(93 days)
Not Found
Not Found
No
The summary describes a motorized device for delivering fluids using needles, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for the delivery of anesthetics, which manages pain, but it does not directly treat a disease or condition itself.
No
The device is described as a "controlled delivery device" for "surgeless delivery of local anesthetics (and fluids) into tissues," and its predicate devices are "manual injection devices." There is no mention of it collecting or analyzing data to determine a medical condition or disease.
No
The device description explicitly states "The Subliminator (motorized, controlled delivery device)" and mentions the use of needles, indicating a physical hardware component for delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "surgeless delivery of local anesthetics (and fluids) into tissues." This describes a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description focuses on the mechanism of delivering substances into the body using needles, which is consistent with a therapeutic or procedural device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to perform tests on samples taken from the body to diagnose diseases or conditions.
Therefore, the Subliminator, as described, is a device for delivering substances into tissues, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
and on the contraction of the consistence of the comments of the finance of the film of the fill
ed the contribution of the construction of the film of the film of the film
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.