(274 days)
Not Found
No
The device description focuses on mechanical features and compliance with standards, with no mention of AI or ML.
No.
The device is strictly for injecting anesthetic solutions and does not directly treat or prevent a medical condition.
No
Explanation: The device is described as a syringe intended to inject anesthetic solutions. Its function is to deliver a substance, not to analyze or identify a medical condition.
No
The device description clearly describes physical hardware components (syringes, handles, plungers, mechanisms) and their mechanical functions, with no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject anesthetic solutions in the oral cavity." This is a direct medical intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details syringes used for injecting substances into the body. This aligns with a medical device used for treatment or intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body).
N/A
Intended Use / Indications for Use
ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.
Product codes (comma separated list FDA assigned to the subject device)
EJI
Device Description
ANTHOGYR has developed cartridge syringes which are substantially equivalent to legally marketed and FDA cleared predicate devices.
Intraligamental syringes
ERGOJECT and MINIJECT are syringes for every kind of anesthesia, especially intraligamental and intraseptal that requires high pressure. ANTHOGYR intraligamental syringes feature an ergonomic handle constructed of thermoplastic resin and have a leverage factor of three (ERGOJECT) or five (MINIJECT) to make it easier to use and an anti-reverse, non-ratcheting mechanism that prevents the plunger from slipping during injection.
Aspirating dental cartridge syringes
ANTHOGYR developed a full range of dental cartridge syringes including: Self aspirating syringe (ISO 9997 Type 2b - Aspiration under the effect of strength produced by the bending of a diaphragm in the cartridge), Aspirating syringe (ISO 9997 Type 2a -Aspiration under the effect of strength produced by the receding of the button in relation to the needle) and dental syringes without aspiration (ISO 9997 Type 1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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)
ANTHOGYR cartridge dental syringes conform to NF EN ISO 9997 (2000) "Dental cartridge syringes" and to ISO 13402 (1995) « Surgical and dental hand instruments -Determination of resistance against autoclaving, corrosion and thermal exposure »
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
510(k) Premarket Notification ANTHOGYR CARTRIDGE SYRINGES
Image /page/0/Picture/2 description: The image shows the word "anthogyr" in a stylized font, with the "a" and "n" in a smaller font size than the rest of the word. Below the word, there are three small squares. The first square is filled with a pattern of small dots, the second square contains a drawing of a screw, and the third square is filled with a solid black color.
DEC 1 4 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. GENERAL INFORMATION
| Submitter | ANTHOGYR (Registration number 8020776)
164 rue des trois lacs
74700 SALLANCHES FRANCE
Phone: 33(0)4 50 58 02 37 Fax: 33(0)4 50 93 78 60 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Eric GENEVE (RD Manager) e.geneve.rd@anthogyr.com
Regulatory Affairs: Idée Consulting (Dr Isabelle DRUBAIX)
idrubaix@nordnet.fr |
| Common Name | CARTRIDGE SYRINGE |
| Classification Name | CARTRIDGE SYRINGE |
| Class | II |
| Product Code | EJI |
| CFR section | 872.6770 |
| Device panel | DENTAL |
2. DEVICE DESCRIPTION
ANTHOGYR has developed cartridge syringes which are substantially equivalent to legally marketed and FDA cleared predicate devices.
Intraligamental syringes
ERGOJECT and MINIJECT are syringes for every kind of anesthesia, especially intraligamental and intraseptal that requires high pressure. ANTHOGYR intraligamental syringes feature an ergonomic handle constructed of thermoplastic resin and have a leverage factor of three (ERGOJECT) or five (MINIJECT) to make it easier to use and an anti-reverse, non-ratcheting mechanism that prevents the plunger from slipping during injection.
Aspirating dental cartridge syringes
ANTHOGYR developed a full range of dental cartridge syringes including: Self aspirating syringe (ISO 9997 Type 2b - Aspiration under the effect of strength produced by the bending of a diaphragm in the cartridge), Aspirating syringe (ISO 9997 Type 2a -Aspiration under the effect of strength produced by the receding of the button in relation to the needle) and dental syringes without aspiration (ISO 9997 Type 1).
1
Image /page/1/Picture/1 description: The image shows the word "anthogyr" in a stylized font above three small, square images. The first image on the left appears to be a textured or patterned square. The middle image contains a white, screw-like object on a dark background. The image on the right appears to be a dark square with some lighter elements, possibly representing a technical or scientific diagram.
3. INTENDED USE
ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.
4. PERFORMANCE DATA
ANTHOGYR cartridge dental syringes conform to NF EN ISO 9997 (2000) "Dental cartridge syringes" and to ISO 13402 (1995) « Surgical and dental hand instruments -Determination of resistance against autoclaving, corrosion and thermal exposure »
5. SUBSTANTIAL EQUIVALENCE
| ANTHOGYR Devices | Predicate devices |
|---|---|
| Ergoject / Miniject intraligamental syringes | Miniject (Spartan Ultrasonics) K991888 |
| Self aspirating Stainless steel anesthetic | |
| syringe | Aspiject (Ronvig Instruments) K002168 |
| Stainless steel and chrome plated | |
| anesthetic syringes | Numerous devices currently on market |
| (Cartridge Syringes - Septodont Inc, | |
| Ranfac, Cook Waite Kodak, Miltex ...) |
ANTHOGYR Devices are substantially equivalent to these predicate devices in terms of intended use, material, design and function.
Summary preparation date: February 23, 2004
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing to the right and has three stripes on its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Mr. Eric Geneve Anthrogyr 164 Rue De Trois Lacs Sallanches. FRANCE. F74700
Re: K040671
Trade/Device Name: ANTHOGYR CARTRIDGE SYRINGES Regulation Number: 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: October 18, 2004 Received: October 18, 2004
Dear Mr. Geneve:
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.
3
Page 2 - Mr. Geneve
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 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/dsma/dsmamain.html
Sincerely vours.
CluLs
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
4
510(k) Premarket Notification ANTHOGYR CARTRIDGE SYRINGES
Image /page/4/Picture/2 description: The image shows the word "anthogyr" in a stylized font, with the "a" and "y" slightly larger than the other letters. Below the word are three small, square images. The first image on the left appears to be a microscopic view of cells or tissue. The middle image shows a stylized representation of a screw or implant. The image on the right shows a celestial scene with stars and a crescent moon.
510(k) Number (if known): K040671
Device Name: ANTHOGYR CARTRIDGE SYRINGES
Indications for Use: ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use
or
Over-the-Counter Use
(PER 21 CFR 801.109)
Susan Munro
(Optional Format 1-2-96)
.
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Antool Roomoontal Devices
510(k) Number. K040671