(206 days)
The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO V-Pro 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The proposed Vis-U-All Self Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It permits sealing of the pouch without need of heat-sealing equipment. The purpose of this submission is to demonstrate the Vis-U-All Self Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297, cleared on October 4, 2007.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vis-U-All Self Seal Pouch:
This document is a 510(k) premarket notification for a sterilization pouch, which is a low-risk device. As such, it does not involve AI or complex software, and therefore, many of the requested categories (like sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission. The assessment focuses on the physical and functional performance of the pouch itself in the context of sterilization.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Not explicitly stated as a numerical criterion, but implies conformity to predicate device materials. The plastic film thickness has changed to 2.0 mil. | Materials of composition have not changed from the predicate (K771032), except for the plastic film thickness which is now 2.0 mil. |
| Sterilization Efficacy | Pouch must be "qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilization System" | Pouch demonstrated qualification for use in the AMSCO® V-PRO 1 Low Temperature Sterilization System. |
| Sterility Maintenance | Pouch must be able to "maintain sterility of the enclosed device until used." | Performance testing demonstrated the pouch is "as safe, as effective, and performs the same as the predicate device" in maintaining sterility. |
| Overall Performance | Must be "as safe, as effective, and performs the same as the predicate device" | Performance testing demonstrated the proposed pouch meets this criterion. |
Study Details
Given the nature of the device (sterilization pouch) and the type of regulatory submission (510(k) premarket notification), this is not a study involving AI or human interpretation of medical images. Instead, it relies on performance testing of the physical product.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided text. This type of information would typically be detailed in the full test reports referenced in the submission, but not in this summary.
- Data Provenance: Not explicitly stated. The company, STERIS, Corporation, is based in Mentor, Ohio, USA, which implies the testing likely occurred in the USA or through US-based labs, but this is an inference. The data would be prospective, as it involves testing the newly designed pouch.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable in the context of this device. Ground truth is established through physical and microbiological testing (e.g., sterility testing, barrier integrity testing) conforming to established standards for sterilization pouches, not through expert human interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, typically in medical imaging or diagnostic contexts. Here, device performance is objectively measured.
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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 device is not an AI-powered diagnostic tool, and therefore, an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on performance standards and objective measurements demonstrating:
- Sterilization efficacy: The ability of the pouch to allow sterilant penetration and kill microorganisms when processed in the AMSCO® V-PRO 1 Low Temperature Sterilization System. This is often verified using biological indicators (BIs) or chemical indicators (CIs) in challenge tests (though the device itself has no CIs).
- Sterility maintenance: The barrier integrity of the pouch in preventing microbial recontamination post-sterilization, often assessed through microbial challenge tests and physical performance tests (e.g., seal strength, burst strength, material integrity after sterilization cycles).
- Material compatibility: Ensuring the materials withstand the sterilization process without degradation that would compromise integrity.
- The "ground truth" for this device is based on performance standards and objective measurements demonstrating:
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
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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).