(780 days)
The Riley Medical MetaPak Multi-Purpose Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.
The Riley Medical MetaPak Multi-Purpose Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
The Riley Medical MetaPak Multi-Purpose Instrument Tray (MetaPak Instrument Tray) is an instrument container consisting of a rectangular box base with a cover that fastens to the base using latches on the short ends. The following sizes of bases and lids are available:
- Tall hase and lid: 22" x 10" x 6" .
- Short base and lid: 22" x 10" x 4" .
- Extra long base and lid: 26" x 10" x 6" .
Insert trays can be stacked in the container base to increase the instrument-carrying capacity of the container. The following insert sizes are available:
- . Full insert: 21" x 9.5" x 2.5"
- Small insert: 10" x 9.5" x 2.5" t
Protective mats are available that can be placed on the insert trays and in the bottom of the container base to stabilize and protect the instruments. Slotted instrument bars and holders are also available to organize, stabilize, and protect the instruments in the container.
The MetaPak Instrument Tray is identical to the predicate MultiPak Instrument Tray, cleared for marketing as K944025, with the exception of a modification to the materials for the container base. The original MultiPak Instrument Tray container base was constructed entirely of Radel plastic. The MetaPak Instrument Tray container base will be offered in aluminum, stainless steel, and an aluminum/Radel combination with the long sides made of aluminum and short sides made of Radel plastic.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray:
Analysis of Acceptance Criteria and Performance Study for Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray
This submission describes a medical device, the MetaPak Multi-Purpose Instrument Tray, which is intended for organizing, sterilizing, transporting, and storing surgical instruments. The key performance aspect is the ability to achieve sterilization conditions within the tray using pre-vacuum steam and ethylene oxide sterilization cycles.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterilization Conditions Achieved | Confirmed that sterilization conditions were achieved in fully loaded MetaPak Instrument Trays using pre-vacuum steam and ethylene oxide sterilization processes. |
| Sterilization Compatibility (Pre-vacuum Steam) | Confirmed compatible with pre-vacuum steam sterilization cycles. |
| Sterilization Compatibility (Ethylene Oxide) | Confirmed compatible with ethylene oxide sterilization cycles. |
| Functionality with fully loaded trays | Sterilization conditions were achieved in fully loaded MetaPak Instrument Trays, including one full insert and two half inserts, protective mats, and accessories. |
| Functionality across material compositions | Sterilization conditions were achieved in trays of all three container base material compositions (aluminum, stainless steel, and aluminum/Radel combination). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical "sample size" for the performance testing in terms of individual trays tested or the number of sterilization cycles performed. It broadly states "Validation testing was conducted."
- Test Set Size: Not explicitly stated as a numerical value for individual test units or cycles. It refers to "MetaPak Instrument Trays of all three container base material compositions containing one full insert and two half inserts, protective mats, and accessories." This implies at least one of each material composition, fully loaded.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal validation by Riley Medical, Inc. The study is retrospective in the sense that the testing was performed, and then the results were submitted for clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to functional performance testing of a sterilization tray, as "ground truth" here is objective (i.e., whether sterilization was achieved or not). The assessment would typically involve laboratory analysis (e.g., biological indicators, chemical indicators) rather than expert human interpretation of complex images or clinical data. Therefore, no information is provided on "experts" in this context.
4. Adjudication Method for the Test Set
Not applicable. The determination of whether sterilization conditions were achieved would be based on objective laboratory methods, not subjective adjudication by human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant for this device. This study focuses on the physical performance of a sterilization tray, not the diagnostic accuracy or effectiveness of human readers using an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical instrument tray, not an algorithm or AI system. Its performance is entirely "standalone" in the sense that it functions based on its design and material properties, undergoing sterilization processes.
7. The Type of Ground Truth Used
The ground truth used for assessing sterilization achievement would be based on objective biological and/or chemical indicators used within the sterilization cycles. While not explicitly detailed, standard sterilization validation protocols involve placing biological indicators (e.g., spores of highly resistant microorganisms) and chemical indicators within the device and then testing for the inactivation of these organisms or changes in the chemical indicators after the sterilization cycle. The text states "confirmed that sterilization conditions were achieved," which implies such objective methods were employed.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).