(108 days)
This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below:
| Name | Material | Material Specification |
|---|---|---|
| Needle tube | 304 stainless steel | SUS304 |
| Needle hub | Polypropylene (PP) | R307Y |
| Needle cap | Polypropylene (PP) | R307Y |
| Hub colorant | Black Masterbatch | Carbon Black |
| Lubricant | Medical Highly Activated Silicone | Highly Reactive Silicone Oil |
| Adhesive | Ultraviolet adhesive | AA 3311 |
The device is classified for patient contact as externally communicating circulating blood in a limited contact duration (
This document is a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needle for Single Use" by Jiangsu Shenli Medical Production Co., Ltd. The purpose of this notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (IMC Hypodermic Needle, K102584).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, a "Sterile Hypodermic Needle for Single Use," the acceptance criteria are based on compliance with various international standards for medical devices, particularly those related to hypodermic needles, biocompatibility, and sterility. The reported device performance is that it meets all these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Method) | Reported Device Performance |
|---|---|---|
| Performance Standards | ISO 9626: Stainless steel needle tubing for medical devices - Requirements and test methods | Meets standard criteria |
| ISO 7864: Sterile hypodermic needles for single use - Requirements and test Methods | Meets standard criteria | |
| ISO 594-1: Conical fittings with a 6% (Luer) taper - Part 1: General requirements | Meets standard criteria | |
| ISO 594-2: Conical fittings with a 6% (Luer) taper - Part 2: Lock fittings | Meets standard criteria | |
| ISO 6009: Hypodermic needles for single use - Colour coding for identification | Meets standard criteria | |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Complies with ISO10993-1 |
| ISO 10993-5: In Vitro Cytotoxicity (MTT Method) | Complies with standard criteria | |
| ISO 10993-10: Skin Sensitization (GPMT Method) | Complies with standard criteria | |
| ISO 10993-10: Intracutaneous Reactivity Test | Complies with standard criteria | |
| ISO 10993-11: Acute Systemic Toxicity | Complies with standard criteria | |
| ISO 10993-4: Coagulation test (APTT, PT, TT, Fibrinogen) | Complies with standard criteria | |
| ISO 10993-4: Complement activity (C3a, SC5b-9) Test | Complies with standard criteria | |
| ASTM F756-13: Hemolytic Properties Test | Complies with standard criteria | |
| ISO 10993-11 / USP 40 : Material-Mediated Pyrogenicity (Rabbit pyrogen test) | Complies with standard criteria | |
| Sterilization | ISO 11135-1: Ethylene oxide sterilization - Requirements for development, validation, and routine control | Complies with standard criteria |
| ISO 11737-1: Sterilization of medical devices - Microbiological methods - Part 1: Determination of bioburden | Complies with standard criteria | |
| ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility | Complies with standard criteria | |
| ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide residuals | Complies with standard criteria | |
| AAMI / ANSI ST72: Bacterial endotoxins - Test methods | Complies with standard criteria | |
| Product Specifications | Hub/needle Bond Strength: ISO 7894:1993 | Meets Standard Criteria |
| SAL (Sterility Assurance Level) | 10-6 (meets standard) | |
| Package Integrity & Shelf Life | Tensile seal strength, package verification, vacuum leak, dye penetration, agar contact-attack, accelerated aging | Test results provide evidence of compliance to standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of AI/ML, but rather refers to various "performance testing" conducted to meet specific standards. For each of these tests (e.g., biocompatibility tests, physical performance tests), the sample sizes used are not explicitly stated in this summary document. The document states that the data is from "Jiangsu Shenli Medical Production Co., Ltd." in Changzhou City, Jiangsu Province, China, indicating the country of origin of the data. The studies are prospective in nature, as they involve testing the newly developed device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is for a traditional medical device (hypodermic needle) and does not involve AI/ML. Therefore, the concept of "ground truth established by experts" in the context of interpretation of results (like in image analysis) is not directly applicable here. The "ground truth" for this device's performance is objective compliance with pre-defined international standards and physical/chemical test parameters. These standards are developed and overseen by international bodies and qualified experts in the field of medical device manufacturing and safety. The expertise lies in the development of these standards and the execution and interpretation of the tests by qualified testing laboratories.
4. Adjudication Method for the Test Set
Not applicable, as this is a traditional medical device submission, not an AI/ML algorithm requiring expert adjudication of results. The "adjudication" is essentially the determination of whether the device's performance metrics meet the specified quantitative and qualitative requirements of the applicable international standards. This is typically done by qualified laboratory personnel and regulatory reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This submission is for a physical medical device (hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance improvement are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective adherence to internationally recognized consensus standards and validated test methods. This includes:
- Quantitative measurements: e.g., bond strength, dimensions, chemical residue levels (Ethylene Oxide).
- Qualitative biological responses: e.g., absence of cytotoxicity, sensitization, hemolysis.
- Sterility levels: Demonstrated by achieving a specific Sterility Assurance Level (SAL).
The ground truth is not subjective expert consensus on interpretations but rather the objective compliance with predefined, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).