(113 days)
Not Found
No
The device is a containment system for surgical instruments and does not involve any computational or analytical functions.
No.
The device is described as an accessory for organizing, enclosing, reprocessing, transporting, and storing other medical devices (surgical instruments) between surgical uses, rather than a device intended to treat or diagnose a medical condition.
No
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory to organize, enclose, reprocess, transport, and store surgical devices. It does not perform any diagnostic function.
No
The device description clearly states it is composed of "intrinsically stable metals and thermoplastic polymers" and describes physical components like "trays and lids," "dividers," and "posts." It also details physical testing like "Handle 100 lbs force test." This indicates it is a physical medical device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for organizing, enclosing, reprocessing, transporting, and storing surgical devices (Stryker Mako Total Knee with Triathlon devices) between surgical uses. This relates to the handling and sterilization of surgical instruments, not the diagnosis of disease or other conditions.
- Device Description: The description reinforces its function as a containment device for surgical instruments, focusing on its materials, design for sterilization, and protection during transport and storage.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) for the purpose of providing information for diagnosis, monitoring, or screening.
The device is an accessory for surgical procedures, specifically related to the reprocessing and handling of reusable surgical instruments.
N/A
Intended Use / Indications for Use
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |
Sterilization validations included the worst case load configurations of the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
- . Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.)
- . No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
- Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon Containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Stryker Mako Total Knee with Triathlon Devices between surgical uses.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.
The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids.
The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.
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)
Summary of Nonclinical Testing
The following non-clinical tests were performed using the subject device:
-
Material Compatibility:
- Purpose: Verify no degradation or lack of functionality after repetitive cleaning and sterilization processing for 25 cycles.
- Methodology: AAMI TIR12:2010, AAMI ST81:2004/R2016, ISO 17665-1:2006/R2013.
- Results: The testing subjected the device to repetitive cleaning and sterilization processing for 25 reprocessing cycles at parameters that represented the worst case conditions. Chemical indicators were utilized to demonstrate steam penetration. The study found no degradation or lack of functionality after 25 cycles.
-
Mechanical Cleaning Validation - Hemoglobin:
- Purpose: Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 µg/cm2 per device.
- Methodology: AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18.
- Results: The mechanical cleaning validation concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a hemoglobin level less than 2.2 µg/cm2 per device.
-
Mechanical Cleaning Validation - Protein Analysis:
- Purpose: Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a protein level less than 6.4 µg/cm2 per device.
- Methodology: AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18.
- Results: The mechanical cleaning validation 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.
-
MEM Elution Cytotoxicity:
- Purpose: Verify the device does not have a cytotoxic potential.
- Methodology: ISO 10993-5:2009 / R2014.
- Results: The cytotoxicity testing concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential.
-
Sterilization Validation:
- Purpose: Verify the device and cycle parameters achieve a Sterility Assurance Level of 10-6.
- Methodology: AAMI ST77:2013, ISO 14937:2009, AAMI ST8:2013.
- Results: The sterilization validation of the EZ-TRAX™ containment system included pre-vacuum steam 132C for 4 minutes. The conclusion could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the following pre-vacuum steam sterilization cycle 132C for 4 minutes.
-
Thermal Profile Study:
- Purpose: Verify the device and cycle parameters demonstrate that adequate sterilant penetration is achieved.
- Methodology: AAMI ST77:2013.
- Results: The thermal profile study of the EZ-TRAX™ Containment Device included pre-vacuum steam 132C for 4 minutes. The study demonstrated that adequate sterilant penetration can be achieved. The EZ-TRAX™ Containment Device can reach and maintain a steady state thermal conditions throughout the exposure phase when processed in the following pre-vacuum steam sterilization cycle 132C for 4 minutes.
-
Drying Time Test:
- Purpose: Verify the device is properly dried using the specified cycle parameters.
- Methodology: AAMI ST77:2013, ISO 17665-1:2006/R 2013.
- Results: The results demonstrate EZ-TRAX™ meets or exceeds the minimum acceptance criteria for dry time. The EZ-TRAX™ is considered properly dried following processing in the steam pre-vacuum sterilization cycle of 132 C / 270F, Exposure Time 4.0 minutes, and Dry Time 10.0 minimum.
-
Handle 100 lbs force test:
- Purpose: Verify the handles do not show evidence of permanent distortion, cracking, or other evidence of failure when tested with a force of 50 lbs.
- Methodology: AAMI ST77:2013.
- Results: None of the tray handles broke loose showed evidence of permanent distortion, cracking, or other evidence of failure when tested with force of 50 lbs.
-
Sterilization Validation of the Stryker Mako Triathlon Instrument Set #1 with MICS with EZ-TRAX™:
- Purpose: Verify that the device with instrument set specific to device and specified cycle parameters achieve a Sterility Assurance Level of 10-6.
- Methodology: AAMI ST8:2013, TIR12:2010, ST77:2013/R2018, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013.
- Results: The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing Stryker Mako Triathlon Instrument Set #1 with MICS in a steam pre-vacuum cycle at 132C and 4 minutes.
-
Sterilization validation of Stryker Mako Triathlon Universal TKA with EZ-TRAX™:
- Purpose: Verify that the device with implants specific to device and specified cycle parameters achieve a Sterility Assurance Level of 10-6.
- Methodology: AAMI ST77:2013, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013.
- Results: The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing Stryker Mako Triathlon Universal TKA01 and TKA03 in a steam pre-vacuum cycle at 132C and 4 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EZ-TRAX™ Containment Device, K192487
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 2, 2020
K1 Medical LLC % Joseph Azary Regulatory Consultant / Application Correspondent Joseph Azary 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K202270
Trade/Device Name: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 30, 2020 Received: November 6, 2020
Dear Joseph Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number ( if known ) | K202270 |
|---|---|
| ----------------------------------- | --------- |
Device Name
EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device
Indications for Use (Describe)
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |
Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
- . Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.)
- . No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
- Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier
system + Stryker Mako Total Knee with Triathlon Containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
K1 Medical LLC's EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270
Submitter
K1 Medical LLC 56 Newton Road Woodbridge, CT 06525
Contact Person: Joseph Azary, Requlatory Consultant
Phone: 203-242-6670 Date Prepared: November 24, 2020
Name of Device: EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device
Common or Usual Name: Sterilization Cassette
Classification Name: Sterilization Wrap Regulatory Class: Class II, 21 CFR 880.6850
Product Code: KCT
Predicate Device:
EZ-TRAX™ Containment Device, K1 Medical, K192487
Device Description
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Stryker Mako Total Knee with Triathlon Devices between surgical uses.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.
The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids.
The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.
510(k) Summary Page 1 of 8
4
Intended Use / Indications for Use
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |
Sterilization validations included the worst case load configurations of the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
- -Contents in the validation configuration include: reusable surgical instruments (impactors, trials, MICS, sagittal saws, arrays, etc).
- -No lumended devices were validated within the tray system as part of the product load. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims.
- Healthcare facilities should not exceed 25 pounds (EZ-TRAX™) Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes: .
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |
5
Summary of Technological Characteristics
Provided below is a comparison of the subject device to the predicate device.
Technological Characteristics Comparison Table
| TRADENAME | K1 Medical LLC
EZ-TRAX™ Stryker
Mako Total Knee with
Triathlon Containment
Device
K202270 | K1 Medical LLC
EZ-TRAX™
Containment Device
K192487 | 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 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-TRAXTM 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-TRAXTM
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. | The EZ-TRAXTM
Containment Device is
intended for use as an
accessory in healthcare
facilities to organize,
enclose, reprocess,
transport, and store
medical devices between
surgical and other
medical uses. The EZ-
TRAXTM 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: 270F /
132C
Exposure Time: 4
minutes
Drying Time: 10 minutes
Sterilization validations
included a worst case
EZ-TRAXTM
Containment Device and
a medical device
challenge set comprising
of:
- Lumen
dimensions (3)
1mm x 500mm - Conjoined/mated
surfaces:
forceps, clamps,
bending pliers,
ratchet handles,
retractors - Cannulated: drill
bits, taps,
guides,
screwdrivers,
cannulated
screws - A total weight of
42 lbs
comprising of
(EZ-TRAXTM
Containment | The subject device has specific
indications for use with the
Stryker Mako Total Knee with
Triathlon Containment device.
The parameters including cycle,
temperature, exposure time, and
drying time are identical with no
difference.
The contents and load
configurations of the subject
device are different because they
are specific to the Stryker Mako
Total Knee with Triathlon
Containment device. |
| | Cycle: Dynamic Air
Removal
Temperature: 270F/132C
Exposure Time: 4
minutes
Drying Time: 10 minutes
The validated worst case
load configurations of the
EZ- TRAXTM Stryker
Mako Total Knee with
Triathlon Containment
Device were utilized. | | |
| | Brand Name
Model
Dimensions | | |
| | EZ-TRAXTM (L) 22.97"
BASE.ASSY. (W) 11.18"
AL.24.12.2.4 (H) 2.44" | | |
| | EZ-TRAXTM (L) 19.97"
BASE.ASSY. (W) 11.18"
AL.21.12.4 (H) 4.187" | | |
6
7
| - 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. | Device + sterile
barrier system +
medical device
load) as a worst
case challenge
to the system.
Healthcare
facilities should
not exceed 25
pounds (EZ-
TRAX™
Containment
Device + sterile
barrier system +
medical device
load).
The EZ-TRAX™ is
offered in the following
sizes:
Brand Model
Name Dimensions
EZ-TRAX™ (L) 22.97"
BASE.ASSY (W) 11.18"
AL.12.12.2 (H) 2.04"
EZ-TRAX™ (L) 22.97" |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8
Summary of Nonclinical Testing
Provided below is a summary table of the non-clinical testing that were performed using the subject device. The result demonstrated that the subject device nonclinical test results met the acceptance criteria of the standards.
| Test / | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Methodology | |||
| AAMI TIR12:2010 | |||
| AAMI | |||
| ST81:2004/R2016 | |||
| ISO 17665- | |||
| 1:2006/R2013 | Material | ||
| Compatibility | Verify no degradation or lack | ||
| of functionality after repetitive | |||
| cleaning and sterilization | |||
| processing for 25 cycles. | Material compatibility | ||
| pre-vacuum 132C for 4 | |||
| minutes - Mechanical | |||
| Washing and Steam | |||
| Sterilization | |||
| The testing subjected | |||
| the device to repetitive | |||
| cleaning and | |||
| sterilization processing | |||
| for 25 reprocessing | |||
| cycles at parameters | |||
| that represented the | |||
| worst case conditions. | |||
| AAMI TIR12:2010 | |||
| AAMI | |||
| ST81:2004/R2016 | |||
| ISO 17665- | |||
| 1:2006/R2013 | Chemical indicators | ||
| were utilized to | |||
| demonstrate steam | |||
| penetration. The study | |||
| found no degradation | |||
| or lack of functionality | |||
| after 25 cycles. | |||
| AAMI TIR30:2011 | |||
| ASTM F32018-18 | |||
| ASTM F3293-18 | Mechanical | ||
| Cleaning Validation |
- Hemoglobin | Verify cleaning instructions
provided are efficacious 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. |
| AAMI TIR30:2011
ASTM F32018-18
ASTM F3293-18 | Mechanical
Cleaning Validation - Protein Analysis | Verify cleaning instructions
provided are efficacious for
removing gross amounts of
soil to a protein level less
than 6.4 µg/cm2 per device. | The mechanical cleaning
validation of the EZ-
TRAX™ containment
system protein concluded
that the manufacturer's
cleaning instructions are |
| | | | efficacious for removing
gross amounts of soil from
the EZ-TRAX™
containment system to a
protein level less than 6.4
ug/cm2 per device. |
| ISO 10993-5:2009
/ R2014 | MEM Elution
Cytotoxicity | Verify the device does not
have a cytotoxic potential. | The cytotoxicity testing
was conducted per ISO
10993-5:2009/(R)2014
and concluded that test
articles met the
requirements of the test
and are NOT considered
to have a cytotoxic
potential. |
| AAMI ST77:2013
ISO 14937:2009
AAMI ST8:2013 | Sterilization
Validation | Verify the device and cycle
parameters achieve a
Sterility Assurance Level of
10-6. | The sterilization validation
of the EZ-TRAX™
containment system
included pre-vacuum
steam 132C for 4 minutes.
The conclusion could
achieve a Sterility
Assurance Level (SAL) of
10-6 after processing in
the following pre-vacuum
steam sterilization cycle
132C for 4 minutes. |
| AAMI ST77:2013 | Thermal Profile
Study | Verify the device and cycle
parameters demonstrate that
adequate sterilant
penetration is achieved. | The thermal profile study
of the EZ-TRAX™
Containment Device
included pre-vacuum
steam 132C for 4 minutes.
The study demonstrated
that adequate sterilant
penetration can be
achieved. The EZ-
TRAX™ Containment
Device can reach and
maintain a steady state
thermal conditions
throughout the exposure
phase when processed in
the following pre-vacuum
steam sterilization cycle
132C for 4 minutes. |
| AAMI ST77:2013
ISO 17665-
1:2006/R 2013 | Drying Time Test | Verify the device is properly
dried using the specified
cycle parameters. | 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. |
| AAMI ST77:2013 | Handle 100 lbs
force test | Verify the handles do not
show evidence of permanent
distortion, cracking, or other
evidence of failure when
tested with a force of 50 lbs. | None of the tray handles
broke loose showed
evidence of permanent
distortion, cracking, or
other evidence of failure
when tested with force of
50 lbs. |
| AAMI ST8:2013
TIR12:2010
ST77:2013/R2018
ISO
14937:2009/R2013
ISO 17665-
1:2006/R2013 | Sterilization
Validation of the
Stryker Mako
Triathlon Instrument
Set #1 with MICS
with EZ-TRAX™ | Verify that the device with
instrument set specific to
device and specified cycle
parameters achieve a
Sterility Assurance Level of
10-6. | The testing verified that a
Sterility Assurance Level
of 10-6 can be achieved
after processing Stryker
Mako Triathlon Instrument
Set #1 with MICS in a
steam pre-vacuum cycle
at 132C and 4 minutes. |
| AAMI ST77:2013
ISO
14937:2009/R2013
ISO 17665-
1:2006/R2013 | Sterilization
validation of Stryker
Mako Triathlon
Universal TKA with
EZ-TRAX™ | Verify that the device with
implants specific to device
and specified cycle
parameters achieve a
Sterility Assurance Level of
10-6. | The testing verified that a
Sterility Assurance Level
of 10-6 can be achieved
after processing Stryker
Mako Triathlon Universal
TKA01 and TKA03 in a
steam pre-vacuum cycle
at 132C and 4 minutes. |
Non-Clinical Performance Testing Table
9
10
Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is as safe, as effective, and performs as well as or better than the legally marketed EZ-TRAX™ Containment Device.