The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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

Validations included the worst case load configurations of the EZ- TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Devices.

. Contents in the validated configuration include reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc)
No lumened devices were validated within the tray system as part of the product load. The EZ-. TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims.
Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices).

Device Description

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store G7 Acetabular System / Taperloc Complete Hip System Devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 subject device protects the inteterior components during transportation, sterilization, and storage.

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 travs are fully perforated with an evenly distributed hole pattern. The sides of the travs are partially perforated. The travs 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.

AI/ML Overview

This document describes the safety and performance of the EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device, a sterilization cassette. The information provided relates to non-clinical testing for mechanical, thermal, and biological compatibility, not a study involving human subjects or AI-assisted diagnosis.

Therefore, many of the requested categories, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and effect size of human reader improvement with AI assistance, are not applicable to this type of device and study.

Here's the information that can be extracted and a clear indication of why other information is not present:

Acceptance Criteria and Reported Device Performance

The device passed all non-clinical performance tests.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Results)
Material Compatibility (AAMI 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 132C for 4 minutes. Mechanical Washing and Steam Sterilization. The testing subjected the device to repetitive cleaning and sterilization processing cycles at parameters that represented worst case conditions. Chemical indicators were utilized to demonstrate steam penetration.	No degradation or lack of functionality after 25 cycles. (Passed)
Mechanical Cleaning Validation - Hemoglobin (AAMI 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 ug/cm2 per device.	The mechanical cleaning validation concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 ug/cm2 per device.	Manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 ug/cm2 per device. (Passed)
Mechanical Cleaning Validation - Protein Analysis (AAMI 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 ug/cm2 per device.	The mechanical cleaning validation concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a protein level less than 6.4 ug/cm2 per device.	Manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a protein level less than 6.4 ug/cm2 per device. (Passed)
MEM Elution Cytotoxicity (ISO 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 /R2014 and concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential.	Test articles met the requirements and are NOT considered to have a cytotoxic potential. (Passed)
Sterilization Validation (AAMI 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 132C (270F) for 4 minutes.	The sterilization validation concluded the device could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the specified pre-vacuum steam sterilization cycle.	Sterility Assurance Level (SAL) of 10-6 achieved. (Passed)
Thermal Profile Study (AAMI ST77:2013)	To verify that adequate sterilant penetration can be achieved when processed in pre-vacuum steam sterilization cycle of 132C (270F) for 4 minutes.	The thermal profile study demonstrated that adequate sterilant penetration can be achieved. The device can reach and maintain steady-state thermal conditions throughout the exposure phase.	Adequate sterilant penetration achieved; device maintained steady-state thermal conditions. (Passed)
Drying Time Test (AAMI ST77:2013, ISO 17665-1:2006/R2013)	To verify that the device is properly dried following processing in pre-vacuum steam sterilization cycle of 132C for 4.0 minutes and dry time of 10 minutes.	The results demonstrate the device meets or exceeds the minimum acceptance criteria for dry time. The device is considered properly dried.	Device meets/exceeds minimum acceptance criteria for dry time; considered properly dried. (Passed)
Handle 100 lbs force test (AAMI ST77:2013)	To verify that tray handles did not break or show 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.	No breakage, distortion, cracking, or failure. (Passed)
Sterilization Validation of the EZ-TRAX™ Zimmer G7 Acetabular & Taperloc Containment Device (unorganized) steam pre-vacuum 132C (270F) for 4 minutes (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.	The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing in a steam pre-vacuum cycle at 132C (270F) and 4.0 minutes.	Sterility Assurance Level of 10-6 achieved. (Passed)

2. Sample size used for the test set and the data provenance

This document describes non-clinical laboratory testing of a medical device (sterilization cassette), not a study involving patient data. Therefore, concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they relate to clinical or AI diagnostic studies are not applicable. The sample size for each specific test (e.g., number of units tested for mechanical cleaning, number of cycles for material compatibility) is not explicitly detailed in this summary document beyond "repetitive cleaning and sterilization processing cycles" or testing a specific number of cycles (e.g., 25 cycles for material compatibility). The data provenance is from laboratory testing performed according to recognized standards (e.g., AAMI, ISO, ASTM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. Ground truth, in this context, refers to scientific and engineering standards for evaluating physical and biological performance (e.g., sterility, cleanliness levels, material degradation). These are established through validated test methods and instrumentation, not through expert human interpretation of medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as it pertains to human interpretation/diagnosis, not physical device performance testing.

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

This is not applicable. This device is a sterilization cassette, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established engineering and microbiological standards and measurable parameters (e.g., sterility assurance level (SAL) of 10-6, specific levels of residual hemoglobin and protein, material integrity after defined cycles, maintenance of temperature profiles). This is determined by validated laboratory test methods, not clinical expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 28, 2021

K1 Medical LLC % Joseph Azary Consultant Joseph Azary 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K213209

Trade/Device Name: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: September 27, 2021 Received: September 29, 2021

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

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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,

For Clarence Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213209

Device Name

EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

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 ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Devices.

. Contents in the validated configuration include reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc)
No lumened devices were validated within the tray system as part of the product load. The EZ-. TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims.
Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices).

The EZ- TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is offered in the following size:

Brand Name	Model	Dimensions	Dry Weight
EZ-TRAX™	BASE.ASSY.AL.24.12.2.4	L) 22.97" (W) 11.18" (H) 2.44"	4.25 lbs

Type of Use (Select one or both, as applicable)

7 Prescription Use (Part 21 CFR 801 Subpart D)

y Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY K1 Medical LLC's EZ-TRAX Containment Device K213209

Submitter

K1 Medical LLC 56 Newton Road

Woodbridge, CT 06525

Contact Person: Joseph Azary

Phone: 203-242-6670

Date Prepared: December 23, 2021

Name of Device: EZ-TRAXTM Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

Common or Usual Name: Sterilization Cassette

Classification Name: Sterilization Wrap

Regulatory Class: Class II, 21 CFR 880.6850

Product Code: KCT

II. PREDICATE DEVICE:

EZ-TRAX™Persona Knee Containment Device K211007

III.DEVICE DESCRIPTION

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store G7 Acetabular System / Taperloc Complete Hip System Devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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.

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The subject device protects the inteterior components during transportation, sterilization, and storage.

The lids and bottom of travs are fully perforated with an evenly distributed hole pattern. The sides of the travs are partially perforated. The travs are used with locking lids,

IV. INTENDED USE / INDICATIONS FOR USE

The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to orqanize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 AirRemoval	270 F/132 C	4 minutes	10 minutes

Validations included the worst case load configurations of the EZ-TRAXTM Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices.

Contents in the validation configuration include: reusable surgical instruments -(impactors, trials, acetabular reamers, broaches, etc).
No lumended devices were validated within the tray system as part of the product load. -

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The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims.

Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + sterile barrier system + Zimmer G7 Acetabular System / Taperloc Complete Hip System containment devices).

The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is offered in the following sizes:

Brand Name	Model	Dimensions	Dry 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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VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

PROVIDED BELOW IS A TECHNOLOGICAL COMPARISON OF THE SUBJECT DEVICE TO THE PREDICATE DEVICE.

TRADENAME	K1 Medical LLCEZ-TRAXTM Zimmer G7Acetabular System / TaperlocComplete Hip SystemContainment DeviceK213209	K1 Medical LLCEZ-TRAXTM Persona KneeContainment DeviceK211007	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 2.4"	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 Barrier	Used with FDA cleared sterilebarrier system	Used with FDA cleared sterile barriersystem	Identical
MaterialCompatibility	Materials compatible with sterilizationmethod	Materials compatible with sterilizationmethod	Identical
Biocompatibility	Biocompatible	Biocompatible	Identical
Intended Use/ Indications for Use
	The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 RemovalTemperature: 270 F/132 CExposure Time: 4 minutesDrying Time: 10 minutesValidations include the worst case load configurations of the EZ-TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices.- Contents in the validated configuration include: reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc.).- No lumened devices were validated within the tray system as part of the product load. The EZ-TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims.-Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + sterile barrier	The EZ-TRAX TM 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 TM 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: Dynamic Air RemovalTemperature: 270 F/132 CExposure Time: 4 minutesDrying Time: 10 minutesSterilization validations included the worst case load configurations of Persona Knee Containment Device utilized the Persona Knee 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 TM Persona Knee Containment Device does not have any lumen claims.-Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + sterile barrier system + Persona Knee Containment Devices).	Same

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system + Zimmer G7 Acetabular
System / Taperloc Complete Hip

System Devices).


The EZ-TRAX™ Zimmer G7
Acetabular System / Taperloc
Complete Hip System Containment

Device is offered in the following size:

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EZ-TRAX™BASE.ASSY.AL.24.12.2.4(L) 22.97" (W) 11.18"(H) 2.44"Dry weight 4.25 lbs.	The EZ-TRAX™ Persona KneeContainment Device is offered in thefollowing sizes:Brand Name Model DimensionsEZ-TRAX™BASE.ASSY.AL.24.12.2.4(L) 22.97" (W) 11.18" (H) 2.44" (DryWeight 4.25 lbs).EZ-TRAX™ BASE.ASSY.AL.21.12.4(L) 19.97" (W) 11.18" (H) 4.187"
--------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--

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.

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NON-CLINICAL PERFORMANCE TESTING TABLE VIII.

Test Methodology	Purpose	Acceptance Criteria	Results
Material CompatibilityAAMI TIR12:2010AAMI ST81:2004/R2016ISO 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 132C for 4 minutes.Mechanical Washing and Steam SterilizationThe testing subjected the device to repetitive cleaning and sterilization processing cycles at parameters that represented 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 CleaningValidation - Hemoglobin**AAMI TIR30:2011ASTM F32018-18ASTM 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 ug/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 ug/cm2 per device.	Passed
Mechanical CleaningValidation - ProteinAnalysis**AAMI TIR30:2011ASTM F32018-18ASTM 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 ug/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.	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 /R2014 and concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential.	Passed
Sterilization ValidationAAMI ST77:2013ISO 14937:2009AAMI 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 132C (270F) for 4 minutes.	The sterilization validation of the EZ-TRAX™ Containment System included pre-vacuum steam 132C for 4 minutes. The conclusion is the device could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the following pre-vacuum steam sterilization cycle 132C (270F) 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 132C (270F) for 4 minutes.	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 (270F) for 4 minutes.	Passed
Drying Time TestAAMI ST77:2013ISO 17665-1:2006/R2013	To verify that the device is properly dried following processing in pre-vacuum steam sterilization cycle of 132C for 4.0 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 prevacuum sterilization cycle of 132C / 270F, Exposure Time 4.0 minutes and Dry Time 10.0 minutes minimum.	Passed
Handle 100 lbs force testAAMI ST77:2013	To verify that tray handles did not break or show evidence of distortion, cracking or other	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
	failure following testing withforce of 50 lbs.
Sterilization Validation of theEZ-TRAXTM Zimmer G7Acetabular & TaperlocContainment Device(unorganized) steam pre-vacuum 132C (270F) for 4minutes.	To verify that a SterilityAssurance Level of 10-6 can beachieved after processing inpre-vacuum steam.	The testing verified that a SterilityAssurance Level of 10-6 can be achievedafter processing EZ-TRAXTM G7Acetabular System / Taperloc CompleteHip System Containment Device in a steampre-vacuum cycle at 132C (270F) and 4.0minutes.	Passed
AAMI ST8:2013TIR12:2010ST77:2013/R2018ST79:2017ISO 14937:2009/R2013ISO 17665-1:2006/R2013

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IX. CONCLUSIONS

The conclusions drawn from the nonclinical tests demonstrate that the EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is as safe, as effective and performs as well as or better than the legally marketed device EZ-TRAX™Persona Knee Containment Device (K211007).

Regulation Number and Section

§ 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).