(93 days)
Not Found
The Subliminator (motorized, controlled delivery device) utilizes the identical needles in an identical way ie, they are either disposable or reusable, attached onto the Subliminator, discarded after use in Sharp's containers when they are removed, and sterilized exactly the same as described above.
This document is a 510(k) premarket notification for a dental injection device called "The Subliminator." It asserts substantial equivalence to existing manual injection devices marketed prior to May 28, 1976. The information provided is a declaration of substantial equivalence rather than a study demonstrating the device meets specific acceptance criteria based on performance data.
Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) cannot be filled with direct evidence from this submission.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics. The implicit acceptance criteria are that the device is "substantially equivalent in terms of safety and effectiveness" to predicate devices.
- Reported Device Performance: No quantitative performance metrics are reported. The "performance" described is functional equivalence to manual injectors in terms of:
- Purpose: Injecting local anesthetics into tissues for infiltration and block anesthesia.
- Anesthetics Used: Incorporates Lidocaine (Procaine), Polocaine, Ravocaine, Citanest, and Isocaine in predosed glass ampules.
- Needles: Uses identical disposable or reusable needles, attached and disposed of/sterilized in the same manner.
- Piston Mechanism: Employs a piston to push the ampule's plunger.
- Aspiration Capability: Allows for aspiration to detect inadvertent intravascular injection.
- Unique Feature: Ergonomically designed for controlled (motor-driven), slow, uniform, "surgeless" delivery, resulting in diminished injection pain compared to manual injections. This is a claimed benefit, not a reported performance metric with supporting data in this submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or performance data from a specific study is provided in this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is mentioned.
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
- Not Applicable. This device is a medical instrument for drug delivery, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a medical instrument, not an algorithm. Its operation inherently involves a human operator (clinician).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The basis for this submission is substantial equivalence to predicate devices, not performance against a "ground truth" derived from patient data or expert consensus. The "ground truth" in this context is the established safety and effectiveness of the existing manual injection devices it seeks to be equivalent to.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set.
Summary of the document's argument for acceptance:
The document argues for acceptance based on substantial equivalence to predicate manual injection devices by detailing similarities in:
- Intended Use: Injection of local anesthetics for infiltration and block anesthesia.
- Anesthetics & Packaging: Uses the same local anesthetics supplied in identical sterile predosed glass ampules.
- Mechanism of Action: Both use a plunger/piston to drive fluid through a needle.
- Needle Use: Utilizes identical disposable or reusable needles, attached and handled (disposal/sterilization) in the same manner.
- Safety Features: Both have aspiration capability to prevent intravascular injection. For the Subliminator, this is automated when the finger is removed from lever A.
The primary differential claimed feature of the Subliminator is its motor-driven, controlled, slow, uniform delivery, which is stated to result in "diminished injection pain when compared to manual injections." However, no data or study is presented within this 510(k) summary to support this claim or any specific performance metrics. The submission relies solely on the functional parallels between the Subliminator and the predicate manual devices.
§ 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.