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510(k) Data Aggregation
(249 days)
POGO SCREW INSTRUMENTATION TRAY
The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Sterilization Cycle Parameters
Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes
or
Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes
The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap.
The POGO Screw Instrumentation Tray is a device designed to enclose and protect medical device instrumentation, facilitate the sterilization process by allowing sterilant penetration and air removal, and maintain the sterility of the internal components when used with an FDA-cleared sterilization wrap. The device's performance was validated through sterilization validation testing, demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: | The POGO Screw Instrumentation Tray is intended to enclose medical devices during steam sterilization. |
| Technological Characteristics (Design, Materials): | The design and materials (perforated plastic tray from thermoplastic RADEL, stainless steel latch, silicone containment brackets) allow free steam passage. Substantially equivalent to the predicate device in size and volume. |
| Sterilization Efficacy (Pre-vacuum Steam): | Capable of effective sterilization at 132°C for 4 minutes exposure with 30 minutes drying time, when used with an FDA-cleared sterilization wrap. |
| Sterilization Efficacy (Gravity Steam): | Capable of effective sterilization at 132°C for 15 minutes exposure with 80 minutes drying time, when used with an FDA-cleared sterilization wrap. |
| Equivalence to Predicate Device (PolyVac Tray K040223): | Demonstrated substantial equivalence in design, materials, construction, and intended use to the predicate device. |
| Compliance with Performance Standards: | Met the requirements of ISO 11134. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size for the test set used in the sterilization validation. However, it indicates Sterilization Validation was conducted. The data provenance is not specified, but it would typically be prospective testing performed by the manufacturer, FxDEVICES, in a controlled lab environment to assess the device's ability to withstand and facilitate sterilization effectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For sterilization validation, the "ground truth" is typically established through recognized industry standards (e.g., ISO 11134) and validated laboratory protocols, rather than expert consensus on individual cases. The expertise lies in the validation engineers and microbiologists conducting the testing and interpreting the results against established sterilization efficacy parameters.
4. Adjudication Method for the Test Set:
Not applicable in this context. Sterilization validation involves objective measurements of sterility assurance levels (SAL) based on challenge tests (e.g., biological indicators) and physical parameters, not subjective interpretation 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 device is an instrumentation tray for sterilization, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product, not an algorithm. Its performance is assessed through its physical properties and its ability to facilitate a sterilization process.
7. The Type of Ground Truth Used:
The ground truth for sterilization validation is based on:
- Sterility Assurance Level (SAL): Objective, quantifiable evidence that the sterilization process has achieved a predefined probability of a single viable microorganism being present on an item after sterilization (typically 10^-6 for critical devices).
- Compliance with Industry Standards: Adherence to recognized standards like ISO 11134 for steam sterilization, which outlines the requirements for the development, validation, and routine control of a sterilization process for medical devices. This involves using biological indicators and physical parameter monitoring.
- Predicate Device Equivalence: The performance of the new device is compared to a legally marketed predicate device (PolyVac Tray K040223) that has already demonstrated safety and effectiveness for the same intended use.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device.
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