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510(k) Data Aggregation
(141 days)
CrossRoads Tray System
The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The CrossRoads Tray System are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization for the worst-case CrossRoads Tray System included surgical instruments such as drills, inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Tray System were validated for a maximum load of 8.5 lbs (tray + instruments).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Prevacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Drying time: 20 minutes
The tray is 20.60" length x 9.80" width x 2.00" depth.
The subject CrossRoads Tray System is a reusable sterilization tray or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. All components are perforated for steam penetration. The tray can hold implants and instruments such as inserters, K-wire guides, fixation pins, reamers and ratcheting handles.
The tray is 20.60" length x 9.80" width x 2.00" depth.
The CrossRoads Tray System tray is manufactured from aluminum conforming to ASTM B029, silicone, 304 stainless steel conforming to ASTM A240 and ASTM A313, 18-8 stainless steel, 17-4 stainless steel 304 stainless steel, and 316 stainless steel.
This document pertains to the CrossRoads Tray System, a reusable sterilization tray for medical devices. The primary study presented verifies the sterilization efficacy and cleanability of the tray and its contents, along with its biocompatibility.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | No growth on half cycles. No moisture on full drying cycle. | In three pre-vacuum autoclave cycles, 2 minutes at 270°F was sufficient to sterilize the biological indicators (BI's) in the DynaBunion Non-Sterile Set, 15NS-4800, when seeded with (8) BI carriers impregnated with Geobacillus stearothermophilus and (2) SporView self-contained BI's. As this was a half-cycle validation, the 4-minute full cycle exposure time is expected to provide the required Sterility Assurance Level (SAL) of 10-6. Positive controls showed growth for all three cycles, and negative controls remained negative (no growth). There was no evidence of moisture on or within the sterilized package, wrap, and instruments, and no recorded weight gain after each pre-vacuum sterilization cycle. |
| Reprocessing (Instruments) | Meets AAMI TIR-30 guideline acceptance criteria of $\le$ 6.4µg/cm² protein residuals and $\le$ 2.2µg/cm² for hemoglobin residuals. | Three (3) cleaning cycles were performed on 5 instruments and met the acceptance criteria. |
| Reprocessing (Tray) | Meets AAMI TIR-30 guideline acceptance criteria of $\le$ 6.4µg/cm² protein residuals and $\le$ 2.2µg/cm² for hemoglobin residuals. | Three (3) cleaning cycles were performed on the tray and met the acceptance criteria. |
| Biocompatibility | Pass is a score of less than 2. | No cytotoxic reaction was observed (Grade 0) on the ratchet handle for any sample extracts at 24 and 48 hours contact. Positive controls were positive (Grade 4) at 24 and 48 hours. |
2. Sample size used for the test set and the data provenance:
- Sterilization Efficacy: The test involved Geobacillus stearothermophilus biological indicators (8 BI carriers and 2 SporView self-contained BIs) placed in areas deemed most difficult for sterilant penetration, within the CrossRoads Tray System containing a maximum load. The specific DynaBunion Non-Sterile Set, 15NS-4800, was used as the representative load. The test was performed over three pre-vacuum autoclave cycles. This appears to be a prospective test conducted specifically for this device submission. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA given the FDA submission.
- Reprocessing (Cleanability):
- Instruments: Three cleaning cycles were performed on 5 instruments.
- Tray: Three cleaning cycles were performed on the tray.
- This is a prospective test. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA.
- Biocompatibility: The test involved the ratchet handle component of the tray system. The specific number of samples tested is not explicitly stated, but "any of the sample extracts at 24 and 48hrs contact" implies multiple extracts were tested. This is a prospective test. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of study does not involve expert readers establishing ground truth in the way a medical image interpretation study would. Ground truth in these types of performance tests (sterilization, cleaning, biocompatibility) is established through standardized laboratory methods and analytical measures (e.g., assessing microbial growth, measuring residual protein/hemoglobin levels, observing cytotoxic reactions) performed by qualified laboratory personnel following established protocols (e.g., ANSI/AAMI/ISO 14937:2013, AAMI TIR12-2010, AAMI TIR30-2011, ANSI/AAMI/ISO 10993-5:2009). The "experts" are the scientists and technicians conducting these validated tests. Their qualifications are inherent in the adherence to these recognized standards.
4. Adjudication method for the test set:
Not applicable for these types of laboratory performance tests. The results are based on objective measurements against predefined acceptance criteria, not subjective human assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted device or a diagnostic device involving human readers or case interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (sterilization tray), not an algorithm or AI system. The tests evaluate the physical performance of the tray itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for these tests is based on objective laboratory measurements and adherence to established scientific and regulatory standards:
- Sterilization Efficacy: Ground truth is the observable absence of microbial growth in biological indicators after sterilization, confirming a 6-log reduction in the indicator organism as required for a Sterility Assurance Level (SAL) of 10-6.
- Reprocessing (Cleanability): Ground truth is the quantitative measurement of residual protein and hemoglobin levels on the instruments and tray, falling below the specified AAMI TIR-30 guideline acceptance criteria.
- Biocompatibility: Ground truth is the absence of a cytotoxic reaction (Grade 0 score) in in-vitro tests, indicating the material does not harm cells.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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