(62 days)
The TERUMO® SurGuard 2™ SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdraw 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 needlestick.
The SurGuard 2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes are 18gauge to 25gauge and the needle lengths are 5/8" to 1 ½". The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SurGuard 2™ Safety Needle will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe (as cleared under K771205 and K980181).
Here's a breakdown of the acceptance criteria and the study information for the TERUMO® SurGuard 2™ Safety Needle, based on the provided document.
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission seeking substantial equivalence, the acceptance criteria are not explicitly defined as pass/fail thresholds in the same way they would be for a de novo or PMA application. Instead, the "acceptance criteria" are implied by the comparison to predicate devices and the demonstration that the new device performs similarly and does not raise new safety or effectiveness issues. The reported device performance is presented as a list of tests conducted, with the overarching conclusion that these tests support substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance similar to predicate devices for safety features | Activation Force, Deactivation Force, Puncture Resistance, Sheath Removal Force, Collar Removal Force, Sheath Radial Force, Protector Fit, Simulated Use Study |
| Biocompatibility of blood-contacting materials | Biocompatibility testing per FDA G95-1 (ISO-10993 Part 1) |
| Sterility Assurance Level (SAL) per recognized standard | SAL of 10^-6 validated according to ANSI/AAMI/ISO 11137-1994 |
| No new issues of safety and effectiveness compared to predicates | Risk analysis conducted; "None of the data raises any new issues of safety and effectiveness." |
Study Details
This 510(k) submission primarily relies on bench testing/performance testing rather than a clinical study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test set, experts for ground truth, MRMC study, training set) are not applicable in their typical sense for this type of device.
1. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each performance criterion. The document states "The following tests were performed on the SurGuard 2TM Safety Needle," implying that a sufficient number of devices were tested to draw conclusions.
- Data Provenance: The tests were performed internally by Terumo Medical Corporation (the manufacturer). The country of origin for the data is implied to be the USA, given the submission is to the FDA in the US. The data is prospective as it was generated specifically for this 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a mechanical safety device undergoing bench testing, "ground truth" is established by direct measurement and standardized test methods, not expert consensus on interpretations.
3. Adjudication method for the test set:
- Not Applicable. As per point 2, ground truth is based on direct measurement, not assessment by humans requiring adjudication.
4. 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 medical device (safety hypodermic needle), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not incorporate an AI algorithm.
6. The type of ground truth used:
- For the performance tests (e.g., Activation Force, Puncture Resistance), the "ground truth" is the measured physicochemical and mechanical properties of the device, assessed against pre-defined engineering specifications or comparative data from predicate devices.
- For biocompatibility, the ground truth is established by laboratory testing results compliant with ISO-10993 Part 1.
- For sterility, the ground truth is established by sterilization validation results compliant with ANSI/AAMI/ISO 11137-1994.
7. The sample size for the training set:
- Not Applicable. There is no training set as no AI/machine learning algorithm is involved.
8. How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
§ 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).