(153 days)
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55℃ (130 ° F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=109) of the enclosed device until used.
These pouches are manufactured from a medical grade paper and plastic film that is aged to are heat sealed on three sides. The fourth side has an addesive tape that is wed to seal the pouch or heat-seated by the heat-seel machine. The modical brade pager conforms to recognized material standards and can be steellized by steam or conforms fo recognized material starkers childreators has the same intended use, Essential Component, Raw material, Sterillzator method, manufacturing mellods and same technological characteristics as these predical testing of Substantial equivalent to the predicate device was established by physical testing of the medical grade paper (pressure drop vs. five and fifthelion officiency) and tilln (thickness, tensile strength and elongation) from non-stermanner of these linished ellygene oxice sterlilzed linished devices, as well as, performance diatribution for devices (seal strength, package burst, dye migralian cride sterfitzalion for steam and ethytene oxide sterlilzabions, ataam and ethylene oxide storibalion of shoum and einytene balde bennizators meet the performance requirements of ANSI/AAMMSO 11140-1:2005 standard entitled "Sterlizztion of health caro products-ANOMANICAL indications- Part 1: General requirements".
The pouches are manufactured from modical grade paper that is the fourth side an to laminated film on the left, right, and bottom of pouch. The fourth side has an edhealve tape that is used to that is used to see to see to section dealers. The pouches heat-seal machine prior to sterlization of the enclosed medical devices were processed contain extennal chemical indicators used to indicato the pouches were processed to via steam or EIO sterilization. See Chatper 10 for a detailed device description via steam or ENO sterility achievement and compatibility with stearn and EIO starilization processes and Bill of Materialis.
The provided document is a 510(k) Premarket Notification for a medical device: "Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria in the way a new drug or high-risk device might.
Therefore, the study outlined here is a substantial equivalence comparison study against predicate devices, rather than a traditional efficacy study with AI components. The "acceptance criteria" are effectively demonstrating that the device performs similarly or identically to the predicate device across various parameters and meets relevant performance standards.
Here's an attempt to extract the information requested within the context of this 510(k) submission:
Acceptance Criteria and Reported Device Performance
The study aims to demonstrate substantial equivalence to predicate devices (Winner Medical USA, Inc. - K062704 and K051242). The "acceptance criteria" are implicitly met if the "Proposed Device" performs at least as well as, or comparably to, the "Predicate Device" in the specified tests and adheres to the relevant standards.
| Acceptance Criteria (Demonstrates Substantial Equivalence via) | Reported Device Performance (Summary from Submission) |
|---|---|
| Sterilant Penetration | Demonstrated substantial equivalence to predicate devices. |
| Drying Time | Demonstrated substantial equivalence to predicate devices. |
| Aeration | Demonstrated substantial equivalence to predicate devices. |
| Biocompatibility | Demonstrated substantial equivalence to predicate devices. |
| Package Integrity | Demonstrated substantial equivalence to predicate devices. |
| Material Compatibility | Demonstrated substantial equivalence to predicate devices. |
| Sterility Maintenance | Demonstrated substantial equivalence to predicate devices. |
| Chemical Indicator Efficacy (meets ISO 11140-1:2005) | Meets the performance requirements of ANSI/AAMISO 11140-1:2005 standard. |
| Physical testing of medical grade paper (pressure drop vs. time, filtration efficiency) | Testing established substantial equivalence to the predicate device. |
| Physical testing of film (thickness, tensile strength, elongation) | Testing established substantial equivalence to the predicate device. |
| Performance distribution for finished devices (seal strength, package burst, dye migration) | Testing established substantial equivalence to the predicate device. |
| Sterilization performance (steam and ethylene oxide) | Testing established substantial equivalence to the predicate device; indicators meet performance requirements of ANSI/AAMISO 11140-1:2005. |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not explicitly state numerical sample sizes for each test (e.g., how many pouches were tested for seal strength or sterilant penetration).
- The data provenance is not specified in terms of country of origin, but the testing was conducted to support a submission to the U.S. FDA (K112591), implying it adheres to U.S. regulatory standards.
- The study is retrospective in the sense that it's a series of laboratory and physical tests comparing a newly manufactured device to existing predicate devices and established standards. It's not a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and study type. "Ground truth" here refers to the objective measurements of physical properties, performance characteristics (e.g., sterilization indicator color change, seal strength), and adherence to recognized standards (like ISO 11140-1:2005). These are determined by established testing methodologies and equipment, not expert consensus in the same way an image diagnosis might be.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data, which is not the case for material property or performance testing of a sterilization pouch.
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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:
- No, this is a physical medical device (sterilization pouch) and does not involve AI or human readers in an MRMC study context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not involve an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on:
- Objective physical measurements: (e.g., thickness, tensile strength, elongation of film; pressure drop, filtration efficiency of paper; seal strength, package burst, dye migration of pouches).
- Standardized chemical indicator response: The indicator's color change proving exposure to sterilant, validated against the requirements of ANSI/AAMISO 11140-1:2005.
- Material properties and performance parameters defined by recognized industry standards for sterilization packaging.
- The "ground truth" for this device's performance is based on:
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The sample size for the training set:
- This is not applicable as there is no "training set" in the machine learning sense. The device is a physical product, not an algorithm.
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How the ground truth for the training set was established:
- Not applicable.
§ 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).