(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.
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JUL 2 1 2005 (As Required by 21 C.F.R. §807.92)
| Submitted by: | Hager Worldwide, Inc.13322 Byrd DriveOdessa, FL 33556 | |
|---|---|---|
| Date of summary: | This summary was prepared on June 30, 2005. | |
| Device name: | Hager MIRAMATIC Safety Syringe System | |
| Common name: | Dental cartridge syringe system with antistick feature, needle re-capper,and sharps container. | |
| Classification names: | Regulation Number and ProCode | Classification Name |
| 872.6770, EJI | Cartridge Syringe | |
| 872.4730, DZM | Dental Needle | |
| Predicate Devices | SafeStep™ Safety Dental Cartridge Injector K022959 ("1-Shot™ SafetySyringe."). Dental needles are 510(k) exempt. | |
| Modifications | The device employs a compression fit loading and ejecting needle hubrather than threaded connection. | |
| Intended Use | Indicated for use with pre-filled anesthetic cartridges and press fit dentalneedles for the manual injection of local dental anesthetics into the oraltissues. | |
| The cartridge syringe may aid in the reduction of needle stick injuries. | ||
| TechnologicalCharacteristics | The Hagar MIRAMATIC System consists of a cartridge syringe (theMIRAMATIC) and dental needles (MIRAJECT). | |
| The MIRAMATIC System is a manual system designed exclusively foruse with MIRAJECT needles. The hub of the syringe is designed toreceive the needle using a compression fit mechanism rather than athreaded screw-on motion or slip-fit. The needles have a correspondingspecially designed cone to allow seating by push fit on to the hub. Thesyringe hub has locked and unlocked positions. | ||
| Testing | Testing activities were conducted to establish the performance andreliability characteristics of the new device with respect to the predicates.Testing involved mechanical testing, cleaning and sterilization efficacyand simulated clinical evaluation. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the top half of the circle. In the center of the circle is a stylized image of a human figure, represented by three curved lines. The figure is facing to the right and appears to be in motion.
Public Health Service
JUL 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hager Worldwide, Incorporated c/o Mr. James Delaney 4 Lincoln Street Andover, Massachusetts 01810
Re: K043322
Trade/Device Name: Miramatic Safe Syringe System Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge syringe Regulatory Class: II Product Code: EJI Dated: July 1, 2005 Received: July 5, 2005
Dear Mr. Delaney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Delaney
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Davers
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043322
Device Name: Hagar MIRAMATIC Safe Svringe System
Indications for Use:
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.
Prescription Use 关 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mhe Udshle for MSR
(Division Sign Division of Anesthesiolo Infection Control, De
510(k) Number:
Page _ of __ _
(Posted November 13, 2003)
§ 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.