(262 days)
No
The device description focuses on mechanical components and a spring-driven system, with no mention of AI or ML. The performance studies compare mechanical characteristics to predicate devices.
No.
The device is used to deliver medications, but it does not inherently provide a therapeutic effect itself. Its function is to facilitate the administration of other therapeutic agents.
No
The device is an injection system used to deliver medications, not to diagnose a condition or illness.
No
The device description details physical components like a handpiece, syringes, and a reset mechanism, indicating it is a hardware-based system for delivering injections. There is no mention of software as a component or the primary function.
Based on the provided text, the LectraJet Needle-Free Injection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications." This describes a device used for administering substances into the body, not for testing samples from the body.
- Device Description: The description details a system for delivering injections, including syringes, a handpiece, and a reset mechanism. There is no mention of components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The LectraJet is clearly described as a device for drug delivery, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
Product codes
KZE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
child/adult
Intended User / Care Setting
physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.
patients to self inject or to have other individuals administer injections of prescribed medications.
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)
Injection Force Profile: The injection force profile for the LectraJet® is substantially equivalent to that of the Biojector 2000® and the Medi-Jector Vision®.
Injection Duration: The injection duration for the LectraJet® is substantially equivalent to that of the Biojector 2000® and the Medi-Jector Vision®.
Depth and Dispersion: 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®
ISO EN 10993 -1:2003 Biocompatibility testing per ISO 10993-1:2003 will be completed prior to product launch.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road
East Syracuse, NY 13057
Telephone: (315) 463-4999
Fax: (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®,
K960373
Medi-Jector Vision®
K962956 |
| | Device Description: | 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. |
| | Intended 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. |
| | | The intended use of the LectraJet® is substantially the same
as the Biojector2000® and the Medi-Jector Vision®. |
| C. | Comparison of Required
Technological
Characteristics: | Injection Force Profile:
The force profile is a measure of the force of the injection
stream. The injection stream is directed at a force sensor,
which measures the amount of force of the impinging injection
stream. The test is used as both a comparative test (one
device versus another) and as a way to evaluate the
consistency of performance of an individual device. |
| | | Injection Duration:
The injection duration is the time extent of the injection from
start to finish and is obtained by injecting onto a force sensor
held just in front of the syringe orifice. Injection start is defined
as the time point when the force measured by the force
sensor rises sharply. Injection finish is defined as the time
point when the force on the force sensor falls sharply.
Depth and Dispersion of Jet Stream into Homogeneous
Substrate:
The depth and dispersion of the jet stream is determined by
giving an injection of a standardized colored injectate into a
homogeneous foam substrate. The injectate is allowed to dry
in the foam, and the foam is then sliced open to measure the
depth and dispersion of the injectate. |
| D. | Summary and Conclusion
of Non Clinical and Clinical
Testing | Conclusions of the following tests:
Injection Force Profile: The injection force profile for
the LectraJet® is substantially equivalent to that of the
Biojector 2000® and the Medi-Jector Vision®. Injection Duration: The injection duration for the
LectraJet® is substantially equivalent to that of the
Biojector 2000® and the Medi-Jector Vision®. Depth and Dispersion: 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® ISO EN 10993 -1:2003 Biocompatibility testing per ISO
10993-1:2003 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.
4
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
5
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