(238 days)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a syringe for general purpose fluid injection/aspiration.
The provided document K210232 "Sterile Hypodermic Needles for Single Use" is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving performance against specific acceptance criteria for a new, non-comparative device.
Therefore, the information presented in the document is primarily related to comparison with a predicate device and adherence to recognized standards, rather than a standalone performance study with detailed acceptance criteria and results for the device itself.
Based on the provided text, I can infer some aspects related to acceptance criteria and the "study" (mostly non-clinical testing) that proves the device meets the criteria.
Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K210232)
1. Table of Acceptance Criteria and Reported Device Performance:
The document defines "acceptance criteria" primarily through compliance with established international standards for hypodermic needles and related medical device characteristics. The "performance" is reported as demonstrating compliance with these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity) | Meets requirements; evaluation of testing items meets requirements. |
| Sterilization | ISO 11135:2014 (Ethylene oxide sterilization validation) | Method validated to ISO 11135; determined routine control and monitoring parameters. |
| Sterilization Residuals | ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Implied compliance through use of standard |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Achieved (stated in comparison table). |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic (stated in comparison table). |
| Shelf-life | ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems) | Determined based on stability study including aging test. |
| Packaging integrity | ISO 11607-1:2019, ISO 11607-2:2019 | Implied compliance through use of standards. |
| Packaging Test Methods | ASTM D4169-16 (Shipping Containers), ASTM F88/F88M-15 (Seal Strength), ASTM F1140/F1140M-13 (Internal Pressurized Failure), ASTM F1929-15 (Seal Leaks), ASTM F2096-11 (Gross Leakage) | Implied compliance through use of standards. |
| Physical Performance (Needles) | ISO 7864:2016 (Sterile hypodermic needles - Requirements and test methods) | Complies with ISO 7864. |
| Material (Stainless Steel Tubing) | ISO 9626:2016 (Stainless Steel Needle Tubing) | Complies with ISO 9626. |
| Small-bore Connectors | ISO 80369-7:2016 (Connectors for intravascular or hypodermic applications) | Complies with ISO 80369-7. |
| Labeling | 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each test. For medical devices like hypodermic needles, sample sizes for performance testing (e.g., force to penetrate, cannula rigidity) are typically defined by the relevant ISO standards (e.g., ISO 7864) and would vary based on the specific test and lot size. Biocompatibility testing often involves a smaller number of samples for each specific assay.
- Data Provenance: The testing is non-clinical/bench testing. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China. The data would originate from their internal testing labs or contract research organizations (CROs) in China or elsewhere, conducting tests according to the specified international standards. The data is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for hypodermic needles is established by objective, quantitative measurements against published international consensus standards (e.g., ISO 7864, ISO 9626) and regulatory requirements (e.g., 21 CFR 801, ISO 10993 for biocompatibility). There is no "ground truth" established by human experts in the sense of image interpretation or diagnostic accuracy for this type of device. The "experts" involved would be technicians and engineers skilled in performing the standardized tests and interpreting their results according to the defined specifications.
4. Adjudication Method for the Test Set:
- Not applicable. Performance is objectively measured against a quantifiable pass/fail criterion defined by the relevant standards (e.g., "force shall not exceed X N," "no hemolysis greater than Y," "no pyrogenicity detected"). No human adjudication of results is described, nor is it typically necessary for these types of physical and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study (comparative effectiveness, MRMC, human-in-the-loop with AI) is relevant for diagnostic devices, especially those incorporating AI, where human interpretation affects clinical outcomes. This document is for a physical medical device (hypodermic needle) where performance is determined by physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this is not applicable. The device is a physical hypodermic needle, not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherently physical and does not involve an "algorithm" operating independently.
7. The Type of Ground Truth Used:
- The "ground truth" is established by international consensus standards and regulatory guidelines. For example, the ground truth for biocompatibility is whether the device materials pass specific biological tests (cytotoxicity, irritation, sensitization) as defined by ISO 10993. The ground truth for needle performance is whether it meets the physical and mechanical specifications (e.g., dimensions, penetration force, corrosion resistance) outlined in standards like ISO 7864 and ISO 9626.
8. The Sample Size for the Training Set:
- Not applicable. This device is a manufactured medical product that undergoes physical and biological performance testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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).