(87 days)
Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.
Denjector is a gun type electronic dental anesthetic cartridge syringe. This device is used with injectable local anesthetics packaged in cartridge form. The device consists of: Injector gun, battery, battery charger stand, DC adapter for battery charger stand, Cartridge holder and Cartridge pushing/pulling pin. Standard needles may be used with the device.
This document is a 510(k) summary for the Denjector, an electronic dental anesthetic cartridge syringe. It indicates that no clinical tests were performed to establish its safety and effectiveness. Instead, the submission relies on non-clinical tests and a comparison to a predicate device to claim substantial equivalence. Therefore, the information requested regarding acceptance criteria and a study proving those criteria cannot be extracted from this document, as such a study was not conducted.
Here is a summary of the information that can be extracted, along with explanations for the missing data:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (No specific acceptance criteria for performance were defined or tested clinically in this submission.) | (No device performance metrics from a clinical study are reported as no clinical study was performed.) |
Explanation: The document explicitly states, "Clinical testing was not conducted." Therefore, there are no acceptance criteria derived from clinical performance and no reported device performance against such criteria. The substantial equivalence claim is based on non-clinical standards and comparison to a predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable (No clinical test set was used).
- Data Provenance: Not applicable (No clinical data was used).
Explanation: As no clinical testing was performed, there is no test set or associated data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable (No clinical test set requiring ground truth established by experts).
- Qualifications: Not applicable.
Explanation: Without clinical testing, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
Explanation: No clinical test set means no adjudication method was necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No.
- Effect Size: Not applicable.
Explanation: An MRMC comparative effectiveness study involves human readers and clinical cases. Since no clinical testing was done, no such study was conducted.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No.
Explanation: The "Denjector" is a hardware device (an electronic dental anesthetic cartridge syringe), not a software algorithm. Therefore, a standalone algorithm-only performance study is not relevant. The testing mentioned (EN 60601-1, EN 61000-3-2, and EN 61000-3-3) refers to electrical safety and electromagnetic compatibility standards for medical devices, which are not performance studies in the clinical sense.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable.
Explanation: There are no clinical outcomes or diagnostic assessments to establish ground truth for, as no clinical study was performed.
8. Sample Size for the Training Set:
- Sample Size: Not applicable.
Explanation: The Denjector is a hardware device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Method: Not applicable.
Explanation: As no training set was used, no ground truth needed to be established for it.
In summary, the provided 510(k) submission for the Denjector explicitly states that no clinical trials were conducted. The device's safety and effectiveness were established through non-clinical testing against recognized standards (EN 60601-1, EN 61000-3-2, EN 61000-3-3) and a comparison to a predicate device (CC:3; computer controlled syringe by DENTSPLY Midwest Professional Ltd., K983105) to demonstrate substantial equivalence.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.