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510(k) Data Aggregation
(14 days)
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may also be used by patients authorized by their physicians to self-inject, or have other individuals administer injections of prescribed medication.
The PharmaJet 0.1 ml Needle-free Iniection System (PharmaJet Svstem) is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet System consists of an injector; a reset station; a single use, sterile disposable filling adapter; and, a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet System are unique and cannot be used with any other needle-free system.
An injector is placed in the reset station and the lid is depressed to reset the spring in the injector. A health care worker puts a filling adapter into a vial of liquid medicine or vaccine. A Needle-free syringe is placed into the filling adapter, the liquid is drawn into the Needle-free syringe and is slightly over filled. The filled Needle-free syringe is removed from the adapter and the plunger is broken off and discarded. The Needle-free syringe is placed into the injector with a ¼ turn to the right, which positions the plunger so that a 0.1ml dose is ready for use. The Needle-free syringe is placed against the injection site; gentle pressure is applied until the inner housing stops. This action allows the trigger to be released. By depressing the trigger the spring is released and the plunger moves forward into the needle-free syringe barrel discharging the contents. Once the injection has been performed, the Needle-free syringe is properly disposed of and a new syringe may be filled, injector reset, and the system again prepped for use.
Acceptance Criteria and Study for PharmaJet 0.1 ml Needle-free Injector System
The PharmaJet 0.1 ml Needle-free Injector System underwent non-clinical testing to establish its performance and substantial equivalence to existing devices. The primary focus was on meeting the requirements of the PharmaJet 0.1ml Product and Engineering Specifications, as well as the essential requirements of ISO21649:2006 Needle-free injectors for medical use - Requirements and test methods.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Category | Specific Test | Acceptance Limit (Implied/Standard) | Reported Device Performance (Outcome) |
|---|---|---|---|
| Bench Testing (ISO21649:2006) | Temperature (Storage) | Not explicitly stated, implied to withstand transportation/storage conditions | Successfully completed |
| Free-fall | Not explicitly stated, implied to withstand typical handling | Successfully completed | |
| Vibration | Not explicitly stated, implied to withstand typical handling/transportation | Successfully completed | |
| Shock | Not explicitly stated, implied to withstand typical handling/transportation | Successfully completed | |
| Dose Accuracy | Not explicitly stated, but critical for drug delivery as per ISO21649:2006 | Successfully completed | |
| Life Cycle | 20,000 actuations (for spring life cycle) | Successfully completed (PharmaJet 0.1ml & 0.5ml both reported 20,000) | |
| Performance Profile (Upper/Lower Limits) | Not explicitly stated, defined by ISO21649:2006 | Successfully completed | |
| Emitted Noise | Not explicitly stated, defined by ISO21649:2006 | Successfully completed | |
| Material Robustness | Needle-free Syringe Irradiated Dose Test | Maintain structural integrity and function after maximum irradiated sterilization dose | Successfully completed for Robustness |
| Microbial Ingress | Microbial Ingress Testing (Filling Adapter) | Prevent microbial ingress after disinfection | Successfully completed |
| Biocompatibility | Biological Testing (Syringe & Filling Adapter) | Meet requirements for safe short-term exposure | Successfully demonstrated |
| Disinfection Compatibility | Functional Testing after Disinfection | No degradation of performance or damage to Injectors/Reset Stations after Gluteraldehyde-based and peroxide-based high-level disinfection | Successfully demonstrated |
| Substantial Equivalence (Animal Testing) | Bleb Diameter | Comparable to Terumo 1cc Allergy Syringe | Substantially equivalent |
| Depth of Penetration (based on dermal height) | Comparable to Terumo 1cc Allergy Syringe | Substantially equivalent | |
| Dye Dermal Contact Area | Comparable to Terumo 1cc Allergy Syringe | Substantially equivalent | |
| Skin Volume Occupied by Dye (calculated) | Comparable to Terumo 1cc Allergy Syringe | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for most of the non-clinical bench tests (temperature, free-fall, vibration, shock, dose accuracy, life cycle, performance profile, emitted noise, irradiated dose test, microbial ingress, functional testing after disinfection, biological testing). These tests are typically performed on a statistically significant number of units to ensure reliability, but the exact numbers are not provided.
For the animal testing (comparative effectiveness study), the sample size is also not explicitly stated. The data provenance regarding the country of origin and whether it was retrospective or prospective is not mentioned for any of the tests. Given it's animal testing, it was inherently prospective for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are primarily engineering and biological studies, where "ground truth" is established by direct measurement against defined standards and technical specifications, rather than expert interpretation of data like in medical imaging.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. As mentioned above, the tests are objective measurements against established technical standards (e.g., ISO21649:2006 benchmarks, physical measurements, biological assays), rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There was no MRMC comparative effectiveness study involving human readers with and without AI assistance mentioned. The comparative study was an animal study comparing the device against a predicate device (Terumo 1cc Allergy Syringe) to demonstrate substantial equivalence in intradermal injection characteristics. Therefore, there is no effect size given for human reader improvement with AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance
This device is a physical medical device (a needle-free injector system), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only) performance" does not apply to this submission. The tests performed demonstrate the physical and functional performance of the device itself.
7. Type of Ground Truth Used
For the various bench tests, the ground truth was established by engineering specifications, international standards (ISO21649:2006), and direct physical/chemical measurements.
For the animal study demonstrating substantial equivalence, the ground truth was based on quantifiable biological endpoints (bleb diameter, depth of penetration based on dermal height, dye dermal contact area, skin volume occupied by dye) directly measured from the animal subjects after injection.
8. Sample Size for the Training Set
The document does not mention a "training set" as this is not an AI/machine learning device. The tests described are for the validation and verification of a hardware medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
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