Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies focus on mechanical design, material properties, and sterilization, with no mention of AI or ML.

Therapeutic

No
A therapeutic device is one that treats or heals a medical condition. This device is used to inject anesthetic, which facilitates a medical procedure, but does not directly treat a condition itself.

Diagnostic

No

The device is used for injecting anesthetic solutions, which is a treatment, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical syringe and needle system made of materials like chrome plated brass and stainless steel, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the LeEject 2 Syringe and Needle System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the "injection of anesthetic solutions in the oral cavity." This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
Device Description: The device is a syringe and needle system designed for delivering substances into the body. This is characteristic of a medical device used for treatment or diagnosis in vivo, not for testing in vitro.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LeEject 2 Syringe and Needle System does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

"The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity."

Product codes (comma separated list FDA assigned to the subject device)

EJI, DZM

Device Description

The LeEject 2 Syringe and Needle System is a side-loading dental syringe with a plastic guard "Safeguard" to secure the needle. After inserting the LeEject Needle hub into the opening of the plastic Safeguard, rotating the "Safeguard" guard clockwise secures the dental needle.

The LeEject 2 Syringe and Needle System give the user the option of recapping the dental needle prior to disposal or unlocking the "Safeguard" and allowing the needle to fall into the sharps container without recapping.

The LeEject 2 Syringe's main body is shaped like a standard syringe, apart from having a tapered end with a plastic "safeguard" attached, but has no threads on the tip to screw on the needle. The LeEject 2 Syringe is mostly made of chrome plated brass with the exception of the harpoon and piston rod, which is made of stainless steel.

The LeEject 2 Syringe is sold non-sterile, uses a standard 1.8mL anesthetic cartridge. The LeEject needles are EO sterilized, single use and sold separately.

Only the LeEject Needle can be used with the LeEject 2 Syringe.

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)

Nonclinical Testing was performed based on several ISO, AAMI, ANSI, EN, and ASTM standards.
Clinical testing was not performed with this device.

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.

K083796, Exempt

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

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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font, also in blue.

Advanced Technology and Capital, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K171254

Trade/Device Name: LeEject 2 Dental Syringe and Needle System Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: Class II Product Code: EJI, DZM Dated: October 16, 2017 Received: October 17, 2017

Dear E.J. Smith:

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.

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

November 16, 2017

1

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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K171254

Device Name

The LeEject 2 Syringe and Needle System

Indications for Use (Describe)

"The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity."

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

K171254 510(k) Summary

SPONSOR

Company Name:	Advanced Technology and Capital, Inc
Company Address:	5 Sylvan Ave., Englewood Cliffs, New Jersey 07632
Telephone:	201.803.5202
Contact Person:	Alexander Lee, DDS
Summary Preparation Date:	November 15, 2017

DEVICE NAME

Trade Name:	The LeEject 2 Syringe and Needle System
Common/Usual Name:	Dental Aspirating Syringe
Classification Name:	Syringe, Cartridge
Regulation Number:	21 CFR 872.4730
Product Code:	EJI, DZM
Device Class:	Class 1

PREDICATE DEVICE

Legally Marketed Equivalent Device
Company	Product	510(k) #
Miltex, Inc.	Miltex Dental Aspirating Syringe	K083796
Biodent Co.	Denject Disposable Dental Needles	Exempt

DEVICE DESCRIPTION

Image /page/3/Figure/9 description: This image shows a close-up of a medical device, possibly a needle or injection pen, with a safeguard mechanism. The diagram illustrates how to lock and unlock the safeguard by rotating it in the direction of the arrows. The text labels "LOCK", "UNLOCK", and "SAFEGUARD" are included to provide clear instructions on how to use the device.

The LeEject 2 Syringe and Needle System is a side-loading dental syringe with a plastic guard "Safeguard" to secure the needle. After inserting the LeEject Needle hub into the opening of the plastic Safeguard, rotating the "Safeguard" guard clockwise secures the dental needle.

Image /page/3/Picture/11 description: In the image, a pair of tweezers is being used to pick up a needle. The needle is inside of a container. The tweezers are being held by a hand. The image is a black and white drawing.

The LeEject 2 Syringe and Needle System give the user the option of recapping the dental needle prior to disposal or unlocking the "Safeguard" and allowing the needle to fall into the sharps container without recapping.

The LeEject 2 Syringe's main body is shaped like a standard syringe, apart from having a tapered end with a plastic "safeguard" attached, but has no threads on the tip to screw on the needle. The LeEject 2 Syringe is mostly made of chrome plated brass with the exception of the harpoon and piston rod, which is made of stainless steel.

4

The LeEject 2 Syringe is sold non-sterile, uses a standard 1.8mL anesthetic cartridge. The LeEject needles are EO sterilized, single use and sold separately.

Only the LeEject Needle can be used with the LeEject 2 Syringe.

Part	Chemical Name
Needle	Stainless steel
Needle Hub	Polypropylene
Needle Cap	Polypropylene
Dental Syringe	Chrome Plated Brass and stainless steel
Plastic Guard	Mineral Reinforced Nylon Resin (version 3-black)

Material Composition Table

DEVICE INDICATIONS FOR USE

LeEject 2 Syringe and Needle System is indicated to be used in conjunction with the LeEject needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

COMPARISON OF TECHNICAL CHARACTERISTICS

Syringe Comparison

Parameter	Subject Device	Predicate Device
510(k) Number	K171254	K083796
Intended Use:	LeEject 2 Syringe and
Needle System is
indicated to be used in
conjunction with
the LeEject needles
and anesthetic
cartridges for
injection of
anesthetic solutions
in the oral cavity.	Miltex® Dental
Aspirating Syringes
are indicated to be
used in conjunction
with anesthetic
needles and
anesthetic cartridges
for injection of
anesthetic solutions in
the oral cavity.
Syringe Type	Cartridge Syringe	Cartridge Syringe
Principle of
Operation	Manual	Manual
Specific Drug Use	Pre-filled local
anesthetics cartridge
1.8 mL	Pre-filled local
anesthetics cartridge
1.8 cc
Length	14.6 cm	13.2 cm
Diameter	1.25 cm	1.2 cm
Tip Type	Side-loading	Screw

5

| Volume | 1.8 mL Pre-filled
anesthetic cartridge | 1.8 cc Pre-filled
anesthetic cartridge |
|------------------------------|---------------------------------------------|---------------------------------------------|
| Barrel Transparency | Dentist can observe
cartridge during use | Dentist can observe
cartridge during use |
| Material Used | Chrome Plated Brass,
Stainless steel | Chrome Plated Brass
Stainless steel |
| Sterility upon sales | Non-sterile | Non-sterile |
| Reusable | Yes | Yes |
| Validated Cleaning
Method | Yes | Yes |

Dental Needle Comparison

| Element of
Comparison for

Dental Needle	Subject Device	Biodent
510(k) Number	Exempt	Exempt
Product Code	DZM	DZM
CFR	§872.4730	§872.4730
Intended Use	The LeEject dental
needle is a double-
pointed needle with
plastic needle hub to
be inserted and
secured inside the
LeEject 2 Syringe and
to inject local
anesthetics.

The LeEject dental
needles are available
as individually
packaged, sterile, and
single use. | A dental needle is a
double-pointed
needle with plastic
needle hub intended
to be attached onto a
dental syringe and to
inject local
anesthetics.

2 kg in push or pull | Epoxy glue
2 kg in push or pull |
| Materials | Stainless Steel
Needle with
Polypropylene Hub | Stainless Steel
Needle with
Polypropylene Hub |
| Biocompatibility | Excellent | Excellent |

6

Similarities and Differences 12.1

The LeEject 2 Syringe has equivalent Indications for Use, Intended Use, and material choice for the syringe as the predicate dental syringe. In addition, the LeEject 2 Syringe has a plastic Safeguard which is made of mineral reinforced nylon resin. Both are sold non-sterile with validated cleaning and sterilization methods.

7

The LeEject Needle has equivalent indications for use, intended use, materials, needle style, and is EO sterilized as the predicate.

The technological characteristics are substantially similar. The differences between the new device and the predicate device are:

. The new device has a different tip design which allows side loading of the needle onto the LeEject 2 Syringe versus the predicate's traditional screw-on tip. The LeEject dental needle, once inserted into the side opening of the syringe, is secured by our "safeguard" versus screwing the needle to the syringe. Both systems provide a secured attachment of the dental needle to the dental syringe and are substantially equivalent.
. The LeEject 2 Syringe and Needle System gives the user the option of recapping the dental needle or unlocking the "Safeguard" and allow the needle to fall into the sharps container without recapping. The predicate device requires recapping and unscrewing of the dental needle prior to disposal into a sharps container. Both dental syringes allow for recapping prior to disposal and are substantially equivalent.

These differences raise no new questions concerning safety or effectiveness. The LeEject 2 Syringe and Needle System is substantially equivalent to the predicate device.

PERFORMANCE DATA

Nonclinical Testing

ISO 9626:1991/Amd.1:2001(E), Section 10 and Annex D:" Resistance to Breakage . and Custom Needle Deflection"
. AAMI TIR12:2010. "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities. A guide for medical device manufacturers."
. ANSI/AAMI/ISO 17665-1:2006, "Sterilization of health care products – Moist heat-Part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices"
ANSI/AAMI/ISO 11135:2007, "Sterilization of healthcare products: Ethylene . oxide. Requirements for development, validation and routine control of a sterilization process for medical devices."

8

. EN 556-1: 2001, Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices.
. EN 1174:1996, "Sterilization of medical devise. Estimation of the population of micro-organisms on product. Requirements."
. EN 866:1997, "Biological systems for testing sterilizers and sterilization processes. General requirements"
. ISO 10993-7:2008, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals"
. ANSI/AAMI/ISO 11607:2006. "Packaging for Terminally Sterilized Medical Devices"
. ISO 14971 Second Edition 2007-03-01. Medical Devices – Application of risk management to Medical devices
. ANSI/AAMI/ISO 14937:2009/(R)2013, Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices.
ANSI/AAMI ST79: 2010 /A4:2013 Comprehensive guide to steam sterilization and . sterility assurance in health care facilities.
ANSI/AAMI ST81:2004 (R) 2010. Sterilization of medical devices information to . be provided by the manufacturer for the processing of resterilizable medical devices
. ASTM F 1980:2011. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
. ISO 10993-5: 2009 / (R) 2014 (GLP) Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity
. ISO 10993-10: 2010/ (R) 2014. Tests for irritation and delayed type hypersensitivity

Clinical testing was not performed with this device.

CONCLUSION

The LeEject 2 Syringe and Needle System meets the functional claims and intended use as described in the product labeling. The proposed device, the LeEject 2 Syringe and Needle System is substantially equivalent to the predicate devices, Miltex Dental Aspirating Syringe and Biodent dental needles.