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510(k) Data Aggregation
(202 days)
| Classification Name: | Syringe, Cartridge |
| Regulation Number: | 21 CFR 872.4730
|
| CFR | §872.4730
| §872.4730
The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
The LeEject 2 Syringe and Needle System is a side-loading dental syringe with a plastic guard "Safeguard" to secure the needle. After inserting the LeEject Needle hub into the opening of the plastic Safeguard, rotating the "Safeguard" guard clockwise secures the dental needle. The system gives the user the option of recapping the dental needle prior to disposal or unlocking the "Safeguard" and allowing the needle to fall into the sharps container without recapping. The LeEject 2 Syringe's main body is shaped like a standard syringe, apart from having a tapered end with a plastic "safeguard" attached, but has no threads on the tip to screw on the needle. The LeEject 2 Syringe is mostly made of chrome plated brass with the exception of the harpoon and piston rod, which is made of stainless steel. The LeEject 2 Syringe is sold non-sterile, uses a standard 1.8mL anesthetic cartridge. The LeEject needles are EO sterilized, single use and sold separately. Only the LeEject Needle can be used with the LeEject 2 Syringe.
The provided text describes a 510(k) premarket notification for a dental syringe and needle system (LeEject 2). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document are primarily related to non-clinical performance testing against recognized standards and a comparison to predicate devices, not a clinical study to assess human-in-the-loop performance or algorithm-only performance as might be seen for AI/ML medical devices.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard/Test) | Reported Device Performance (Compliance) |
|---|---|
| Mechanical/Physical Performance: | |
| ISO 9626:1991/Amd.1:2001(E), Section 10 and Annex D: "Resistance to Breakage and Custom Needle Deflection" | Implied compliance through successful non-clinical testing. |
| Hub/Needle Bond Strength (>2 kg in push or pull) | Achieved (>2 kg in push or pull) |
| Reprocessing (for reusable syringe): | |
| AAMI TIR12:2010: "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities. A guide for medical device manufacturers." | Implied compliance through successful non-clinical testing and validated cleaning method. |
| ANSI/AAMI ST81:2004 (R) 2010: "Sterilization of medical devices information to be provided by the manufacturer for the processing of resterilizable medical devices" | Implied compliance through successful non-clinical testing and validated cleaning method. |
| ANSI/AAMI ST79: 2010 /A4:2013: "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." | Implied compliance through successful non-clinical testing and validated cleaning method. |
| Sterilization (for needles): | |
| ANSI/AAMI/ISO 17665-1:2006: "Sterilization of health care products – Moist heat-Part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices" | Implied compliance (Needles are EO sterilized, not moist heat. This standard might refer to re-sterilization of the syringe.) |
| ANSI/AAMI/ISO 11135:2007: "Sterilization of healthcare products: Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices." | Implied compliance (Needles are EO sterilized). |
| EN 556-1: 2001: "Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices." | Implied compliance for sterile needles. |
| EN 1174:1996: "Sterilization of medical devise. Estimation of the population of micro-organisms on product. Requirements." | Implied compliance for sterile needles. |
| EN 866:1997: "Biological systems for testing sterilizers and sterilization processes. General requirements" | Implied compliance for sterile needles. |
| Biocompatibility: | |
| ISO 10993-7:2008: "Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals" | Implied compliance for EO sterilized needles. |
| ISO 10993-5: 2009 / (R) 2014 (GLP): "Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity" | Implied compliance. |
| ISO 10993-10: 2010/ (R) 2014: "Tests for irritation and delayed type hypersensitivity" | Implied compliance. |
| Packaging/Shelf Life: | |
| ANSI/AAMI/ISO 11607:2006: "Packaging for Terminally Sterilized Medical Devices" | Implied compliance for sterile needles. |
| ASTM F 1980:2011: "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" | Implied compliance for sterile needles. |
| Risk Management: | |
| ISO 14971 Second Edition 2007-03-01: "Medical Devices – Application of risk management to Medical devices" | Implied compliance. |
| ANSI/AAMI/ISO 14937:2009/(R)2013: "Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices." | Implied compliance. |
| Functional Claims/Intended Use: | "The LeEject 2 Syringe and Needle System meets the functional claims and intended use as described in the product labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. It only lists the standards to which the device was tested. The data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted lab to meet the specified international and national standards. This testing is not based on patient data provenance (e.g., country of origin) but rather on engineering and material performance tests. These are prospective tests performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information (number of experts, qualifications, ground truth establishment) is not applicable to this 510(k) submission. The "ground truth" for non-clinical performance refers to the objective pass/fail criteria of the specified engineering and biocompatibility tests and comparison to the predicate device's characteristics. No clinical "ground truth" established by medical experts is discussed.
4. Adjudication Method for the Test Set
This is not applicable as there is no human review or classification of data points in this non-clinical testing context. The "adjudication" is based on meeting the quantitative or qualitative requirements of the listed standards.
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
A MRMC study is not applicable as this is a traditional medical device (dental syringe and needle system), not an AI/ML-driven device. No AI assistance or human reader performance improvement is being evaluated.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is not an algorithm. It is a physical dental syringe and needle system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is based on established international and national standards for medical device performance, materials, sterilization, and biocompatibility. The comparison to the predicate device also serves as a form of "ground truth" for substantial equivalence. There is no expert consensus, pathology, or outcomes data presented as a basis for ground truth in this non-clinical submission.
8. The Sample Size for the Training Set
This is not applicable as there is no "training set" involved. This is a traditional medical device, not an AI/ML device that requires machine learning training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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(231 days)
| Cartridge Syringe |
| | 872.4730
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.
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(179 days)
. § 872.4730 Dental injecting needle. (a) Identification.
- Administration of intraosseous anesthesia for dental indications.
The Cyberjet™ is a dental device intended for intraosseous injection of local anesthetics. Intraosseous injection requires the dentist to drill a small hole in the bone adjacent to the problem tooth. The dentist then uses a standard anesthesia needle and svringe to inject the local anesthetic solution into the previously drilled hole to numb the nerve of the tooth. The Cyberjet™ combines the dental drill and the injection needle into one device and performs both the drilling and injection functions with the same device. After an appropriate injection site has been identified, a topical anesthetic is applied to the gum, followed by a few minutes wait to allow the topical anesthetic to take effect. The previously selected injection site is located and the injection motor and the injection motor are turned on. The tip of the drill/needle is placed on the overlying gum and pressure is applied. The drill/needle passes through the soft tissue and starts to perforate the cortical plate. After the penetration of the cortical plate, the drill motor is turned off by releasing the momentary-switch on the foot-pedal. Local anesthetic is continuously dispensed into the tissue during and after the drilling process through the Infuser. Use of the Cyberjet™ will result in a simple one-step intraosseous injection for dental anesthesia. The system includes 5 components: 1. A Hollow Tubing Needle referred to as a drill/needle or Infuser that serves as a drill as well as a hypodermic iniection needle.
The provided document is a 510(k) Premarket Notification Summary of Safety and Effectiveness Information for the Cyberjet™ Local Anesthesia System. It focuses on regulatory classifications and substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them based on the text provided. The document primarily addresses regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test sets, data provenance, or details about the experts establishing ground truth.
- Adjudication methods.
- Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
The document's purpose is to outline the device's classification, intended use, and its substantial equivalence to the predicate device Stabident System Intraosseous Local Anesthesia K910446.
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