(179 days)
The Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
The Video Trays listed above are intended to be used to enclose ConMed medical devices including hand instruments, trocars, camera heads, adapters, endoscopes, light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider.
The instrument trays were validated as per below sterilization parameters: Steam (wrapped) sterilization Pre-vacuum cycle at 270 F ( 132 °C) for 4 minutes Cool down to 48°C for 118 minutes
VP1003 Video Extended Length Tray (RADEL) dry cycle is 35 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with an outer diameter not less than 5.5mm or greater than 10mm with lengths no greater than 530mm. and light guides with a length no greater than 10ft.
VP1005 Video Tray Single Level (RADEL) dry cycle is 40 minutes. ConMed Corporation instruments which can be sterilized in this tray are Scopes. Sheaths, Cannulas and Bridge System with internal diameters not less than 2.3mm. outer diameter not less than 2.9mm or greater than 10mm, and with lengths no greater than 404mm. Non-Cannulated. Non-Porous instruments with outer diameters not less than 2.9mm or greater than 3.2mm and with lengths no greater than 404mm may also be sterilized in this tray.
VP1006 Video Arthroscope Tray (RADEL) dry cycle is 20 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 2.9mm or greater than 4mm. with lengths no greater than 233mm.
VP1007 Video Laparoscope Tray (RADEL) dry cycle is 25 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 5.5mm or greater than 10mm. with lengths no greater than 404mm.
VP1003 Video Extended Length Tray (RADEL), VP1005 Video Tray Single Level (RADEL), VP1006 Video Arthroscope Tray (RADEL) and VP1007 Video Laparoscope Tray (RADEL) - are constructed of RADEL with perforations to facilitate steam sterilant penetration, evacuation and drying. These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap K082177 must be used to maintain sterility of the contents. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray. Although these trays are reusable they will not be serviced or repaired.
We are looking at sterilamp.
1. Acceptance Criteria and Device Performance:
The acceptance criteria for each test and the corresponding device performance are detailed in the "Summary of Non Clinical Tests" section of the 510(k) summary, specifically on pages 9 and 10 of the provided document.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Risk Management (TR13-707) | Risks associated with device use constitute acceptable risks when weighed against benefits, compatible with high protection of health and safety, and overall residual risk is acceptable. | "The risks associated with the use of these devices constitute acceptable risks when weighed against the benefits to the patient and are compatible with high level of protection of health and safety. It has been determined that the overall residual risk is acceptable." |
| Steam Sterilization Qualification (VP1003, TR12-343) | Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-007 Protocol were met. | "Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-007 Protocol were met." |
| Steam Sterilization Qualification (VP1005, TR12-345) | Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-010 Protocol were met. | "Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-010 Protocol were met." |
| Steam Sterilization Qualification (VP1006, TR12-346) | Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-008 Protocol were met. | "Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-008 Protocol were met." |
| Steam Sterilization Qualification (VP1007, TR12-347) | Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-009 Protocol were met. | "Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-009 Protocol were met." |
| Cleaning Validation (TR13-121) | Devices meet specifications for acceptance; manual cleaning method using soft bristled brush and mild neutral pH detergent to clean all surfaces is validated. | "Devices tested meet specifications for acceptance. The manual cleaning using a soft bristled brush and mild neutral pH detergent to clean all surfaces described in the cleaning method. This cleaning method is validated for VP1003, VP1005, VP1006, VP1007 Video Trays." |
| Transportation Qualification (TR13-050) | Non-sterile product and packaging maintain physical properties and characteristics for intended use after transportation conditioning. | "The results of this study support the Transportation and Distribution Storage Qualification of the trays. The results of the qualification demonstrate that the non sterile product and packaging maintained physical properties and characteristics for intend use after transportation conditioning." |
| Verification Report Handle Weight Requirement (TR13-390) | Handle load requirements of ANSI/AAMI ST77:2006, Section 4.3.6.4 (b) are met, with test trays withstanding a 32-pound force without breaking free, permanent cracking, or deforming. | "The handle load requirements of ANSI/AAMI ST77:2006. Section 4.3.6.4 (b) are met. The test trays met the requirement of withstanding a 32 pound force without breaking free from the tray or permanently cracking or deforming." |
| Cool Down Time Validation (TR14-027) | Successful validation of the 118-minute cool down time for all listed video trays. | "This report documents the successful validation of the 118 minute cool down time for the VP1003, VP1005, VP1006, and VP1007 Video Trays." |
| Biological Evaluation (TR13-517) | Materials used in video trays demonstrate acceptable biocompatibility profile for intended use, do not pose a biological safety risk, and meet biological evaluation requirements of ISO 10993-1:2009 and FDA #G95-1. | "The materials used in the Video Trays have been tested and have demonstrated an acceptable biocompatibility profile for its intended use. It can be concluded that use of the Video Trays does not pose a biological safety risk as identified in the Preliminary Hazard Analysis. Based on these comprehensive tests, the benefits of the materials for the intended use outweigh the clinical risks. In conclusion, it was demonstrated that these devices meet the biological evaluation requirements of ISO 10993-1:2009 and FDA #G95-1." |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of trays tested for sterilization, cleaning, etc.). It refers to "three half cycles" for sterilization qualification, which likely indicates a specific number of sterilization runs. The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, beyond indicating that the studies were conducted by ConMed Corporation (the submitter).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This device (sterilization containers) is not a diagnostic or prognostic device that relies on expert interpretation of images or other subjective data to establish ground truth. The ground truth for this type of medical device is established through objective performance metrics and standardized test methods (e.g., sterilization efficacy, material compatibility, mechanical strength). Therefore, information regarding "number of experts" or their "qualifications" for establishing ground truth in the context of diagnostic interpretation is not applicable and not provided in the document.
4. Adjudication Method for the Test Set:
Adjudication methods like "2+1" or "3+1" are typically used in studies where there is subjective interpretation of data (e.g., reviewing medical images). For a device like a sterilization container, the tests involve objective measurements and established scientific protocols (e.g., sterility testing, material strength testing). Therefore, an explicit "adjudication method" in the sense of expert consensus on subjective findings is not applicable and not mentioned in the document. The studies were concluded based on whether the results met the predefined acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a sterilization container, not a diagnostic or AI-assisted interpretation tool. The concept of "human readers improving with AI vs without AI assistance" is not relevant to this type of medical device.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical device (sterilization container), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on objective performance metrics and established scientific and regulatory standards. This includes:
- Sterility Assurance Level (SAL) of 10^-6: This is a widely accepted standard for demonstrating effective sterilization.
- Material compatibility: Assessed against standards like ISO 10993 for biocompatibility.
- Mechanical integrity: Measured against standards like ANSI/AAMI ST77 for handle load requirements.
- Cleaning efficacy: Evaluated through validation studies to ensure effective removal of contaminants.
- Physical property maintenance: Ensuring the product and packaging withstand transportation conditions.
These are not based on expert consensus on subjective findings, pathology, or outcomes data in the way a diagnostic device would be.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this device. This is a physical medical device, not a machine learning model or algorithm that requires training data. The studies conducted are verification and validation tests of the device's physical and functional properties.
9. How the Ground Truth for the Training Set Was Established:
Since there is no "training set" for this physical device, the question of how its ground truth was established is not applicable. The device's performance is evaluated against predetermined, objective criteria as detailed in section 7.
§ 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).