(404 days)
The Biojector® 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® 2000 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector@ 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
The Biojector® 2000 is a needle free injection management system designed to deliver drugs both subcutaneously (SC) and intramuscularly (IM). It is a non-electrically powered device which is intended to administer an injection by means of a high velocity jet of fluid that penetrates the surface of the skin and delivers drug to the bodv. The system is comprised of three major components: The single use sterile medication syringe (medication container), the Biojector® (injector), and the Carbon Dioxide (CO2) cartridge (power source). The device is also capable of being powered with a CO2 tank with a specialized adapter.
The syringe holds a variable volume of drug up to a maximum of one cubic centimeter (cc) or milliliter (ml.). Volume increments are marked at 0.10, 0.20, 0.25, 0.30, 0.40, 0.50, 0.60, 0.75, 0.80, 0.90, and 1.0 cc or ml. The syringe is filled using either a fill needle, or a plastic fluid transfer device. Once the syringe is filled, it is loaded in the Biojector®. Syringes are available in five sizes which are numbered 2, 3, 4, 5 and 7. The syringe sizes have the following orifice diameters: 0.004, 0.008, 0.010 & 0.014 inches, respectively. The number 2 syringe is used for all subcutaneous injections. The remaining syringes, numbered 3, 4, 5, and 7, are used for intramuscular injections. Depth of penetration of the drug varies with the orifice diameter selected. The larger the orifice diameter, the deeper the penetration of the drug.
Activation of the Biojector® is initiated when the actuator is depressed. CO2 gas is released. through the action of a series of valves within the injector. This causes the plunger to push the drug out of the sterile syringe, through the syringe orifice at a high velocity, allowing it to penetrate the skin and be deposited in the tissue. Exhaust CO2 is expelled, through the exhaust and bleed valves, in the rear section of the Biojector®, as well as into the cartridge compartment. The CO2 does not come in contact with the drug.
This 510(k) summary describes modifications to the Biojector 2000 device, asserting its substantial equivalence to a previously cleared predicate device (K920631). As such, the document focuses on demonstrating that the modified device is as safe and effective as the predicate without introducing new safety or efficacy issues.
Here's an analysis of the provided information relevant to acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance | Study Type/Evidence |
|---|---|---|---|
| Functional Equivalence | Deliver subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. | The Biojector® 2000 (modified device) is found to be functionally equivalent to the predicate device in delivering SC and IM injections. | Product qualification testing and biocompatibility data compared to the predicate device. |
| Material Changes | New plastic parts and alternate vendors for existing materials must not negatively impact performance or safety. | Performance and safety are maintained despite material changes. | Product qualification testing and biocompatibility data. |
| CO2 Efficiency & Performance | Improved CO2 efficiency and performance of exhaust and bleed valves. | Modifications to exhaust and bleed valves improve CO2 efficiency and performance. | Implied by the statement of modification and the overall functional equivalence claim. |
| Safety & Effectiveness | No new safety and efficacy issues compared to the predicate device. The device is as safe and effective. | No new safety and efficacy issues were raised. The device is as safe and effective as the predicate. | Product qualification testing and biocompatibility data. Comparison of intended use, labeling, design, materials, and operational principle to the predicate device. |
| Intended Use | Maintain the same intended use as the predicate device (delivery of SC or IM injections by various practitioners and authorized patients). | No changes in intended use. | Comparison of intended use to predicate device. |
| Operational Principle | Maintain the same operational principle as the predicate device. | No changes in operational principle. | Comparison of operational principle to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are referred to as "Product qualification testing and biocompatibility data," which are general categories and not detailed clinical studies with specific test sets in the traditional sense. It's likely that "test set" here refers to a set of devices or components undergoing engineering and biocompatibility evaluations, not human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that the focus is on device modification and functional equivalence to a predicate, "ground truth" would likely relate to engineering specifications and performance metrics rather than clinical diagnoses.
4. Adjudication Method for the Test Set
This information is not provided. Since the studies appear to be primarily engineering and biocompatibility assessments, a traditional adjudication method for human subject data is not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this document. The submission focuses on substantial equivalence based on material and design modifications, not on improved human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done. The Biojector 2000 is a physical medical device for drug delivery, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context would implicitly be defined by:
- Engineering Specifications: Performance parameters (e.g., injection pressure, drug delivery volume accuracy, CO2 efficiency, depth of penetration for different syringe sizes) set during the design and manufacturing of the device.
- Predicate Device Performance Data: The known and accepted performance characteristics of the legally marketed predicate device (Biojector® 2000 Jet Injection System, K920631).
- Biocompatibility Standards: Established standards for materials that come into contact with the patient.
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this particular submission, as it's a modification of an existing device seeking substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As noted, this is not an AI/algorithm-based device that would require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reasons mentioned in point 8.
§ 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).