(112 days)
The SteriTite Universal Container System, with MediTray products, is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a perforated base and lid, with filter retention plates, and disposable polypropylene filters. The SteriTite container system is compatible for use with AMSCO V-PRO 1 Plus low temperature Sterilization System, Lumen and Non-lumen Cycle, and AMSCO V-PRO maX low temperature Sterilization System Lumen, Non-lumen and Flexible Cycle. The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts, including brackets, posts and partitions. The SteriTite container may be used for sterilization of medical devices, including full instrument sets and mixed loads.
- 30 days of real time shelf-life testing with handling events has been conducted for SteriTite . containers after sterilization in Amsco V-PRO sterilization lumen cycle.
- Reuse testing: Material Compatibility was assessed after 100 cycles of AMSCO V-PRO 1 lumen ● cycles.
SteriTite Universal Container System is recommended for use in:
V-PRO 1 Plus sterilizer in: 1.
- Non-lumen cycles to sterilize non-luments, including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors.
- Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of ● forceps and scissors, and medical devices, including rigid endoscopes, with a single stainless steel lumen, with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load.
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- V-PRO maX sterilizer in:
- Non-lumen cycles to sterilize non-luments including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors.
- Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of . forceps and scissors, and medical devices, including rigid endoscopes with a single stainless steel lumen with an inside diameter of 3mm or larger, and a length of 400mm or shorter for a maximum of 20 lumens per load.
- Flexible cvcles to sterilize single or dual lumen surgical flexible endoscopes in either of two load . configurations (per sterilizer manufacturer instruction):
- Two flexible endoscopes and no additional load, each having either: a.
- a single lumen with an inside diameter of 1mm or larger, and a length of . 1050mm or shorter, or
- two lumens, with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter, and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
- One flexible endoscope and load, each having either: b.
- a single lumen with an inside diameter of 1mm or larger and a length of . 1050mm or shorter, or
- two lumens with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
- Two flexible endoscopes and no additional load, each having either: a.
The SteriTite Universal Container System is recommended to be used for the sterilization of surfaces and rigid or flexible lumens:
| Table 1: SteriTite Universal Container System in AMSCO V-PRO sterilization. | |||||
|---|---|---|---|---|---|
| -- | ----------------------------------------------------------------------------- | -- | -- | -- | -- |
| Sterilizer | Cycle | Rigid lumens 3mm
dia. or larger and
400 mm long or
shorter | Flexible lumens 1 mm
dia. or larger and
1050mm long or
shorter | Surfaces |
|-----------------------|-----------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|----------|
| Amsco V-PRO
1 Plus | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| Amsco V-PRO
Max | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| | Flexible cycle | | X | |
Note:
Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.
Non-Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.
The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for use in Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle has a perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.
The provided document is a 510(k) premarket notification for a medical device: the SteriTite Universal Container System with MediTray Products. This type of submission is a declaration of substantial equivalence to a predicate device, and thus does not typically include detailed clinical study data or acceptance criteria in the manner a novel device might. The document explicitly states: "All data presented demonstrate Substantial Equivalence to the predicate devices."
Therefore, many of the requested data points (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training set) are not applicable to this type of submission as the primary goal is to show equivalence.
However, the document does describe performance evaluations to demonstrate compatibility and safety with new sterilization cycles.
Here's a breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for algorithm performance. Instead, it describes validated compatibility and performance. The acceptance criterion implied is the successful completion of sterilization cycles while maintaining sterility and material integrity.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Compatibility (Amsco V-PRO 1 Plus & V-PRO Max) | Successful sterilization of contained instruments using various cycles (Lumen, Non-lumen, Flexible) as per sterilizer manufacturer instructions and AAMI standards. | The SteriTite Universal Container System (with MediTray products, inoculated product, insert boxes, multilevel tray systems, various inserts including brackets, posts, partitions, and inoculated flexible lumens) was "fully validated" for: |
- Amsco V-PRO 1 Plus: Lumen and Non-Lumen cycles.
- Amsco V-PRO Max: Lumen, Non-Lumen, and Flexible cycles.
Specifics:
- V-PRO 1 Plus (Non-lumen): For non-lumened rigid endoscopes and hinged instruments.
- V-PRO 1 Plus (Lumen): For instruments with diffusion restricted areas (e.g., hinged forceps/scissors), and rigid endoscopes with single stainless steel lumen (≥3mm diameter, ≤400mm long, max 20 lumens/load).
- V-PRO Max (Non-lumen): For non-lumened rigid endoscopes and hinged instruments.
- V-PRO Max (Lumen): For instruments with diffusion restricted areas (e.g., hinged forceps/scissors), and rigid endoscopes with single stainless steel lumen (≥3mm diameter, ≤400mm long, max 20 lumens/load).
- V-PRO Max (Flexible): For single or dual lumen surgical flexible endoscopes in two load configurations:
- Two flexible endoscopes (single lumen ≥1mm diameter, ≤1050mm long; OR two lumens: one ≥1mm diameter, ≤998mm long; second ≥1mm diameter, ≤850mm long).
- One flexible endoscope and load (single lumen ≥1mm diameter, ≤1050mm long; OR two lumens: one ≥1mm diameter, ≤998mm long; second ≥1mm diameter, ≤850mm long).
Note: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' was completed." |
| Shelf Life | Maintain sterility for 30 days after sterilization with handling events. | "30 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after sterilization in Amsco V-PRO sterilization lumen cycle." |
| Material Compatibility/Reuse | Maintain material integrity and functionality after 100 sterilization cycles. | "Reuse testing / Material Compatibility was performed after 100 of AMSCO V-PRO 1 lumen cycles." |
| Internal Stacking | Safe and effective sterilization with specified stacking configurations. | In Steris V-PRO 1 Plus, and V-PRO Max Non Lumen and Flexible Cycles, up to two (2) layers of baskets with insert box or four (4) layers of trays with insert box may be stacked within the SteriTite Universal Container System. |
Study Proving Device Meets Acceptance Criteria:
The document describes "validation testing" conducted at "qualified independent laboratories" in accordance with FDA guidance and AAMI standards. This testing aimed to demonstrate the compatibility of the SteriTite Universal Container System with MediTray Products for the specified Amsco V-PRO sterilization cycles and conditions.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions and inoculated flexible lumens." The type and number of containers (listed in Table 2) were likely used as test subjects.
- Data Provenance: Not specified, but the testing was conducted at "qualified independent laboratories." Given the company's location (South Hackensack, NJ), it's highly probable the testing occurred within the United States. The studies were prospective in nature, as they were specifically undertaken to validate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. For sterilization validation studies, the "ground truth" is typically established by physical/biological testing (e.g., sterility testing, biological indicators) and adherence to recognized standards (e.g., AAMI, ISO), not by expert consensus on visual assessment or interpretation. Sterilization efficacy is an objective outcome measured by specific lab procedures.
- Qualifications of Experts: N/A. The "experts" would be laboratory personnel skilled in microbiology and sterilization validation techniques, interpreting results from biological indicators and physical parameters.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "ground truth" for sterilization is based on objective laboratory test results, not subjective interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. This is a sterilization container, not an AI diagnostic device. MRMC studies are not relevant for this type of device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This document is about a physical medical device (sterilization container), not an algorithm or AI.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- Sterilization Efficacy: Biological indicators (not explicitly named but implied by "inoculated product") and physical/chemical indicators to determine the presence or absence of viable microorganisms after sterilization. This falls under microbiological testing/outcomes data (i.e., achieving sterility).
- Material Compatibility/Integrity: Visual inspection and functional testing, adhering to material science and mechanical engineering principles. This is a form of physical testing/outcomes data.
- Shelf Life: Maintenance of sterility and physical integrity over time, verified by microbiological testing and physical assessment.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "validation testing" described is for performance verification.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of 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).