(262 days)
The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications.
The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.
The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.
The components of the LectraJet® Needle-Free Injection System include the needle-free single-use syringes with disposable vial adapter and cap with plunger rod attached and the injector handpiece with manual reset mechanism.
The LectraJet® handpiece and reset mechanism are sold as a complete injection system contained within a carrying case. The carrying case is an accessory of convenience that provides for portability, organization, and ease of use for the practitioner.
The LectraJet® syringes are packaged sterile and designed to be filled by the end user at the time of use. The polycarbonate syringes have a molded orifice at the front end. The syringe orifice is available in sizes 0.006", 0.008", 0.010" and 0.012" diameter, which allows the user to choose the syringe appropriate for the desired depth of penetration (IM/SQ) and patient selection (child/adult).
The syringes have a flange at the back end that is held by the injector handpiece when delivering the injection. Syringes are designed to be used immediately upon filling, similar to a traditional needle and syringe, and identical to the Biojector 2000® and Medi-Jector Vision® syringe filling philosophy. After the syringes are filled, they are inserted directly into the LectraJet® handpiece.
The LectraJet® handpiece contains a spring drive system that, when compressed, provides the energy to deliver the injection. To compress the spring, the handpiece is placed in a manual reset mechanism and hand pressure is applied to the reset mechanism lever. In the Medi-Jector Vision®, the manual power source used to compress the spring is a hand-twist knob. In the Biojector 2000®, the power source is either a gas cartridge or a gas cylinder.
When the LectraJet® handpiece is actuated, the spring drive system is released, and the handpiece ram contacts the syringe piston to drive the injectate out through the syringe orifice, creating a jet stream with enough energy to penetrate the tissue. This is identical in principle to the Biojector 2000® and the spring powered Medi-Jector Vision®.
After the injection, the used syringe is released into an appropriate trash container.
Little maintenance is required for the LectraJet® handpiece. There are no o-rings or seals to change. No sterilization of the handpiece is required.
All of the above features are similar to the Biojector 2000® and the Medi-Jector Vision®, predicate devices and accessories.
The LectraJet® Needle-Free Injection System demonstrates substantial equivalence to predicate devices (Biojector 2000® and Medi-Jector Vision®) based on a non-clinical study evaluating injection force profile, injection duration, and depth/dispersion into a homogeneous substrate.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly define "acceptance criteria" in a quantitative sense with specific thresholds. Instead, the study's conclusion is that the LectraJet® is substantially equivalent to the predicate devices based on the test results. The device performance is reported in a comparative manner against these predicates.
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (LectraJet®) |
|---|---|
| Injection Force Profile similar to predicate devices | "The injection force profile for the LectraJet® is substantially equivalent to that of the Biojector 2000® and the Medi-Jector Vision®." |
| Injection Duration similar to predicate devices | "The injection duration for the LectraJet® is substantially equivalent to that of the Biojector 2000® and the Medi-Jector Vision®." |
| Depth & Dispersion similar to predicate devices | "Depth and dispersion of injections into a homogeneous substrate indicate that the LectraJet® performance is substantially equivalent to the performance of the Biojector 2000® and the Medi-Jector Vision®." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set (number of injections performed or devices tested).
- Data Provenance: The study is reported within a 510(k) submission to the FDA, suggesting it was likely conducted by or for D'Antonio Consultants International, Inc. (DCI, Inc.) at their facility or a contracted lab. The country of origin of the data is not explicitly stated but can be inferred as the USA, given the submitter's location (East Syracuse, NY) and the FDA submission context. The study is non-clinical (bench testing), not referring to patient data, therefore the terms retrospective or prospective do not apply in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the study described is a non-clinical bench test comparing physical characteristics of the device against predicate devices. There is no "ground truth" established by experts in the context of clinical outcomes or imaging interpretation. The ground truth for the comparison is the measured performance of the predicate devices themselves.
4. Adjudication Method for the Test Set
This section is not applicable. As a non-clinical bench test, there is no need for adjudication by experts in the way clinical studies or image interpretation studies would. The measurements of force, duration, depth, and dispersion are objective physical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The described study is a non-clinical performance evaluation of the device itself, not a comparative study of human readers' performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The LectraJet® is a physical medical device (a needle-free injection system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant. The study evaluates the standalone performance of the physical device.
7. The Type of Ground Truth Used
The ground truth for this non-clinical study is the measured physical performance of the predicate devices (Biojector 2000® and Medi-Jector Vision®) for the parameters of injection force profile, injection duration, and depth/dispersion into a homogeneous substrate. The LectraJet®'s performance was then compared to these established predicate device measurements to determine substantial equivalence.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" for this type of non-clinical device performance study. The LectraJet® is a mechanical device, not an AI model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for a mechanical device.
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APPENDIX 5
| 510(k) Summary | |
|---|---|
| (As required by 21 CFR 807.92(a)) |
DEC 2 4 2009
"
| A. | Submitter Information | D'Antonio Consultants International, Inc. (DCI, Inc.)6308 Fly RoadEast Syracuse, NY 13057Telephone: (315) 463-4999Fax: (315) 463-5267 |
|---|---|---|
| B. | Device Information | |
| Trade/Proprietary Name: | LectraJet® Needle-Free Injection System, LectraJet® | |
| Common Name: | Needle Free Injector, Jet Injector | |
| Classification Name: | Jet Injector, Non Electrically Powered Fluid Injector | |
| Predicate Device: | Biojector 2000®,K960373Medi-Jector Vision®K962956 | |
| Device Description: | The components of the LectraJet® Needle-Free InjectionSystem include the needle-free single-use syringes withdisposable vial adapter and cap with plunger rod attached andthe injector handpiece with manual reset mechanism.The LectraJet® handpiece and reset mechanism are sold as acomplete injection system contained within a carrying case.The carrying case is an accessory of convenience thatprovides for portability, organization, and ease of use for thepractitioner.The LectraJet® syringes are packaged sterile and designed tobe filled by the end user at the time of use. The polycarbonatesyringes have a molded orifice at the front end. The syringeorifice is available in sizes 0.006", 0.008", 0.010" and 0.012"diameter, which allows the user to choose the syringeappropriate for the desired depth of penetration (IM/SQ) andpatient selection (child/adult).The syringes have a flange at the back end that is held by theinjector handpiece when delivering the injection. Syringes aredesigned to be used immediately upon filling, similar to atraditional needle and syringe, and identical to the Biojector2000® and Medi-Jector Vision® syringe filling philosophy.After the syringes are filled, they are inserted directly into theLectraJet® handpiece. | |
| The LectraJet® handpiece contains a spring drive systemthat, when compressed, provides the energy to deliver theinjection. To compress the spring, the handpiece is placed in amanual reset mechanism and hand pressure is applied to thereset mechanism lever. In the Medi-Jector Vision®, themanual power source used to compress the spring is a hand-twist knob. In the Biojector 2000®, the power source is eithera gas cartridge or a gas cylinder. | ||
| When the LectraJet® handpiece is actuated, the spring drivesystem is released, and the handpiece ram contacts thesyringe piston to drive the injectate out through the syringeorifice, creating a jet stream with enough energy to penetratethe tissue. This is identical in principle to the Biojector 2000®and the spring powered Medi-Jector Vision®. | ||
| After the injection, the used syringe is released into anappropriate trash container. | ||
| Little maintenance is required for the LectraJet® handpiece.There are no o-rings or seals to change. No sterilization ofthe handpiece is required. | ||
| All of the above features are similar to the Biojector 2000®and the Medi-Jector Vision®, predicate devices andaccessories. | ||
| Intended Use: | The LectraJet Needle-Free Injection System is intended todeliver subcutaneous (SQ) or intramuscular (IM) injections ofvaccines and other injectable medications. | |
| The LectraJet Needle-Free Injection System may be used byphysicians, nurses, veterinarians, podiatrists and otherpractitioners who routinely administer injections. | ||
| The LectraJet Needle-Free Injection System may also beused by patients to self inject or to have other individualsadminister injections of prescribed medications. | ||
| The intended use of the LectraJet® is substantially the sameas the Biojector2000® and the Medi-Jector Vision®. | ||
| C. | Comparison of RequiredTechnologicalCharacteristics: | Injection Force Profile:The force profile is a measure of the force of the injectionstream. The injection stream is directed at a force sensor,which measures the amount of force of the impinging injectionstream. The test is used as both a comparative test (onedevice versus another) and as a way to evaluate theconsistency of performance of an individual device. |
| Injection Duration:The injection duration is the time extent of the injection fromstart to finish and is obtained by injecting onto a force sensorheld just in front of the syringe orifice. Injection start is definedas the time point when the force measured by the forcesensor rises sharply. Injection finish is defined as the timepoint when the force on the force sensor falls sharply.Depth and Dispersion of Jet Stream into HomogeneousSubstrate:The depth and dispersion of the jet stream is determined bygiving an injection of a standardized colored injectate into ahomogeneous foam substrate. The injectate is allowed to dryin the foam, and the foam is then sliced open to measure thedepth and dispersion of the injectate. | ||
| D. | Summary and Conclusionof Non Clinical and ClinicalTesting | Conclusions of the following tests:Injection Force Profile: The injection force profile forthe LectraJet® is substantially equivalent to that of theBiojector 2000® and the Medi-Jector Vision®. Injection Duration: The injection duration for theLectraJet® is substantially equivalent to that of theBiojector 2000® and the Medi-Jector Vision®. Depth and Dispersion: Depth and dispersion ofinjections into a homogeneous substrate indicate that theLectraJet® performance is substantially equivalent to theperformance of the Biojector 2000® and the Medi-JectorVision® ISO EN 10993 -1:2003 Biocompatibility testing per ISO10993-1:2003 will be completed prior to product launch. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Joseph P. D'Antonio Vice President of Business Development D'Antonio consultants International, Incorporated (DCI) 6308 Fly Road East Syracuse, New York 13057
DEC 2 4 2009
Re: K090959
Trade/Device Name: LectraJet Needle Free Infection System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: November 20, 2009 Received: December 1, 2009
Dear Mr. D' Antonio:
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.
..............................................................................................................................................................................
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.
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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
$\hat{N}$ for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: LectraJet Needle Free Injection System
Indications For Use:
The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications.
The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.
The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles Moore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090959
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).