R2013ISO 17665-1:2006/R2013 | SterilizationValidation of theStryker MakoTriathlon InstrumentSet #1 with MICSwith EZ-TRAX™ | Verify that the device withinstrument set specific todevice and specified cycleparameters achieve aSterility Assurance Level of10-6. | The testing verified that aSterility Assurance Levelof 10-6 can be achievedafter processing StrykerMako Triathlon InstrumentSet #1 with MICS in asteam pre-vacuum cycleat 132C and 4 minutes. |
| AAMI ST77:2013ISO14937:2009/R2013ISO 17665-1:2006/R2013 | Sterilizationvalidation of StrykerMako TriathlonUniversal TKA withEZ-TRAX™ | Verify that the device withimplants specific to deviceand specified cycleparameters achieve aSterility Assurance Level of10-6. | The testing verified that aSterility Assurance Levelof 10-6 can be achievedafter processing StrykerMako Triathlon UniversalTKA01 and TKA03 in asteam pre-vacuum cycleat 132C and 4 minutes. |
Non-Clinical Performance Testing Table
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Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is as safe, as effective, and performs as well as or better than the legally marketed EZ-TRAX™ Containment 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).