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.

Device Description

Hu-Friedy dental cartridge syringes are made from chrome-plated brass and stainless steel. Syringes are reusable, sterilizable and packaged non-sterile.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Hu-Friedy Dental Cartridge Syringes, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative or objective pass/fail manner with corresponding numerical results. Instead, it describes performance characteristics that were demonstrated to be "within recommended specifications" of various ISO standards. Therefore, I will derive the acceptance criteria from the mentioned ISO standards and summarize the finding as "Conforms to applicable clauses."

Acceptance Criteria (Derived from ISO Standards)	Reported Device Performance
Pertaining to ISO 9997:1999 (Dental Cartridge Syringes):
Loading of cartridges (compatibility with 1.8ml anesthetic vial)	Conforms to applicable clauses
Plunger rod testing	Conforms to applicable clauses
Plunger movement testing	Conforms to applicable clauses
Aspiration testing	Conforms to applicable clauses
Corrosion testing	Conforms to applicable clauses
Pertaining to ISO 11499:2007 (Dental Cartridges for Local Anesthetics):
General compatibility and performance related to anesthetic cartridges	Conforms to applicable clauses
Pertaining to ISO 13402:1995 (Surgical and Dental Hand Instruments):
General instrument characteristics and performance	Conforms to applicable clauses
Reprocessing and sterilization:
Successful steam sterilization cycles per ANSI/AAMI ST79	Conforms to ANSI/AAMI ST79

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size (number of syringes) used for the in-house performance testing. It also does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given it was "in-house testing," it's prospective testing conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the device described. The "test set" here refers to the physical dental syringes undergoing engineering and performance testing against established international standards (ISO standards). The "ground truth" is determined by measurements and observations as per the test methodologies outlined in those standards, not by expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Testing against ISO standards typically involves objective measurements and predefined pass/fail criteria, not consensus-based adjudication from multiple human reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data/images (e.g., radiologists reading scans), which is not relevant to a dental cartridge syringe.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described is a standalone evaluation of the device's physical and functional characteristics against established standards. There is no "algorithm" involved, and the human role is in conducting the tests and verifying compliance, not in interpreting the device's output within a clinical context.

7. The Type of Ground Truth Used

The ground truth used for establishing the performance of the device comprises:

International Standards: Specifically, ISO 9997:1999, ISO 11499:2007, and ISO 13402:1995 provide the "truth" or benchmark for acceptable performance.
ANSI/AAMI ST79: This standard serves as the ground truth for establishing successful steam sterilization cycles.
Manufacturer's Recommended Specifications: The document states that performance was "within recommended specifications of the applicable clauses," implying that the manufacturer's internal specifications, aligned with the ISO standards, were used as the benchmark for "ground truth."

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device.

Summary

{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

K120659

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:

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 CartridgeSyringes (Pre-amendment)
Indications for Use/Intended Use	These devices are intended for use by dentalprofessionals only. The devices are indicated tobe used in conjunction with anesthetic needlesand anesthetic cartridges for injection ofanesthetic solutions in the oral cavity.	These devices are intended for use by dentalprofessionals only. The devices are indicatedto be used in conjunction with anestheticneedles and anesthetic cartridges for injectionof 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 stainlesssteel	• Chrome plated brass and stainlesssteel
Compatibility with otherdevices	• Compatible with industry standard1.8ml anesthetic vial	• Compatible with industry standard1.8ml anesthetic vial
Reprocessing andcleaning methods	• Tested in accordance with ANSI/AAMIST 79	• Tested in accordance with ISO17664/17665
Sterility	• Product is supplied non-sterile	• Product is supplied non-sterile
Performance StandardsMet	• ISO 9997:1999• ISO 11499:2007• ISO 13402:1995	• ISO 9997:1999• ISO 11499:2007• ISO 13402:1995

. ·

{2}------------------------------------------------

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:

Susan Cunise

(Division Sign-Off) Division of Anesthesioiogy Ganaral Hospital Infection Control, Dental Devices

120659 510(k) Number:

Regulation Number and Section

§ 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.