(103 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization compatibility, and containment function of the device, with no mention of AI or ML.
No
The device is described as an accessory for organizing, enclosing, reprocessing, transporting, and storing medical devices, and is not intended to maintain sterility on its own or to provide medical treatment.
No
Explanation: The device is described as a "Containment Device" used to organize, enclose, reprocess, transport, and store medical devices. It does not perform any diagnostic function.
No
The device description explicitly details physical components made of metals and thermoplastic polymers, and the performance studies focus on cleaning, sterilization, life cycle, and biocompatibility of these physical materials. There is no mention of software.
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 for organizing, enclosing, reprocessing, transporting, and storing medical devices. It is an accessory used in healthcare facilities for handling other medical devices.
- Device Description: The description focuses on the physical construction and materials of the containment device, designed for sterilization and protection of other medical devices.
- 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.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used for these purposes.
- Performance Studies: The performance studies described relate to cleaning, sterilization, life cycle testing, and biocompatibility – all relevant to a device used for handling and sterilizing other medical devices, but not characteristic of IVD performance studies (which would involve analytical and clinical performance related to specimen testing).
- Predicate Device: The predicate device is a "Transportation / Sterilization Cassette," which aligns with the function of a device for handling and sterilizing other medical devices, not an IVD.
In summary, the EZ-TRAX™ Containment Device is a medical device accessory used in the process of handling and sterilizing other medical devices, not a device used for in vitro diagnostic testing of human specimens.
N/A
Intended Use / Indications for Use
The EZ-TRAX™ 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-TRAX™ 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The EZ-TRAXTM Containment Device includes bases with dividers, lids, and brackets fabricated from a variety of materials commonly used to enclose, protect, and organize non-sterile medical devices.
The subject device is not intended to maintain sterility, but it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization wrap.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX TM 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 bases are fully perforated with an evenly distributed hole pattern. The sides of the bases are partially perforated. The trays are used with locking lids.
The bases / lid assembly was 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.
The following EZ-TRAXTM models / sizes are offered:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ TRAXTM | BASE.ASSY.AL.24.12.2 | (L) 22.97" (W) 11.18" (H) 2.04" |
| EZ TRAXTM | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |
The maximum load is 25 lbs and can be used with different types of medical devices including:
- Devices with lumens up to 500mm in length -
- Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors
- Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws
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 Data
Cleaning instructions were validated using microbiological, protein, and hemoglobin assays. Sterilization, including sterilant penetration and drying time, was performed according to ANSV/AAMI/ISO 17665-2. Life cycle (simulated usage) testing was performed, which inspection, component dimensional fit verification, and functional closure (lid- bottom latch) verification. Biocompatibility testing was performed using methods described in ANSI/AAMI/ISO 10993-5 (cytotoxicity). No clinical data were included in this submission.
As the EZ-TRAXTM Containment Device has been subjected to performance testing including:
Non-Clinical Performance Testing Table
| Test | Standard | Comments | Result |
|---|---|---|---|
| Material Compatibility | AAMI TIR12:2010 AAMI ST79:2017 AAMI ST81:2004/R2016 ISO 17665-1:2006/R2013 | Material compatibility pre-vacuum 132C for 4 minutes – Mechanical Washing and Steam Sterilization. The testing subjected the EZ-TRAXTM 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 ASTM F32018-18 ASTM F3293-18 | The mechanical cleaning validation of the EZ-TRAXTM concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAXTM containment system to a hemoglobin level less than 2.2 μg/cm2 per device. | Passed |
| Mechanical Cleaning Validation – Protein Analysis | AAMI TIR30:2011 ASTM F32018-18 ASTM F3293-18 | The mechanical cleaning validation of the EZ-TRAXTM protein concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ- TRAXTM to a protein level less than 6.4 μg/cm2 per device. | Passed |
| MEM Elution Cytotoxicity | ISO 10993-5:2009 / R2014 | The cytotoxicity testing was conducted per ISO 10993- 5:2009/(R)2014 and concluded that EZ-TRAXTM 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 | The sterilization validation of the EZ- TRAXTM 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 AAMI ST79:2017 | The thermal profile study of the EZ- TRAXTM included pre-vacuum steam 132C for 4 minutes. The study demonstrated that adequate sterilant penetration can be achieved. The EZ- TRAXTM 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. | Passed |
| Drying Time Test | AAMI ST77:2013 | The study concluded that the EZ- TRAXTM meets or exceeds the minimum acceptance criteria for dry time of 10 minutes. | Passed |
| Handle 100 lbs force test | AAMI ST77:2013 | 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 on each handle. The study concluded that the EZ- TRAXTM can carry a minimum of four times maximum recommended weight of 25 lbs without deforming, cracking, or exhibiting other evidence of damage. | Passed |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility Assurance Level (SAL) of 10-6
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.
Medtronic Transportation / Sterilization Cassettes (K152241)
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 23, 2019
K1 Medical LLC % Joseph Azary Regulatory Consultant K1 Medical Technologies 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K192487
Trade/Device Name: EZ-TRAX™ Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 24, 2019 Received: November 27, 2019
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.
1
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 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 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.
CAPT. Elizabeth Claverie Williams, M.S. 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) K192487
Device Name
EZ-TRAX™ Containment Device
Indications for Use (Describe)
The EZ-TRAXIM 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-TRAX™ 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.
Validated Cycle Times for Dynamic Air Removal Steam Sterilization Cycles
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air | |||
| Removal | 270° F/ 132° C | 4 minutes | 10 minutes |
Sterilization validations included a worst case EZ-TRAX™ 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-TRAX" " Containment Device + sterile barrier system + medical device load) as a worst case challenge to the system. Healthcare facilities should not exceed 25 pounds (EZ-TRAXIM Containment Device + sterile barrier system + medical device load).
The EZ-TRAX™ is offered in the following sizes:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ-TRAXTM | BASE.ASSY.AL.24.12.2 | (L) 22.97" (W) 11.18" (H) 2.04" |
| EZ-TRAXTM | 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)
ZOver-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
3
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4
510(K) SUMMARY
K1 Medical LLC's EZ-TRAX'M Containment Device K192487
Submitter
K1 Medical LLC 56 Newton Road Woodbridge, CT 06525 Contact Person: Joseph Azary, Regulatory Consultant
Phone: 203-242-6670
Date Prepared: December 21, 2019
Name of Device: EZ-TRAXTM 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: Medtronic Transportation / Sterilization Cassettes (K152241)
Intended Use / Indications for Use
The EZ-TRAX™ 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-TRAX™ 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.
Validated Cycle Times for Dynamic Air Removal Steam Sterilization Cycles
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Dynamic Air | |||
| Removal | 270° F/ 132° C | 4 minutes | 10 minutes |
Sterilization validations included a worst case EZ-TRAX™ 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 Device + sterile barrier system + medical device load) as a worst case challenge to the system. Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + sterile barrier system + medical device load).
5
Device Description
The EZ-TRAXTM Containment Device includes bases with dividers, lids, and brackets fabricated from a variety of materials commonly used to enclose, protect, and organize non-sterile medical devices.
The subject device is not intended to maintain sterility, but it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization wrap.
The subject device protects the interior components during transportation, and storage.
The EZ-TRAX TM 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 bases are fully perforated with an evenly distributed hole pattern. The sides of the bases are partially perforated. The trays are used with locking lids.
The bases / lid assembly was 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.
The following EZ-TRAXTM models / sizes are offered:
| Brand Name | Model | Dimensions |
|---|---|---|
| EZ TRAXTM | BASE.ASSY.AL.24.12.2 | (L) 22.97" (W) 11.18" (H) 2.04" |
| EZ TRAXTM | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |
The maximum load is 25 lbs and can be used with different types of medical devices including:
- Devices with lumens up to 500mm in length -
- -Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors
- -Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws
6
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K1 Medical LLC | |||
| EZ-TRAXTM Containment | |||
| Device K192487 | Medtronic Transportation / | ||
| Sterilization Cassettes K152241 | |||
| Indications | |||
| for Use | 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. | |||
| The following parameters | |||
| and cycles have been | |||
| validated to attain sterility | |||
| assurance level (SAL) of | |||
| 10-6. | |||
| Cycle Times for Dynamic Air | |||
| Removal Steam Sterilization | |||
| Cycles | |||
| 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 Device
- sterile barrier | Intended for use in healthcare
facilities to organize, enclose,
sterilize, transport, and store
medical devices and other
instrumentation between surgical
and other medical uses. The system
is not intended on its own to
maintain sterility; it is intended to
be used in conjunction with a
legally marketed, validated, FDA-
cleared sterilization wrap.
Sterilization validations included
implants and common surgical
instruments such as rasps, drivers,
trials, handles, inserters, probes,
drills, etc. The validated total
weight of 28.4 lbs. The validated
worst case loading configuration
included the following worst case
lumen dimensions 363 x 1.575mm
and 247.5 x 4.1mm.
Cycle: Gravity Displacement
Temperature: 250F, 270F, and
275F Exposure Time: 30, 15, and
10 minutes Min Dry Time: 30
minutes
Cycle: Dynamic Air Removal
Temperature: 270F and 275F
Exposure Time: 4 and 3 minutes | Similar |
| | | | |
| | system + medical | | |
| | device load) as a | | |
| | worst case challenge | | |
| | to the system. | | |
| | Healthcare | | |
| | facilities should | | |
| | | | |
| | not exceed 25 | | |
| | pounds (EZ- | | |
| | TRAXTM | | |
| | Containment | | |
| | Device + sterile | | |
| | barrier system + | | |
| | medical device | | |
| | load). | | |
| Fundamental | Sterilization Cassette | Sterilization Cassette | Same |
| Scientific | | | |
| Technology | | | |
| Product Code | KCT | KCT | Same |
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| Material
Composition | Thermoplastic polymers,
Aluminum,
and stainless steel | Thermoplastic polymers, Aluminum,
and stainless steel | Same |
| Design | Base, lid with locking latch and
individual inserts | Base, lid with locking latch and
individual inserts | Same |
| Dimensions | Worst case 24 x 12 x 2.4" | Worst case 22.75 x 11.26 x 5.51" | Similar |
| Configuration | Perforated bases, lids and inserts | Perforated bases, lids and inserts | Same |
| Air Permeance | Yes | Yes | Same |
| Percent
Perforation | Evenly distributed pattern | Evenly distributed hole pattern | Same |
| Sterilization
Method | Dynamic Air Removal | Dynamic Air Removal
Gravity Displacement | Similar |
| Sterilization
Parameters | Dynamic Air
Removal
Temperature: 270F
/ 132C Exposure
Time: 4 minutes
Drying Time: 10
minutes | Gravity Displacement
250F, 30 minutes, and 30 minutes
dry
270F, 15 minutes, and 30 minutes
dry
275F, 10 minutes, and 30 minutes
dry
Dynamic Air Removal
270F, 4 minutes, and 30 minutes
dry
275F, 3 minutes, and 30 minutes
dry | Similar |
| Reusable | Yes | Yes | Same |
| Microbial
Barrier
Properties | Used with FDA approved sterile
barrier system | Used with FDA approved
sterilization wrap | Same |
| Material
Compatibility | Materials compatible with
sterilization method | Materials compatible with
sterilization method | Same |
| Toxicological | Biocompatible | Biocompatible | Same |
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
7
8
The following technological differences exist between the subject and predicate devices:
- The predicate device has additional processing parameters
Summary of Technological Characteristics
The subject device is composed of anodized aluminum, stainless steel and thermoplastic polymers. The base and lid is perforated with an evenly distributed pattern and designed to be used for sterilization via steam sterilization. The device is designed in such a way to withstand reported sterilization cycles.
Non-Clinical Performance Data
Cleaning instructions were validated using microbiological, protein, and hemoglobin assays. Sterilization, including sterilant penetration and drying time, was performed according to ANSV/AAMI/ISO 17665-2. Life cycle (simulated usage) testing was performed, which inspection, component dimensional fit verification, and functional closure (lid- bottom latch) verification. Biocompatibility testing was performed using methods described in ANSI/AAMI/ISO 10993-5 (cytotoxicity). No clinical data were included in this submission.
As the EZ-TRAXTM Containment Device has been subjected to performance testing including:
9
Non-Clinical Performance Testing Table
| Test | Standard | Comments | Result |
|---|---|---|---|
| Material | |||
| Compatibility | AAMI TIR12:2010 | ||
| AAMI ST79:2017 | |||
| AAMI ST81:2004/R2016 | |||
| ISO 17665-1:2006/R2013 | Material compatibility pre-vacuum 132C for 4 minutes – | ||
| Mechanical Washing and | |||
| Steam Sterilization. | |||
| The testing subjected the EZ-TRAXTM 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 | ||
| ASTM F32018-18 | |||
| ASTM F3293-18 | The mechanical cleaning validation of | ||
| the EZ-TRAXTM concluded that the | |||
| manufacturer's cleaning instructions are | |||
| efficacious for removing gross amounts | |||
| of soil from the EZ-TRAXTM | |||
| containment system to a hemoglobin | |||
| level less than 2.2 μg/cm2 per device. | Passed | ||
| Mechanical Cleaning | |||
| Validation | |||
| – Protein Analysis | AAMI TIR30:2011 | ||
| ASTM F32018-18 | |||
| ASTM F3293-18 | The mechanical cleaning validation of | ||
| the EZ-TRAXTM protein concluded | |||
| that the manufacturer's cleaning | |||
| instructions are efficacious for removing | |||
| gross amounts of soil from the EZ- | |||
| TRAXTM to a protein level less than | |||
| 6.4 μg/cm2 per device. | Passed | ||
| MEM Elution | |||
| Cytotoxicity | ISO 10993-5:2009 / | ||
| R2014 | The cytotoxicity testing was | ||
| conducted per ISO 10993- | |||
| 5:2009/(R)2014 and concluded that | |||
| EZ-TRAXTM requirements of the | |||
| test and are NOT considered to have | |||
| a cytotoxic potential. | Passed | ||
| Test | Standard | Comments | Result |
| Sterilization | |||
| Validation | AAMI ST77:2013 | ||
| ISO 14937:2009 | |||
| AAMI ST8:2013 | The sterilization validation of the EZ- | ||
| TRAXTM 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 | ||
| AAMI ST79:2017 | The thermal profile study of the EZ- | ||
| TRAXTM included pre-vacuum steam | |||
| 132C for 4 minutes. The study | |||
| demonstrated that adequate sterilant | |||
| penetration can be achieved. The EZ- | |||
| TRAXTM 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. | Passed | ||
| Drying Time Test | AAMI ST77:2013 | The study concluded that the EZ- | |
| TRAXTM meets or exceeds the minimum | |||
| acceptance criteria for dry time of 10 | |||
| minutes. | Passed | ||
| Handle 100 lbs | |||
| force test | AAMI ST77:2013 | 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 on each handle. | |||
| The study concluded that the EZ- | |||
| TRAXTM can carry a minimum of four | |||
| times maximum recommended weight of 25 | |||
| lbs without deforming, cracking, or | |||
| exhibiting other evidence of damage. | Passed |
10
Conclusions
The EZ-TRAXTM Containment Device has the same intended use and principles of operation, and very similar indications for use and technological characteristics, as the predicate device. The minor differences between the EZ-TRAXTM Containment Device and the predicate device does not alter its therapeutic purpose or raise new issues of safety or effectiveness, and performance data demonstrate that the EZ-TRAX™ Containment Device is as safe and effective as the predicate device. Thus, the EZ-TRAX™ Containment Device is substantially equivalent to the Medtronic Transportation / Sterilization Cassettes (K152241).
K1 Medical concludes that based on the nonclinical tests performed that the subject device, EZ- TRAXTM Containment Device, is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, Medtronic Transportation / Sterilization Cassettes (K152241), Class II (21 CFR 880.6850), product code KCT.