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The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: · organize and protect stainless steel, aluminum, plastic* and silicone surgical instruments that will be sterilized · allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) · When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised · When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, plastic and silicone surgical instruments. *The use of plastic instruments has only been confirmed for steam sterilization. For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid. basket/tray contents is defined in Table 1. For each cvcle type the qualified lumen size is the minimum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.

The Symmetry Surgical Quad-Lock® Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The filter lids, security lids, and container bottoms are made from anodized aluminum. The security lids help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, filter lid, security lid, filters and other accessories.

The provided text describes the acceptance criteria and a study to demonstrate the performance of the Symmetry Surgical Quad-Lock™ Container System.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Temperature: 132°C
• Exposure Time: 4 minutes
• Drying Time: 30 minutes
• Stackable: Yes, up to three containers
• Qualified Lumen Size (Full/Three Quarter): 3mm x 400mm
• Qualified Lumen Size (Half Size): 3mm x 250mm
• Maximum Quantity: 4 lumen per container
• Load Requirements: 25 lbs (all sizes)
  Ethylene Oxide:
• Concentration: 725mg/L
• Temperature: 55°C
• Exposure Time: 60 minutes
• Humidity: 50-70%
• Aeration Time: 8 hours at 110°F (43°C)
• Stackable: No
• Qualified Lumen Size (Full/Three Quarter): 3mm x 400mm
• Qualified Lumen Size (Half Size): 2mm x 250mm
• Maximum Quantity: 4 Lumen per container
• Load Requirements: 25 lbs (all sizes)
  Low Temperature H2O2 Sterilizers: (Parameters are set by sterilizer manufacturer)
  • STERRAD 100NX Standard/DUO: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (Full Size): 2mm x 400mm
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 5 Lumen per container
    • Load Requirements (Full): 21.4 lbs
    • Load Requirements (Three Quarter/Half): 13.85 lbs (DUO: 13.2 lbs)
  • STERRAD 100NX FLEX: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (All Sizes): One 1mm x 850mm Flexible Endoscope per container
    • Load Requirements (Full): 16.65 lbs
    • Load Requirements (Three Quarter): 12.40 lbs
    • Load Requirements (Half): 10.75 lbs
  • STERRAD NX Standard/Advanced: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (Full Size): 1mm x 400mm (Standard) / 2mm x 250mm (Advanced)
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 5 Lumen per container
    • Load Requirements (Full): 21.4 lbs
    • Load Requirements (Three Quarter/Half): 13.85 lbs
  • STERRAD 100S Standard: Fixed Cycle Type, Stackable: No
    • Qualified Lumen Size (Full Size): 3mm x 400mm
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 5 Lumen per container
    • Load Requirements (All Sizes): 18.2 lbs
  • STERIS V-PRO™ 1 PLUS Lumen/No Lumen: Cycle time = 55 minutes, Stackable: No
    • Qualified Lumen Size (Full Size): 3mm x 400mm
    • Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm
    • Maximum Quantity: 10 lumen per container
    • Load Requirements (All Sizes): 19.65 lbs
      All sterilization efficacy and simulated use testing to achieve SAL of 10-6 passed. |
      | Maintenance of Sterility (Shelf Life) | Maintain sterility for up to 180 days with prevacuum steam sterilization.
      Maintain sterility for up to 30 days with ethylene oxide and low-temperature hydrogen peroxide sterilization cycles. | Prevacuum Steam: Sterility maintained for up to 180 days during storage and transport within the healthcare facility, as long as container integrity is not compromised.
      Ethylene Oxide & Low Temperature H2O2: Sterility maintained for up to 30 days during storage and transport within the healthcare facility, as long as container integrity is not compromised.
      The shelf life testing for 30 days of storage passed. |
      | Reuse Testing | Demonstrate microbial challenge following multiple sterilization cycles for up to 100 sterilization cycles. | Microbial Challenge following multiple sterilization cycles verified for up to 100 sterilization cycles passed. |
      | Biocompatibility | In vitro evaluations for biocompatibility, extractables, and leachables must have acceptable results. | In vitro evaluations for these tests had acceptable results. |
      | Functional Strength of Handles | Testing performed in accordance with ST77 (presumably ANSI/AAMI ST77, a standard for sterile packaging). | Testing performed in accordance with ST77 had acceptable results. |

2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for the test set for its performance studies (sterilization efficacy, shelf life, reuse testing, biocompatibility, or functional strength).
The data provenance is not explicitly mentioned as a country of origin or whether it's retrospective or prospective; however, the submission is from "Symmetry Surgical, Inc." which is based in Antioch, TN, USA, suggesting the studies likely occurred in the US. The studies are described as "performance testing" and "non-clinical tests," implying they were conducted specifically for this submission, making them prospective in nature for this application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies are described as laboratory-based performance testing rather than studies requiring expert interpretation of results for ground truth establishment (e.g., medical image analysis).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the document. The studies described are objective performance tests (e.g., sterilization assurance levels, material properties) that do not typically involve human adjudication in the way medical diagnostic studies do.

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:
This information is not applicable and therefore not provided in the document. The device is a sterilization container system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and therefore not provided in the document. The device is a physical medical device (sterilization container), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance studies appears to be based on objective, measurable criteria derived from scientific and engineering principles for sterilization, material integrity, and functionality. For instance, "sterilization efficacy" ground truth is defined by achieving a specified Sterilization Assurance Level (SAL of 10-6), which is typically confirmed through validated microbiological testing (e.g., biological indicators). Shelf life is determined by maintaining sterility over time, also verified through microbiological methods. Biocompatibility relies on established in vitro evaluation standards.

8. The sample size for the training set:
This information is not applicable and therefore not provided in the document. The product is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.

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