(196 days)
The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.
The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
The Sterile Disposable Safety Needle is intended to be used with a luer slip or lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.
The Sterile Disposable Syringe is intended for manual and single use only, which consists of piston, barrel, and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock and luer slip configurations, which are intended to be connected with a hypodermic needle.
The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Compared with The Sterile Disposable Safety Needle, The Sterile Disposable Needle has the same components and specifications except without safety mechanism.
The Sterile Disposable Syringe with Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
Compared with The Sterile Disposable Syringe with Safety Needle, The Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism.
The proposed devices are sterilized by Ethylene Oxide a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
The provided text describes a 510(k) premarket notification for several sterile disposable syringe and needle devices, comparing them to a predicate device (K193526). This submission focuses on establishing substantial equivalence through non-clinical testing and comparison of characteristics, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for acceptance criteria and study design (like ground truth, expert qualifications, effect size for AI assistance, MRMC studies, and training set details) are not applicable to this type of submission.
The acceptance criteria for each device are defined by their compliance with relevant international and national standards, and the non-clinical tests performed to verify these compliances. The "reported device performance" is essentially that the devices met these acceptance criteria as demonstrated by the test results.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the devices are primarily established by the relevant ISO and ASTM standards. The reported device performance is that it met the requirements of these standards.
Table of Acceptance Criteria and Reported Device Performance (Summary derived from Sections 6 and 8):
| Category / Item | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Irritation/Sensitization), ISO 10993-11:2017 (Systemic Toxicity), ISO 10993-4:2017 (Blood Interaction) | No cytotoxicity, no intracutaneous reactivity, no sensitization, no systemic toxicity, no hemolysis, no pyrogen, no thrombogenicity, no complement activation potentials |
| Integrity of Sterile Barrier Packaging | ASTM F1886/F1886M-16 (Visual Inspection), ASTM F88/F88M-15 (Seal Strength), ASTM F1929-15 (Dye Penetration) | Maintained integrity |
| Sterilization | ISO 10993-7:2008 (EO and ECH Residuals), USP (Bacterial Endotoxins) | EO/ECH residues did not exceed limit, Endotoxin limit did not exceed 20EU/device, maintained sterility for 5 years |
| Hypodermic Needles (General) | ISO 7864:2016 (Cleanliness, Acidity/Alkalinity, Extractable Metals, Size Designation, Color Coding, Needle Hub, Needle Cap, Needle Tube, Needle Point, Bond between Hub/Needle, Patency of Lumen) | Met requirements of related standards |
| Stainless Steel Needle Tubing | ISO 9626:2016 (Surface Finish/Appearance, Cleanliness, Acidity/Alkalinity, Size Designation, Dimensions, Stiffness, Resistance to Breakage/Corrosion) | Met requirements of related standards |
| Small-bore Connectors (Luer) | ISO 80369-7:2016 (Fluid Leakage, Sub-atmospheric Pressure Air Leakage, Stress Cracking, Resistance to Separation from Axial Load/Unscrewing, Resistance to Overriding) | Met requirements of related standards |
| Hypodermic Syringes (Manual Use) | ISO 7886-1:2017 (General requirements, Extraneous matter, Lubricant, Tolerance on Graduated Capacity, Graduated Scale, Barrel, Piston/Plunger Assembly, Nozzle, Performance) | Met requirements of related standards |
| Sharps Injury Protection (Safety Features) | ISO 23908:2011, FDA Guidance "Medical Device with Sharps Injury Prevention Feature" | Met pre-established criteria |
| Particulate Matter | USP | Met requirements of related standards |
| Shelf-Life Evaluation | Physical, Mechanical, Chemical, Package Tests on aging samples | Device maintained performance during claimed 5-year shelf life |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For most non-clinical tests (biocompatibility, physical, mechanical, chemical, packaging, sterilization, shelf-life), specific sample sizes are not explicitly stated in the provided document. The document usually states "tests were performed" or "test results show."
- For the "Simulated Clinical Study" and "Safety Feature Test," the sample size is also not explicitly stated, only that "a simulated clinical study was performed" and "the safety feature test was performed on both proposed device and predicate device."
- Data Provenance: The document does not specify the country of origin for the test data. All studies described are non-clinical bench tests and simulated studies, not involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the evaluation relies entirely on non-clinical, bench testing against established international and national standards. There is no "ground truth" established by experts in the context of clinical interpretation, but rather adherence to engineering and material science specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective interpretations (e.g., image reading). The tests performed here are objective measurements against defined standards.
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:
- This is not applicable. No MRMC study was conducted. This product is a physical medical device (syringes and needles), not an AI/software device intended for diagnostic assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This product is a physical medical device, not an algorithm, so a standalone algorithm performance evaluation is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is implicitly defined by the requirements and methodologies outlined in the referenced ISO and ASTM standards. For example, the "ground truth" for injectability might be defined by the force required to depress the plunger as per ISO 7886-1, or for biocompatibility, the absence of cytotoxicity as per ISO 10993-5. There is no clinical or expert consensus ground truth involved in this type of submission.
8. The sample size for the training set:
- This is not applicable. There is no "training set" as this is not a machine learning or AI device. The document describes pre-market non-clinical validation testing.
9. How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.
§ 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).