(230 days)
FlashPak® is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement flash sterilization using a 10 minute cycle at 132° C and with pre-vacuum flash sterilization using a 4 minute cycle at 132° C. FlashPak is recommended for surface sterilization of stainless steel instruments and for lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
The FlashPak Container System consists of a family of rigid reusable containers that provide an effective sterilization packaging method for surgical instruments requiring flash steam sterilization. Each FlashPak system is comprised of an upper lid that seals by means of a silicone gasket and latches to a lower base creating a totally enclosed environment. A stainless steel wire basket is utilized inside the container to facilitate handling of sterilized items. The lid and base incorporate pressure actuated valves that open to allow sterilant to enter the container during the pressurization portion of the sterilization cycle and then close to seal the container once the cycle is over so the container and its contents can be removed from the sterilizer and immediately transported to the point of use without the risk of recontamination.
This is not an AI-enabled device. This is a medical device, specifically a sterilization container system, for which the submitted information confirms its substantial equivalence to a predicate device.
Therefore, questions regarding AI-specific elements such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established are not applicable.
Here's the relevant information based on the provided text for the FlashPak® Sterilization Container System:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are established by demonstrating that it functions as intended and is substantially equivalent to a legally marketed predicate device (K871202) by meeting applicable standards, specifically ANSI/AAMI ST77:2006 "Containment Devices for Reusable Medical Device Sterilization".
The "performance" section of the 510(k) summary (page 2) outlines the key performance aspects that were evaluated.
| Acceptance Criteria (Performance Aspect) | Reported Device Performance (New Device) | Discussion (Comparison to Predicate) |
|---|---|---|
| Sterilant Penetration (Sterilization Efficacy) | Gravity-displacement Cycle: 10 minutes at 132°C (270°F) for porous and cannulated devices. | |
| Dynamic-air-removal Cycle: 4 minutes at 132°C (270°F) for porous and cannulated devices. | ||
| Thermal mapping studies demonstrating container temperature closely matches sterilizer chamber. | Equivalent (to predicate's 10 min gravity, 5 min dynamic-air-removal cycles, and thermal mapping performance). The new device has a shorter dynamic-air-removal cycle. | |
| Microbial Barrier Properties (Packaging Integrity) | The container completely encapsulates the items sterilized inside and prevents recontamination during transport to the point of use immediately after sterilization. | Same as predicate |
| Material Compatibility | Materials used are compatible with the recommended sterilization method and cleansers. | Same as predicate |
| Toxicological Properties (Biocompatibility) | Cytotoxicity per ISO 10993-5. | |
| Irritation per ISO 10993-10. | Equivalent (to predicate which used medical grade polymers or stainless steel, with no patient contact). | |
| Drying Time | Intended for flash sterilization and immediate use, implying no specific drying time acceptance criterion for a separate dry storage period. | Same as predicate |
Study Information
The study demonstrating the device meets the acceptance criteria is a series of performance tests and validations adhering to the ANSI/AAMI ST77:2006 standard.
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Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test (e.g., number of containers tested, number of sterilization cycles). It states that "Testing to applicable standard, ANSVAAMI ST77:2006... has been completed with acceptable outcomes."
- Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing conducted by Symmetry Medical Inc. (the device manufacturer). This would typically be prospective testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is defined by passing specific physical, chemical, and biological performance tests according to established standards. This is not a diagnostic device requiring expert interpretation of results.
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Adjudication method for the test set: Not applicable. Test results are objectively measured against predefined criteria in the standard.
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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-enabled device and does not involve human readers interpreting data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used:
- Performance against established standards: The ground truth is determined by objective measurements and biological indicators (e.g., sterility assurance level for sterilization validation, absence of cytotoxicity/irritation for biocompatibility, physical integrity for handle strength/valve life) as defined in ANSI/AAMI ST77:2006 and ISO 10993 standards.
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The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and manufacturing process for the physical device are based on engineering principles and material science.
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How the ground truth for the training set was established: Not applicable. No training set is used for a physical medical device like this.
§ 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).