(84 days)
The intended use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.
The Gettig Styrl-Ject® Delivery System is a sterile, single use hypodermic syringe cartridge device designed to be similar to current single use products. The device consists of two basic constituents - a previously filled glass carpule, and plastic syringe. The carpule features a plastic retainer with a frangible button. When ready to use, the carpule retainer button is snapped off, exposing the rubber diaphragm insert. Until, the button is snapped the carpule needle path remains sterile, thus eliminating the need for an alcohol swab. The plastic syringe is also sterile until ready for use via the plunger rod encapsulating the needle rear extension. After removal of the threaded plunger rod, the carpule is then inserted into the clear plastic syringe allowing the syringe needle rear extension to puncture the rubber diaphragm creating a path for medicament administration. Then the syringe plunger rod is engaged with the plunger and the cover (needle or luer) is removed, to allow aspiration and injection. The syringe can be configured for a variety of needle sizes for subcutaneous injection as well as for I.V. applications via butyl and needleless access ports.
The Gettig Styrl-Ject® Delivery System is a hypodermic syringe cartridge. The provided documents detail its design, intended use, and the non-clinical bench tests performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document lists various performance bench tests. However, it does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that the tests conform to the "same protocols and standards used for the evaluation of our standard syringe products." Without specific numerical targets from those standards, it's impossible to create a table with quantitative acceptance criteria.
The document lists the following performance bench tests and implies that the Gettig Styrl-Ject® Delivery System successfully met the standards for these tests, as the FDA cleared the device.
| Test | Reported Device Performance (Implicit) |
|---|---|
| Mechanical/Seal Integrity: | |
| Carpule Leak Test | Met established protocols and standards for syringe products (implies no significant leaks). |
| Vacuum Dye | Met established protocols and standards for syringe products (implies no significant leaks/voids). |
| Air Gauge - Federal DimensionAire | Met established protocols and standards for syringe products (implies dimensional accuracy and integrity). |
| Button Snap Tests (Before Sterilization) | Met established protocols and standards for syringe products (implies appropriate force to snap, indicating sterility seal integrity). |
| Button Snap Tests (After Sterilization) | Met established protocols and standards for syringe products (implies appropriate force to snap, indicating sterility seal integrity). |
| Glass Neck Snap-Off (Schott revision 1 & 2) | Met established protocols and standards for syringe products (implies proper break-away force without excessive glass fragmentation). |
| Functionality/Delivery: | |
| Plunger Extrusion Force (Using O-Ring Universal Plunger Chattilon Gauge) | Met established protocols and standards for syringe products (implies smooth and consistent plunger movement with appropriate force). |
| Needle Sharpness (22 ga & 25 ga Penetration Drag) | Met established protocols and standards for syringe products (implies acceptable penetration force and minimal drag). |
| Needle Rear Extension Penetration | Met established protocols and standards for syringe products (implies successful and consistent penetration of the carpule diaphragm). |
| Needle Retention (Instron Pull) | Met established protocols and standards for syringe products (implies sufficient needle retention force). |
| Cover Pull-off Force (Instron Pull 22 ga & 25 ga, 22 ga & 23 ga, N. H. P. Fastener Corp.) | Met established protocols and standards for syringe products (implies appropriate force to remove the cover without accidental displacement). |
| Needle Rear Extension Coring (22 ga & 25 ga Rear Beveled, 22 ga Blunt w/Rear Blunt) | Met established protocols and standards for syringe products (implies minimal to no coring during carpule diaphragm penetration). |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the various bench tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective. Given that these are bench tests for a medical device prior to market, they are inherently prospective in nature, being performed as part of the device's development and regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the provided documentation. The "ground truth" for a device like a hypodermic syringe is established through physical and mechanical testing against recognized standards and protocols, not through expert human assessment of subjective data (like in areas such as image analysis). The "experts" involved would be the engineers and technicians conducting the tests and interpreting the results against established engineering specifications. Their qualifications are not detailed.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human assessment where there's a need to resolve discrepancies in expert opinions (e.g., in reading medical images). For physical bench tests, the outcome is objective (e.g., a measurement, a pass/fail according to a tolerance), and thus, expert adjudication in that sense is not performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the AI's impact on human performance. The Gettig Styrl-Ject® Delivery System is a physical medical device, not a diagnostic one, so an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in essence, standalone performance testing was done. The listed "Performance Bench Tests" are precisely this – tests of the device's inherent physical and mechanical properties and functionality, independent of human interaction during the testing phase (though human technicians conducted the tests). The device itself (not an algorithm) is the "standalone" entity being tested for its performance against defined benchmarks.
7. The Type of Ground Truth Used:
The ground truth used for these bench tests is based on established engineering specifications, industry standards, and recognized test protocols for hypodermic syringes and their components. This forms an objective "ground truth" against which the device's performance is measured. For example, a "Carpule Leak Test" would have specific criteria for what constitutes a leak according to a standard, and the test result would be compared to that.
8. The Sample Size for the Training Set:
This information is not applicable. The Gettig Styrl-Ject® Delivery System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. Manufacturing process control and design iterations would involve testing different batches, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.