Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties, reprocessing, and containment capabilities of a surgical instrument tray, with no mention of AI or ML technologies.

Therapeutic

No.
The device is described as an accessory for organizing, enclosing, reprocessing, transport, and storing other medical devices (Persona Knee devices), not for treating any medical condition or directly interacting with the patient in a therapeutic way.

Diagnostic

No

The device is a containment system for surgical instruments, used for organizing, reprocessing, transporting, and storing them. It is not designed to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of "intrinsically stable metals and thermoplastic polymers" and describes physical components like trays, lids, dividers, and posts. It also details physical testing like mechanical cleaning validation and handle force tests. This indicates it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the device is an accessory used in healthcare facilities to organize, enclose, reprocess, transport, and store surgical devices (Persona Knee devices). It is used between surgical uses and is involved in the sterilization process.
Device Description: The description reinforces its function as a containment device for surgical instruments during reprocessing and storage.
Lack of IVD Characteristics: An IVD is a device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or in order to determine susceptibility to a disease or condition, or to determine the safety and compatibility with potential recipients of medical products. The EZ-TRAX™ Persona Knee Containment Device does not interact with human specimens or provide diagnostic information.

The device's function is related to the handling and sterilization of surgical instruments, which falls under the category of medical devices used in the surgical setting, but not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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: 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™ Persona Knee Devices.

Contents in the validated 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: EZ-TRAX™
Model: BASE.ASSY.AL.24.12.2.4
Dimensions: (L) 22.97" (W) 11.18" (H) 2.44"

Product codes

KCT

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed per specification of the standard and test methodology. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology. All tests concluded with "Passed" results.
Study Types: Material Compatibility, Mechanical Cleaning Validation – Hemoglobin, Mechanical Cleaning Validation – Protein Analysis, MEM Elution Cytotoxicity, Sterilization Validation, Thermal Profile Study, Drying Time Test, Handle 100 lbs force test, Sterilization Validation of the Zimmer Persona Total Knee Set with EZ-TRAX™ Cassette (unorganized).
Sample Size: Not explicitly stated for each test, but related to the tested device.
Key Results:

Material Compatibility: The study found no degradation or lack of functionality after 25 cycles of repetitive cleaning and sterilization processing.
Mechanical Cleaning Validation – Hemoglobin: 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.
Mechanical Cleaning Validation – Protein Analysis: The manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a protein level less than 6.4 ug/cm2 per device.
MEM Elution Cytotoxicity: Test articles met the requirements of the test and are NOT considered to have a cytotoxic potential.
Sterilization Validation: A Sterility Assurance Level (SAL) of 10-6 can be achieved after processing in the pre-vacuum steam sterilization cycle of 132C for 4 minutes.
Thermal Profile Study: Adequate sterilant penetration can be achieved, and the EZ-TRAX™ Containment Device can reach and maintain a steady state thermal conditions throughout the exposure phase when processed in the pre-vacuum steam sterilization cycle 132C for 4 minutes.
Drying Time Test: The EZ-TRAX™ meets or exceeds the minimum acceptance criteria for dry time and is considered properly dried following processing in the steam pre-vacuum sterilization cycle of 132 C / 270F, Exposure Time 4.0 minutes, and Dry Time 10.0 minimum.
Handle 100 lbs force test: None of the tray handles broke loose, showed evidence of permanent distortion, cracking, or other evidence of failure when tested with a force of 50 lbs.
Sterilization Validation of the Zimmer Persona Total Knee Set with EZ-TRAX™ Cassette (unorganized): 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 132C (270F) and 4.0 minutes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K202270

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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

2

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

3

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

4

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.

5

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
EZ-TRAX ™ Persona Knee
Containment Device
K211007 | K1 Medical LLC
EZ-TRAX™ Stryker Mako Total
Knee with Triathlon Containment
Device
K202270 | Comparison |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Fundamental
Scientific
Technology | Sterilization Cassette | Sterilization Cassette | Identical |
| Product Code | KCT | KCT | Identical |
| Material
Composition | Thermoplastic polymers, Aluminum,
and stainless steel | Thermoplastic polymers, Aluminum,
and stainless steel | Identical |
| Design | Base, lid with locking latch and
individual inserts | Base, lid with locking latch and
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
Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Identical |
| Sterilization
Method | Dynamic Air Removal | Dynamic Air Removal | Identical |
| Sterilization
Parameters | Dynamic Air Removal
Temperature: 270F
Exposure Time: 4 minutes
Drying Time: 10 minutes | Dynamic Air Removal
Temperature: 270F
Exposure Time: 4 minutes
Drying Time: 10 minutes | Identical |
| Reusable | Yes | Yes | Identical |
| Microbial Barrier
Properties | Used with FDA approved sterile
barrier system | Used with FDA approved sterile barrier
system | Identical |
| Material
Compatibility | Materials compatible with sterilization
method | Materials compatible with sterilization
method | Identical |
| Toxicological | Biocompatible | Biocompatible | Identical |
| 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: Dynamic Air Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes

Validations include the worst case
load configurations of the EZ-
TRAX™ Persona Knee 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 | The EZ-TRAX™ Stryker Mako Total
Knee with Triathlon Containment
Device is intended for use as an
accessory in healthcare facilities to
organize, enclose, reprocess,
transport, and store Stryker Mako
Total Knee with Triathlon Devices
between surgical uses. The EZ-
TRAX™ Stryker Mako Total Knee with
Triathlon Containment Device is not
intended on its own to maintain
sterility; it is intended to be used in
conjunction with a legally marketed,
validated, FDA-cleared sterile barrier
system.

Cycle: Dynamic Air Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes

Sterilization validations included the
worst case load configurations of
Stryker Mako Total Knee with
Triathlon Containment Device utilized
the Stryker Mako Total Knee with
Triathlon Devices required to perform
an arthroplasty procedure.

Contents in the validated
configuration include: reusable
surgical instruments (impactors, trials,
MICS, sagital saws,.arrays, etc.)
No lumened devices were validated
within the tray system as part of the
product load. The EZ- TRAX™ Stryker
Mako Total Knee with Triathlon
Containment Device does not have
any lumen claims.

-Healthcare facilities should not
exceed 25 pounds (EZ-TRAX™
Containment Device + sterile barrier
system + Stryker Mako Total Knee
with Triathlon Containment Devices). | Same |
| EZ-TRAX™
BASE.ASSY.AL.24.12.2.4
(L) 22.97" (W) 11.18"
(H) 2.44" | The EZ-TRAX™ Stryker Mako Total
Knee with Triathlon Containment
Device is offered in the following
sizes: | | |
| | Brand Name Model Dimensions
EZ-TRAX™BASE.ASSY.AL.24.
12.2.4
(L) 22.97" (W) 11.18" (H) 2.44"
EZ-TRAX™ BASE.ASSY.AL.21.
12.4
(L) 19.97" (W) 11.18” (H) 4.187” | | |
| | | | |

7

8

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
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
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 – Hemoglobin
AAMI TIR30:2011	To verify the
manufacturer's
cleaning	The mechanical cleaning
validation of the EZ-TRAXTM
containment system concluded	Passed
ASTM F32018-18
ASTM F3293-18	instructions are
effective for
removing gross
amounts of soil
to a hemoglobin
level less than
2.2 ug/cm2 per
device.	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.
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 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 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/(R)2014 and concluded
that test articles met the
requirements of the test 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 132F
for 4 minutes.	The sterilization validation of the
EZ-TRAX™ containment system
included pre-vacuum steam
132C for 4 minutes. The
conclusion could achieve a
Sterility Assurance Level (SAL)
of 10-6 after processing in the
following pre-vacuum steam
sterilization cycle 132C for 4
minutes.	Passed
Thermal Profile Study
AAMI ST77:2013	To verify that
adequate
sterilant
penetration can
be achieved
when processed
in pre-vacuum	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™	Passed
	steam
sterilization
cycle of 132C
for 4 minutes.	Containment Device can reach
and maintain a steady state
thermal conditions throughout
the exposure phase when
processed in the following pre-
vacuum steam sterilization cycle
132C for 4 minutes.
Drying Time Test
AAMI ST77:2013
ISO 17665-1:2006/R
2013	To verify that
the device is
properly dried
following
processing in
pre-vacuum
steam
sterilization
cycle of 132C
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 / 270F, Exposure Time 4.0
minutes, and Dry Time 10.0
minimum.	Passed
Handle 100 lbs force
test** AAMI 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 132C
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 132C
(270F) and 4.0 minutes.	Passed

9

10

11

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).