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510(k) Data Aggregation
(79 days)
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams.
The weight of the empty KIT WT SNIPER is 620 grams.
The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT SNIPER JSI
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams.
The weight of the empty KIT WT SNIPER JSI is 620 grams.
The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT INTERNA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams.
The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT VEGA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT VEGA and the associated instruments is 820 grams.
The weight of the empty KIT WT VEGA is 620 grams.
The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT ESSENTIAL
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterlization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams.
The weight of the empty KIT WT ESSENTIAL is 620 grams.
The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT MEDGUIDE®
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams.
The weight of the empty KIT MEDGUIDE® is 160 grams.
The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
The subject device trays are designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the tray by the healthcare provider . The base, inner trav, and lid components are designed to be integrated into a single unit (the complete trav) which contains and protects the interior components during sterilization. The lid latches to the base to secure the tray into a single unit. The base, inner tray, and lid components are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam) sterilization and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone and AISI 316L stainless steel. Holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device trays are summarized in the following table Summary of Tray Dimensions and Contents.
The provided text is a 510(k) summary for the KLOCKNER KITS, a medical device intended to enclose other medical devices for sterilization. The information provided focuses on the non-clinical testing performed to demonstrate the device meets acceptance criteria and is substantially equivalent to predicate devices. It does not contain information about a study proving a device (like AI/ML software) meets acceptance criteria for a diagnostic aid, which would involve concepts like sensitivity, specificity, human reader performance, expert ground truth, and training data.
Therefore, many of the requested elements for describing the acceptance criteria and a study proving device performance (especially those related to AI/ML or diagnostic performance) cannot be extracted from this document. This document describes a physical medical device (sterilization kits) and its validation through standard engineering and sterility testing, not an AI/ML diagnostic software.
However, I can extract the available information as best as possible, interpreting "device performance" in the context of this specific regulatory submission for the KLOCKNER KITS.
Device: KLOCKNER KITS (Sterilization Trays)
Purpose of the Study: To demonstrate that the KLOCKNER KITS are safe, effective, and perform as well as or better than legally marketed predicate devices, specifically regarding their ability to be cleaned, sterilized, and maintain integrity over multiple uses. This is a non-clinical validation study, not a clinical trial or a diagnostic AI performance study.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|---|
| Manual Cleaning Validation | To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective. | Cleaning instructions were validated and demonstrated that the subject devices could be visually and quantifiably cleaned. | Pass |
| Sterilization Validation (incl. sterilant penetration & dry time validation) | To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents. | 3 consecutive half-cycles performed for each of 4 configurations of trays demonstrate complete inactivation of all biologic indicators; A minimum SAL (Sterility Assurance Level) of 10-6 is achieved if the Instructions for Use are followed. | Pass |
| Dry time Validation | To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage. | Using pre-cycle and post-cycle weights, the weight gain after drying will be < 3%. | Pass |
| Life Cycle / Simulated Use-life | To validate the service life of the trays as stated in the Instructions for Use. | Subject kits were challenged with at least 40 reprocessing cycles. All kits met inspection and performance criteria after 40 uses. (For a safety factor of 2X, a maximum of 20 uses is recommended in labeling). | Pass |
| Biocompatibility (Cytotoxicity) | To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. | The in vitro assay performed on the test article showed no reactivity. | Pass |
2. Sample size(s) used for the test set and the data provenance:
- Cleaning Validation: Not explicitly stated, but implies multiple units or repeats to demonstrate "visually and quantifiably cleaned."
- Sterilization Validation: "3 consecutive half-cycles performed for each of 4 configurations of trays."
- Dry Time Validation: Not explicitly stated, likely performed alongside sterilization validation.
- Life Cycle / Simulated Use-life: "Subject kits were challenged with at least 40 reprocessing cycles." The number of individual kits tested is not specified but would be a subset of the configurations.
- Biocompatibility: Not explicitly stated, but standard practice involves testing material samples.
The data provenance is from non-clinical laboratory testing and validation studies conducted by the manufacturer, SOADCO, S.L., as part of their 510(k) submission. No geographic origin of the test data is provided beyond the manufacturer's address in Andorra. The studies are by nature prospective tests performed to validate the device's design and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in this document. The ground truth for these non-clinical tests (sterility, cleanliness, physical integrity) is established through standardized laboratory methods (e.g., biological indicators for sterility, gravimetric analysis for dryness, visual/quantitative assays for cleanliness, physical inspection for life cycle), not through expert consensus or interpretation by human clinicians/radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. Here, the tests are objective, laboratory-based validations.
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:
This information is not applicable and not provided. An MRMC study is relevant for evaluating the performance of diagnostic AI (Artificial Intelligence) systems, often in radiology. This document concerns a physical medical device (sterilization trays) and its non-clinical performance characteristics, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This concept relates to the performance of an AI algorithm, which is not the device described in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these tests is based on:
- Sterility: Absence of microbial growth (biological indicators achieving SAL of 10-6).
- Cleanliness: Absence of visible or quantifiable biological/chemical residues.
- Dryness: Minimal weight gain (less than 3%).
- Life Cycle: Retention of physical and functional integrity after repeated cycles (visual inspection, functional closure).
- Biocompatibility: No cytotoxic response in cell culture.
These are established scientific and engineering standards, not clinical "outcomes data" or "expert consensus" in the diagnostic sense.
8. The sample size for the training set:
This information is not applicable and not provided. The KLOCKNER KITS are a physical sterilization device, not an AI/ML model, and therefore do not have a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the same reason as point 8.
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