(60 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 used for the administration of therapeutic agents (insulin, allergy medication) but is not itself a therapeutic device as it does not directly treat a condition. It is a delivery mechanism.
No
The device is described as a syringe for the aspiration and injection of fluids, and for withdrawing medication. Its purpose is to deliver or remove substances from the body, not to diagnose a medical condition.
No
The device description clearly outlines a physical syringe with a needle and a safety feature, indicating it is a hardware device. The performance studies also focus on physical characteristics like force and integrity.
Based on the provided text, the Surguard™ Safety Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the manual aspiration and injection of fluids into parts of the body below the surface of the skin, and for withdrawing medication from vials. This involves direct interaction with the patient's body.
- Device Description: The description details a hypodermic syringe with a needle and a safety feature. This is a device designed for delivering or withdrawing substances from a living organism.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Surguard Safety Syringe does not mention any such use or interaction with patient specimens outside the body.
Therefore, the Surguard™ Safety Syringe is a medical device intended for in-vivo use (within the body), not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Surguard™ Safety Syringe is a device intended for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. This device is intended for insulin, allergy, or general use injections. Additionally, after withdrawing the needle from the patient, the safety feature can be manually activated to cover the needle to minimize the risk of accidental needlestick.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF
Device Description
The Surguard Safety Syringe consists of a graduated hypodermic syringe barrel with a permanently affixed needle (also called cannula) and an integrated safety feature component, which is permanently attached at the top of the syringe barrel close to the needle. The safety feature component can swivel to allow users additional flexibility in positioning the syringe and bevel for use. The locking mechanisms are located within the body of the sheath and at the collar that attaches to the top of the syringe barrel.
The syringe portion is the same as Terumo's Insulin and Terumo's Allergy/General Syringe that are the subject of K882083 and K980796 respectively. No changes were made to the syringes other than a minor modification to outside of the barrel to allow for secure attachment of the safety feature.
The syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. The syringe barrel will be graduated in insulin units for use with insulin or in cc/ml units for allergy or general use. The allergy/ general use syringe is offered with an intradermal bevel for intradermal injections and a regular bevel typically used for subcutaneous injections. The general use syringe has a regular bevel, which can be used for common injections such as intradermal, intramuscular, or subcutaneous. The insulin syringe will contain orange-colored needle cap and the allergy/general use syringe will contain a noncolored (white) cap.
The safety sheath is activated after syringe use and 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, thereby engaging the needle into the sheath. The user will visually confirm the needle is locked beneath the locking tab.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin.
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 Safety Syringe:
- Activation Force .
- Deactivation Force ●
- Sheath Penetration Force .
- Sheath Removal Force ●
- Collar Removal Force ●
- Sheath Swivel Force .
- Hinge Integrity ●
- Residual Volume .
- 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 Safety Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Insulin Syringe (K822083), the Terumo Allergy Syringe (K980796), and the Portex Needle-Pro® Syringe (K011925).
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.
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
A. Device Name
FEB 2 1 2003
Proprietary Name
TERUMO® SURGUARD™ Safety Syringe or similar proprietary name
Classification Name
Piston Syringe with Single Lumen Needle (880.5860) with antistick
Classification: Class II 80FMF & 80MEG
Common Name
Hypodermic syringe with safety sheath or Syringe with needle protection device
B. Intended Use
The Surguard™ Safety Syringe is a device intended for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. This device is intended for insulin, allergy, or general use injections. Additionally, after withdrawing the needle from the patient, the safety feature can be manually activated to cover the needle to minimize the risk of accidental needlestick.
1
C. Device Description
The Surguard Safety Syringe consists of a graduated hypodermic syringe barrel with a permanently affixed needle (also called cannula) and an integrated safety feature component, which is permanently attached at the top of the syringe barrel close to the needle. The safety feature component can swivel to allow users additional flexibility in positioning the syringe and bevel for use. The locking mechanisms are located within the body of the sheath and at the collar that attaches to the top of the syringe barrel.
The syringe portion is the same as Terumo's Insulin and Terumo's Allergy/General Syringe that are the subject of K882083 and K980796 respectively. No changes were made to the syringes other than a minor modification to outside of the barrel to allow for secure attachment of the safety feature.
The syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. The syringe barrel will be graduated in insulin units for use with insulin or in cc/ml units for allergy or general use. The allergy/ general use syringe is offered with an intradermal bevel for intradermal injections and a regular bevel typically used for subcutaneous injections. The general use syringe has a regular bevel, which can be used for common injections such as intradermal, intramuscular, or subcutaneous. The insulin syringe will contain orange-colored needle cap and the allergy/general use syringe will contain a noncolored (white) cap.
The safety sheath is activated after syringe use and 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, thereby engaging the needle into the sheath. The user will visually confirm the needle is locked beneath the locking tab.
D. Substantial Equivalence
The Surguard Safety Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Insulin Syringe (K822083), the Terumo Allergy Syringe (K980796), and the Portex Needle-Pro® Syringe (K011925).
2
E. Principle of Operation and Technology
The Terumo Surguard Safety Syringe, the Terumo Insulin and Allergy/General Syringes, and the Portex Needle Pro Syringe are all operated manually.
Materials F.
The materials used for the syringe portion of the Surguard Safety Syringe are identical to the materials used for the Terumo Insulin and Allergy syringes. The material selected for the safety feature is the same type of material used for the Portex Needle Pro. Differences in materials between the Surguard Safety Syringe and the Portex Needle Pro (K011925) raise no new issues of safety and effectiveness.
G. Specifications
| Product Code | Cap Color | Description |
|---|---|---|
| SG10M2913 | Orange | 1cc Insulin Syringe with 29g x ½" needle |
| SG05M2913 | Orange | 1/2cc Insulin Syringe with 29g x ½" needle |
| SG30M2913 | Orange | 3/10cc Insulin Syringe with 29g x ½" needle |
| SG10M2813 | Orange | 1cc Insulin Syringe with 28g x ½" needle |
| SG05M2813 | Orange | 1/2cc Insulin Syringe with 28g x ½" needle |
| SG10A2713T | White (No color) | 1cc Allergy Syringe with 27g x ½" needle– |
| Multi-piece tray | ||
| SG10A2613T | White (No color) | 1cc Allergy Syringe with 26g x ½" needle– |
| Multi-piece tray | ||
| SG10A2710IDT | White (No color) | 1cc Allergy Syringe with 27g x 3/8" |
| Intradermal needle– Multi-piece tray | ||
| SG10A2610IDT | White (No color) | 1cc Allergy Syringe with 26g x 3/8" |
| Intradermal needle– Multi-piece tray | ||
| SG01D2516 | White (No color) | 1cc (General) Syringe with 25g x 5/8" needle– |
| Low deadspace | ||
| SG01D2713 | White (No color) | 1cc (General) Syringe with 27g x ½" needle– |
| Low Deadspace | ||
| SG01D2610ID | White (No color) | 1cc (General) Syringe with 26 x 3/8" |
| Intradermal needle |
3
H. Performance
The following tests were performed on the Surguard Safety Syringe:
- Activation Force .
- Deactivation Force ●
- Sheath Penetration Force .
- Sheath Removal Force ●
- Collar Removal Force ●
- Sheath Swivel Force .
- Hinge Integrity ●
- Residual Volume .
- 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 Safety Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Insulin Syringe (K822083), the Terumo Allergy Syringe (K980796), and the Portex Needle-Pro® Syringe (K011925).
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 Safety Syringe is sterilized to provide a Sterility Assurance Level (SAL) of 106.
The Terumo Surguard Safety Syringe is classified as Externally Communicating Device, Blood Path Indirect, Limited Duration of Contact (