(28 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration
- trays* containing medical devices in a single or double pouch configuration
- small items requiring surface sterilization in a single pouch configuration within a tray*
NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
to be sterilized in the:
- Lumen. Non Lumen. Flexible. Fast Non Lumen and Fast Cvcles of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are:
- Directly pouched
- Placed inside of a tray and the tray pouched
The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO Low Temperature Sterilization Systems
- Default Cycle of the STERRAD®* 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
- wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
Or - placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO or STERRAD Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self-seal pouch, a heat-seal pouch, or heat-seal tubing.
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and STERRAD Sterilizers. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K183402) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers and sterilization mats are provided as accessories.
This document, a 510(k) Premarket Notification from the FDA, describes the acceptance criteria and the study proving the device meets these criteria for two products: "Vis-U-All Low Temperature Sterilization Pouches/Tubing" and "PRO-LITE Sterilization Trays."
Since the request is about "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically for a device (implying a medical device with an associated study), and the document describes the performance testing for these sterilization products, I will extract and synthesize the information relevant to these performance tests as evidence of meeting acceptance criteria.
Note: The provided document is a 510(k) summary for medical devices (sterilization pouches and trays), not an AI/ML powered device. Therefore, typical AI/ML study components like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "effect size of human readers improving with AI," "standalone performance," "training set size," and "ground truth for training set" are not applicable to this type of submission. The document focuses on demonstrating substantial equivalence through non-clinical performance testing (e.g., sterilization efficacy).
Here's an analysis of the acceptance criteria and proof, as presented for these sterilization devices:
1. A table of acceptance criteria and the reported device performance
For both devices, the acceptance criteria implicitly align with demonstrating "Sterile efficacy" and the "ability to sterilize medical devices" under various conditions and cycles. The performance is reported as meeting these implicit criteria, indicated by "PASS" results for all tests.
For "Vis-U-All Low Temperature Sterilization Pouches/Tubing" (Table 3, Page 18):
| Acceptance Criteria (Implicit) | Reported Device Performance (Result) | Conclusion |
|---|---|---|
| Sterile Efficacy for Mated Surfaces under Worst-Case Conditions in V-PRO Sterilizer Cycles | Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the V-PRO Sterilizer cycles. | PASS |
| Sterile Efficacy with Standard Injection Weight | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. | PASS |
| Ability to Sterilize Medical Devices under Worst-Case Processing Conditions (Simulated Use) | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | PASS |
| Ability to Sterilize Patient-Soiled, Clinically-Cleaned Medical Instruments (In Use) | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | PASS |
For "PRO-LITE Sterilization Tray" (Table 8, Page 29-30):
| Acceptance Criteria (Implicit) | Reported Device Performance (Result) | Conclusion |
|---|---|---|
| Sterile Efficacy for Mated Surfaces under Worst-Case Conditions in V-PRO Sterilizer Cycles | Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the V-PRO Sterilizer cycles. | PASS |
| Sterile Efficacy with Standard Injection Weight | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. | PASS |
| Ability to Sterilize Medical Devices under Worst-Case Processing Conditions (Simulated Use) | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | PASS |
| Ability to Sterilize Patient-Soiled, Clinically-Cleaned Medical Instruments (In Use) | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | PASS |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes (e.g., number of pouches/trays, number of sterilization cycles) used for each test. It refers to "worst-case conditions" and "validation load." Similarly, data provenance (country of origin, retrospective/prospective) is not specified, but the testing would typically be prospective and conducted in a controlled laboratory or simulated clinical environment.
3. 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)
This is not applicable to the type of device and study presented. Ground truth for sterilization efficacy is typically established through scientific methods like sterility testing (e.g., microbial challenge tests, biological indicators) and physical/chemical monitoring, not human expert interpretation of images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is related to human interpretation of data, which is not the primary method for evaluating sterilization efficacy.
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. These are physical devices for sterilization, not AI-powered diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept pertains to AI algorithms, not sterilization instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for sterilization efficacy is established through direct measurements of sterility (e.g., absence of viable microorganisms after sterilization) and functional performance under simulated and actual use conditions as described in the summary:
- Sterile efficacy: Demonstrated through microbial challenge and physical/chemical indicators.
- Simulated Use Test: Verifies the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions.
- In Use Test: Demonstrates the ability to sterilize patient-soiled, clinically-cleaned medical instruments.
This involves direct, objective testing for sterility, rather than interpretation by human experts.
8. The sample size for the training set
Not applicable. These devices do not use "training sets" as they are not AI/ML models.
9. 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).