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The over the counter Medi-Jector Choice Needle-Free Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin. The injector is labeled as suitable for administration of 2 to 50 insulin units in a 0.5 unit increment.

Needle-Free Insulin Delivery System

This submission is for a labeling change only, specifically to allow the Medi-Jector Choice Needle-Free Insulin Delivery System to be sold over the counter. No new studies were performed or are included in this document to demonstrate device performance against acceptance criteria.

Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are typically associated with studies demonstrating device efficacy or safety, which are absent in this submission.

The document explicitly states:

• "Summary of Nonclinical Tests: None were performed in support of this submission. This request is for a labeling change only." (Section D, Page 0)

This implies that the device's performance characteristics were previously established and deemed acceptable under its prior 510(k) clearance (K962956), and this submission does not involve re-evaluating those performance aspects.

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The Medi-Jector Choice Needle-Fee Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin.

The Medi-Jector Choice Needle-Free Insulin Delivery System consists of a spring powered windable power pack injector assembly, a detachable sterile reusable needle-free syringe and a sterile adapter for connecting the needle-free syringe to a drug the vial. Spring energy is provided by winding the power pack to compress the spring. The power pack also contains a dial mechanism that defines the dosage to be injected. The needle-free syringe consists of a chamber or barrel and a plunger. Both the chamber and the plunger connect to the power pack. One end of the syringe barrel or chamber reduces to a micro-orifice and comes in contact with the injection site; the other end of the syringe connects to the power pack. The adapter consists of a plastic body and seal and connects the needle-free syringe on the power pack to the drug vial. An elastomeric seal in the adapter is compressed against the syringe tip aligning at the micro-orifice to make connection; the connection with the drug vial is by means of plastic spike capable of puncturing the vial septum. Additionally, the adapter end connection with the drug vial has locking tabs to stabilize the vial and to promote the discarding of the adapter with the vial (which is the intended usage).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device: Medi-Jector Choice Needle-Free Insulin Delivery System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Dosage Delivery:
    • "thirty (30) injections" for the initial saline test (more than 100% of indicated usage for a single syringe).
    • "over the course of 14 days, with two ejections per day," for insulin types (totaling 28 injections per insulin type, or 84 injections across the three insulin types).
  • Penetration: Not explicitly stated, but implies a sufficient number of tests to establish comparability.
• Data Provenance: Not explicitly stated, but given the nature of the device (insulin delivery) and the regulatory submission, the testing would likely have been conducted in a controlled laboratory environment. There is no mention of country of origin or whether it was retrospective or prospective, but these types of tests are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This device is a mechanical fluid injector. Its performance is evaluated against objective, measurable physical criteria (ISO standards for dosage delivery, physical comparison for penetration). There is no "ground truth" established by human experts in the context of diagnostic interpretation.

4. Adjudication Method for Test Set

• None. As the evaluation relies on objective measurements against ISO standards and physical comparability, no human adjudication was required.

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

• No. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, often with and without AI assistance, to assess performance improvement. The Medi-Jector Choice is a drug delivery device, not a diagnostic one, so an MRMC study is not applicable.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence. The entire evaluation described is a "standalone" performance study of the device itself. There is no human-in-the-loop component being evaluated. The device's mechanical performance is directly measured without human intervention in the delivery process being part of the performance metric.

7. Type of Ground Truth Used

• Objective Standards and Physical Comparability:
  • Dosage Delivery: ISO insulin syringe standards. These are internationally recognized, objective benchmarks for accuracy.
  • Penetration: Direct comparison to physical streams produced by a predicate device (Medi-Jector Needle-Free Bio-Tropin™ Drug Delivery System) into an artificial test matrix (Whatman #3 filter paper). This is a physical, measurable comparison rather than a human-interpreted "ground truth."

8. Sample Size for the Training Set

• Not Applicable. As a mechanical device, there is no "training set" in the machine learning sense. The device's design is based on engineering principles and materials science, not on learning from a dataset.

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

• Not Applicable. There is no training set for a mechanical device like this. Its performance is inherent in its design and manufacturing.

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The device is intended only for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. It is intended for the subcutaneous administration of the reconstituted drug by highpressure injection either by health care practitioners or directly by patients.

The Medi-Jector Needle-Free Human Growth Hormone Injection System is a needle-free, springpowered human growth hormone (hGH) injection system. It is comprised of a "power pack" with a detachable nozzle. The power pack contains the spring and has a plastic housing, injection release button, safety latch, and dosage display window; it is wound to draw up the desired dose of reconstituted hGH (up to 0.5 ml of hGH in bacteriostatic saline). The reusable stainless steel nozzle is supplied non-sterile and requires cleaning and boiling sterilization by the user prior to first use and every two weeks thereafter. The device is not supplied pre-loaded with hGH; rather, it utilizes a supplied sterile "bottle adapter" accessory, with an integral spike, to aseptically penetrate the rubber seal of a standard vial of reconstituted hGH, accept the Medi-Jector's nozzle end, and thus draw a calibrated dose of reconstituted hGH into the chamber of the opaque nozzle assembly by way of winding motion of the power pack.

Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting studies:

Acceptance Criteria and Device Performance for Medi-Jector Needle-Free Bio-Tropin™ Drug Delivery System

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Medi-Jector Needle-Free Bio-Tropin™ Drug Delivery System does not explicitly present acceptance criteria in a formal table with specific thresholds. Instead, it describes performance characteristics where the device was assessed against predicate devices or general principles of safety and effectiveness. The "acceptance criteria" are implied by the conclusions drawn about "no differences," "similar," or "bioequivalent."

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

• Clinical Study (Bioequivalence/Bioequipotency):
  • Sample Size: 12 healthy young male volunteers.
  • Data Provenance: Prospective (clinical study conducted for this submission), likely from the country of the manufacturer (USA) unless specified otherwise.
• Clinical Study (Growth Hormone Therapy in Children):
  • Sample Size: Not explicitly stated, refers to "hGH-deficient children."
  • Data Provenance: Retrospective (cited published report: Igarashi et al., 1993), likely Japanese given author names and publication title (Clin. Rep.).

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

• Clinical Studies: No external "experts" were used to establish ground truth in the sense of adjudication for the clinical test sets. The ground truth was based on objective physiological measurements (hGH, IGF-I, free fatty acids) or clinical outcomes (height increase, growth rate) from the subjects themselves, compared against conventional syringe injection. Medical professionals (nurses, physicians) would have administered the injections and collected the data, but their "expertise" was in performing the study, not in establishing a separate ground truth.

4. Adjudication Method for the Test Set

• Clinical Studies: Not applicable. The studies involved direct measurement of physiological responses (bioavailability, bioactivity markers) or direct clinical outcomes, not subjective interpretations requiring adjudication.

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

• Not applicable. This device is a drug delivery system, not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and "human readers improved with AI" metrics are not relevant. The comparison was between the device and conventional syringe injection.

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

• Not applicable. This is a mechanical drug delivery device. Its performance is inherent to its design and function, not an algorithm's output. The "standalone" performance is simply the device's ability to inject safely and effectively, as demonstrated by the various in vitro and clinical tests.

7. The Type of Ground Truth Used

• Sterility: Sterility Assurance Level (SAL) of 10^-6 for the bottle adapter.
• Biocompatibility: Microscopic and macroscopic evaluation of porcine dermal alterations.
• Biochemical Integrity: Chemical assays (dimer, oxidized, deamidated forms of hGH) and spectrophotometric/chromatographic analysis.
• Delivery Accuracy: Measured volume of liquid (bidistilled water) delivered vs. target dose.
• Contamination Prevention: Absence of bacterial contamination (Pseudomonas putida) after exposure.
• Bioequivalence/Bioequipotency (Clinical): Measured serum concentrations of hGH, IGF-I, and free fatty acids in human volunteers.
• Clinical Efficacy (Children): Measured height increase and growth rate.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of an algorithm. All samples and tests described are for evaluation of the physical device's performance.

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

• Not applicable. As there is no training set for an algorithm, this question is not relevant.

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