(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.
§ 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).