(274 days)
ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.
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).
The Anthogyr Cartridge Syringes, K040671, received 510(k) clearance based on substantial equivalence to predicate devices, rather than a study demonstrating meeting specific acceptance criteria for performance metrics like sensitivity or specificity. This type of clearance relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.
Here's an breakdown of the information provided in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not applicable for this 510(k) submission. Acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy) and their reported performance are typically required for diagnostic devices or devices with measurable output that directly impacts clinical decisions. For device types like cartridge syringes, the submission focuses on functional equivalence, material safety, and adherence to relevant standards.
Instead of a typical performance table, the submission indicates compliance with relevant standards:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance Statement) |
|---|---|
| NF EN ISO 9997 (2000) "Dental cartridge syringes" | ANTHOGYR cartridge dental syringes conform to NF EN ISO 9997 (2000) |
| ISO 13402 (1995) "Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure" | ANTHOGYR cartridge dental syringes conform to ISO 13402 (1995) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a separate test set for performance evaluation in the typical sense of a diagnostic or algorithmic device. Compliance with the ISO standards listed above would involve testing of representative samples of the manufactured syringes to ensure they meet the standard's requirements for design, materials, and functional aspects (e.g., proper fit of cartridges, smooth injection, resistance to sterilization). The specific number of devices tested to demonstrate compliance is not detailed in this summary.
- Data Provenance: The document does not specify the origin of any data (e.g., country of origin, retrospective/prospective). It implicitly refers to internal testing by Anthogyr to ensure compliance with the mentioned ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. For a device like a cartridge syringe, "ground truth" in the context of expert review for diagnostic accuracy is not relevant. Compliance with engineering standards and functional specifications does not typically involve expert clinical review of test results for a ground truth determination.
4. Adjudication method for the test set
This is not applicable. As there is no clinical "ground truth" established by experts, an adjudication method for conflicting expert opinions is not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated and compared. Cartridge syringes are instruments, and their effectiveness is assessed through their mechanical function and safety, not through human reader interpretation performance.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI is not applicable. This device is a physical, mechanical instrument and does not incorporate any algorithms or AI component.
7. The type of ground truth used
The "ground truth" in this context is adherence to established mechanical, material, and functional specifications outlined in the international standards (NF EN ISO 9997 and ISO 13402). This can be thought of as a "conformance to standard" ground truth, verified through engineering and quality control testing, rather than a clinical ground truth like pathology or outcome data.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a device that learns from data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this mechanical device, there is no ground truth to establish for it.
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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 lacs74700 SALLANCHES FRANCEPhone: 33(0)4 50 58 02 37 Fax: 33(0)4 50 93 78 60 |
|---|---|
| Contacts | Eric GENEVE (RD Manager) e.geneve.rd@anthogyr.comRegulatory 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).
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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 anestheticsyringe | Aspiject (Ronvig Instruments) K002168 |
| Stainless steel and chrome platedanesthetic 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
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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.
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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
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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
§ 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.