FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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).

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Dosage Delivery	Delivered dosage within ISO insulin syringe standards for both low (10 units) and high (50 units) volumes.	"Dosages delivered... was well within the ISO standards and was therefore deemed to be safe." (Tested over 30 injections, exceeding 100% of indicated usage.)
	Delivered dosage within ISO insulin syringe standards over 14 days, with two ejections per day, using three common insulin types (R, NPH, Ultralente).	"Dosages delivered at 100% over the indicated usage were found to be safely within the ISO standards for all types of insulin."
Penetration	Penetration of saline streams into an artificial test matrix (Whatman #3 filter paper) comparable to a cited predicate device (Medi-Jector Needle-Free Bio-Tropin™ Drug Delivery System).	"The penetration of saline streams produced by the Medi-Jector Choice Needle-Free Insulin Delivery Systerm into an artificial test matrix (Whatman #3 filter paper) was comparable to that seen with cited predicate device."

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.

Summary

Regulation Number and Section

§ 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).