(22 days)
The SURGUARD2™ SAFETY NEEDLE device for 26 to 30gauge needles 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 SURGUARD2™ 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 26gauge to 30gauge and the needle lengths are 3/8" (9mm) to 1" (13mm). 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 SURGUARD2™ SAFETY NEEDLE will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe.
The Terumo SURGUARD2™ Safety Needle is an existing device (K031453) that the manufacturer is trying to expand to cover 26-gauge to 30-gauge needles. The safety and effectiveness of these additional needle sizes are being demonstrated through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria in a quantitative table format. Instead, it states that tests were performed and implies successful completion by declaring substantial equivalence. However, we can infer the tested parameters and the general intention, which is to demonstrate performance comparable to the predicate device and ensure safety.
| Test Parameter | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Activation Force | Consistent and adequate force for safe, manual activation | Performance found to be acceptable; contributes to substantial equivalence. |
| Deactivation Force | Appropriate force to indicate proper locking without premature deactivation | Performance found to be acceptable; contributes to substantial equivalence. |
| Puncture Resistance | Sufficient resistance to prevent accidental needlesticks | Performance found to be acceptable; contributes to substantial equivalence. |
| Simulated Use Study | Demonstrates effective and safe use in simulated clinical settings | Performance found to be acceptable, addressing safety and effectiveness concerns for smaller needles. |
| Biocompatibility | Meet ISO-10993 requirements for blood-contacting materials | Results demonstrate that blood-contacting materials are biocompatible. |
| Sterility | Sterility Assurance Level (SAL) of 10^-6 | Sterilized using a validated method to achieve SAL of 10^-6. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for each performance test (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study). It only states that "The following tests were performed on the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles."
- Data Provenance: The data is prospective, generated specifically for this 510(k) submission by Terumo Medical Corporation in Elkton, Maryland, USA. The testing was conducted to prove the safety and effectiveness of the extended product line.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a medical needle, and the "ground truth" is established through engineering and biological performance testing, not expert interpretation of outputs like images.
4. Adjudication Method for the Test Set:
Not applicable for this type of device and testing. Performance data is generated directly from physical tests, not through expert adjudication of subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/algorithm-based diagnostic device where human reader performance would be a relevant metric.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The tests listed (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study, Biocompatibility, Sterility) are all standalone evaluations of the device's physical and biological properties. There is no human-in-the-loop component in these specific tests determining the core performance of the safety mechanism.
7. Type of Ground Truth Used:
The ground truth used is based on:
- Engineering Specifications/Standards: For tests like Activation Force, Deactivation Force, and Puncture Resistance, the ground truth is the measured physical property against predefined engineering limits or industry standards for safety needles.
- Simulated Clinical Scenarios: For the Simulated Use Study, the "ground truth" would be the observed successful activation and prevention of needlestick injuries under controlled, simulated conditions.
- Biological Standards: For Biocompatibility, the ground truth is compliance with ISO-10993 standards, demonstrated through specific in-vitro and/or in-vivo tests.
- Sterilization Standards: For Sterility, the ground truth is achieving a specified Sterility Assurance Level (SAL) through a validated process according to ANSI/AAMI/ISO 11137-1998.
Essentially, the ground truth is derived from objective, measurable physical, chemical, and biological properties and adherence to established regulatory and industry standards for medical devices.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing process are established through engineering principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device. The design and validation are based on established engineering, manufacturing, and regulatory compliance practices.
§ 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).