(149 days)
Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor frame components, lighting accessories, and blade or frame accessories between used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity.
| CYCLE | CYCLE TEMP | EXPOSURE TIME | DRY TIME |
|---|---|---|---|
| Prevacuum | 132°C (270°F) | 4 Minutes | 30 Minutes |
| Gravity | 121°C (250°F) | 30 Minutes | 30 Minutes |
Thompson Surgical Instruments “MIS Spine Frame Instrument Case,” model 50000MSF, is intended to hold surgical instruments such as retractor blades, retractor frame components, lighting accessories, and blade or frame accessories during storage, transportation, and sterilization, as indicated. It is composed of materials that can be reused with steam sterilization methods and DCG graphics may be used. It has a distribution of perforations on the outer surfaces and between case levels that allow for optimal steam penetration. Vent to volume is .110. It is reusable and provided to the customer in a non-sterile conditions. This case can be described as an accessory for the Thompson Retractor.
The provided document describes the Thompson Surgical Instruments MIS Spine Frame Instrument Case (K151347), which is a device for storing, transporting, organizing, and sterilizing surgical instruments. The testing focuses on its ability to perform sterilization effectively.
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device appears to be its ability to achieve a six-log reduction of an indicator organism during sterilization cycles, demonstrating effective sterilization. The cleaning and biocompatibility tests also represent criteria for safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Pre-vacuum Steam): Effective sterilization, demonstrating a six-log reduction of indicator organism. Validated parameters: 132°C (270°F) for 4 minutes with 30 minutes dry time. | The MIS Spine Frame Instrument Case, containing the maximum load and wrapped in an FDA cleared sterilization wrap, was exposed to the specified steam sterilization half cycles. Results indicated that half cycles provided a six-log reduction of the indicator organism. |
| Sterilization Efficacy (Gravity Steam): Effective sterilization, demonstrating a six-log reduction of indicator organism. Validated parameters: 121°C (250°F) for 30 minutes with 30 minutes dry time. | The MIS Spine Frame Instrument Case, containing the maximum load and wrapped in an FDA cleared sterilization wrap, was exposed to the specified steam sterilization half cycles. Results indicated that half cycles provided a six-log reduction of the indicator organism. (Though not explicitly separated for gravity, the general statement implies both validated cycles were tested and passed.) |
| Cleanability: The device must be cleanable. | The MIS Spine Frame Instrument Case was tested for cleanability, and the results indicated a pass. |
| Biocompatibility: The device should be non-cytotoxic. | The MIS Spine Frame Instrument Case is considered non-cytotoxic as based on MEM elution test results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise numerical sample size for the "test set" (i.e., the number of MIS Spine Frame Instrument Cases or biological indicators used). It states that the device "and the predicate containing the maximum load were inoculated with biological indicators." This implies at least one of each device type was used per sterilization cycle condition. Given the nature of sterilization validation, multiple runs for each cycle condition would typically be performed, but the exact number isn't provided.
- Data Provenance: The study was conducted by Thompson Surgical Instruments, Inc. as part of their 510(k) submission to the FDA. This indicates the testing was performed internally or by a contracted lab for the manufacturer. The data is prospective as it was generated specifically to demonstrate the performance of this device for regulatory submission. The country of origin of the data is implicitly the United States, where the submitting company is based and where FDA regulations apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This type of device does not typically involve expert review for ground truth in its performance testing. The "ground truth" for sterilization efficacy is established by the biological indicators (BIs) which contain a known quantity of resistant microorganisms. A six-log reduction is a quantitatively measurable outcome. For cleaning, "pass" indicates meeting pre-defined cleanliness criteria. For biocompatibility, MEM elution test results are directly interpreted. Human experts are not used to establish a subjective "ground truth" for these performance characteristics.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1, 3+1) are typically used for studies involving subjective human interpretation of data, such as medical image analysis, where discrepancies between expert opinions need to be resolved. For objective tests like biological indicator reduction, cleanability pass/fail, and cytotoxicity, an adjudication method is not relevant. The results are based on direct measurement against defined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This device is a medical instrument case, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance in interpretation is not applicable. The study assesses the physical and functional performance of the device itself.
6. Standalone (Algorithm Only) Performance Study
N/A. This device does not involve an algorithm or AI. Its performance is entirely physical and functional, assessed through empirical laboratory testing.
7. Type of Ground Truth Used
The ground truth for the performance studies is primarily:
- Biological Indicators: For sterilization efficacy, the ground truth is the complete kill of a known concentration of highly resistant test microorganisms (e.g., Geobacillus stearothermophilus spores for steam sterilization), quantifiable by a log reduction.
- Defined Cleanliness Criteria: For cleanability, the ground truth is adherence to established visual and/or analytical criteria for cleanliness (e.g., no visible soil, acceptable levels of residual protein, hemoglobin, etc.).
- Standardized Cytotoxicity Assays: For biocompatibility (MEM elution test), the ground truth is based on the cellular response to leachables from the material, interpreted against standard reference controls.
8. Sample Size for the Training Set
N/A. This device does not involve machine learning or AI, and therefore no "training set" is applicable. The studies are empirical tests of the manufactured device.
9. How Ground Truth for the Training Set was Established
N/A. As there is no training set, this question is 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).