(90 days)
The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee devices between surgical uses. The EZ-TRAX™ Persona Knee 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.
The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Persona Knee Devices between surgical uses.
The EZ-TRAX™ Persona Knee 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 svstem.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX™ Persona Knee 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 EZ-TRAX™ Persona Knee Containment Device underwent a series of non-clinical tests to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material CompatibilityAAMI TIR12:2010, AAMI ST81:2004/R2016, ISO 17665-1:2006/R2013 | To verify the device did not degrade or lose functionality after 25 reprocessing cycles at worst case conditions. | Material compatibility pre-vacuum 132°C 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. | Passed |
| Mechanical Cleaning Validation – HemoglobinAAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18 | To verify the manufacturer's cleaning instructions are effective for removing gross amounts of soil to a 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. | Passed |
| Mechanical Cleaning Validation – Protein AnalysisAAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18 | To verify the manufacturer's cleaning instructions are effective for removing gross amounts of soil to a protein level of 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 µg/cm² per device. | Passed |
| MEM Elution CytotoxicityISO 10993-5:2009 / R2014 | To verify that the device meets requirements of ISO 10993-5 and is not considered cytotoxic. | 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. | Passed |
| Sterilization ValidationAAMI ST77:2013, ISO 14937:2009, AAMI ST8:2013 | To verify that the device could achieve a sterility assurance level of 10⁻⁶ after processing in pre-vacuum steam sterilization cycle of 132°C for 4 minutes. | The sterilization validation of the EZ-TRAX™ containment system included pre-vacuum steam 132°C 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 132°C for 4 minutes. | Passed |
| Thermal Profile StudyAAMI ST77:2013 | To verify that adequate sterilant penetration can be achieved when processed in pre-vacuum steam sterilization cycle of 132°C for 4 minutes. | The thermal profile study of the EZ-TRAX™ Containment Device included pre-vacuum steam 132°C 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 132°C for 4 minutes. | Passed |
| Drying Time TestAAMI ST77:2013, ISO 17665-1:2006/R2013 | To verify that the device is properly dried following processing in pre-vacuum steam sterilization cycle of 132°C for 4 minutes and dry time of 10 minutes. | 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 / 270°F, Exposure Time 4.0 minutes, and Dry Time 10.0 minimum. | Passed |
| Handle 100 lbs force testAAMI ST77:2013 | To verify that tray handles did not break or showed evidence of distortion, cracking or other failure following testing with 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. | Passed |
| Sterilization Validation of the Zimmer Persona Total Knee Set with EZ-TRAX™ Cassette (unorganized).AAMI ST8:2013, TIR12:2010, ST77:2013/R2018, ST79:2017, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013 | To verify that a Sterility Assurance Level of 10⁻⁶ can be achieved after processing in pre-vacuum steam sterilization cycle of 132°C for 4 minutes while containing the Zimmer Persona Total Knee Set. | The testing verified that a Sterility Assurance Level of 10⁻⁶ can be achieved after processing EZ-TRAX™ Persona Knee Containment Device in a steam pre-vacuum cycle at 132°C (270°F) and 4.0 minutes. | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the specific number of units or samples used for each test. However, the tests are described as non-clinical and they are conducted according to general standards (AAMI, ISO, ASTM). This implies that the tests were likely conducted on specific test articles (i.e., multiple instances of the device or relevant components) in a laboratory setting, rather than on patient data. No information about data provenance (country of origin, retrospective/prospective) is provided, as it is not applicable for this type of non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided nor applicable. The tests performed are laboratory-based compliance tests against established physical and microbiological standards, not diagnostic or interpretive tasks requiring human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are based on objective measurements against predefined criteria and standards, not on subjective assessments requiring 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 device is a sterilization containment device, not a diagnostic tool utilizing AI. Therefore, an MRMC study with human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm or AI system.
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 engineering standards and methodologies (e.g., AAMI, ISO, ASTM). For example:
- Material Compatibility: Physical observation of degradation or loss of functionality after stress cycles.
- Mechanical Cleaning Validation (Hemoglobin/Protein): Quantitative measurement of residual hemoglobin/protein levels below specified thresholds (e.g., < 2.2 µg/cm² for hemoglobin, < 6.4 µg/cm² for protein).
- Cytotoxicity: Evaluation against the requirements of ISO 10993-5.
- Sterilization Validation: Achievement of a Sterility Assurance Level (SAL) of 10⁻⁶, typically demonstrated through biological indicators.
- Thermal Profile Study: Measurement of temperature profiles to ensure adequate sterilant penetration.
- Drying Time Test: Measurement to ensure proper drying within specified parameters.
- Handle Force Test: Physical observation of absence of breakage, distortion, or cracking under specified force.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set is involved.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2021
K1 Medical LLC Walt Oko Manager 56 Newton Road Woodbridge, Connecticut 06525
Re: K211007
Trade/Device Name: EZ-TRAXTM Persona Knee Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 31, 2021 Received: April 2, 2021
Dear Walt Oko:
We have reviewed vour 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below
510(k) Number (if known)
K211007
Device Name
EZ-TRAX™ Persona Knee Containment Device
Indications for Use (Describe)
The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee devices between surgical uses. The EZ-TRAX™ Persona Knee 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 |
Validations included the worst case load configurations of the EZ- TRAX™ Persona Knee Containment Devices.
- Contents in the validated configuration include reusable surgical instruments (impactors, trials, cutting blocks, punches, ankle clamp, etc)
- No lumened devices were validated within the tray system as part of the product load. The EZ-TRAX™ Persona Knee Containment Device does not have any lumen claims.
- Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Persona Knee Devices).
The EZ- TRAX™ Persona Knee Containment Device is offered in the following size:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | L) 22.97" (W) 11.18" (H) 2.44" |
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
区 Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather
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and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number
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510(k) SUMMARY K1 Medical LLC's EZ-TRAX Containment Device K211007
Submitter
K1 Medical LLC 56 Newton Road Woodbridge, CT 06525 Contact Person: Walt Oko
Phone: 203-913-4161 Date Prepared: March 31, 2021
Name of Device: EZ-TRAX™ Persona Knee Containment Device
Common or Usual Name: Sterilization Cassette
Classification Name: Sterilization Wrap Requlatory Class: Class II, 21 CFR 880.6850 Product Code: KCT
Predicate Device:
EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device, K1 Medical, K202270
Device Description
The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Persona Knee Devices between surgical uses.
The EZ-TRAX™ Persona Knee 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 svstem.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX™ Persona Knee 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.
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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.
Intended Use / Indications for Use
The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee devices between surgical uses. The EZ-TRAX™ Persona Knee 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 |
Validations included the worst case load configurations of the EZ-TRAX™ Persona Knee Devices.
- Contents in the validation configuration include: reusable surgical instruments (impactors, trials, cutting blocks, punches, ankle clamp, etc).
- -No lumended devices were validated within the tray system as part of the product load. The EZ-TRAXTM Persona Knee Containment Device does not have any lumen claims.
- Healthcare facilities should not exceed 25 pounds (EZ-TRAX™) Containment Device + sterile barrier system + Persona Knee containment devices).
The EZ-TRAX™ Persona Knee Containment Device is offered in the following sizes: .
| Brand Name | Model | Dimensions | Weight |
|---|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" | 4.25 lbs. |
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Technological Characteristics Comparison Table
Provided below is a technological comparison of the subject device to the predicate device.
| TRADENAME | K1 Medical LLCEZ-TRAX ™ Persona KneeContainment DeviceK211007 | K1 Medical LLCEZ-TRAX™ Stryker Mako TotalKnee with Triathlon ContainmentDeviceK202270 | Comparison |
|---|---|---|---|
| FundamentalScientificTechnology | Sterilization Cassette | Sterilization Cassette | Identical |
| Product Code | KCT | KCT | Identical |
| MaterialComposition | Thermoplastic polymers, Aluminum,and stainless steel | Thermoplastic polymers, Aluminum,and stainless steel | Identical |
| Design | Base, lid with locking latch andindividual inserts | Base, lid with locking latch andindividual inserts | Identical |
| Dimensions | Worst case 24 x 12 x 2.4" | Worst case 24 x 12 x 4" | Identical |
| Configuration | Perforated bases, lids and inserts | Perforated bases, lids and inserts | Identical |
| Air Permeance | Yes | Yes | Identical |
| PercentPerforation | Evenly distributed hole pattern | Evenly distributed hole pattern | 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 |
| Microbial BarrierProperties | Used with FDA approved sterilebarrier system | Used with FDA approved sterile barriersystem | Identical |
| MaterialCompatibility | Materials compatible with sterilizationmethod | Materials compatible with sterilizationmethod | Identical |
| Toxicological | Biocompatible | Biocompatible | Identical |
| Intended Use/Indications forUse | The EZ-TRAX™ Persona KneeContainment Device is intended foruse as an accessory in healthcarefacilities to organize, enclose,reprocess, transport, and storePersona Knee devices betweensurgical uses. The EZ-TRAX™Persona Knee Containment Device isnot intended on its own to maintainsterility; it is intended to be used inconjunction with a legally marketed,validated, FDA-cleared sterile barriersystem.Cycle: Dynamic Air RemovalTemperature: 270 F/132 CExposure Time: 4 minutesDrying Time: 10 minutesValidations include the worst caseload configurations of the EZ-TRAX™ Persona Knee Devices.- Contents in the validatedconfiguration include: reusablesurgical instruments (impactors,trials, cutting blocks, punches, ankleclamp, etc.).- No lumened devices werevalidated within the tray system aspart of the product load. The EZ-TRAX™ Persona Knee ContainmentDevice does not have any lumenclaims.-Healthcare facilities should notexceed 25 pounds (EZ-TRAX™Containment Device + sterile barriersystem + Persona Knee Devices).The EZ-TRAX™ Persona KneeContainment Device is offered in thefollowing size:Brand Name Model Dimensions | The EZ-TRAX™ Stryker Mako TotalKnee with Triathlon ContainmentDevice is intended for use as anaccessory in healthcare facilities toorganize, enclose, reprocess,transport, and store Stryker MakoTotal Knee with Triathlon Devicesbetween surgical uses. The EZ-TRAX™ Stryker Mako Total Knee withTriathlon Containment Device is notintended on its own to maintainsterility; it is intended to be used inconjunction with a legally marketed,validated, FDA-cleared sterile barriersystem.Cycle: Dynamic Air RemovalTemperature: 270 F/132 CExposure Time: 4 minutesDrying Time: 10 minutesSterilization validations included theworst case load configurations ofStryker Mako Total Knee withTriathlon Containment Device utilizedthe Stryker Mako Total Knee withTriathlon Devices required to performan arthroplasty procedure.- Contents in the validatedconfiguration include: reusablesurgical instruments (impactors, trials,MICS, sagital saws,.arrays, etc.)- No lumened devices were validatedwithin the tray system as part of theproduct load. The EZ- TRAX™ StrykerMako Total Knee with TriathlonContainment Device does not haveany lumen claims.-Healthcare facilities should notexceed 25 pounds (EZ-TRAX™Containment Device + sterile barriersystem + Stryker Mako Total Kneewith Triathlon Containment Devices). | Same |
| EZ-TRAX™BASE.ASSY.AL.24.12.2.4(L) 22.97" (W) 11.18"(H) 2.44" | The EZ-TRAX™ Stryker Mako TotalKnee with Triathlon ContainmentDevice is offered in the followingsizes: | ||
| Brand Name Model DimensionsEZ-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 Non-Clinical Testing
Provided below is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Material CompatibilityAAMI TIR12:2010AAMI ST81:2004/R2016ISO 17665-1:2006/R2013 | To verify thedevice did notdegrade or losefunctionalityafter 25reprocessingcycles at worstcase conditions. | Material compatibility pre-vacuum 132C for 4 minutes –Mechanical Washing andSteam SterilizationThe testing subjected thedevice to repetitive cleaningand sterilization processingfor 25 reprocessing cycles atparameters that representedthe worst case conditions.Chemical indicators wereutilized to demonstrate steampenetration. The study foundno degradation or lack offunctionality after 25 cycles. | Passed |
| Mechanical CleaningValidation – HemoglobinAAMI TIR30:2011 | To verify themanufacturer'scleaning | The mechanical cleaningvalidation of the EZ-TRAXTMcontainment system concluded | Passed |
| ASTM F32018-18ASTM F3293-18 | instructions areeffective forremoving grossamounts of soilto a hemoglobinlevel less than2.2 ug/cm2 perdevice. | that the manufacturer's cleaninginstructions are efficacious forremoving gross amounts of soilfrom the EZ-TRAX™containment system to ahemoglobin level less than 2.2ug/cm2 per device. | |
| Mechanical CleaningValidation – ProteinAnalysisAAMI TIR30:2011ASTM F32018-18ASTM F3293-18 | To verify themanufacturer'scleaninginstructions areeffective forremoving grossamounts of soilto a proteinlevel of lessthan 6.4 ug/cm2per device. | The mechanical cleaningvalidation of the EZ-TRAX™containment system proteinconcluded that themanufacturer's cleaninginstructions are efficacious forremoving gross amounts of soilfrom the EZ-TRAX™containment system to a proteinlevel less than 6.4 µg/cm2 perdevice. | Passed |
| MEM Elution CytotoxicityISO 10993-5:2009 /R2014 | To verify thatthe devicemeetsrequirements ofISO 10993-5and is notconsideredcytotoxic. | The cytotoxicity testing wasconducted per ISO 10993-5:2009/(R)2014 and concludedthat test articles met therequirements of the test and areNOT considered to have acytotoxic potential. | Passed |
| Sterilization ValidationAAMI ST77:2013ISO 14937:2009AAMI ST8:2013 | To verify thatthe device couldachieve asterilityassurance levelof 10-6 afterprocessing inpre-vacuumsteamsterilizationcycle of 132Ffor 4 minutes. | The sterilization validation of theEZ-TRAX™ containment systemincluded pre-vacuum steam132C for 4 minutes. Theconclusion could achieve aSterility Assurance Level (SAL)of 10-6 after processing in thefollowing pre-vacuum steamsterilization cycle 132C for 4minutes. | Passed |
| Thermal Profile StudyAAMI ST77:2013 | To verify thatadequatesterilantpenetration canbe achievedwhen processedin pre-vacuum | The thermal profile study of theEZ-TRAX™ Containment Deviceincluded pre-vacuum steam132C for 4 minutes. The studydemonstrated that adequatesterilant penetration can beachieved. The EZ-TRAX™ | Passed |
| steamsterilizationcycle of 132Cfor 4 minutes. | Containment Device can reachand maintain a steady statethermal conditions throughoutthe exposure phase whenprocessed in the following pre-vacuum steam sterilization cycle132C for 4 minutes. | ||
| Drying Time TestAAMI ST77:2013ISO 17665-1:2006/R2013 | To verify thatthe device isproperly driedfollowingprocessing inpre-vacuumsteamsterilizationcycle of 132Cfor 4 minutesand dry time of10 minutes. | The results demonstrate EZ-TRAX™ meets or exceeds theminimum acceptance criteria fordry time. The EZ-TRAX™ isconsidered properly driedfollowing processing in the steampre-vacuum sterilization cycle of132 C / 270F, Exposure Time 4.0minutes, and Dry Time 10.0minimum. | Passed |
| Handle 100 lbs forcetest** AAMI ST77:2013 | To verify thattray handles didnot break orshowedevidence ofdistortion,cracking orother failurefollowing testingwith force of 50lbs. | None of the tray handles brokeloose showed evidence ofpermanent distortion, cracking,or other evidence of failure whentested with force of 50 lbs. | Passed |
| Sterilization Validation ofthe Zimmer PersonaTotal Knee Set with EZ-TRAX™ Cassette(unorganized).AAMI ST8:2013TIR12:2010ST77:2013/R2018ST79:2017ISO 14937:2009/R2013ISO 17665-1:2006/R2013 | To verify that aSterilityAssuranceLevel of 10-6can be achievedafter processingin pre-vacuumsteamsterilizationcycle of 132Cfor 4 minuteswhile containingthe ZimmerPersona TotalKnee Set. | The testing verified that aSterility Assurance Level of 10-6can be achieved after processingEZ-TRAX™ Persona KneeContainment Device in a steampre-vacuum cycle at 132C(270F) and 4.0 minutes. | Passed |
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Conclusions
The conclusions drawn from the nonclinical and clinical tests demonstrate that the EZ-TRAX™ Persona Knee Containment Device is as safe, as effective, and performs as well as or better than the legally marketed device EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device (K202270).
§ 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).