(90 days)
Not Found
No
The device description and performance studies focus on the physical properties, cleaning, and sterilization of a containment device for surgical instruments. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a containment system for organizing and reprocessing hip system devices used in surgery, not a therapeutic device itself.
No
The device is an accessory for organizing, enclosing, reprocessing, transporting, and storing other medical devices, specifically hip system devices. It does not perform any diagnostic function.
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. The performance studies also focus on material compatibility, cleaning, sterilization, and mechanical strength, all related to a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses." This describes a device used for handling and preparing surgical instruments, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the containment device (materials, perforations, design for sterilization) and its function in protecting and facilitating the reprocessing of surgical instruments. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or assays
The device is designed to support the use of surgical implants and instruments by facilitating their organization, transport, and sterilization. This falls under the category of surgical accessories or instrument reprocessing equipment, not in vitro diagnostics.
N/A
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 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 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 containment devices).
The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is offered in the following size:
Brand Name: EZ-TRAX™
Model: BASE.ASSY.AL.24.12.2.4
Dimensions: (L) 22.97" (W) 11.18" (H) 2.44"
Dry Weight: 4.25 lbs.
Product codes
KCT
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 interior 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 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 Performance Testing:
- Material Compatibility (AAMI TIR12:2010, AAMI ST81:2004/R2016, ISO 17665-1:2006/R2013): Verified the device did not degrade or lose functionality after 25 reprocessing cycles at worst case conditions. Result: Passed. Chemical indicators were utilized to demonstrate steam penetration. The study found no degradation or lack of functionality after 25 cycles.
- Mechanical Cleaning Validation - Hemoglobin (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18): Verified 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. Result: Passed.
- Mechanical Cleaning Validation - Protein Analysis (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18): Verified 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. Result: Passed.
- MEM Elution Cytotoxicity (ISO 10993-5:2009 / R2014): Verified that the device meets requirements of ISO 10993-5 and is not considered cytotoxic. Result: Passed.
- Sterilization Validation (AAMI ST77:2013, ISO 14937:2009, AAMI ST8:2013): Verified 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. Result: Passed.
- Thermal Profile Study (AAMI ST77:2013): Verified that adequate sterilant penetration can be achieved when processed in pre-vacuum steam sterilization cycle of 132C (270F) for 4 minutes. Result: Passed. 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.
- Drying Time Test (AAMI ST77:2013, ISO 17665-1:2006/R2013): Verified 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. Result: Passed.
- Handle 100 lbs force test (AAMI ST77:2013): Verified that tray handles did not break or show evidence of distortion, cracking or other failure following testing with force of 50 lbs. Result: Passed. 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 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): Verified that a Sterility Assurance Level of 10-6 can be achieved after processing in pre-vacuum steam. Result: Passed. The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing EZ-TRAX™ G7 Acetabular System / Taperloc Complete Hip System 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): 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.
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
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 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
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,
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
2
Indications for Use
510(k) Number (if known)
Device Name
EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
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 | 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.
3
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4
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.
5
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.
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 Air | |||
| Removal | 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. -
6
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 |
7
VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
PROVIDED BELOW IS A TECHNOLOGICAL COMPARISON OF THE SUBJECT DEVICE TO THE PREDICATE DEVICE.
| TRADENAME | K1 Medical LLC
EZ-TRAXTM Zimmer G7
Acetabular System / Taperloc
Complete Hip System
Containment Device
K213209 | K1 Medical LLC
EZ-TRAXTM Persona Knee
Containment Device
K211007 | 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 2.4" | 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 | Used with FDA cleared sterile
barrier system | Used with FDA cleared sterile barrier
system | Identical |
| Material
Compatibility | Materials compatible with sterilization
method | Materials compatible with sterilization
method | 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 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 ™ 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 Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes
Sterilization 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 |
8
9
| 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: | |
10
| 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 Knee
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" (Dry
Weight 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.
11
NON-CLINICAL PERFORMANCE TESTING TABLE VIII.
| 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 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 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 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 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 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. | 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 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 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 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 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 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 test
AAMI 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 with
force of 50 lbs. | | |
| Sterilization Validation of the
EZ-TRAXTM Zimmer G7
Acetabular & Taperloc
Containment Device
(unorganized) steam pre-
vacuum 132C (270F) for 4
minutes. | 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 EZ-TRAXTM G7
Acetabular System / Taperloc Complete
Hip System Containment Device in a steam
pre-vacuum cycle at 132C (270F) and 4.0
minutes. | Passed |
| AAMI ST8:2013
TIR12:2010
ST77:2013/R2018
ST79:2017
ISO 14937:2009/R2013
ISO 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).