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The over the counter Injex 30 Needle-Free Insulin Injector System is intended for the subcutaneous iniection of U-100 insulin. The Injex 30 Insulin Ampule is labeled as suitable for administration of 5 to 30 insulin units with a scale in 1 unit increments.

Equidyne Systems Injex 30 Needle Free Insulin Injector System is a means of administering insulin in the subcutaneous tissue without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the insulin in the subcutaneous tissue. The process takes place in a fraction of a second.
The Injex 30 Needle-Free Insulin Injector System consists of four main components:

1. Iniex 30 Needle-Free Insulin Injector A small re-usable hand held Iniector.
2. Reset Box - A compact re-usable Reset Box used to reset the Injex 30 Needle Free Insulin Injector,
3. Injex 30 Insulin Ampule - A disposable, sterile 30 unit Injex 30 Insulin Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Injex 30 Insulin Ampule is loaded into the Injex 30 Needle Free Insulin Injector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
4. Vial Adapter - A disposable, sterile Vial Adapter facilitates the transfer of the insulin from the medicine bottle or vial to the Injex 30 Insulin Ampule.
   The Injex 30 Needle Free Insulin Injector can deliver variable doses of insulin from 5 to 30 units. The Injex 30 Insulin Ampule scale is in 1 unit increments.

Here's a breakdown of the acceptance criteria and study details for the Injex 30 Needle-Free Insulin Injector System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Subjects are able to self-administer an injection after viewing training materials (i.e., not difficult or unable). | 1. 100% of subjects said it was either easy or somewhat easy to give themselves an injection after viewing the training video and reading the Instructions for Use.
3. None of the subjects said that it was difficult or they were not able to give themselves an injection after viewing the training video and reading the Instructions for Use. |
   | User Preference | A significant portion of subjects prefer the Injex device or are ambivalent (would use either Injex or needle/syringe) compared to a traditional needle and syringe. | 84% of the subjects said that they either prefer the Injex 30 Needle-Free Insulin Injector or would use either the Injex 30 Needle-Free Insulin Injector or a needle and syringe in the future. |
   | Pain Perception | Pain from the Injex device is perceived as similar to, or less than, a traditional insulin needle and syringe by a significant portion of subjects. | 91% of the subjects said the pain from the Injex 30 Needle-Free Insulin Injector was either the same as, a little less or a lot less than the insulin needle and syringe. |
   | Comparative Ease of Use | Subjects find the Injex device just as easy to use as an insulin needle and syringe. | 91% of the subjects felt that the Injex 30 Needle-Free Insulin Injector was just as easy to use as an insulin needle and syringe. |
   | Comparative Ease of Self-Injection | Subjects find it just as easy to give themselves an injection using the Injex device as with an insulin needle and syringe. | 100% of the subjects felt it was just as easy to give themselves an injection using the Injex 30 Needle-Free Insulin Injector as it was with an insulin needle and syringe. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the exact number of subjects in the clinical study. It mentions a "good distribution of age among the subjects with the average age being 48.5 years with a range of 25 to 77 years old" and provides percentages of education levels. This suggests a reasonably sized cohort, but the specific n is missing.
• Data Provenance: The document does not specify the country of origin. It is a prospective study as subjects were observed administering injections and then surveyed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. This study is based on subjective patient experience and self-reported perceptions (ease of use, pain, preference) when comparing the device to a traditional needle and syringe. There was no "ground truth" to be established by experts in the context of diagnostic accuracy or clinical correctness of the injection, as the purpose was to assess user experience and instruction adequacy.

4. Adjudication Method for the Test Set

• Not applicable. Since the study focuses on subjective user experience and self-reported outcomes, there was no need for an adjudication method by experts. The results are based on direct subject feedback via questionnaires.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This was not an MRMC study. It was a clinical study evaluating user experience, ease of use, and pain perception for a medical device (insulin injector) compared to a predicate device (needle and syringe), not a diagnostic imaging study involving multiple readers and cases. Therefore, no effect size of human readers improving with or without AI assistance is reported.

6. Standalone Performance Study

• Yes, in spirit, but within a user context. The study assessed the Injex 30 Needle-Free Insulin Injector System alone (after subjects viewed training materials) for ease of use and ability to self-administer, comparing these aspects to a traditional needle and syringe. While not a "standalone algorithm" performance, it evaluated the device's functional performance in the hands of users without external assistance during the injection process itself, beyond the provided instructions.

7. Type of Ground Truth Used

• The "ground truth" for this study was subjective patient feedback and self-reported experiences regarding ease of use, pain, and preference, gathered through questionnaires after direct interaction with both the investigational device and the predicate.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device (insulin injector), not a software algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no training set for a physical medical device.

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The Injex 30 Injector System is designed to deliver various medicines and vaccines by means of a narrow, high velocity jet of fluid which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

Equidyne Systems Injex 30 Injector System is a means of administering subcutaneous medications without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the medication in the subcutaneous tissue. The process takes place in a fraction of a second. Needle free injection is useful in a wide range of drug therapy including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may need a number of injections per day.

The Injex 30 Injector system consists of four main components;

1. Injector A small re-usable hand held Injector,
2. Reset Box A compact re-usable Reset Box used to reset and store the Injex 30 Injector,
3. Ampule A disposable, sterile 0.3 ml Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Ampule is loaded into the Iniex 30 Iniector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
4. Vial Adapter A disposable, sterile Vial Adapter facilitates the transfer of the medication from the medicine bottle or vial to the Ampule.

The Injex 30 Injector can deliver variable doses of fluid medication from 0.05 ml to 0.30 ml.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Injex 30 Needle Free Injection System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner for the Injex 30's primary function of medication delivery compared to a predicate. Instead, it describes a comparative study aiming for "substantial equivalence." The "acceptance criteria" are implied by the conclusion of this equivalency testing.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "equivalency tests" involved injecting colored water into chicken breasts. The term "chicken breast" was used as a human subcutaneous tissue model.
• Sample Size: The document does not specify the number of chicken breasts used, or how many injections were performed at each volume.
• Data Provenance: The study was conducted by Equidyne Systems Inc. It is a prospective study, specifically designed to demonstrate equivalence for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• No external experts are mentioned for establishing ground truth regarding the injection performance.
• The comparison was performed internally by Equidyne Systems Inc., with "The injection sites were then dissected and the flow and dispersion of the colored water was examined and compared" to the predicate device. The qualifications of the individuals performing this comparison are not stated.

4. Adjudication Method for the Test Set

• None described. The comparison appears to have been a direct observation and qualitative assessment by the company, not involving a formal adjudication process or multiple independent reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This study solely focused on the physical characteristics of the injection performed by the device, not on human reader interpretation or clinical outcomes with and without AI assistance. The device is a physical delivery system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Yes, a standalone study was done. The "equivalency tests" were conducted on the device itself (Injex 30 Injector System) in a model (chicken breast) to assess its performance in delivering fluid compared to a predicate device, independent of human interaction beyond the operation of the device during the test. There is no AI involved, so the concept of "human-in-the-loop" is not applicable here.

7. Type of Ground Truth Used

• For Biocompatibility: Laboratory test results (non-toxic, non-irritating) are the ground truth.
• For Equivalency (Injection Performance): The "ground truth" was a direct comparison to the predicate device's performance in the same chicken breast model. The predicate's fluid flow and dispersion characteristics served as the benchmark for "substantial equivalence." This is a comparative engineering/performance assessment, not a clinical ground truth like pathology or patient outcomes.

8. Sample Size for the Training Set

• Not applicable. The Injex 30 is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI model, this question is irrelevant to the Injex 30.

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