(202 days)
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.
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 system gives 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.
The provided text describes a 510(k) premarket notification for a dental syringe and needle system (LeEject 2). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document are primarily related to non-clinical performance testing against recognized standards and a comparison to predicate devices, not a clinical study to assess human-in-the-loop performance or algorithm-only performance as might be seen for AI/ML medical devices.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard/Test) | Reported Device Performance (Compliance) |
|---|---|
| Mechanical/Physical Performance: | |
| ISO 9626:1991/Amd.1:2001(E), Section 10 and Annex D: "Resistance to Breakage and Custom Needle Deflection" | Implied compliance through successful non-clinical testing. |
| Hub/Needle Bond Strength (>2 kg in push or pull) | Achieved (>2 kg in push or pull) |
| Reprocessing (for reusable syringe): | |
| AAMI TIR12:2010: "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities. A guide for medical device manufacturers." | Implied compliance through successful non-clinical testing and validated cleaning method. |
| ANSI/AAMI ST81:2004 (R) 2010: "Sterilization of medical devices information to be provided by the manufacturer for the processing of resterilizable medical devices" | Implied compliance through successful non-clinical testing and validated cleaning method. |
| ANSI/AAMI ST79: 2010 /A4:2013: "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." | Implied compliance through successful non-clinical testing and validated cleaning method. |
| Sterilization (for needles): | |
| 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" | Implied compliance (Needles are EO sterilized, not moist heat. This standard might refer to re-sterilization of the syringe.) |
| 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." | Implied compliance (Needles are EO sterilized). |
| EN 556-1: 2001: "Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices." | Implied compliance for sterile needles. |
| EN 1174:1996: "Sterilization of medical devise. Estimation of the population of micro-organisms on product. Requirements." | Implied compliance for sterile needles. |
| EN 866:1997: "Biological systems for testing sterilizers and sterilization processes. General requirements" | Implied compliance for sterile needles. |
| Biocompatibility: | |
| ISO 10993-7:2008: "Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals" | Implied compliance for EO sterilized needles. |
| ISO 10993-5: 2009 / (R) 2014 (GLP): "Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity" | Implied compliance. |
| ISO 10993-10: 2010/ (R) 2014: "Tests for irritation and delayed type hypersensitivity" | Implied compliance. |
| Packaging/Shelf Life: | |
| ANSI/AAMI/ISO 11607:2006: "Packaging for Terminally Sterilized Medical Devices" | Implied compliance for sterile needles. |
| ASTM F 1980:2011: "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" | Implied compliance for sterile needles. |
| Risk Management: | |
| ISO 14971 Second Edition 2007-03-01: "Medical Devices – Application of risk management to Medical devices" | Implied compliance. |
| 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." | Implied compliance. |
| Functional Claims/Intended Use: | "The LeEject 2 Syringe and Needle System meets the functional claims and intended use as described in the product labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. It only lists the standards to which the device was tested. The data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted lab to meet the specified international and national standards. This testing is not based on patient data provenance (e.g., country of origin) but rather on engineering and material performance tests. These are prospective tests performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information (number of experts, qualifications, ground truth establishment) is not applicable to this 510(k) submission. The "ground truth" for non-clinical performance refers to the objective pass/fail criteria of the specified engineering and biocompatibility tests and comparison to the predicate device's characteristics. No clinical "ground truth" established by medical experts is discussed.
4. Adjudication Method for the Test Set
This is not applicable as there is no human review or classification of data points in this non-clinical testing context. The "adjudication" is based on meeting the quantitative or qualitative requirements of the listed standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A MRMC study is not applicable as this is a traditional medical device (dental syringe and needle system), not an AI/ML-driven device. No AI assistance or human reader performance improvement is being evaluated.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is not an algorithm. It is a physical dental syringe and needle system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is based on established international and national standards for medical device performance, materials, sterilization, and biocompatibility. The comparison to the predicate device also serves as a form of "ground truth" for substantial equivalence. There is no expert consensus, pathology, or outcomes data presented as a basis for ground truth in this non-clinical submission.
8. The Sample Size for the Training Set
This is not applicable as there is no "training set" involved. This is a traditional medical device, not an AI/ML device that requires machine learning training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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 (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
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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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 andNeedle System isindicated to be used inconjunction withthe LeEject needlesand anestheticcartridges forinjection ofanesthetic solutionsin the oral cavity. | Miltex® DentalAspirating Syringesare indicated to beused in conjunctionwith anestheticneedles andanesthetic cartridgesfor injection ofanesthetic solutions inthe oral cavity. |
| Syringe Type | Cartridge Syringe | Cartridge Syringe |
| Principle ofOperation | Manual | Manual |
| Specific Drug Use | Pre-filled localanesthetics cartridge1.8 mL | Pre-filled localanesthetics cartridge1.8 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-filledanesthetic cartridge | 1.8 cc Pre-filledanesthetic cartridge |
|---|---|---|
| Barrel Transparency | Dentist can observecartridge during use | Dentist can observecartridge during use |
| Material Used | Chrome Plated Brass,Stainless steel | Chrome Plated BrassStainless steel |
| Sterility upon sales | Non-sterile | Non-sterile |
| Reusable | Yes | Yes |
| Validated CleaningMethod | Yes | Yes |
Dental Needle Comparison
| Element ofComparison forDental Needle | Subject Device | Biodent |
|---|---|---|
| 510(k) Number | Exempt | Exempt |
| Product Code | DZM | DZM |
| CFR | §872.4730 | §872.4730 |
| Intended Use | The LeEject dentalneedle is a double-pointed needle withplastic needle hub tobe inserted andsecured inside theLeEject 2 Syringe andto inject localanesthetics.The LeEject dentalneedles are availableas individuallypackaged, sterile, andsingle use. | A dental needle is adouble-pointedneedle with plasticneedle hub intendedto be attached onto adental syringe and toinject localanesthetics.The short needlepenetrates thediaphragm of a pre-filled cartridge and thelong needle is forparenteral use.The dental needlesare available asindividuallypackaged, sterile, andsingle use. |
| Gauge and Length | 27 G Long27 G x 35 mm | 27 G Long27 G x 35 mm |
| 27 G Short27 G x 25 mm | 27 G Short27 G x 25 mm | |
| 30 G Short30 G x 25 mm | 30 G Short30 G x 25 mm | |
| 30 G X-Short30 G x 12 mm | 30 G X-Short30 G x 12 mm | |
| Gauge | 27G-L27G-S30G-S30G-XS | 27G-L27G-S30G-S30G-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 hubsare yellow/blue incolor, respectively, andare seen throughtranslucent needlecaps.Sterility seals arelabeled with size andcolor coded:Red, Brown, Violet,and Blue on theoutside of the cover. | 27G /30G needle hubsare yellow/blue incolor, respectively, andare seen throughtranslucent needlecaps.Sterility seals arelabeled with size andcolor coded:Red, Brown, Violet,and Blue on theoutside of the cover. |
| Cover Strength | Made ofpolypropylene | Made ofpolypropylene |
| Hub/Needle BondStrength | Epoxy glue;>2 kg in push or pull | Epoxy glue>2 kg in push or pull |
| Materials | Stainless SteelNeedle withPolypropylene Hub | Stainless SteelNeedle withPolypropylene 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.
§ 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.