(62 days)
No
The device description and performance studies focus on mechanical features and physical testing, with no mention of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a safety needle used for aspiration and injection, which are diagnostic or procedural rather than therapeutic functions. Its primary safety feature is to minimize accidental needlesticks.
No.
The device is a safety needle intended for aspiration and injection of fluids, designed to minimize needlestick injuries. Its function is to administer or withdraw substances, not to diagnose conditions.
No
The device description clearly details a physical hypodermic needle with a hinged safety sheath and locking mechanism, indicating it is a hardware device, not software only.
Based on the provided text, the TERUMO® SurGuard 2™ SAFETY NEEDLE device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "aspiration and injection of fluids for medical purposes." This describes a device used on or in the body for therapeutic or diagnostic procedures, not for testing samples outside the body.
- Device Description: The description focuses on the physical components and function of a hypodermic needle and a safety mechanism for preventing needlesticks. This aligns with a device used for administering or withdrawing substances from a patient.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
- Reagents or other components typically associated with IVD tests.
The device is a medical device used for direct patient care, specifically for injections and aspirations. The safety feature is designed to protect healthcare workers from sharps injuries during these procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
FMI, MEG
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed on the SurGuard 2TM Safety Needle:
- Activation Force .
- . Deactivation Force
- Puncture Resistance .
- Sheath Removal Force .
- Collar Removal Force .
- Sheath Radial Force .
- . Protector Fit
- Simulated Use Study .
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
The performance of the SurGuard 2TM Safety Needle submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K923127, K771203, K771205, K980181
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Device Name A.
Proprietary Name
TERUMO® SurGuard 2™ Safety Needle or similar proprietary name
Classification Name
Hypodermic Single Lumen Needle (880.5570)
Classification: Class II 80 FMI
Common Name
Hypodermic needle with safety sheath or needle with needle protection device
B. Intended Use
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.
1
C. Device Description
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).
D. Substantial Equivalence
The SurGuard 2™ Safety Needle without or with syringe attached is substantially equivalent to:
-
- K923127 SurGuard Needle/Syringe with Needle Protection device manufactured by Portex, Inc.
-
- K771203 Terumo Hypodermic Needle
All of these cleared devices serve as predicates for the device which is subject of this 510k.
Principle of Operation and Technology E.
The Terumo SurGuard 2™ Safety Needle, the Surguard device manufactured by Portex, Inc (K923127), the Terumo Hypodermic Needles (K771203) and Terumo Hypodermic Syringes (K771205 and K980181) are all operated manually.
F. Materials
The materials used for the hypodermic needle and syringe portion of the SurGuard 2TM Safety Needle are identical to the materials used for the cleared Terumo Hypodermic Needles (K771203) and Terumo Hypodermic Syringe (K771205 and
2
K980181). The material selected for the safety feature is the same type of material used for the sheath of the Surguard predicate (K923127). Any differences in materials between the SurGuard 2™ Safety Needle and the Surguard predicate raise no new issues of safety and effectiveness.
G. Specifications
| Product Descriptions |
|---|
| 18 gauge x 1" safety needle |
| 18 gauge x 1 ½" safety needle |
| 19 gauge x 1" safety needle |
| 19 gauge x 1 ½" safety needle |
| 20 gauge x 1" safety needle |
| 20 gauge x 1 ½" safety needle |
| 21 gauge x 1" safety needle |
| 21 gauge x 1 ½" safety needle |
| 22 gauge x 1" safety needle |
| 22 gauge x 1 ½" safety needle |
| 23 gauge x 1" safety needle |
| 23 gauge x 1 ½" safety needle |
| 25 gauge x 5/8" safety needle |
| 25 gauge x 1" safety needle |
| 25 gauge x 1 ½" safety needle |
| 1cc/ml syringe with 25 gauge x 5/8" safety needle |
| 3cc/ml syringe with 20 gauge x 1" safety needle |
| 3cc/ml syringe with 20 gauge x 1 ½" safety needle |
| 3cc/ml syringe with 21 gauge x 1" safety needle |
| 3cc/ml syringe with 21 gauge x 1 ½" safety needle |
| 3cc/ml syringe with 22 gauge x 1" safety needle |
| 3cc/ml syringe with 22 gauge x 1 ½" safety needle |
| 3cc/ml syringe with 23 gauge x 1" safety needle |
| 3cc/ml syringe with 25 gauge x 5/8" safety needle |
| 3cc/ml syringe with 25 gauge x 1" safety needle |
| 5cc/ml syringe with 20 gauge x 1" safety needle |
| 5cc/ml syringe with 20 gauge x 1 ½" safety needle |
| 5cc/ml syringe with 21 gauge x 1 ½" safety needle |
| 10cc/ml syringe with 20 gauge x 1" safety needle |
| 10cc/ml syringe with 20 gauge x 1 ½" safety needle |
| 10cc/ml syringe with 21 gauge x 1" safety needle |
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H. Performance
The following tests were performed on the SurGuard 2TM Safety Needle:
- Activation Force .
- . Deactivation Force
- Puncture Resistance .
- Sheath Removal Force .
- Collar Removal Force .
- Sheath Radial Force .
- . Protector Fit
- Simulated Use Study .
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
The performance of the SurGuard 2TM Safety Needle submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the legally marketed predicate devices.
I. Additional Safety Information
Manufacturing controls include visual, functional, and sterility tests.
The sterility of the device is assured using a sterilization method validated in accordance with ANSI/AAMI/ISO 11137-1994 Medical Devices - Validation and Routine Control of Radiation Sterilization. The SurGuard 2TM Safety Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10-6.
The Terumo SurGuard 2™ Safety Needle is classified as Externally Communicating Device, Blood Path Indirect, Limited Duration of Contact (