(183 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 Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the 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 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 gauges and lengths. The safety needle is compatible for use with a luer slip and 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. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.
Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are 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 Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve 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 document describes the 510(k) premarket notification for "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle" (K221247) by Jiangsu Kangbao Medical Equipment Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K170651) based on non-clinical testing.
Here's a breakdown of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various international and ASTM standards that the device was tested against. The acceptance criterion for each standard is implicit within the standard itself (e.g., "complies with the requirements of related standards," "no cytotoxicity," "no hemolysis"). The reported performance consistently states that the proposed device met these criteria.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Biocompatibility Testing | |
| ISO 10993-5:2009 (Cytotoxicity) | No cytotoxicity |
| ISO 10993-10:2010 (Sensitization) | No sensitization |
| ISO 10993-10:2010 (Irritation) | No intracutaneous reactivity |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | No systemic toxicity |
| ASTM F756-17 (Hemolysis) | No hemolysis |
| ISO 10993-4:2017 (Complement activation) | Not show potentials to activate complete system |
| ISO 10993-4:2017 (Thromboresistance study) | No thrombogenicity |
| USP (Pyrogen Test) | No pyrogen |
| Physical, Mechanical, Chemical Testing | |
| ISO 7886-1:2017 (General requirements, Extraneous matter, Lubricant, Tolerance on graduated capacity, Graduated scale, Barrel, Piston/plunger assembly, Nozzle, Performance) | Complies with the requirements of related standards |
| ISO 7864:2016 (Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Size designation, Colour coding, Needle hub, Needle Cap, Needle tube, Needle point, Bond between hub and needle tube, Patency of lumen) | Complies with the requirements of related standards |
| ISO 9626:2016 (Surface finish and appearance, Cleanliness, Limits for acidity and alkalinity, Size designation, Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion) | Complies with the requirements of related standards |
| ISO 80369-7:2016 (Fluid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation form unscrewing, Resistance to overriding) | Complies with the requirements of related standards |
| USP (Particulate testing) | Complies with the requirements of related standards |
| Sterile Barrier Packaging Testing | |
| ASTM F1886 / F1886M-16 (Visual inspection) | Device package can maintain its integrity |
| ASTM F88/F88M-15 (Seal strength) | Device package can maintain its integrity |
| ASTM F1929-15 (Dye penetration test) | Device package can maintain its integrity |
| Sterilization and Shelf Life Testing | |
| ISO 10993-7:2008 (EO residue) | EO ECH residue did not exceed the limit |
| ISO 10993-7:2008 (ECH residue) | EO ECH residue did not exceed the limit |
| USP (Bacteria Endotoxin Limit) | Endotoxin limit did not exceed 20EU/device |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Test) | Device can maintain its performance during the claimed shelf life (5 years) |
| Simulated Clinical Study | |
| FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, ISO 23908:2011 (Safety mechanism evaluation) | Proposed device met the pre-established criteria |
| Safety Feature Test | |
| (Specific criteria not detailed, but states "acceptance criteria") | The proposed device met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each non-clinical test performed on the test set. It mentions "non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device." Similarly, for biocompatibility and packaging tests, it states "The proposed device was evaluated for the following tests" and "Sterile barrier packaging testing were performed on the proposed device."
The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Jiangsu Kangbao Medical Equipment Co., Ltd. from China. The studies are non-clinical, meaning they are lab-based and not involving human subjects. They are inherently prospective in nature as they test the new device against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP). These standards define the test methods and acceptance criteria, and the device's performance is measured against these objective criteria rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the tests are against objective engineering and biological standards, there is no need for an adjudication method typically used in clinical studies involving human interpretation or subjective assessments.
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 done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on non-clinical performance, biocompatibility, and substantial equivalence to a predicate device based on these non-clinical tests. Therefore, there is no effect size reported for human readers with or without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical medical instrument (syringe and needle), not an algorithm or AI-powered system. No standalone "algorithm only" performance was evaluated.
7. The type of ground truth used:
The type of "ground truth" used for this submission is based on established international and national standards and their defined acceptance criteria. For example:
- Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, complement activation, and thrombogenicity as defined by the respective ISO and USP standards.
- Physical/Mechanical/Chemical Performance: Compliance with the specifications and performance requirements outlined in ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and USP .
- Packaging Integrity: Maintenance of sterility barrier as per ASTM F1886/F1886M-16, ASTM F88/F88M-15, and ASTM F1929-15.
- Sterilization: EO/ECH residue within limits (ISO 10993-7), endotoxin limit (USP ), and sterile assurance level (SAL) of 10-6.
- Safety Feature: Meeting pre-established criteria as per FDA Guidance and ISO 23908:2011.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" to establish.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for this type of 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).