(412 days)
The TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The SurGuard®3 Safety Hypodermic Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The SurGuard®3 Safety Hypodernic Needle is compatible for use with standard luer slip and luer lock syringes. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the risk of accidental needlestick. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.
The SurGuard®3 Safety Hypodermic Needle will be individually packaged and sterilized by ethylene oxide.
This document focuses on the Terumo SurGuard®3 Safety Hypodermic Needle (K212095).
Based on the provided text, this is a 510(k) summary for a medical device that claims substantial equivalence to previously cleared devices. It describes design and manufacturing aspects and non-clinical performance testing. It explicitly states that no clinical tests were performed or included in this 510(k) submission. Therefore, the information requested regarding acceptance criteria and studies that prove the device meets these criteria in a clinical context (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
The acceptance criteria and supporting studies mentioned pertain to non-clinical performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against recognized consensus standards and general performance requirements for hypodermic needles. The "acceptance criteria" are implied by compliance with these standards and the "reported device performance" is the statement of this compliance.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| Sterile hypodermic needles (ISO 7864:2016) | Design has been validated in accordance with ISO 7864:2016. |
| Stainless steel needle tubing (ISO 9626:2016) | Design has been validated in accordance with ISO 9626:2016. |
| Small bore connectors (ISO 80369-7:2017) | Design has been validated in accordance with ISO 80369-7:2017. |
| Needle color coding (ISO 6009:2016) | Design has been validated in accordance with ISO 6009:2016. |
| Sharps injury protection (ISO 23908:2013) | Design has been validated in accordance with ISO 23908:2013. |
| Particulate matter (USP ) | Design has been validated in accordance with USP . |
| Biocompatibility (ISO 10993-1:2020) | Biological endpoints addressed: cytotoxicity, sensitization, intracutaneous reactivity, toxicity (acute systemic, pyrogenicity, bacterial endotoxins), and haemocompatibility. Compliance implied by addressing these endpoints according to guidance. |
| Sterilization validation (ISO 11135:2014) | Sterility assured by validated sterilization method in accordance with ISO 11135:2014. Physical and biological validation performed. |
| Sterility Assurance Level (SAL) (10⁻⁶) | Achieves a SAL of at least 10⁻⁶. |
| Ethylene Oxide (EO) residuals (ISO 10993-7:2008/AC:2009) | EO levels after aeration do not exceed 4 mg/device/day. Ethylene chlorohydrin levels do not exceed 9 mg/device/day. |
| Shelf life | 5 years. Accelerated aging performed based on ASTM F1980. |
| Packaging integrity for shipping (ASTM D4169-16) | Simulated shipping performed per ASTM D4169-16. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document for any individual test. The document states that "The design... has been validated... in accordance with the Design Control Requirements and recognized consensus standards." These standards typically define sample sizes for specific tests.
- Data Provenance: The testing was "validated by Terumo Europe N.V." and conducted to "recognized consensus standards." The nature of these standards suggests laboratory-based, non-clinical engineering and biological safety tests. No country of origin for the explicit test data is mentioned beyond Terumo Europe N.V. performing the validation. All testing is retrospective to the device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes non-clinical performance testing against technical standards for a hypodermic needle, not a diagnostic or AI device that requires expert-established ground truth.
4. Adjudication method
- Not applicable, for the same reasons as #3.
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
- Not applicable. This is a hypodermic needle and not an AI-assisted diagnostic device. The document explicitly states "This 510(k) does not include data from clinical tests."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (hypodermic needle), not an algorithm or AI system.
7. The type of ground truth used
- For non-clinical performance and safety testing, the "ground truth" is established by the specifications and requirements defined within the referenced international and national consensus standards (e.g., ISO, USP, ASTM). For example, a needle's sterility is "ground truth" if it achieves a SAL of 10⁻⁶ as per ISO 11135:2014. Biocompatibility is confirmed by meeting the biological endpoints outlined in ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable, for the same reasons as #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).