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510(k) Data Aggregation
(135 days)
The HS Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization. storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures.
Neodent instrument kit cases are intended to allow sterilization of the medical devices included.
Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included.
The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles:
Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes.
Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes.
Neodent instrument kit cases are intended for sterilization of non-porous fillers.
The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams.
The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not be stacked during sterilization.
The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.
This is a medical device submission for the Neodent Implant System - Helix Short Surgical Kit Cases. The submission focuses on sterilization wrap containers (Class II, product code KCT).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manual Cleaning Validation: | |
| * Visual Inspection: No Visible Soil | Passed |
| * Hemoglobin Test: <2.2 µg/cm² | Passed |
| * Protein Test: <6.4 µg/cm² | Passed |
| Sterilization Validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2): | |
| * All Biological Indicators must be incubated for at least 7 days at 55-60°C. | Passed |
| * All positive controls for SAL testing must show characteristic growth of the indicator organism. | Passed |
| Life Cycle (Simulate Usage) Testing (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance): | |
| * The tested samples must withstand 100 cycles of use (cleaning, sterilization and functional tests) without compromising their functionalities. | Passed |
| Biocompatibility (ANSI/AAMI/ISO 10993-5 - Cytotoxicity): | |
| * Less than 30% cell proliferation inhibition | Passed |
| Sterilization Cycles: | |
| * Gravity displacement: Sterilization temperature: 132 °C; Sterilization time: 15 minutes; Drying time: 50 minutes. | The device demonstrated equivalency to the predicate device's cleared cycle parameters, which included these parameters (or similar shorter drying times for the predicate). The subject device's longer drying time (50 min) is within safe parameters. |
| * Dynamic Air Removal (Pre-Vacuum): Sterilization temperature: 132 °C; Sterilization time: 4 minutes; Drying time: 30 minutes. | The device demonstrated equivalency to the predicate device's cleared cycle parameters, which included these parameters (or similar shorter drying times for the predicate). The subject device's longer drying time (30 min) is within safe parameters. |
| Sterile Barrier: Sterilization wrap, FDA-cleared for indicated method and cycles. | Declared "Identical" to the predicate, which uses a sterilization pouch. This implies the device is designed to be used with an FDA-cleared wrap/pouch. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the individual tests (manual cleaning, sterilization, life cycle, cytotoxicity). It refers to "tested samples" for the life cycle testing, but no specific number is provided.
The data provenance is not explicitly mentioned in terms of country of origin or whether studies were retrospective or prospective, beyond the fact that these are non-clinical performance data (laboratory testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies are non-clinical (laboratory tests), and ground truth would have been established by the validated methodologies and acceptance criteria themselves, not by expert consensus on individual "cases."
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are objective laboratory performance validations against predefined criteria, not subjective interpretations requiring "adjudication."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed, nor is it applicable for this type of device (sterilization kit case). This device is not an AI-assisted diagnostic tool that would involve human readers.
6. Standalone Performance Study:
The studies conducted are standalone performance studies in the sense that they evaluate the device itself (e.g., its ability to withstand cleaning, facilitate sterilization, and maintain biocompatibility) against established standards and internal criteria, without direct human interaction as a primary variable. The document refers to them as "Non-Clinical Performance Data."
7. Type of Ground Truth Used:
The ground truth for the non-clinical performance studies is based on:
- Established scientific and regulatory standards/guidance: e.g., ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2 for sterilization, ANSI/AAMI/ISO 10993-5 (Cytotoxicity), and FDA guidance for reprocessing medical devices.
- Validated laboratory methodologies: Custom test methods for cleaning and specific incubation/growth criteria for biological indicators in sterilization.
- Objective measurement: Visual inspection (for soil), quantifiable chemical tests (hemoglobin, protein), and cell proliferation inhibition measurements are objective.
Essentially, the "ground truth" is defined by the objective pass/fail criteria derived from these standards and methods.
8. Sample Size for the Training Set:
This device is not an AI/machine learning product; therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set, this information is not applicable.
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