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510(k) Data Aggregation
(202 days)
LeEject 2 Dental Syringe and Needle System
The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
The LeEject 2 Syringe and Needle System is a side-loading dental syringe with a plastic guard "Safeguard" to secure the needle. After inserting the LeEject Needle hub into the opening of the plastic Safeguard, rotating the "Safeguard" guard clockwise secures the dental needle. The system gives the user the option of recapping the dental needle prior to disposal or unlocking the "Safeguard" and allowing the needle to fall into the sharps container without recapping. The LeEject 2 Syringe's main body is shaped like a standard syringe, apart from having a tapered end with a plastic "safeguard" attached, but has no threads on the tip to screw on the needle. The LeEject 2 Syringe is mostly made of chrome plated brass with the exception of the harpoon and piston rod, which is made of stainless steel. The LeEject 2 Syringe is sold non-sterile, uses a standard 1.8mL anesthetic cartridge. The LeEject needles are EO sterilized, single use and sold separately. Only the LeEject Needle can be used with the LeEject 2 Syringe.
The provided text describes a 510(k) premarket notification for a dental syringe and needle system (LeEject 2). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document are primarily related to non-clinical performance testing against recognized standards and a comparison to predicate devices, not a clinical study to assess human-in-the-loop performance or algorithm-only performance as might be seen for AI/ML medical devices.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard/Test) | Reported Device Performance (Compliance) |
|---|---|
| Mechanical/Physical Performance: | |
| ISO 9626:1991/Amd.1:2001(E), Section 10 and Annex D: "Resistance to Breakage and Custom Needle Deflection" | Implied compliance through successful non-clinical testing. |
| Hub/Needle Bond Strength (>2 kg in push or pull) | Achieved (>2 kg in push or pull) |
| Reprocessing (for reusable syringe): | |
| AAMI TIR12:2010: "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities. A guide for medical device manufacturers." | Implied compliance through successful non-clinical testing and validated cleaning method. |
| ANSI/AAMI ST81:2004 (R) 2010: "Sterilization of medical devices information to be provided by the manufacturer for the processing of resterilizable medical devices" | Implied compliance through successful non-clinical testing and validated cleaning method. |
| ANSI/AAMI ST79: 2010 /A4:2013: "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." | Implied compliance through successful non-clinical testing and validated cleaning method. |
| Sterilization (for needles): | |
| ANSI/AAMI/ISO 17665-1:2006: "Sterilization of health care products – Moist heat-Part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices" | Implied compliance (Needles are EO sterilized, not moist heat. This standard might refer to re-sterilization of the syringe.) |
| ANSI/AAMI/ISO 11135:2007: "Sterilization of healthcare products: Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices." | Implied compliance (Needles are EO sterilized). |
| EN 556-1: 2001: "Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices." | Implied compliance for sterile needles. |
| EN 1174:1996: "Sterilization of medical devise. Estimation of the population of micro-organisms on product. Requirements." | Implied compliance for sterile needles. |
| EN 866:1997: "Biological systems for testing sterilizers and sterilization processes. General requirements" | Implied compliance for sterile needles. |
| Biocompatibility: | |
| ISO 10993-7:2008: "Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals" | Implied compliance for EO sterilized needles. |
| ISO 10993-5: 2009 / (R) 2014 (GLP): "Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity" | Implied compliance. |
| ISO 10993-10: 2010/ (R) 2014: "Tests for irritation and delayed type hypersensitivity" | Implied compliance. |
| Packaging/Shelf Life: | |
| ANSI/AAMI/ISO 11607:2006: "Packaging for Terminally Sterilized Medical Devices" | Implied compliance for sterile needles. |
| ASTM F 1980:2011: "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" | Implied compliance for sterile needles. |
| Risk Management: | |
| ISO 14971 Second Edition 2007-03-01: "Medical Devices – Application of risk management to Medical devices" | Implied compliance. |
| ANSI/AAMI/ISO 14937:2009/(R)2013: "Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices." | Implied compliance. |
| Functional Claims/Intended Use: | "The LeEject 2 Syringe and Needle System meets the functional claims and intended use as described in the product labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. It only lists the standards to which the device was tested. The data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted lab to meet the specified international and national standards. This testing is not based on patient data provenance (e.g., country of origin) but rather on engineering and material performance tests. These are prospective tests performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information (number of experts, qualifications, ground truth establishment) is not applicable to this 510(k) submission. The "ground truth" for non-clinical performance refers to the objective pass/fail criteria of the specified engineering and biocompatibility tests and comparison to the predicate device's characteristics. No clinical "ground truth" established by medical experts is discussed.
4. Adjudication Method for the Test Set
This is not applicable as there is no human review or classification of data points in this non-clinical testing context. The "adjudication" is based on meeting the quantitative or qualitative requirements of the listed standards.
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
A MRMC study is not applicable as this is a traditional medical device (dental syringe and needle system), not an AI/ML-driven device. No AI assistance or human reader performance improvement is being evaluated.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is not an algorithm. It is a physical dental syringe and needle system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is based on established international and national standards for medical device performance, materials, sterilization, and biocompatibility. The comparison to the predicate device also serves as a form of "ground truth" for substantial equivalence. There is no expert consensus, pathology, or outcomes data presented as a basis for ground truth in this non-clinical submission.
8. The Sample Size for the Training Set
This is not applicable as there is no "training set" involved. This is a traditional medical device, not an AI/ML device that requires machine learning training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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