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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.
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I certify that, in my capacity as president of Healex Products, Inc., I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Milton Hodosh, D.m.D.
Milton Hodosh, D.M.D Date Premarket Notification 510 (k) number
JUL 18 1996
Section 2- Summary & Certification
This product, The Subliminator, is substantially equivalent in terms of safety and effectiveness to the marketed manual injection devices of Astra, Schein, Monoject, Cook-Waite, Septodont, and others. These products have been marketed prior to May 28, 1976, and are used to inject local anesthetics into tissues to produce infiltration and block anesthesia . They can use Lidocaine (Procaine), Polocaine, Ravocaine, Citanest, and Isocaine in predosed glass ampules which are inserted into the manual injection devices prior to administering the local anesthetic into tissues. Our injection device is called the "Subliminator", it also is used for the injection of these local anesthetics packaged exactly the same way ie. in sterile predosed glass ampules which are inserted also into the Subliminator for injection into tissues. In this regard manual injectors and the Subliminator are both substantially equivalent as they are both used for the same purpose and in fact, utilize the same local anesthetics packaged exactly the same way. both are driven by a plunger through a needle into the tissues.
The needles used with the Astra, Schein, Monoject, Cook-Waite, Septodont manual injectors are pre-sterilized (ethylene oxide) by the manufacturer and are disposable. Reusable needles can be autoclaved and used with these manual syringes also, they are attached onto the manual injection devices and the Subliminator in the same manner. Disposable needles are discarded in Sharp's containers as required by OSHA and the reusable needles are placed in sterile bags and autoclaved for future use. Our 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. In this regard also, the manual syringes cited and our Subliminator are substantially equivalent.
Manual syringes and the Subliminator both employ a piston which engages the rubber plunger of the fluid filled ampule so as to push the plunger forward driving the fluid through the lumen of the needle. In this regard also the manual syringe and the Subliminator are equivalent.
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The manual devices and our Subliminator both have the capability to aspirate to determine if the needle has been inadvertently inserted into a blood vessel, an undesired happening. This is a very important feature of both devices, as it is important to have the capability to aspirate in order to prevent the clinician from injecting anesthetic into blood vessels and shocking the patient's vascular systems . Having this capability prevents untoward Syncope and/or Vagal/Vagal reactions The clinician will know not to proceed with the injection, and to withdraw the needle out of the blood vessel, change the direction (angle) of the needle penetration, redirect the needle and aspirate to confirm that their needle is not in a blood vessel. If not in a blood vessel the injection can be continued. Both devices possess this safety (feature) With the manual syringe the clinician would draw back on the plunger manually and observe if blood enters the ampule. With the Subliminator all that is necessary is to remove the finger from lever A (see schematic 1 w/ legend) and if the clinician is in the blood vessel a stream of blood will enter the glass ampule.
Both mechanisms are effective and in this regard our Subliminator is substantially equivalent to the manual devices cited and marketed prior to May 28, 1976.
Section 3 Proposed Labeling
The Subliminator will be packaged in a box and sold to dentists and physicians for the surgeless delivery of local anesthetics (and fluids) into tissues. It will be featured as being ergonomically designed for controlled (motor driven), slow uniform, surgeless delivery of these fluids. This results in diminished injection pain when compared to manual injections using hand syringes.
Instruction for use
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Topical anesthetic is applied to the tissue site where the injection of local anesthetics (fluids) are to be given. A sterile needle (disposable or reusable) of the proper gauge is attached to the Subliminator, and the desired local anesthetic is inserted as well. The Subliminator is held in a pen grasp and the forward lever (A) is activated by depressing it with the forefinger. The first green light will go on and the local anesthetic will flow at the slowest rate. The tip of the needle with local anesthetic flowing is inserted into the tissues to only a depth of 1-3 millimeters. It is kept at this depth for several seconds and then slowly moved in the desired direction and depth. Pain from needle advancement is diminished since the flow of anesthetic precedes needle penetration.
When the clinician deems it important he or she merely has to take their finger off lever A and aspiration will take place automatically. There are two additional forward speeds and they can be employed to speed up the injection once anesthesia has begun and the possibility of pain in the tissues is eliminated. Note that there are two additional green lights indicating the forward speed status.
§ 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.