(143 days)
LUBRINA HIM-1 is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: LUBRINA HIM-1 should be used only with pre-cleaned dental handpieces and before they are sterilized.
CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.
The LUBRINA HIM-1 is the maintenance system for handpieces, consisting of a main body and several accessories.
The main body is constructed in a box on which the maximum 4 pieces of handpieces are able to be connected by each connection nut, and two spray cans are set inside the box.
This 510(k) submission for the LUBRINA HIM-1 device does not explicitly describe a study with acceptance criteria and reported device performance in the way typically expected for a new medical device claiming performance characteristics related to diagnostic or treatment efficacy.
Instead, this submission is a Premarket Notification (510(k)) which aims to demonstrate substantial equivalence to already legally marketed predicate devices. For Class I devices like this one, the focus is on showing that the new device has "similar general intended uses, similar principles of operation, and similar technological characteristics" to existing devices, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are largely not applicable or directly available in this type of submission.
Here's a breakdown of what can be inferred or stated based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the nature of a 510(k) for a Class I device focused on substantial equivalence, there are no explicit quantitative acceptance criteria or detailed performance reports for metrics like sensitivity, specificity, or outcomes. The "acceptance criteria" here are inherently tied to demonstrating similarity to predicate devices.
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Indication for Use | Must be identical or nearly identical to predicate devices | Identical to predicate devices |
| Target Population | Must be identical or nearly identical to predicate devices | Identical to predicate devices |
| Design | Must be similar to predicate devices, without raising new safety/effectiveness concerns | Similar to predicate devices |
| Materials | Must be identical or similar to predicate devices, with no new safety/effectiveness concerns | Identical to predicate devices |
| Performance | Must be similar to predicate devices, achieving the same intended function adequately | Similar to predicate devices |
| Sterility | Must be identical to predicate devices (likely referring to the non-sterile nature of the device itself, but used with pre-cleaned instruments) | Identical to predicate devices |
| Biocompatibility | Must be identical to predicate devices (likely meaning non-biocompatibility concerns given the device's function and lack of patient contact) | Identical to predicate devices |
| Mechanical Safety | Must be identical or similar to predicate devices, meeting established safety standards | Identical to predicate devices |
| Chemical Safety | Must be identical or similar to predicate devices, meeting established safety standards | Identical to predicate devices |
| Anatomical Sites | Must be similar to predicate devices (i.e., external maintenance of dental instruments, not used on anatomical sites) | Similar to predicate devices |
| Human Factors | Must be similar to predicate devices, with no new usability issues | Similar to predicate devices |
| Energy Used/Delivered | Must be similar to predicate devices | Similar to predicate devices |
| Compatibility with Environment and Other Devices | Must be similar to predicate devices | Similar to predicate devices |
| Where Used | Must be identical to predicate devices (i.e., in a dental office, separate from patient) | Identical to predicate devices |
| Standards Met | Must be similar to predicate devices (indicating compliance with relevant industry standards for safety, etc.) | Similar to predicate devices |
| Electrical Safety | Must be similar to predicate devices, meeting established safety standards | Similar to predicate devices |
| Thermal Safety | Must be similar to predicate devices, meeting established safety standards | Similar to predicate devices |
Study Description:
The document describes a substantial equivalence comparison rather than a traditional performance study. The core "study" is the comparison against predicate devices to demonstrate that the LUBRINA HIM-1 performs its intended function similarly and safely.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. There is no "test set" in the sense of a dataset for algorithmic performance evaluation. The "sample" here refers to the LUBRINA HIM-1 device itself, which is compared to existing predicate devices.
- Data Provenance: The comparison is based on the characteristics of the LUBRINA HIM-1 and two predicate devices (KaVo QUATTROcare and W & H Assistina), both of which are already marketed in the USA. The manufacturer of LUBRINA HIM-1 is J. MORITA MFG. CORP. in Kyoto, Japan. This is a comparison of product specifications and functions, not a clinical data review. It is not framed as retrospective or prospective data collection from patients or specific device usage tests requiring datasets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no "ground truth" to establish for a test set in this context. The evaluation is based on engineering specifications, intended use, and general performance characteristics compared to existing devices.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is not relevant for a Class I device like a dental handpiece maintenance system aiming for substantial equivalence. MRMC studies are typically for diagnostic imaging devices or treatment efficacy where human reader performance is a critical factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a mechanical/electronic system, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable in the conventional sense of clinical performance studies. The "ground truth" for this substantial equivalence argument is the established safety and effectiveness of the predicate devices. The new device is deemed "safe and effective" because it is demonstrably similar to devices already found safe and effective by the FDA.
8. The Sample Size for the Training Set:
Not applicable. There is no machine learning or algorithmic component to this device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.