(90 days)
The CODMAN QUAD-LOCK Sterilization Container System is indicated for use by hospitals and by health care facilities to:
- organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments that will be sterilized
- allow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)
- maintain the sterility of the contents for up to 180 days during storage and transport within the health care 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, titanium, plastic and silicone surgical instruments.
Lumen inner diameter: 3mm or larger
Lumen length: 400mm or less (medium and large size containers), 250mm or less (small size containers)
Quantity: Up to 4 lumen instruments per container
The system is not intended for the sterilization of endoscopes.
For effective sterilization and drying of any size CODMAN QUAD-LOCK Sterilization Container, the recommended maximum combined weight of the single container, lid, basket/tray and basket/tray contents is 25 lb. (11.3 kg).
Table 1 Sterilization Parameters
Cycle Type: Prevacuum
Temperature: 132°C
Exposure Time: 4 minutes
Dry Time: 30 minutes
The Codman® Quad-Lock™ Sterilization Container Systems can be stacked during sterilization with up to three containers.
The CODMAN QUAD-LOCK Sterilization Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The container lids, safety covers, and container bottoms are made from aluminum. The safety covers help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, lid, safety cover, filters and other accessories.
Codman® Quad-Lock™ Sterilization Container Systems consists of a basket, container base, lids, filters, security seals, labels, ergonomic hand grips, wire base, protective mat, and accessories.
The Codman® Quad-Lock™ Sterilization Container Systems is a device intended for the organization and protection of surgical instruments during sterilization and storage. The 510(k) submission K120117 aims to expand the cleared Indications for Use of this device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Indications for Use) | Reported Device Performance (from 510(k) Summary) |
|---|---|---|
| Sterilization Parameters | Cycle Type: Prevacuum | Achieved (supported by Non-Clinical Performance Testing) |
| Temperature | 132°C | Achieved (supported by Non-Clinical Performance Testing) |
| Exposure Time | 4 minutes | Achieved (supported by Non-Clinical Performance Testing) |
| Dry Time | 30 minutes | Achieved (supported by Non-Clinical Performance Testing) |
| Material Compatibility | Stainless steel, aluminum, titanium, plastic, and silicone surgical instruments | Achieved (supported by Non-Clinical Performance Testing) |
| Lumen Instruments (Min Diameter) | 3mm or larger | Achieved (supported by Non-Clinical Performance Testing) |
| Lumen Instruments (Max Length) | 400mm or less (medium and large containers), 250mm or less (small containers) | Achieved (supported by Non-Clinical Performance Testing) |
| Lumen Instruments (Max Quantity) | Up to 4 lumen instruments per container | Achieved (supported by Non-Clinical Performance Testing) |
| Sterility Maintenance | Up to 180 days during storage and transport within the health care facility, as long as integrity of container is not compromised | Achieved (supported by Non-Clinical Performance Testing) |
| Maximum Combined Weight | 25 lb. (11.3 kg) for single container, lid, basket/tray, and contents for effective sterilization and drying | Achieved (supported by Non-Clinical Performance Testing) |
| Stacking during Sterilization | Up to three containers | Achieved (supported by Non-Clinical Performance Testing) |
| Exclusion | Not intended for sterilization of endoscopes | Explicitly stated as not intended (compliance) |
| Sterility Maintenance (Exclusion) | Not tested for maintenance of sterility after transportation outside the health care facility | Explicitly stated as not tested (compliance) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Testing has been completed and supports the safety and effectiveness of the proposed device for its proposed intended uses." However, specific sample sizes (e.g., number of containers, number of sterilization cycles) for the non-clinical performance testing are not explicitly provided in the summary.
The data provenance is retrospective in the sense that the current submission builds upon previous clearance. The testing mentioned in this particular 510(k) is "Non-Clinical Performance Testing," presumably conducted during the development or re-evaluation of the device. The country of origin of the data is not specified, but the submission is from Codman & Shurtleff, Inc., a U.S.-based company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the testing performed was "Non-Clinical Performance Testing" and involved evaluating the physical and functional aspects of a sterilization container (e.g., ability to withstand sterilization cycles, maintain sterility, accommodate instruments), the concept of "experts establishing ground truth" in the diagnostic sense is not directly applicable here. The "ground truth" would be established by validated test methods and measurements, typically performed by laboratory technicians or engineers, showing compliance with predefined specifications and industry standards for sterilization efficacy and container functionality. The document does not specify the number or qualifications of experts involved in analyzing these non-clinical results.
4. Adjudication Method for the Test Set
As the evaluation primarily relies on objective non-clinical performance testing against predefined specifications (e.g., temperature, time, instrument dimensions, weight), an "adjudication method" in the context of expert review or consensus (like 2+1 or 3+1) is not applicable or described in the submission. The compliance is determined by the test results meeting the specified criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. The device is a sterilization container system, not an AI or imaging diagnostic device where human reader performance would be a relevant metric. The submission explicitly states, "There were no Clinical Tests performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is a sterilization container system and does not involve an algorithm or AI. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth for this device is based on validated non-clinical test methods and predefined technical specifications related to sterilization parameters (temperature, exposure time, dry time), material compatibility, instrument dimensions, weight limits, and sterility maintenance duration. This is not "expert consensus," "pathology," or "outcomes data" in the typical medical imaging or diagnostic sense, but rather objective measurements and successful completion of sterilization cycle challenges.
8. The Sample Size for the Training Set
There is no training set as this device is a physical sterilization container system and does not employ machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for this device, the concept of establishing ground truth for a training set does not apply.
§ 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).