(21 days)
No
The device description and intended use clearly define a manual syringe with no mention of AI or ML capabilities. The performance studies focus on equivalence to existing manual syringes.
No
A therapeutic device is one that treats a disease or condition. This device is used to inject insulin, which is a medication, but the device itself does not provide therapy; it is a delivery mechanism for a therapeutic agent.
No
The device is described as an insulin syringe for fluid aspiration and injection, not for diagnosing medical conditions.
No
The device description clearly states it is a physical syringe with a needle, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device's intended use: The description clearly states the device is for the "manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin." This involves interacting directly with the body, not analyzing samples outside of it.
- Specific application: The device is specifically intended for the aspiration and injection of insulin, which is a medication administered directly into the body.
The information provided describes a device used for administering substances into the body, which falls under the category of a general medical device, not an IVD.
N/A
Intended Use / Indications for Use
The TERUMO® U-100 Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin.
Product codes
FMF
Device Description
The Terumo U-100 Insulin Syringe is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, designed for manual use. The syringe is available in 1/2cc and 3/10cc volumes with a 30 gauge by 3/8 inch fixed hypodermic single lumen needle.
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
The performance of the TERUMO® U-100 Insulin Syringe submitted in this 510k is equivalent to the performance of the cleared TERUMO U-100 Insulin Syringe (K822083) and to the Becton-Dickinson® Ultra Fine II Insulin Syringe (K955235). Testing was performed to demonstrate the substantial equivalence of the TERUMO U-100 Insulin Syringe with 30G x 3/8" cannula to the cleared Terumo U-100 Insulin Syringe and the B-D Ultra Fine II Insulin Syringe with 30G x 5/16" cannula. Sterilization conditions have been validated according to the European Standard, EN 556: Sterilization of Medical Devices - Requirements for Medical Devices to Be Labeled Sterile, to provide a Sterility Assurance Level (SAL) of 106. Manufacturing control test methods include functional and sterility tests. LAL testing is performed on production samples from of every lot number. Blood contacting materials were tested in accordance with the tests recommended in 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." [External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (
§ 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
SEP g 1999
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
TERUMO® U-100 Insulin Syringe, or similar proprietary name Device Name: Piston syringe with fixed hypodermic single lumen needle Classification Name:
INTENDED USE
The TERUMO® U-100 Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin.
DESCRIPTION
The Terumo U-100 Insulin Syringe is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, designed for manual use. The syringe is available in 1/2cc and 3/10cc volumes with a 30 gauge by 3/8 inch fixed hypodermic single lumen needle.
SUBSTANTIAL EQUIVALENCE
The Terumo U-100 Insulin Syringe submitted in this 510k, is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083). There is no intended change in how this device is used.
With respect to the 30G x 3/8" cannula, the Terumo U-100 Insulin Syringe submitted in this 510k is substantially equivalent to the cleared Becton Dickinson® Ultra Fine II Insulin Syringe with 30G x 5/16" cannula (K955235).
PRINCIPLE OF OPERATION/TECHNOLOGY
The Terumo U-100 Insulin Syringe is operated manually.
MATERIALS
The materials used in the manufacture of the Terumo U-100 Insulin Syringe are the same materials used in the manufacture of the predicate device.
PERFORMANCE
The performance of the TERUMO® U-100 Insulin Syringe submitted in this 510k is equivalent to the performance of the cleared TERUMO U-100 Insulin Syringe (K822083) and to the Becton-Dickinson® Ultra Fine II Insulin Syringe (K955235).
1
Testing was performed to demonstrate the substantial equivalence of the TERUMO U-100 Insulin Syringe with 30G x 3/8" cannula to the cleared Terumo U-100 Insulin Syringe and the B-D Ultra Fine II Insulin Syringe with 30G x 5/16" cannula.
ADDITIONAL SAFETY INFORMATION
Sterilization conditions have been validated according to the European Standard, EN 556: Sterilization of Medical Devices - Requirements for Medical Devices to Be Labeled Sterile, to provide a Sterility Assurance Level (SAL) of 106.
Manufacturing control test methods include functional and sterility tests. LAL testing is performed on production samples from of every lot number.
Blood contacting materials were tested in accordance with the tests recommended in 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." [External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (