(22 days)
No
The device description and performance studies focus on mechanical features and physical testing, with no mention of AI or ML.
No
The device is a safety needle intended for the aspiration and injection of fluids and for preventing needlestick injuries, not for treating a disease or condition.
No
Explanation: The device is described as a safety needle for aspiration and injection of fluids, designed to prevent needlestick injuries. Its function is to administer or withdraw substances, not to provide diagnostic information about a patient's condition.
No
The device description clearly outlines physical components like a hypodermic needle, hinged safety sheath, and locking mechanism, indicating it is a hardware device with a safety feature.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration and injection of fluids for medical purposes" and minimizing needlestick risk. This describes a device used on or in the body for direct medical procedures, not for testing samples outside the body.
- Device Description: The description details a hypodermic needle with a safety mechanism. This is consistent with a device used for administering or withdrawing substances from a patient.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or any other activity typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device is a tool for interacting directly with the body.
N/A
Intended Use / Indications for Use
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.
Product codes
FMI, MEG
Device Description
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.
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
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Summary of Performance Studies
The following tests were performed on the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles:
- Activation Force .
- Deactivation Force
- . Puncture Resistance
- Simulated Use Study ●
A risk analysis was conducted and any new or different issues of safety and effectiveness were identified and mitigated appropriately.
The SURGUARD2™ SAFETY NEEDLE submitted in this 510k for 26 to 30gauge needles is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the legally marketed predicate SURGUARD2™ SAFETY NEEDLE device (K031453) and TERUMO® Hypodermic Needles (K771203 & K012646).
Key Metrics
Not Found
Predicate Device(s)
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
TERUMO MEDICAL CORPORATION SPECIAL 510(k) - SURGUARD2™ SAFETY NEEDLE Section II. Summary & Certification
MAR 2 3 2004
SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
A. Device Name
Proprietary Device Name: TERUMO® SURGUARD2™ SAFETY NEEDLE
Needle, Hypodermic, Single Lumen with antistick Classification Name:
B. Reason for Submission:
This 510k is being submitted to extend the cleared SURGUARD2™ Safety Needle (K031453) product line to include 26 to 30gauge needle sizes taking into consideration the potential issues of safety and effectiveness specific for sheathing a smaller/thinner needles after use. This 510k will provide supporting information that the SURGUARD2™ Safety Needle design is safe and effective for smaller needle sizes (26 to 30g) and an acceptable extension of the current cleared SURGUARD2™ Safety Needle device (K031453).
C. Intended Use:
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.
Note: This is the same intended use us the predicate device, SURGUARD2™ SAFETY NEEDLE (K031453).
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D. Description
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.
E. Substantial Equivalence
The SURGUARD2™ SAFETY NEEDLE is substantially equivalent in intended use, design, technology/principals of operation, materials, and performance to the SURGUARD2™ SAFETY NEEDLE cleared under K031453 and TERUMO® Hypodermic Needles cleared under K771203 and K012646.
Differences between the devices do not raise any significant issues of safety and effectiveness.
F. Principals of Operation/Technology
The proposed SURGUARD2™ SAFETY NEEDLE for 26 to 30g needles and the predicate SURGUARD2™ SAFETY NEEDLE (K031453) and TERUMO® Hypodermic Necdles (K771203 & K012646) are operated manually.
G. Materials
The materials used for the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles are identical to the materials used for the cleared SURGUARD2™ SAFETY NEEDLE (K031453) and TERUMO® Hypodermic Needles (K771203 & K012646).
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H. Specifications
| Product Description |
|---|
| 26gauge x 1" (13mm) safety needle |
| 27gauge x 1" (13mm) safety needle |
| 30gauge x 1" (13mm) safety needle |
| 26gauge x 3/8" (9mm) safety needle with attached 1cc syringe |
| 27gauge x 1" (13mm) safety needle with attached 1cc syringe |
I. Performance
The following tests were performed on the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles:
- Activation Force .
- Deactivation Force
- . Puncture Resistance
- Simulated Use Study ●
A risk analysis was conducted and any new or different issues of safety and effectiveness were identified and mitigated appropriately.
The SURGUARD2™ SAFETY NEEDLE submitted in this 510k for 26 to 30gauge needles is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the legally marketed predicate SURGUARD2™ SAFETY NEEDLE device (K031453) and TERUMO® Hypodermic Needles (K771203 & K012646).
J. 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 11137-1998 Medical Devices – Validation and Routine Control of Radiation Sterilization. The SURGUARD2™ SAFETY NEEDLE is sterilized to provide a Sterility Assurance Level (SAL) of 10th.
The Terumo SURGUARD2™ SAFETY NEEDLE is classified as Externally Communicating Device, Blood Path Indirect. Limited Duration of Contact (