(229 days)
The Global Medi Products Retractable Safety Syringe is a sterile, single use, disposable and non-reusable manual retractable safety syringe intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse.
The GMP Retractable Safety Syringe are always provided with preassembled needs whereas the DuoProSS can be ordered with and without needles. GMP Retractable Safety Syringe currently uses a male luer lock needle connector design where the DuoProSS uses a luer slip ne connector design. Both syringes are provided sterile, single use, and disposable. There are minor differences between the GMP Retractable Safety Syringe and DuoProSS which is syringe volume (and associated dimensions). Both syringes have two part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break of the plunger rod, and discard the pieces.
The provided text describes a 510(k) summary for the Global Medi Products Retractable Safety Syringe, dated October 17, 2012. This device is a manual retractable safety syringe intended for injecting fluids into the body while reducing the risks of sharps injuries and preventing syringe reuse.
The submission claims substantial equivalence to the Meditech Co, DuoProSS Ret retractable safety syringe (K022806).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria alongside reported device performance values. Instead, it states that the Global Medi Products Retractable Safety Syringe "is substantially equivalent and meets the same acceptance criteria as the predicate device in K022806" and lists the standards against which it was tested.
However, we can infer the acceptance criteria are adherence to the listed international and national standards for syringe and needle performance. The reported performance is that the device meets these standards.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-4 (Interactions with blood), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation & Sensitization), ISO 10993-11 (Systemic Toxicity) | Device found to comply with biocompatibility standards. |
| Syringe Performance: ISO 7886-1 (Sterile hypodermic syringes for manual use), ISO 7886-4 (Syringes with re-use prevention feature) | Device found to comply with syringe performance standards, including manual use and re-use prevention features. |
| Conical Fittings: ISO 594 (Conical fittings with a 6% (Luer) taper for syringes) | Device found to comply with Luer taper fitting standards. (The document mentions minor differences in Luer lock vs. Luer slip connector design compared to the predicate, but asserts this does not affect performance). |
| Sterilization Validation: ISO 11135 (Ethylene Oxide Sterilization), GB/T 14233.1-1998 Part 1 (Methods for chemical analysis - EO Residuals), ISO 10993-7 (Biological evaluation of medical devices - Ethylene oxide sterilization residuals, including allowable limits for EO and ECH) | Device found to comply with sterilization validation standards using Ethylene Oxide, and residual limits for EO and ECH. |
| Hypodermic Needle Performance: ISO 7864:1993 (Sterile hypodermic needles for single use), ISO 594-1:1986 & ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper) | Device's hypodermic needles found to comply with standards for single-use needles and Luer taper conical fittings. |
| Substantial Equivalence to Predicate Device K022806: Comparisons in intended use, design, technological, and operational characteristics and performance. | The submitting company believes the device is substantially equivalent to the predicate device K022806, with minor differences (syringe volume, luer lock vs. luer slip) that do not affect safety or effectiveness. All specifications and performance are comparable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units) used for each of the performance tests (e.g., biocompatibility lot size, number of syringes tested for ISO 7886-1).
The data provenance is not explicitly stated as retrospective or prospective, nor does it detail the country of origin for the data itself beyond the submitter's location in Australia. However, the tests are performed against international ISO standards and a Chinese national standard (GB/T), suggesting either international lab testing or internal testing conforming to these global benchmarks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is performance-based against engineering and biological standards, not expert-opinion based "ground truth" for diagnostic or AI systems.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. "Adjudication method" typically refers to how disagreements among multiple experts are resolved to establish a ground truth in studies involving human interpretation (e.g., imaging studies). The tests performed here are objective measurements against defined technical standards (e.g., sterility, strength, fluid flow), 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic algorithms or imaging systems where human readers interpret cases. The Global Medi Products Retractable Safety Syringe is a physical medical device, not an AI or diagnostic tool. Therefore, there's no concept of human readers or AI assistance in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm is not applicable to this device, as it is a physical medical device and not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests of this physical device is established by compliance with pre-defined technical and biological standards (e.g., ISO 7886-1 for syringe performance, ISO 10993 for biocompatibility). For example, a successful biocompatibility test means the device material passed specific cytotoxicity, irritation, sensitization, and systemic toxicity limits as defined by the ISO 10993 series. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it might be for a diagnostic tool.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are used in machine learning and AI model development. This submission describes performance testing of a physical medical device against established standards, not the development or validation of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for this device, this question is not applicable.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).