(14 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a hypodermic needle, with no mention of AI or ML.
No
The device is a hypodermic needle, which is used for injection or withdrawal of fluids, but it does not directly provide therapy itself. It is a tool used in medical procedures, some of which may be therapeutic, but the needle itself is not a therapeutic device.
No.
Explanation: The device is described as a hypodermic needle intended for injecting or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is comprised of a metal tube and a female connector (hub), indicating it is a physical hardware device, not software. The performance studies also focus on physical characteristics like adhesion, fit, and penetration force.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description of a needle and hub for mating with a syringe or administration set aligns with a device used for administering substances or collecting samples from the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (in a test tube or other laboratory setting) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This hypodermic needle is a tool for accessing the body, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It is intended to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Product codes (comma separated list FDA assigned to the subject device)
NN3013R
Device Description
The TERUMO® 30 Gauge hypodermic needle is comprised 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.
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 performance tests were performed on the Terumo 30g Hypodermic Needle:
- Cannula Adhesion
- Protector Fit
- Needle Penetration Force
- Leakage
- Blocked Cannula
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conduct and there were no risks identified that warranted any design changes.
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.
K771203, BD 30 Gauge (Precision Glide) Hypodermic Needle
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
§ 880.5570 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
AUG 2 7 2001
SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
A. Device Name
Proprietary Device Name: TERUMO® 30 Gauge Hypodermic Needle
Classification Name: Needle, Hypodermic, Single Lumen
B. Reason for Submission:
This 510k is being submitted to extend the cleared Terumo Hypodermic Needle* (K771203) product line. (*also referred to as the standard Terumo needle.) The size of the 30g needle is smaller than what is currently cleared under the current Hypodermic needle 510k (K771203). This Special 510k is being submitted because of potential issues of safety and effectiveness specific for a smaller/thinner needles. This 510k will provide supporting information that Terumo's 30 Gauge hypodermic needle is safe and effective and an acceptable extension of the current hypodermic needle product line.
C. Intended Use:
The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It is intended to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Note: This is the same intended use as the predicate device, Terumo Hypodermic Needle - K771203.
D. Description
The TERUMO® 30 Gauge hypodermic needle is comprised 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.
E. Substantial Equivalence
The TERUMO® 30Gauge Hypodermic Needle is substantially equivalent in intended use. design, technology/principals of operation, materials, and performance to both the following cleared devices:
- TERUMO® Hypodermic Needle 1. (K771203)
- BD 30 Gauge (Precision Glide) Hypodermic Needle 2. *Pre-amendment
1
- Unable to identify the 510(k) number for this device through published resources. It is believed to be a pre-amendment device although this could not be confirmed.
Differences between the devices do not raise any significant issues of safety and effectiveness.
F. Principals of Operation/Technology
The TERUMO® 30Gauge Hypodermic Needle, Terumo Hypodermic needle (K771203), and BD 30G Precision Glide Hypodermic Needle (Pre-amendment) are all operated manually.
G. Materials
The TERUMO® 30Gauge Hypodermic Needle, standard Terumo needle, and BD 30G Precision TIFE TEKOMO® 50Gage 113podemic stainless steel tubing attached to a plastic hub by Onec Trypodeline Neduce are an ials used in the proposed 30G needle and the cleared Terumo needle are the same.
H. Specifications
| Product Code | Gauge Size | Needle
Length | Hub Color* |
|--------------|------------|------------------|------------|
| NN3013R | 30g | 1/2" | Yellow |
*Per ISO 6009
I. Performance
The following performance tests were performed on the Terumo 30g Hypodermic Needle:
- Cannula Adhesion ●
- Protector Fit .
- Needle Penetration Force ●
- Leakage ●
- Blocked Cannula .
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conduct and there were no risks identified that warranted any design changes.
2
J. Additional Safety Information
- a. Sterilization
Sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11137-1994 Medical Devices – Validation and Routine Control of Radiation Sterilization. This device is sterilized to a Sterility Assurance Level (SAL) of 10°
b. Biocompatibility Testing
The TERUMO® 30Gauge Hypodermic Needle, like the standard Terumo Hypodermic needle K771203, is an Externally Communicating device, Circulating Blood, Limited Exposure (24 hrs). Blood contacting materials have been tested in accordance with the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, " Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. (The yellow colorant is the same colorant used in the cleared Terumo 20g Hypodermic Needle.) The needle in this 510k uses the same materials and method of sterilization as the standard Terumo Hypodermic needle, which has shown to be biocompatible. Therefore, no further testing was deemed necessary.
-
c. Expiration Dating
Expiration Dating for the Terumo 30g Hypodermic Needle will be 60 months (5 years) which is the same as the standard Terumo needle. -
d. Pyrogen Testing
Pyrogen testing is performed in accordance with the requirements of the US Pharmacopoeia XXIII. Additionally, each lot is tested for the absence of endotoxins using the Limulus Amebocyte Lysate (LAL) gel clot test.
3
K. Conclusion
In summary, the TERUMO® 30Gauge Hypodermic Needle is substantially equivalent in intended use, design, technology/principals of operation, materials, and performance to both the following cleared devices:
- TERUMO® Hypodermic Needle (K771203) 1.
- BD 30 Gauge (Precision Glide) Hypodermic Needle (Pre-amendment) 2.
Differences between the devices do not raise any significant issues of safety and effectiveness.
Terumo's statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.
Date Prepared: July 31, 2001
Prepared by: Barbara Smith Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921 Phone#: 410-392-7241 Fax#: 410-398-6079
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your distantial equivalence of your device to a legally marketed nouthoute device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 11 you desire books an in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-1500. I radiation f Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monfacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Intended Use
Page 1 of 1
| 510(k) Number (if known): | K012593 |
|---|---|
| Device Name: | VITROS Chemistry Products Magnetic HDL-Cholesterol |
| Reagent | |
| VITROS CHOL Slide | |
| VITROS Chemistry Products Calibrator Kit 2 | |
| Intended Use: | For in vitro diagnostic use only. |
| The VITROS Magnetic HDL-Cholesterol Reagent and VITROS | |
| CHOL Slides quantitatively measure HDL cholesterol (HDLC) | |
| concentration in serum and plasma. | |
| VITROS Calibrator Kit 2 | |
| For in vitro diagnostic use only. | |
| VITROS Calibrator Kit 2 is intended for use in calibration of the | |
| VITROS Chemistry Systems for the quantitative measurement | |
| of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG. | |
| Summary and Explanation of | |
| Test: | HDL cholesterol is used to evaluate the risk of developing |
| coronary heart disease (CHD). The risk of CHD increases with | |
| lower HDL cholesterol concentrations. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
Keria Alexander for Joan Cooper
(Division Sign-Off)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012593
6
510(k) Number (if known): K012446
TERUMO® 30 Gauge Hypodermic Needle Device Name:
Indications For Use:
The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or The TEXOMO& 50 garge if pour body below the surface of the skin. It is intended to mate with withidraw from ple) of a piston syringe or an intravascular administration set.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Latour Crescenti
ivision of Dental, Infection Control, and General Hospital Devices
510(k) Number K012046