Search Results

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.

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.

Ask a specific question about this device

The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.

This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.

Target Population: Patients who have to be injected with liquid pharmaceuticals.

The INJEX™ and ROJEX™ Systems Extra are medical devices to apply liquid medicine needle-free through the skin into the subcutaneous tissue. The process is based on the generation of a defined high velocity jet of fluid to penetrate the skin and to transport the medicine to the subcutaneous tissue. The energy source to accelerate the fluid within the ampoule is an internal spring.

The INJEX™ Injector is designed for multi- use. To tense the spring within the small hand- held injector for injection the reset box is used. For patient's safety the injector is equipped with two safety mechanisms. The automatic mechanism will be deactivated by mounting the ampoule onto the injector, and before injecting

The ROJEX™ Injector is a disposable medical device for single- use. For patient's safety the injector is equipped with a manual safety mechanism, the safety ring. Before injecting the dose of medicine to the individual the safety ring needs to be shifted into the safe- off position.

To transfer the medicine from its different repositories into the ampoule several adapters are designed. In case, medicines in cartridges are used an aid is available: the transporter.

The INJEX™ Systems Extra consist of two main components which are re- usable:

• . INJEX™ Injector
• . Reset Box

The ROJEX™ Systems Extra represent the disposable medical device:

• · ROJEX™ Injector, pre- tensed

The three accessories for INJEX™ needle- free Injection systems Extra are:

• Transporter, re- usable .
• Adapter, sterile, usable for one medicine repository .
• Ampoule, sterile, for single- use .

The provided text describes a 510(k) premarket notification for the INJEX™/ROJEX™ Needle-free Injection System Extra. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given information:

1. A table of acceptance criteria and the reported device performance:

• This information is not available in the provided text. The submission focuses on substantial equivalence rather than presenting specific performance acceptance criteria and corresponding test results.

2. Sample size used for the test set and the data provenance:

• This information is not available in the provided text. The document mentions non-clinical tests but does not specify a test set sample size or data provenance in the context of device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not available in the provided text. The submission does not describe a study involving expert-established ground truth for performance evaluation.

4. Adjudication method for the test set:

• This information is not available in the provided text.

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:

• This information is not available in the provided text. The device is a needle-free injection system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This information is not available in the provided text. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• This information is not available in the provided text in the context of device performance. The submission discusses "biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation" as part of non-clinical tests, which could be considered a form of ground truth for safety, but not for broader device performance as typically understood in the context of acceptance criteria.

8. The sample size for the training set:

• This information is not available in the provided text. The device does not involve a "training set" in the context of machine learning or algorithms.

9. How the ground truth for the training set was established:

• This information is not available in the provided text. As above, this concept is not applicable to the device described.

Summary of available information regarding compliance/testing:

The submission states:

• "In addition to the supplier's raw material testing reqarding the ampoule, biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation were analysed."
• "The body contact of the ampoule is classified as short term (

Ask a specific question about this device