(246 days)
Pre-amendment
Not Found
No
The device description and performance studies focus on the mechanical and sterilization properties of a reusable dental syringe, with no mention of AI or ML capabilities.
No
The device is a syringe used for injecting anesthetic solutions, which is a delivery mechanism, not a device that directly performs therapy.
No
The device, a dental cartridge syringe, is used for injecting anesthetic solutions. It is not described as being used to identify or analyze a disease or condition. Its function is interventional (delivery of medication), not diagnostic.
No
The device description explicitly states it is made from chrome-plated brass and stainless steel, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a dental cartridge syringe used for injecting anesthetic solutions into the oral cavity. This is a procedure performed on the body, not a test performed on a specimen taken from the body.
- Intended Use: The intended use is for injecting anesthetic, not for analyzing a biological sample.
The device is a surgical/dental instrument used for a therapeutic procedure (administering anesthetic), not a diagnostic test.
N/A
Intended Use / Indications for Use
These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Product codes
EJI
Device Description
Hu-Friedy dental cartridge syringes are made from chrome-plated brass and stainless steel. Syringes are reusable, sterilizable and packaged non-sterile.
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
Children and adults
Intended User / Care Setting
Dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity. / Dental operatory
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)
Results of in-house testing with Hu-Friedy dental cartridge syringes demonstrated that they performed within recommended specifications of the applicable clauses of ISO 9997-Dental Cartridge Syringes, ISO 11499-Dental Cartridges for Local Anesthetics and ISO 13402-Surgical and Dental Hand Instruments. Verification criteria included loading of cartridges, plunger rod testing, plunger movement testing, aspiration testing and corrosion testing.
In addition, Hu-Friedy successfully completed an outside laboratory qualification study of the proposed steam sterilization cycles. The resulting recommended instructions to dental facilities for routine sterilization of the reusable dental syringes conform to ANSI/AAMI ST79.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pre-amendment
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for Hu-Friedy, a company that manufactures dental instruments and products. The logo is displayed in white text on a black, rounded rectangular background. The text is bold and slightly stylized, with a small registered trademark symbol in the bottom right corner.
Hu-Friedy Mfg. Co., LLC Chicago, Illinois USA 60618-5935 Phone: 773-975-3975 ext.3495 Fax: 773-868-3558 www.hu-friedy.com
510(k) SUMMARY
Submitted by:
Hu-Friedy Mfg. Co., LLC 3232 N. Rockwell Street Chicago, IL 60618
6 2012 NOV
Contact Person:
Maria Vrabie, Regulatory Affairs Manager Phone: (773) 975-3975 ext. 3495 Fax: (773) 868-3558
Date Prepared: Device Trade Name: Classification Name: Regulation number: Regulatory Class: Product Code:
02/29/2012 Hu-Friedy Dental Cartridge Syringes Syringe, Cartridge 21 CFR 872.6770 11 76 EJI
Device Description:
Hu-Friedy dental cartridge syringes are made from chrome-plated brass and stainless steel. Syringes are reusable, sterilizable and packaged non-sterile.
Intended Use:
These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Technological Characteristics:
Hu-Friedy will offer 2 patterns of syringes, the CW type cartridge syringe and the A type cartridge syringe. Both patterns of cartridge syringe are compatible with a standard 1.8ml anesthetic vial. According to ISO 9997: 1999, both patterns are classified as type 2a- aspiration by force produced by drawing the plunger away from the needle. The needle mounting threads for both patterns are available in standard imperial threads.
Performance Characteristics:
Results of in-house testing with Hu-Friedy dental cartridge syringes demonstrated that they performed within recommended specifications of the applicable clauses of ISO 9997-Dental Cartridge Syringes, ISO 11499-Dental Cartridges for Local Anesthetics and ISO 13402-Surgical and Dental Hand Instruments. Verification criteria included loading of cartridges, plunger rod testing, plunger movement testing, aspiration testing and corrosion testing.
In addition, Hu-Friedy successfully completed an outside laboratory qualification study of the proposed steam sterilization cycles. The resulting recommended instructions to dental facilities for routine sterilization of the reusable dental syringes conform to ANSI/AAMI ST79. Predicate Device:
| 510(k)# | Device | Manufacturer |
|---|---|---|
| Pre-amendment | Cartridge Syringes | Henke-Sass Wolf GmbH |
An ISO 13485 International Company
1
3232 N. Rockwell Street 0202 N. Rookston Books.
Chicago, 173-975-978-80000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Device Comparison
| Criteria | Hu-Friedy Cartridge Syringes | Predicate: Henke Sass Wolf Cartridge
Syringes (Pre-amendment) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use/
Intended Use | These devices are intended for use by dental
professionals only. The devices are indicated to
be used in conjunction with anesthetic needles
and anesthetic cartridges for injection of
anesthetic solutions in the oral cavity. | These devices are intended for use by dental
professionals only. The devices are indicated
to be used in conjunction with anesthetic
needles and anesthetic cartridges for injection
of anesthetic solutions in the oral cavity. |
| Target Population | Children and adults | Children and adults |
| Anatomical sites | Oral cavity | Oral cavity |
| Where used | Dental operatory | Dental operatory |
| Design | Patterns:
• Type A
• Type CW | Patterns:
• Type A
• Type CW |
| Materials used | • Chrome plated brass and stainless
steel | • Chrome plated brass and stainless
steel |
| Compatibility with other
devices | • Compatible with industry standard
1.8ml anesthetic vial | • Compatible with industry standard
1.8ml anesthetic vial |
| Reprocessing and
cleaning methods | • Tested in accordance with ANSI/AAMI
ST 79 | • Tested in accordance with ISO
17664/17665 |
| Sterility | • Product is supplied non-sterile | • Product is supplied non-sterile |
| Performance Standards
Met | • ISO 9997:1999
• ISO 11499:2007
• ISO 13402:1995 | • ISO 9997:1999
• ISO 11499:2007
• ISO 13402:1995 |
. ·
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three thick, curved lines representing its wings or body. The bird is positioned above a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle, following its curvature.
DEPARTMENT OF HEALTH & HUMAN SERVICES
November 6, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Hu-Friedy Manufacturing, Company, Limited Liability Company Ms. Maria Vrabie Regulatory Affairs Manager 3232 North Rockwell Street Chicago, Illinois 60618
Re: K120659
Trade/Device Name: Hu-Friedy Dental Cartridge Syringe Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: October 3, 2012 Received: October 3, 2012
Dear Ms. Vrabie:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Ms. Vrabie
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/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A.
Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
for
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Hu-Friedy, a company that manufactures dental instruments and products. The logo is in a black rounded rectangle with the company name in white, bold, sans-serif font. The letters are closely spaced and slightly slanted to the right, giving the logo a dynamic and modern look. The registered trademark symbol is visible in the bottom right corner of the rectangle.
Hu-Friedy Mfg. Co., LLC Chicago, Illinois USA 60618-5935 Phone: 773-975-3975 ext.3495 Fax: 773-868-3558 www.hu-friedy.com
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Hu-Friedy® Dental Aspirating Syringes
Intended Use:
These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Susan Cunise
(Division Sign-Off) Division of Anesthesioiogy Ganaral Hospital Infection Control, Dental Devices
120659 510(k) Number: