(231 days)
Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues.
The cartridge syringe may aid in the reduction of needle stick injuries.
The Hagar MIRAMATIC System consists of a cartridge syringe (the MIRAMATIC) and dental needles (MIRAJECT).
The MIRAMATIC System is a manual system designed exclusively for use with MIRAJECT needles. The hub of the syringe is designed to receive the needle using a compression fit mechanism rather than a threaded screw-on motion or slip-fit. The needles have a corresponding specially designed cone to allow seating by push fit on to the hub. The syringe hub has locked and unlocked positions.
The Hager MIRAMATIC Safe Syringe System is a dental cartridge syringe system with an antistick feature, needle re-capper, and sharps container, indicated for use with pre-filled anesthetic cartridges and press-fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The device is also stated to aid in the reduction of needle stick injuries.
1. Acceptance Criteria and Reported Device Performance
The provided submission does not explicitly state quantitative acceptance criteria for the Hager MIRAMATIC Safe Syringe System. However, it indicates that the device's performance and reliability characteristics were established through various tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Testing) |
|---|---|
| Mechanical integrity and functionality. | Mechanical testing was conducted. |
| Cleaning and sterilization efficacy. | Cleaning and sterilization efficacy was tested. |
| Performance in a simulated clinical environment, particularly regarding safety features. | Simulated clinical evaluation was performed. |
| Substantial equivalence to predicate device (SafeStep™ Safety Dental Cartridge Injector K022959, "1-Shot™ Safety Syringe"). | The device was found substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the mechanical testing, cleaning, sterilization efficacy, or simulated clinical evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The submission does not specify the number of experts used or their qualifications for establishing ground truth, particularly for the simulated clinical evaluation.
4. Adjudication Method for the Test Set
The submission does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided document. The device is a physical medical device (syringe system) rather than an AI-powered diagnostic tool, so such a study would not typically be applicable in this context.
6. Standalone Performance Study
The submission describes "Testing activities" conducted to establish the performance and reliability characteristics of the new device. This refers to the standalone performance of the device itself and its components (syringe, needles, and their interaction), rather than an algorithm. This includes mechanical testing, cleaning and sterilization efficacy, and simulated clinical evaluation.
7. Type of Ground Truth Used
The "ground truth" for this medical device would be established based on:
- Mechanical Engineering Principles and Standards: For mechanical testing (e.g., ensuring secure fit, proper ejection, durability).
- Microbiology/Sterilization Standards: For cleaning and sterilization efficacy (e.g., absence of viable microorganisms after specified processes).
- Clinical Safety and Efficacy Observations in a Simulated Environment: For the simulated clinical evaluation, focusing on the device's function as intended, particularly the "antistick feature" and ease of use. This would likely involve observing the device's operation under controlled conditions and confirming that it performs its intended functions effectively and safely.
The document does not detail specific "ground truth" methodologies beyond these general categories.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/software product, the concept of a "training set" in the context of machine learning does not apply. The development and testing process would involve iterative design, prototyping, and testing of physical components and assemblies to meet specified design requirements.
9. How the Ground Truth for the Training Set Was Established
Since the concept of a "training set" is not applicable, there is no corresponding method for establishing a ground truth for it. The device's design and functionality would be validated against engineering specifications, user needs, and regulatory requirements through the testing activities mentioned.
§ 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.