EZ-TRAXTM Persona Knee Containment Device
Device Facts
| Record ID | K211007 |
|---|---|
| Device Name | EZ-TRAXTM Persona Knee Containment Device |
| Applicant | K1 Medical, LLC |
| Product Code | KCT · General Hospital |
| Decision Date | Jul 1, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
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.
Device Story
Sterilization cassette for organizing and transporting Persona Knee surgical instruments; used in healthcare facilities. Device consists of perforated anodized aluminum trays, stainless steel handles, aluminum dividers, and thermoplastic polymer posts. Used in conjunction with an FDA-cleared sterile barrier system; placed in standard hospital autoclaves for steam sterilization. Protects instruments during reprocessing, transport, and storage. Healthcare providers load instruments into the tray; tray is then wrapped in a sterile barrier system and processed via dynamic air removal steam sterilization (270°F/132°C for 4 minutes). Output is a sterilized, organized set of instruments ready for surgical use. Benefits include efficient instrument management and protection of surgical tools during the sterilization cycle.
Clinical Evidence
No clinical data. Bench testing only. Validations included material compatibility (25 cycles), mechanical cleaning efficacy (hemoglobin <2.2 µg/cm², protein <6.4 µg/cm²), cytotoxicity (ISO 10993-5), sterilization validation (SAL 10^-6), thermal profile, drying time, and mechanical handle strength (50 lbs force).
Technological Characteristics
Materials: Anodized aluminum, stainless steel, medical-grade thermoplastic polymers. Design: Perforated tray with locking lid. Sterilization: Steam (dynamic air removal, 132°C). Standards: AAMI TIR12, AAMI ST81, ISO 17665-1, AAMI TIR30, ASTM F32018, ASTM F3293, ISO 10993-5, AAMI ST77, AAMI ST8. Dimensions: 22.97" x 11.18" x 2.44".
Indications for Use
Indicated for use in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee surgical instruments between uses. Not intended to maintain sterility independently; must be used with an FDA-cleared sterile barrier system. Validated for use with reusable surgical instruments (impactors, trials, cutting blocks, punches, ankle clamps). Not validated for lumened devices. Maximum weight limit: 25 lbs.
Regulatory Classification
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.
Predicate Devices
- EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device (K202270)
Submission Summary (Full Text)
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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:
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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 LLC<br>EZ-TRAX ™ Persona Knee<br>Containment Device<br>K211007 | K1 Medical LLC<br>EZ-TRAX™ Stryker Mako Total<br>Knee with Triathlon Containment<br>Device<br>K202270 | Comparison |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Fundamental<br>Scientific<br>Technology | Sterilization Cassette | Sterilization Cassette | Identical |
| Product Code | KCT | KCT | Identical |
| Material<br>Composition | Thermoplastic polymers, Aluminum,<br>and stainless steel | Thermoplastic polymers, Aluminum,<br>and stainless steel | Identical |
| Design | Base, lid with locking latch and<br>individual inserts | Base, lid with locking latch and<br>individual 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 |
| Percent<br>Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Identical |
| Sterilization<br>Method | Dynamic Air Removal | Dynamic Air Removal | Identical |
| Sterilization<br>Parameters | Dynamic Air Removal<br>Temperature: 270F<br>Exposure Time: 4 minutes<br>Drying Time: 10 minutes | Dynamic Air Removal<br>Temperature: 270F<br>Exposure Time: 4 minutes<br>Drying Time: 10 minutes | Identical |
| Reusable | Yes | Yes | Identical |
| Microbial Barrier<br>Properties | Used with FDA approved sterile<br>barrier system | Used with FDA approved sterile barrier<br>system | Identical |
| Material<br>Compatibility | Materials compatible with sterilization<br>method | Materials compatible with sterilization<br>method | Identical |
| Toxicological | Biocompatible | Biocompatible | Identical |
| Intended Use/<br>Indications for<br>Use | The EZ-TRAX™ Persona Knee<br>Containment Device is intended for<br>use as an accessory in healthcare<br>facilities to organize, enclose,<br>reprocess, transport, and store<br>Persona Knee devices between<br>surgical uses. The EZ-TRAX™<br>Persona Knee Containment Device is<br>not intended on its own to maintain<br>sterility; it is intended to be used in<br>conjunction with a legally marketed,<br>validated, FDA-cleared sterile barrier<br>system.<br><br>Cycle: Dynamic Air Removal<br>Temperature: 270 F/132 C<br>Exposure Time: 4 minutes<br>Drying Time: 10 minutes<br><br>Validations include the worst case<br>load configurations of the EZ-<br>TRAX™ Persona Knee Devices.<br><br>- Contents in the validated<br>configuration include: reusable<br>surgical instruments (impactors,<br>trials, cutting blocks, punches, ankle<br>clamp, etc.).<br><br>- No lumened devices were<br>validated within the tray system as<br>part of the product load. The EZ-<br>TRAX™ Persona Knee Containment<br>Device does not have any lumen<br>claims.<br><br>-Healthcare facilities should not<br>exceed 25 pounds (EZ-TRAX™<br>Containment Device + sterile barrier<br>system + Persona Knee Devices).<br><br>The EZ-TRAX™ Persona Knee<br>Containment Device is offered in the<br>following size:<br><br>Brand Name Model Dimensions | The EZ-TRAX™ Stryker Mako Total<br>Knee with Triathlon Containment<br>Device is intended for use as an<br>accessory in healthcare facilities to<br>organize, enclose, reprocess,<br>transport, and store Stryker Mako<br>Total Knee with Triathlon Devices<br>between surgical uses. The EZ-<br>TRAX™ Stryker Mako Total Knee with<br>Triathlon Containment Device is not<br>intended on its own to maintain<br>sterility; it is intended to be used in<br>conjunction with a legally marketed,<br>validated, FDA-cleared sterile barrier<br>system.<br><br>Cycle: Dynamic Air Removal<br>Temperature: 270 F/132 C<br>Exposure Time: 4 minutes<br>Drying Time: 10 minutes<br><br>Sterilization validations included the<br>worst case load configurations of<br>Stryker Mako Total Knee with<br>Triathlon Containment Device utilized<br>the Stryker Mako Total Knee with<br>Triathlon Devices required to perform<br>an arthroplasty procedure.<br><br>- Contents in the validated<br>configuration include: reusable<br>surgical instruments (impactors, trials,<br>MICS, sagital saws,.arrays, etc.)<br><br>- No lumened devices were validated<br>within the tray system as part of the<br>product load. The EZ- TRAX™ Stryker<br>Mako Total Knee with Triathlon<br>Containment Device does not have<br>any lumen claims.<br><br>-Healthcare facilities should not<br>exceed 25 pounds (EZ-TRAX™<br>Containment Device + sterile barrier<br>system + Stryker Mako Total Knee<br>with Triathlon Containment Devices). | Same |
| EZ-TRAX™<br>BASE.ASSY.AL.24.12.2.4<br>(L) 22.97" (W) 11.18"<br>(H) 2.44" | The EZ-TRAX™ Stryker Mako Total<br>Knee with Triathlon Containment<br>Device is offered in the following<br>sizes: | | |
| | Brand Name Model Dimensions<br>EZ-TRAX™BASE.ASSY.AL.24.<br>12.2.4<br>(L) 22.97" (W) 11.18" (H) 2.44"<br>EZ-TRAX™ BASE.ASSY.AL.21.<br>12.4<br>(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 Compatibility<br>AAMI TIR12:2010<br>AAMI ST81:2004/R2016<br>ISO 17665-1:2006/R2013 | To verify the<br>device did not<br>degrade or lose<br>functionality<br>after 25<br>reprocessing<br>cycles at worst<br>case conditions. | Material compatibility pre-<br>vacuum 132C for 4 minutes –<br>Mechanical Washing and<br>Steam Sterilization<br>The testing subjected the<br>device to repetitive cleaning<br>and sterilization processing<br>for 25 reprocessing cycles at<br>parameters that represented<br>the worst case conditions.<br>Chemical indicators were<br>utilized to demonstrate steam<br>penetration. The study found<br>no degradation or lack of<br>functionality after 25 cycles. | Passed |
| Mechanical Cleaning<br>Validation – Hemoglobin<br>AAMI TIR30:2011 | To verify the<br>manufacturer's<br>cleaning | The mechanical cleaning<br>validation of the EZ-TRAXTM<br>containment system concluded | Passed |
| ASTM F32018-18<br>ASTM F3293-18 | instructions are<br>effective for<br>removing gross<br>amounts of soil<br>to a hemoglobin<br>level less than<br>2.2 ug/cm2 per<br>device. | that the manufacturer's cleaning<br>instructions are efficacious for<br>removing gross amounts of soil<br>from the EZ-TRAX™<br>containment system to a<br>hemoglobin level less than 2.2<br>ug/cm2 per device. | |
| Mechanical Cleaning<br>Validation – Protein<br>Analysis<br>AAMI TIR30:2011<br>ASTM F32018-18<br>ASTM F3293-18 | To verify the<br>manufacturer's<br>cleaning<br>instructions are<br>effective for<br>removing gross<br>amounts of soil<br>to a protein<br>level of less<br>than 6.4 ug/cm2<br>per device. | The mechanical cleaning<br>validation of the EZ-TRAX™<br>containment system protein<br>concluded that the<br>manufacturer's cleaning<br>instructions are efficacious for<br>removing gross amounts of soil<br>from the EZ-TRAX™<br>containment system to a protein<br>level less than 6.4 µg/cm2 per<br>device. | Passed |
| MEM Elution Cytotoxicity<br>ISO 10993-5:2009 /<br>R2014 | To verify that<br>the device<br>meets<br>requirements of<br>ISO 10993-5<br>and is not<br>considered<br>cytotoxic. | The cytotoxicity testing was<br>conducted per ISO 10993-<br>5:2009/(R)2014 and concluded<br>that test articles met the<br>requirements of the test and are<br>NOT considered to have a<br>cytotoxic potential. | Passed |
| Sterilization Validation<br>AAMI ST77:2013<br>ISO 14937:2009<br>AAMI ST8:2013 | To verify that<br>the device could<br>achieve a<br>sterility<br>assurance level<br>of 10-6 after<br>processing in<br>pre-vacuum<br>steam<br>sterilization<br>cycle of 132F<br>for 4 minutes. | The sterilization validation of the<br>EZ-TRAX™ containment system<br>included pre-vacuum steam<br>132C for 4 minutes. The<br>conclusion could achieve a<br>Sterility Assurance Level (SAL)<br>of 10-6 after processing in the<br>following pre-vacuum steam<br>sterilization cycle 132C for 4<br>minutes. | Passed |
| Thermal Profile Study<br>AAMI ST77:2013 | To verify that<br>adequate<br>sterilant<br>penetration can<br>be achieved<br>when processed<br>in pre-vacuum | The thermal profile study of the<br>EZ-TRAX™ Containment Device<br>included pre-vacuum steam<br>132C for 4 minutes. The study<br>demonstrated that adequate<br>sterilant penetration can be<br>achieved. The EZ-TRAX™ | Passed |
| | steam<br>sterilization<br>cycle of 132C<br>for 4 minutes. | Containment Device can reach<br>and maintain a steady state<br>thermal conditions throughout<br>the exposure phase when<br>processed in the following pre-<br>vacuum steam sterilization cycle<br>132C for 4 minutes. | |
| Drying Time Test<br>AAMI ST77:2013<br>ISO 17665-1:2006/R<br>2013 | To verify that<br>the device is<br>properly dried<br>following<br>processing in<br>pre-vacuum<br>steam<br>sterilization<br>cycle of 132C<br>for 4 minutes<br>and dry time of<br>10 minutes. | The results demonstrate EZ-<br>TRAX™ meets or exceeds the<br>minimum acceptance criteria for<br>dry time. The EZ-TRAX™ is<br>considered properly dried<br>following processing in the steam<br>pre-vacuum sterilization cycle of<br>132 C / 270F, Exposure Time 4.0<br>minutes, and Dry Time 10.0<br>minimum. | Passed |
| Handle 100 lbs force<br>test** AAMI ST77:2013 | To verify that<br>tray handles did<br>not break or<br>showed<br>evidence of<br>distortion,<br>cracking or<br>other failure<br>following testing<br>with force of 50<br>lbs. | None of the tray handles broke<br>loose showed evidence of<br>pe…
