Search Results
Found 1 results
510(k) Data Aggregation
(112 days)
NUVENTUS NV.C Surgical Cassette and Tray
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.
The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.
The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.
The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.CTM instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.
This document is a 510(k) summary for the NUVENTUS NV.C™ Surgical Cassette and Tray, a rigid sterilization container. The information provided heavily focuses on non-clinical testing for substantial equivalence, rather than a clinical study involving human readers and AI for diagnostic improvement. Therefore, many of the requested elements for an AI-assisted diagnostic device study (like MRMC, human-in-the-loop, expert consensus for ground truth on a test set, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the device's functional validation as presented in the non-clinical testing summary.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Validation of the Manual Cleaning Process According to the ISO 17664 and the AAMI ST98 Standards | Evaluate and validate the manual cleaning of the subject devices | Extraction Recovery: The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction. | |
| Residual marker testing (Protein Assay): less than 6.4 µg/cm² (Assay quantitation limits: 2.5 µg/mL) | |||
| Residual marker testing (Hemoglobin assay): less than 2.2 µg/cm² (Assay quantitation limits: 10.0 µg/mL) | Pass | ||
| Validation of the Automated Cleaning Process According to the ISO 17664 and the AAMI ST98 Standards | Evaluate and validate the automated cleaning of the subject devices | Extraction Recovery: The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction. | |
| Residual marker testing (Protein Assay): less than 6.4 µg/cm² (Assay quantitation limits: 2.5 µg/mL) | |||
| Residual marker testing (Hemoglobin assay): less than 2.2 µg/cm² (Assay quantitation limits: 10.0 µg/mL) | Pass | ||
| Sterilization Validation According to the ISO 17664 - ISO 17665 Standards and the AAMI TIR 12 Technical Report | Validate a sterilization cycle and drying time of the subject devices | Sterilization Effectiveness: 3 consecutive half-cycles will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10⁻⁶ is achieved if the Instructions for Use are followed. | |
| Drying Time: Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed +3% | Pass | ||
| Use Life Testing (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling and ISO 13402:1995) | Life Cycle (simulated use) testing after 225 cleaning, disinfection and sterilization cycles | Durability/Functionality: Visual inspection, functional verification for 225 use cycles. | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) ISO 10993-5, ISO 10993-12 | Evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay | Cytotoxicity: ≤ 2 reactivity grade after exposure to extract of the device | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of surgical cassettes tested, but rather the number of cycles or repetitions for certain tests.
- Cleaning Validation: Not explicitly stated as a number of devices, but implies multiple tests to meet extraction efficiency and residual marker criteria.
- Sterilization Validation: "3 consecutive half-cycles" implies a specific test setup for validation, not a large sample of devices.
- Use Life Testing: The device was tested for "225 cleaning, disinfection and sterilization cycles." This refers to repeated cycles on a single or limited number of test units to simulate usage over time.
- Biocompatibility: Not specified as a number of devices.
- Data Provenance: Not specified in terms of country of origin. The study appears to be entirely non-clinical bench testing, conducted to demonstrate the device's functional performance and safety (e.g., ability to be cleaned and sterilized, durability, biocompatibility), rather than a clinical study on patient data. It is therefore retrospective in the sense that prototypes were subjected to rigorous testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" here is the objective measurement of chemical residuals, biological indicator inactivation, weight change, and visual/functional inspection against defined engineering and regulatory standards.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or interpretations involved in establishing ground truth for this type of test, no adjudication method is needed or mentioned.
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
- Not Applicable. This is not an AI-assisted diagnostic device. It's a medical device (surgical cassette and tray) intended for sterilization. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm for diagnostic purposes. The device is a physical object.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is established by objective physical and chemical measurements against pre-defined performance standards based on recognized test methodologies (ISO, AAMI standards). This includes:
- Quantitative measurements of protein and hemoglobin residuals after cleaning.
- Verification of biological indicator inactivation for sterilization efficacy.
- Weight measurements to assess drying.
- Visual inspection and functional verification against product specifications for use life.
- Cytotoxicity assays for biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
In summary, the provided document details the non-clinical performance validation of a reusable surgical cassette and tray to demonstrate its substantial equivalence to a predicate device, focusing on its ability to be cleaned, sterilized, its durability, and biocompatibility. It is not an AI/ML-enabled diagnostic device, so many of the requested elements for such a study are irrelevant to this submission.
Ask a specific question about this device
Page 1 of 1