(253 days)
The sterile Hypodermic Syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile Insulin Syringe for Single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.
The sterile Insulin Syringe for Single use with the callbration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.
The sterile Hypodermic needle for Single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient.
Configuration: Piston, Plunger, Barrel, (Needle) for Hypodermic Syringe; Needle cover, Needle, Piston, Barrel, Plunger, End cap for Insulin Syringe; Protective cap, Needle tube, Adhesives, Needle hub for Hypodermic Needle.
Operation Mode: For manual use only.
Nozzle: Luer Slip, Luer Lock for Hypodermic Syringe and Hypodermic Needle; Fixed Needle for Insulin Syringe.
Volume/Sizes: Luer slip: 1,2,3,5,10,20,30,35,50,60(ml), Luer Lock: 1,2,3,5,10,20,30,35,50,60(ml), 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Syringe; 0.3, 0.5, 1(ml), 29G, 30G, 31G for Insulin Syringe; 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Needle.
Material: Plunger: polypropylene (PP); Barrel: polypropylene (PP); Piston: isoprene rubber; Hypodermic needle: polypropylene (PP), stainless steel; for Hypodermic Syringe; Needle cover: polypropylene (PP); Needle: stainless steel (SUS); Piston: isoprene rubber; Barrel: polypropylene (PP); Plunger: polypropylene (PP); End cap: polypropylene (PP); for Insulin Syringe; Protective cap: polypropylene (PP), Needle tube: stainless steel (SUS), Adhesives: epoxy resin, Needle hub: polypropylene (PP) for Hypodermic Needle.
This document is a 510(k) Summary for a Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, and Sterile Hypodermic needle for Single use. It does not describe a study in the context of validating an AI/ML device but rather demonstrates substantial equivalence to a predicate device through non-clinical performance testing against recognized standards.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document lists various ISO standards as the acceptance criteria for product performance, sterilization, and biocompatibility. The reported device performance is that the "test results demonstrated that the proposed device complies with the following standards" or "The test results show that the proposed device complies with the requirements."
There isn't a table directly comparing specific quantitative acceptance criteria with measured device performance values in this summary. Instead, it states compliance with recognized standards.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| For Sterile Hypodermic Syringe for single use, with/without needle: | |
| ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use. | Complies with ISO 7886-1. (Specifically mentioned for 60mL syringe as well). |
| ISO 594-1:1986, Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements. | Complies with ISO 594-1. |
| ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings. | Complies with ISO 594-2. |
| For Sterile Insulin Syringe for single use, with needle: | |
| ISO 8537:2016 Sterile single-use syringes, with or without needle. for insulin. | Complies with ISO 8537. |
| ISO 594-1:1986, Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements. | Complies with ISO 594-1. |
| ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings. | Complies with ISO 594-2. |
| For Sterile Hypodermic Needle for single use: | |
| ISO 7864:2017, Sterile Hypodermic Needles for Single Use. | Complies with ISO 7864. |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods. | Complies with ISO 9626. |
| ISO 594-1:1986, Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements. | Complies with ISO 594-1. |
| ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings. | Complies with ISO 594-2. |
| Sterilization & Packaging: | |
| ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. | Complies with ISO 11135. |
| ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. | Complies with ISO 10993-7. |
| USP39-NF34 Bacterial Endotoxin Limit (20 EU per device) | Complies with USP39-NF34 . (Endotoxin Limit: 20 EU per device). |
| ASTM F88/F88M-15 standard test method for seal strength of flexible barrier materials. | Complies with ASTM F88/F88M-15. |
| ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration. | Complies with ASTM F1929-15. |
| Material properties and Biocompatibility: | |
| ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. | Tested for Cytotoxicity, Irritation, Sensitization, Material Mediated Pyrogenicity, Acute Systemic Toxicity. Results indicate compliance. |
| USP Particulates in Injections. | Tested for particulates and found compliant. |
| Shelf Life: | |
| 5 year shelf life | Accelerated aging testing was conducted to substantiate the 5-year shelf life. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical bench tests or the number of individual devices tested to demonstrate compliance with the standards. It only states that "Bench tests were conducted" and "test results demonstrated that the proposed device complies."
The sponsor is Shanghai Kohope Medical Devices Co., Ltd from China. The tests would presumably have been conducted there or by a contract lab on behalf of the manufacturer. The data provenance is not explicitly stated as retrospective or prospective in the context of a clinical study, as these are engineering/materials tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described. The "ground truth" here is compliance with established international and national standards for medical devices (ISO, ASTM, USP), which are quantitative and objective measures, not subjective expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving expert review of medical images or patient outcomes, not for bench testing of physical device properties against engineering 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 information is not applicable. MRMC studies are used for AI/ML devices involving human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (syringes and needles) and does not involve AI or human readers in an diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as this device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is defined by the technical specifications and performance requirements outlined in the referenced international and national standards (ISO, ASTM, USP). This is objective, measurable data related to physical properties (e.g., fluid tightness, force required for plunger movement, sterility, endotoxin levels, material biocompatibility, seal strength).
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device that requires a training set or establishment of ground truth for such a set.
§ 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).