(75 days)
The Small Volume 0.2mL Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Small Volume 0.2mL Syringe is intended for manual, single use. It is a small volume 0.2 mL syringe. It is comprised of a PP barrel, ABS plunger, TPE plunger stopper, PP plunger shield and PP Luer protective cap. The device has a Luer lock connection type that enables connection to a hypodermic needle for liquid injection or withdrawal. The device has a plunger stopper to prevent any liquid residual from remaining in the syringe barrel, maximizing the efficiency of liquid usage. The feature is called Low Dead Space/Volume. The Luer protective cap serves to safeguard the small Luer connector from potential damage during transportation. Similarly, the plunger shield is utilized to ensure the small plunger remains undamaged during transportation. The Luer protective cap and the plunger shield are optional to be used. The device has been manufactured without any silicone oil. The device has six models, each equipped with a 0.2 mL Luer lock syringe. Among these models, three include an additional feature for enhanced dosing technology (EDT), which comprises a colored reference line on the plunger surface to improve visibility. These include identifying markings to distinguish the EDT models from the regular 0.2 mL syringe.
The provided FDA 510(k) clearance letter and summary for the "Small Volume 0.2mL Syringe" do not contain any information related to AI/ML or software-driven medical devices. The submission is for a physical medical device (syringe) and, as such, the acceptance criteria and study descriptions are entirely focused on the physical and material properties, performance, biocompatibility, and sterility of the syringe itself.
Therefore, I cannot provide details on:
- A table of acceptance criteria for AI/ML performance
- Sample sizes for a test set or data provenance for AI/ML
- Number of experts and their qualifications for establishing AI/ML ground truth
- Adjudication methods for AI/ML test sets
- MRMC comparative effectiveness study for AI with human readers
- Standalone AI algorithm performance
- Type of ground truth for AI/ML
- Training set sample size for AI/ML
- How ground truth for AI/ML training was established
The document explicitly states "9. Clinical testing: Not applicable for this submission." This further confirms that no studies involving human interaction or clinical performance for a software/AI component were conducted or required for this purely mechanical device.
If the request was intended to be about the acceptance criteria and studies for the physical device as described in the 510(k) summary, here is the relevant information extracted:
Acceptance Criteria and Study for the "Small Volume 0.2mL Syringe" (Physical Device)
The device, a "Small Volume 0.2mL Syringe," is a physical medical device. The acceptance criteria and the studies proving it meets these criteria are related to its mechanical performance, material safety, and sterility, in accordance with recognized medical device standards. There is no AI/ML component described in this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary references compliance with specific standards, rather than providing explicit numerical acceptance criteria directly in a table. The device performance is generally stated as "met the standards' requirements."
| Category | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Material Safety | Complies with ISO 10993-1: |
- Cytotoxicity
- Irritation
- Sensitization
- Acute systemic toxicity
- Hemocompatibility
- Pyrogenicity
- Particulate Matter per USP
- Bacterial Endotoxins per USP | All tested endpoints met the acceptance criteria (Implied: complied with ISO 10993-1, USP , and USP ). |
| Syringe Performance | Complies with ISO 7886-1:2017 (e.g., accuracy, force, freedom from leakage, residual volume) | Met all necessary requirements of the standard. |
| Luer Connector Performance | Complies with ISO 80369-7:2016 and ISO 80369-20:2015 (e.g., connection integrity, leakage) | Met the standards' requirements. |
| Dead Space Specification | ≤ 0.0058 mL (95% confidence/ 95% reliability) | Meets requirements (stated as "a lower dead space volume is achieved" compared to predicate). |
| Sterilization | Complies with ISO 11135 (EO sterilization process validation) | Validation results confirm compliance. |
| Ethylene Oxide (EO) & Ethylene Chlorohydrin (ECH) Residuals | Do not exceed limits according to ISO 10993-7 | Residues do not exceed the limits. |
| Shelf-Life | Device functionality maintained through 3 years (accelerated aging per ASTM F1980-16) | Demonstrated device functionality through the claimed shelf-life of 3 years. (Real-time testing is ongoing to confirm). |
| Packaging Integrity | Complies with ISO 11607-1, ISO 11607-2, ASTM D4169-22, ASTM F88/F88-15, ASTM F1929-15 | All packaging was deemed acceptable for protection of product and sterility maintenance. |
| Sterile Barrier Testing | Complies with USP | Confirmed compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes used for each specific test (e.g., biocompatibility endpoints, performance testing per ISO 7886-1) are not detailed in the 510(k) summary. The summary generally states that testing was conducted on "samples" or "unconditioned samples as well as samples aged... and samples transit conditioned."
- Data Provenance: The studies were conducted by the manufacturer, Prosum Medical Limited, and their testing partners, likely in the United Kingdom or through contract laboratories that adhere to international standards. The data is prospective as it involves new testing specifically for this device submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. For a physical device like a syringe, "ground truth" as it relates to expert consensus for image interpretation or clinical outcomes is not relevant. The ground truth here is derived from objective measurements and compliance with established engineering and biological standards. Testing is performed by qualified laboratory personnel following validated protocols.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication typically applies to subjective assessments (e.g., expert reads). For objective measurements on a physical device, statistical analysis of measured values against predefined acceptance limits determines compliance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not Applicable. MRMC studies are used for assessing the impact of AI/software on human performance in diagnostic tasks and do not apply to a physical syringe device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This refers to AI algorithm performance, which is not part of this submission.
7. The type of ground truth used
The "ground truth" for this device's performance and safety is based on objective, quantifiable measurements and compliance with internationally recognized consensus standards (e.g., ISO 7886-1 for syringe performance, ISO 10993-1 for biocompatibility). These standards define acceptable ranges for various parameters (e.g., dead space, force to push plunger, leakage, material toxicity).
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not Applicable. There is no "training set" as this is not an AI/ML device.
§ 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).