LeEject 2 Dental Syringe and Needle System

K171254 · Advanced Technology and Capital, Inc. · EJI · Nov 16, 2017 · Dental

Device Facts

• Record ID: K171254
• Device Name: LeEject 2 Dental Syringe and Needle System
• Applicant: Advanced Technology and Capital, Inc.
• Product Code: EJI · Dental
• Decision Date: Nov 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Side-loading dental syringe system; includes chrome-plated brass syringe body and mineral-reinforced nylon 'Safeguard' mechanism. User inserts LeEject needle into Safeguard; rotates clockwise to secure. Enables needle disposal into sharps container via unlocking mechanism, reducing need for manual recapping. Used in dental clinics by dentists/hygienists. Provides secure needle attachment; facilitates safer disposal compared to traditional screw-on syringes. Benefits patient/clinician by minimizing needle-stick injury risk during disposal.

Clinical Evidence

No clinical data. Bench testing only, including ISO 9626 needle deflection/breakage testing, biocompatibility (ISO 10993-5, 10993-10), and sterilization validation (ISO 17665-1, ISO 11135, ISO 10993-7).

Technological Characteristics

Manual cartridge syringe; chrome-plated brass and stainless steel construction. Side-loading tip with mineral-reinforced nylon 'Safeguard' locking mechanism. Compatible with 1.8mL anesthetic cartridges. Non-sterile delivery; reusable syringe with validated cleaning/sterilization protocols. Needle components: stainless steel needle, polypropylene hub/cap, epoxy glue bond (>2kg strength).

Indications for Use

Indicated for use in the oral cavity by dental professionals to inject anesthetic solutions using LeEject needles and 1.8mL anesthetic cartridges.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Miltex Dental Aspirating Syringe (K083796)
• Denject Disposable Dental Needles (Exempt)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | <input checked="" type="checkbox"/> |
|----------------------------------------------|-------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

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### 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.

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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<br>Needle System is<br>indicated to be used in<br>conjunction with<br>the LeEject needles<br>and anesthetic<br>cartridges for<br>injection of<br>anesthetic solutions<br>in the oral cavity. | Miltex® Dental<br>Aspirating Syringes<br>are indicated to be<br>used in conjunction<br>with anesthetic<br>needles and<br>anesthetic cartridges<br>for injection of<br>anesthetic solutions in<br>the oral cavity. |
| Syringe Type | Cartridge Syringe | Cartridge Syringe |
| Principle of<br>Operation | Manual | Manual |
| Specific Drug Use | Pre-filled local<br>anesthetics cartridge<br>1.8 mL | Pre-filled local<br>anesthetics cartridge<br>1.8 cc |
| Length | 14.6 cm | 13.2 cm |
| Diameter | 1.25 cm | 1.2 cm |
| Tip Type | Side-loading | Screw |

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

#### Dental Needle Comparison

| Element of<br>Comparison for<br>Dental Needle | Subject Device | Biodent |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Exempt | Exempt |
| Product Code | DZM | DZM |
| CFR | §872.4730 | §872.4730 |
| Intended Use | The LeEject dental<br>needle is a double-<br>pointed needle with<br>plastic needle hub to<br>be inserted and<br>secured inside the<br>LeEject 2 Syringe and<br>to inject local<br>anesthetics.<br><br>The LeEject dental<br>needles are available<br>as individually<br>packaged, sterile, and<br>single use. | A dental needle is a<br>double-pointed<br>needle with plastic<br>needle hub intended<br>to be attached onto a<br>dental syringe and to<br>inject local<br>anesthetics.<br><br>The short needle<br>penetrates the<br>diaphragm of a pre-<br>filled cartridge and the<br>long needle is for<br>parenteral use.<br>The dental needles<br>are available as<br>individually<br>packaged, sterile, and<br>single use. |
| Gauge and Length | 27 G Long<br>27 G x 35 mm | 27 G Long<br>27 G x 35 mm |
| | 27 G Short<br>27 G x 25 mm | 27 G Short<br>27 G x 25 mm |
| | 30 G Short<br>30 G x 25 mm | 30 G Short<br>30 G x 25 mm |
| | 30 G X-Short<br>30 G x 12 mm | 30 G X-Short<br>30 G x 12 mm |
| Gauge | 27G-L<br>27G-S<br>30G-S<br>30G-XS | 27G-L<br>27G-S<br>30G-S<br>30G-XS |
| Tip Configuration | Tri-bevel Point | Tri-bevel Point |
| Cover Dimensions | 1.0 x 7.6 cm | 1.0 x 8 cm |
| Cover Color | 27G /30G needle hubs<br>are yellow/blue in<br>color, respectively, and<br>are seen through<br>translucent needle<br>caps.<br>Sterility seals are<br>labeled with size and<br>color coded:<br>Red, Brown, Violet,<br>and Blue on the<br>outside of the cover. | 27G /30G needle hubs<br>are yellow/blue in<br>color, respectively, and<br>are seen through<br>translucent needle<br>caps.<br>Sterility seals are<br>labeled with size and<br>color coded:<br>Red, Brown, Violet,<br>and Blue on the<br>outside of the cover. |
| Cover Strength | Made of<br>polypropylene | Made of<br>polypropylene |
| Hub/Needle Bond<br>Strength | Epoxy glue;<br>>2 kg in push or pull | Epoxy glue<br>>2 kg in push or pull |
| Materials | Stainless Steel<br>Needle with<br>Polypropylene Hub | Stainless Steel<br>Needle with<br>Polypropylene Hub |
| Biocompatibility | Excellent | Excellent |

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#### 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.

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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."

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- . 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.