(103 days)
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.
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 provided text is a 510(k) summary for the EZ-TRAX™ Containment Device, which is a sterilization cassette. This document describes non-clinical performance data to demonstrate substantial equivalence to a predicate device, rather than a study involving human-in-the-loop performance or expert interpretation of AI output.
Therefore, many of the requested elements related to AI/human reader studies, expert ground truth establishment, adjudication methods, and training/test set sample sizes (as they pertain to AI model development) are not applicable to this submission.
However, I can extract information related to the acceptance criteria and the studies that prove the device meets these criteria in the context of device performance, specifically its ability to be cleaned, sterilized, and withstand repeated use.
Here's a breakdown of the applicable information:
Acceptance Criteria and Device Performance (Non-Clinical Study)
The EZ-TRAX™ Containment Device is a medical device accessory used for organization, reprocessing, transport, and storage of medical devices, specifically designed to withstand steam sterilization cycles. The performance studies detailed are validation tests to ensure the device itself can be effectively cleaned, sterilized, and remains functional over time.
1. Table of Acceptance Criteria & Reported Device Performance:
| Test Category | Specific Test / Criterion | Acceptance Criteria (Implied/Stated) |
|---|---|---|
| Material Compatibility | Material compatibility post repetitive cleaning and steam sterilization (25 cycles @ 132°C for 4 min) | No degradation or lack of functionality (e.g., permanent distortion, cracking, or other evidence of failure) after 25 reprocessing cycles. |
| Cleaning Validation | Mechanical Cleaning Validation – Hemoglobin residue | Hemoglobin level less than 2.2 μg/cm² per device after cleaning. |
| Mechanical Cleaning Validation – Protein analysis | Protein level less than 6.4 μg/cm² per device after cleaning. | |
| Biocompatibility | MEM Elution Cytotoxicity | Device must NOT be considered to have a cytotoxic potential (as per ISO 10993-5:2009/(R)2014). |
| Sterilization Efficacy | Sterilization Validation (pre-vacuum steam 132°C for 4 minutes with a medical device challenge set including lumens, conjoined/mated surfaces, cannulated items, and a total weight of 42 lbs) | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Thermal Profile Study (pre-vacuum steam 132°C for 4 minutes) | Demonstrate that adequate sterilant penetration can be achieved and the device can reach and maintain steady state thermal conditions throughout the exposure phase. | |
| Drying Efficacy | Drying Time Test | Meet or exceed the minimum acceptance criteria for dry time of 10 minutes. |
| Mechanical Strength | Handle 100 lbs force test (tested with 50 lbs on each handle, total 100 lbs force) | None of the tray handles break loose, show evidence of permanent distortion, cracking, or other evidence of failure. The device should be able to carry a minimum of four times the maximum recommended weight of 25 lbs (i.e., 100 lbs total) without deforming, cracking, or exhibiting other evidence of damage. |
Reported Device Performance: All tests listed above were reported as "Passed".
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the devices tested in these non-clinical performance studies (e.g., number of EZ-TRAX™ units). However, for material compatibility, it states "repetitive cleaning and sterilization processing for 25 reprocessing cycles." This implies each test subject underwent 25 cycles.
- Data Provenance: The studies are non-clinical, conducted as part of the device's development and regulatory submission. The document inherently suggests these were prospective, controlled laboratory studies. No country of origin for the data is explicitly mentioned, but it's part of a U.S. FDA submission (K1 Medical LLC, based in Woodbridge, CT).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This document describes non-clinical performance testing of a physical device. Ground truth, in this context, refers to measured physical and biological parameters (e.g., residual protein levels, sterility assurance levels, material integrity), established by standardized laboratory procedures and scientific instruments, not expert interpretation or consensus.
4. Adjudication Method for the Test Set:
- Not Applicable. This is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting data, typically in diagnostic studies. Here, the "ground truth" is determined by objective measurements meeting predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No. This is a non-clinical evaluation of a physical medical device (sterilization cassette), not an AI system that requires human reader interaction.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. The "standalone" performance here refers to the device's inherent ability to undergo cleaning and sterilization processes and maintain its integrity.
7. The type of ground truth used:
- Objective Measurement Data and Compliance with Standards. The ground truth for these tests was established through:
- Direct Analytical Measurements: For cleaning validation (hemoglobin, protein levels) and biocompatibility (cytotoxicity).
- Performance Metrics: For sterilization validation (achieving SAL 10⁻⁶), thermal profile (adequate sterilant penetration, steady-state thermal conditions), drying time (meeting minimum dry time), and mechanical strength (no deformation/failure under specified force).
- Adherence to Recognized Standards: Each test referenced relevant ISO, AAMI, and ASTM standards (e.g., ISO 10993-5, AAMI ST77, AAMI ST79, AAMI TIR30, ASTM F32018-18, ASTM F3293-18).
8. The sample size for the training set:
- Not Applicable. This refers to empirical testing of a physical device, not the training of an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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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.
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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
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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 AirRemoval | 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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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 AirRemoval | 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).
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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
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| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K1 Medical LLCEZ-TRAXTM ContainmentDevice K192487 | Medtronic Transportation /Sterilization Cassettes K152241 | ||
| Indicationsfor Use | The EZ-TRAXTMContainment Device isintended for use as anaccessory in healthcarefacilities to organize, enclose,reprocess, transport, and storemedical devices betweensurgical and other medicaluses. The EZ-TRAXTMContainment Device is notintended on its own tomaintain sterility; it isintended to be used inconjunction with a legallymarketed, validated, FDA-cleared sterile barrier system.The following parametersand cycles have beenvalidated to attain sterilityassurance level (SAL) of10-6.Cycle Times for Dynamic AirRemoval Steam SterilizationCyclesCycle: Dynamic AirRemoval Temperature:270F / 132C ExposureTime: 4 minutes DryingTime: 10 minutesSterilization validationsincluded a worst case EZ-TRAXTM ContainmentDevice and a medical devicechallenge set comprising of:- Lumen dimensions(3) 1mm x 500mm- Conjoined/matedsurfaces: forceps,clamps, bendingpliers, ratchethandles, retractors- Cannulated: drillbits, taps, guides,screwdrivers,cannulated screws- A total weight of 42lbs comprising of(EZ-TRAXTMContainment Device+ sterile barrier | Intended for use in healthcarefacilities to organize, enclose,sterilize, transport, and storemedical devices and otherinstrumentation between surgicaland other medical uses. The systemis not intended on its own tomaintain sterility; it is intended tobe used in conjunction with alegally marketed, validated, FDA-cleared sterilization wrap.Sterilization validations includedimplants and common surgicalinstruments such as rasps, drivers,trials, handles, inserters, probes,drills, etc. The validated totalweight of 28.4 lbs. The validatedworst case loading configurationincluded the following worst caselumen dimensions 363 x 1.575mmand 247.5 x 4.1mm.Cycle: Gravity DisplacementTemperature: 250F, 270F, and275F Exposure Time: 30, 15, and10 minutes Min Dry Time: 30minutesCycle: Dynamic Air RemovalTemperature: 270F and 275FExposure 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 |
| MaterialComposition | Thermoplastic polymers,Aluminum,and stainless steel | Thermoplastic polymers, Aluminum,and stainless steel | Same |
| Design | Base, lid with locking latch andindividual inserts | Base, lid with locking latch andindividual 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 |
| PercentPerforation | Evenly distributed pattern | Evenly distributed hole pattern | Same |
| SterilizationMethod | Dynamic Air Removal | Dynamic Air RemovalGravity Displacement | Similar |
| SterilizationParameters | Dynamic AirRemovalTemperature: 270F/ 132C ExposureTime: 4 minutesDrying Time: 10minutes | Gravity Displacement250F, 30 minutes, and 30 minutesdry270F, 15 minutes, and 30 minutesdry275F, 10 minutes, and 30 minutesdryDynamic Air Removal270F, 4 minutes, and 30 minutesdry275F, 3 minutes, and 30 minutesdry | Similar |
| Reusable | Yes | Yes | Same |
| MicrobialBarrierProperties | Used with FDA approved sterilebarrier system | Used with FDA approvedsterilization wrap | Same |
| MaterialCompatibility | Materials compatible withsterilization method | Materials compatible withsterilization method | Same |
| Toxicological | Biocompatible | Biocompatible | Same |
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
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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:
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Non-Clinical Performance Testing Table
| Test | Standard | Comments | Result |
|---|---|---|---|
| MaterialCompatibility | AAMI TIR12:2010AAMI ST79:2017AAMI ST81:2004/R2016ISO 17665-1:2006/R2013 | Material compatibility pre-vacuum 132C for 4 minutes –Mechanical Washing andSteam Sterilization.The testing subjected the EZ-TRAXTM to repetitive cleaning andsterilization processing for 25reprocessing cycles at parametersthat represented the worst caseconditions. Chemical indicatorswere utilized to demonstrate steampenetration. The study found nodegradation or lack of functionalityafter 25 cycles. | Passed |
| Mechanical CleaningValidation– Hemoglobin | AAMI TIR30:2011ASTM F32018-18ASTM F3293-18 | The mechanical cleaning validation ofthe EZ-TRAXTM concluded that themanufacturer's cleaning instructions areefficacious for removing gross amountsof soil from the EZ-TRAXTMcontainment system to a hemoglobinlevel less than 2.2 μg/cm2 per device. | Passed |
| Mechanical CleaningValidation– Protein Analysis | AAMI TIR30:2011ASTM F32018-18ASTM F3293-18 | The mechanical cleaning validation ofthe EZ-TRAXTM protein concludedthat the manufacturer's cleaninginstructions are efficacious for removinggross amounts of soil from the EZ-TRAXTM to a protein level less than6.4 μg/cm2 per device. | Passed |
| MEM ElutionCytotoxicity | ISO 10993-5:2009 /R2014 | The cytotoxicity testing wasconducted per ISO 10993-5:2009/(R)2014 and concluded thatEZ-TRAXTM requirements of thetest and are NOT considered to havea cytotoxic potential. | Passed |
| Test | Standard | Comments | Result |
| SterilizationValidation | AAMI ST77:2013ISO 14937:2009AAMI ST8:2013 | The sterilization validation of the EZ-TRAXTM included pre-vacuum steam132C for 4 minutes. The conclusion couldachieve a Sterility Assurance Level (SAL)of 10-6 after processing in the followingpre-vacuum steam sterilization cycle 132Cfor 4 minutes. | Passed |
| Thermal ProfileStudy | AAMI ST77:2013AAMI ST79:2017 | The thermal profile study of the EZ-TRAXTM included pre-vacuum steam132C for 4 minutes. The studydemonstrated that adequate sterilantpenetration can be achieved. The EZ-TRAXTM can reach and maintain a steadystate thermal conditions throughout theexposure phase when processed in thefollowing pre-vacuum steam sterilizationcycle 132C for 4 minutes. | Passed |
| Drying Time Test | AAMI ST77:2013 | The study concluded that the EZ-TRAXTM meets or exceeds the minimumacceptance criteria for dry time of 10minutes. | Passed |
| Handle 100 lbsforce test | AAMI ST77:2013 | None of the tray handles broke loose,showed evidence of permanent distortion,cracking or other evidence of failure whentested with a force of 50 lbs on each handle.The study concluded that the EZ-TRAXTM can carry a minimum of fourtimes maximum recommended weight of 25lbs without deforming, cracking, orexhibiting other evidence of damage. | Passed |
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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.
§ 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).