(78 days)
No
The device description and performance studies focus on mechanical features and physical properties, with no mention of AI or ML.
No.
The device is a safety needle intended for aspiration and injection of fluids, and its primary function is to minimize the risk of accidental needlestick injuries, not to treat a disease or condition.
No
The device is a safety needle intended for the aspiration and injection of fluids. It does not perform any diagnostic function.
No
The device description clearly outlines a physical hypodermic needle with a hinged safety sheath and optional attached syringe, indicating it is a hardware medical device.
Based on the provided information, the TERUMO® SurGuard2™ SAFETY NEEDLE device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the aspiration and injection of fluids for medical purposes." This describes a device used for administering or withdrawing substances from the body, which is a clinical procedure, not an in vitro diagnostic test.
- Device Description: The description focuses on the physical components of a hypodermic needle and syringe with a safety mechanism. It does not mention any components or functions related to analyzing samples outside of the body.
- Performance Studies: The performance studies listed (Activation Force, Puncture Resistance, Leakage, etc.) are related to the physical and functional performance of a needle and syringe for injection/aspiration, not the analytical performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, which is the core function of an IVD.
In summary, the TERUMO® SurGuard2™ SAFETY NEEDLE is a medical device used for administering or withdrawing fluids from the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The TERUMO® SurGuard2™ 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 withdrawal 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 (comma separated list FDA assigned to the subject device)
80 FMI, 80 MEG
Device Description
The SurGuard2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. 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 fall within the 18 to 30gauge range and the needle lengths are 3/8" 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 SurGuard2™ Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 1. 3,5, and 10cc/ml.
The specification of the needle and safety feature portions are identical to the SurGuard2TM Safety Needle cleared under K031453 and K040531. manufactured by Terumo Medical Corporation, Elkton, MD, USA. The attached 3, 5, and 10cc/ml syringes are identical to those syringe cleared under K023271. manufactured by Terumo Philippines Corporation. Information provided in this 510k will show that the 1cc/ml syringe manufactured by Terumo Philippines Corporation is substantially equivalent to the 1cc/ml manufactured by Terumo Medical Corporation, USA, cleared under K 771205.
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 SurGuard2™ Safety Needle:
- Activation Force .
- Deactivation Force ●
- Puncture Resistance .
- Sheath Removal Force .
- Collar Removal Force ◆
- . Sheath Radial Force
- Protector Fit ◆
- Adhesive Hold .
- Simulated Use Study .
The following tests were performed on the Terumo Philippines 1cc/ml syringe:
- Leakage (Aspiration and Injection) ●
- Plunger Gasket Fit .
- Nominal Graduation Capacity .
- . Deadspace
- . Conical Fitting
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 SurGuard27M 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031453 TERUMO® SURGUARD2™ SAFETY NEEDLE (18 to 25g) with or without syringe, K040531 TERUMO® SURGUARD2™ SAFETY NEEDLE (26 to 30g) with or without syringe, K023271 TERUMO® SYRINGE, K771205 TERUMO® HYPODERMIC SYRINGE (1cc/ml)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Device Name A.
Proprietary Name
TERUMO® SurGuard2™ Safety Needle or similar proprietary name
Classification Name
Hypodermic Single Lumen Needle (880.5570) with antistick
Product Code: 80 FMI / 80 MEG
Classification: Class II
Common Name
Hypodermic needle with safety sheath or needle with needle protection device
B. Intended Use
The TERUMO® SurGuard2™ 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 withdrawal 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 SurGuard2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. 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 fall within the 18 to 30gauge range and the needle lengths are 3/8" 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 SurGuard2™ Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 1. 3,5, and 10cc/ml.
The specification of the needle and safety feature portions are identical to the SurGuard2TM Safety Needle cleared under K031453 and K040531. manufactured by Terumo Medical Corporation, Elkton, MD, USA. The attached 3, 5, and 10cc/ml syringes are identical to those syringe cleared under K023271. manufactured by Terumo Philippines Corporation. Information provided in this 510k will show that the 1cc/ml syringe manufactured by Terumo Philippines Corporation is substantially equivalent to the 1cc/ml manufactured by Terumo Medical Corporation, USA, cleared under K 771205.
D. Substantial Equivalence
The SurGuard2TM Safety Needle manufactured by Terumo Philippines Corporation is substantially equivalent to:
-
- K031453 TERUMO® SURGUARD2™ SAFETY NEEDLE (18 to 25g) with or without syringe manufactured by Terumo Medical Corporation, Elkton, Maryland.
-
- K040531 TERUMO® SURGUARD2™ SAFETY NEEDLE (26 to 30g) with or without syringe manufactured by Terumo Medical Corporation. Elkton, Maryland.
-
- K023271 TERUMO® SYRINGE manufactured by Terumo (Philippines) Corporation, Binan, Laguna, Philippines
- K771205 TERUMO® HYPODERMIC SYRINGE (1cc/ml) manufactured by ধ: Terumo Medical Corporation, Elkton, Maryland
2
All of these cleared devices serve as predicates for the device which is subject of this 510k.
E. Principle of Operation and Technology
The Terumo SurGuard2™ Safety Needle device with and without syringe manufactured by Terumo (Philippines) Corporation and Terumo Medical Corporation, USA (K040531 and K031453) and all referenced predicate devices are operated manually.
F. Materials
The type of materials used for the hypodermic needle, safety feature and syringe of the SurGuard2™ Safety Needle device are identical to the materials used for the cleared SurGuard2TM Safety Needle cleared under K031453 and K040531. Any differences in materials between the SurGuard27M Safety Needle manufactured by Terumo (Philippines) Corporation and the SurGuard2TM predicate manufactured by Terumo Medical Corporation, USA, raise no new issues of safety and effectiveness.
G. Specifications
| Product Descriptions |
|---|
| 18gauge x 1" (25mm) safety needle |
| 18gauge x 1 1/2" (38mm) safety needle |
| 19gauge x 1" (25mm) safety needle |
| 19gauge x 1 1/2" (38mm) safety needle |
| 20gauge x 1" (25mm) safety needle |
| 20gauge x 1 1/2" (38mm) safety needle |
| 21gauge x 1" (25mm) safety needle |
| 21gauge x 1 1/2" (38mm) safety needle |
| 22gauge x 1" (25mm) safety needle |
| 22gauge x 1 1/2" (38mm) safety needle |
| 23gauge x 1" (25mm) safety needle |
| 23gauge x 1 1/2" (38mm) safety needle |
| 25gauge x 5/8" (16mm) safety needle |
| 25gauge x 1" (25mm) safety needle |
| 25gauge x 1 1/2" (38mm) safety needle |
| 26gauge x 1/2" (13mm) safety needle |
| 27gauge x 1/2" (13mm) safety needle |
3
| 30 gauge x 1/2" (13mm) safety needle |
|---|
| 1cc/mL syringe with 25gauge x 5/8" (16mm) safety needle |
| 1cc/mL syringe with 26gauge x 3/8" (9mm) safety needle |
| 1cc/mL syringe with 27gauge x 1/2" (13mm) safety needle |
| 3cc/mL syringe with 20gauge x 1" (25mm) safety needle |
| 3cc/mL syringe with 20gauge x 1 1/2" (38mm) safety needle |
| 3cc/mL syringe with 21gauge x 1" (25mm) safety needle |
| 3cc/mL syringe with 21 gauge x 1 1/2" (38mm) safety needle |
| 3cc/mL syringe with 22gauge x 1" (25mm) safety needle |
| 3cc/mL syringe with 22gauge x 1 1/2" (38mm) safety needle |
| 3cc/mL syringe with 23gauge x 1" (25mm) safety needle |
| 3cc/mL syringe with 25gauge x 5/8" (16mm) safety needle |
| 3cc/mL syringe with 25gauge x 1" (25mm) safety needle |
| 5cc/mL syringe with 20gauge x 1" (25mm) safety needle |
| 5cc/mL syringe with 20gauge x 1 1/2" (38mm) safety needle |
| 5cc/mL syringe with 21gauge x 1 1/2" (38mm) safety needle |
| 10cc/mL syringe with 20gauge x 1" (25mm) safety needle |
| 10cc/mL syringe with 20gauge x 1 1/2" (38mm) safety needle |
| 10cc/mL syringe with 21gauge x 1" (25mm) safety needle |
H. Performance
The following tests were performed on the SurGuard2™ Safety Needle:
- Activation Force .
- Deactivation Force ●
- Puncture Resistance .
- Sheath Removal Force .
- Collar Removal Force ◆
- . Sheath Radial Force
- Protector Fit ◆
- Adhesive Hold .
- Simulated Use Study .
The following tests were performed on the Terumo Philippines 1cc/ml syringe:
- Leakage (Aspiration and Injection) ●
- Plunger Gasket Fit .
- Nominal Graduation Capacity .
4
KOSIECT
5 of 6
- . Deadspace
- . Conical Fitting
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 SurGuard27M 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.
l. 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 SurGuard2TM Safety Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10th.
The Terumo SurGuard2TM Safety Needle is classified as Externally Communicating Device, Blood Path Indirect, Limited Duration of Contact (