(78 days)
Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.
This document is a 510(k) Premarket Submission for a Cartridge Dental Syringe (K092943). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as it's a premarket notification document for a medical device seeking market clearance, not a study report.
The document indicates that the device is a simple cartridge syringe for dental anesthetic injections and is being found "substantially equivalent" to existing devices on the market. This type of submission relies on demonstrating that the new device has similar technological characteristics and intended use as a legally marketed predicate device, rather than requiring new clinical performance data against specific, quantitative acceptance criteria.
Therefore, it is not possible to fill out the requested table and information points from the provided text.
Explanation of what this document is (and isn't):
- 510(k) Premarket Submission: This is a regulatory pathway in the US for medical devices that are substantially equivalent to a legally marketed predicate device. It demonstrates that the new device is as safe and effective as the predicate.
- Substantial Equivalence: This means the device has the same intended use and the same technological characteristics as the predicate, or it has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the predicate device.
- Absence of Acceptance Criteria and Performance Study: For many Class I and Class II devices seeking 510(k) clearance, extensive clinical studies with quantifiable acceptance criteria are not required if substantial equivalence can be established through technological comparison, design features, and material properties. The FDA letter confirms the device classification (Class II) and that it's subject to general controls, indicating that a full PMA (Premarket Approval) with extensive clinical trial data was not necessary.
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510 (k) Premarket Submission
Page: 8
Document No: Revision: 1.1 Date: 08/27/2009
DEC 1 1 2009
510(k) Summary
Submitter: Arnold Tuber Industries DBA Sci-Dent, Inc. Address: 97 Main Street, Hamburg, NY 14075 Phone number: 716-648-3363 Fax number: 716-648-9296 Contact person: Michael Tuber Date prepared: 08/27/2009 Trade name: Cartridge Dental Syringe Common name: Cartridge Syringe Classification name: Cartridge Syringe Substantial equivalence claimed to: 510(k) Number - K083796
l . Miltex 510(k) Number - K040671 2. Anthogyr
Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.
Intended use: Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Summary of technological characteristics: Cartridge syringes are produced with various sized thumb rings to accommodate a large spectrum of practitioners. They also come in different colors.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 1 2009
:::
Mr. Michael Tuber President Arnold Tuber Industries 97 Main Street Hamburg, New York 14075
Re: K092943
Trade/Device Name: Cartridge Syringe Regulation Number: 21CFR 872.6770 Regulation Name: Cartridge System Regulatory Class: II Product Code: EJI Dated: August 27, 2009 Received: September 24, 2009
Dear Mr. Tuber:
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 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. Tuber
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Document No: Revision: 1.1 Date: 08/27/2009
Cartridge Svringe 510 (k) Premarket Submission
Indications for Use
510(k) Number:
Device Name: Cartridge Syringe
Indications for Use: Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Prescription Use 15 (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ruitzstetz mrs Lor Dr. Keina Maly (Acting)
(Division Sign-Off) Division of Anesthestology, General H Infection Control, Dantal Devices
510(k) Number: K092943
§ 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.