(231 days)
Not Found
No
The device description and intended use clearly describe a manual mechanical system for dental anesthetic injection, with no mention of AI or ML capabilities.
No
The device is described as a manual system for injecting local dental anesthetics, and its function is to aid in the reduction of needle stick injuries, which are mechanical functions for administering drugs rather than providing a therapeutic effect itself.
No
The device is described as a system for the manual injection of local dental anesthetics, and there is no mention of it being used to identify or analyze a disease or condition.
No
The device description clearly states it consists of a cartridge syringe and dental needles, which are physical hardware components.
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 manual injection of local dental anesthetics into oral tissues. This is a procedure performed directly on a patient's body, not on a sample taken from the body.
- Device Description: The device is a syringe and needle system for delivering medication. This is a therapeutic or procedural device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EJI, DZM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicates. Testing involved mechanical testing, cleaning and sterilization efficacy and simulated clinical evaluation.
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.
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
JUL 2 1 2005 (As Required by 21 C.F.R. §807.92)
| Submitted by: | Hager Worldwide, Inc.
13322 Byrd Drive
Odessa, 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™ Safety
Syringe."). Dental needles are 510(k) exempt. | |
| Modifications | The device employs a compression fit loading and ejecting needle hub
rather than threaded connection. | |
| Intended 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. | |
| Technological
Characteristics | 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. | |
| Testing | Testing activities were conducted to establish the performance and
reliability characteristics of the new device with respect to the predicates.
Testing involved mechanical testing, cleaning and sterilization efficacy
and simulated clinical evaluation. | |
1
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.
2
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
3
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)