(19 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a syringe, with no mention of AI or ML technology.
No.
The device description indicates it is used for injecting or withdrawing fluids, not for treating a disease or condition. While essential in medical procedures, a syringe itself does not provide therapy.
No
Explanation: The device description states its purpose is "to inject fluids into or withdraw fluids from the body", which describes a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like polypropylene, thermoplastic elastomer, and stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to inject fluids into or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes (like drawing blood for testing, but the syringe itself isn't the test).
- Device Description: The description details the physical components of a syringe and needle, which are used for administering or collecting substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, analyzers, or other components designed for laboratory analysis.
The device described is a standard medical device used for administering or collecting substances from a patient.
N/A
Intended Use / Indications for Use
The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Iml Terumo Syringe with/without Needle consists of 3 main parts or 4 parts, i.e., a barrel, plunger, gasket and a hypodermic needle (for with needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The needle is made from stainless steel. The 1 ml Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened. The product is for single use only and is not intended for reuse.
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 Iml Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests:
- Leakage (Aspiration and Injection) ●
- . Plunger Mobility
- Plunger Gasket Fit .
- Plunger Stopper Strength .
- Deadspace .
- Nominal Graduation Capacity .
- Packaging Seal Strength .
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
510k Summary
Device Name
Proprietary Name: TERUMO® Syringe with/without Needle Classification Name: Syringe, Piston with or without hypodermic single lumen needle Common Name: Hypodermic Syringe with/without needle
Intended Use
The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Note: This is the same intended use as the predicate device, Terumo Syringe with/without needle (K023271).
Device Description
The Iml Terumo Syringe with/without Needle consists of 3 main parts or 4 parts, i.e., a barrel, plunger, gasket and a hypodermic needle (for with needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The needle is made from stainless steel. The 1 ml Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.
Principles of Operation/Technology
The Iml Terumo Syringe with/without needle is operated manually.
Materials
The materials used in the Iml Terumo Syringe with/without needle are substantially equivalent to the materials used in the predicate Terumo Syringe with/without needle device cleared under K023271.
Specifications
| PRODUCT DESCRIPTION |
|---|
| 1ml Luer Slip Tip syringe without needle |
| 1 ml Luer Slip Tip syringe with 23g x 1" needle |
| 1 ml Luer Slip Tip syringe with 25g x 5/8" needle |
| 1ml Luer Slip Tip syringe with 25g x 1" needle |
| 1 ml Luer Slip Tip syringe with 26g x 3/8" needle |
| 1 ml Luer Slip Tip syringe with 26g x 1/2" needle |
| 1 ml Luer Slip Tip with 27g x 1/2" needle |
ct 2
1
Performance
The Iml Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests:
- Leakage (Aspiration and Injection) ●
- . Plunger Mobility
- Plunger Gasket Fit .
- Plunger Stopper Strength .
- Deadspace .
- Nominal Graduation Capacity .
- Packaging Seal Strength .
Substantial Equivalence
The Iml Terumo Syringe with/without needle is substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271. Any differences raise no new issues of safety and effectiveness.
Additional Safety Information
Manufacturing controls included visual, functional, dimensional and sterility tests.
The Iml Terumo Syringe with/without needle is classified as an Externally Communicating Device, Limited contact. The device's 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 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. Results of the testing demonstrate that the blood contacting materials are biocompatible.
Sterilization conditions have been validated in accordance with ISO 11137-1995. Medical Devices - Validation and Routine control of Radiation Sterilization. The device is sterilized to a SAL of 10".
Submitter Information
Prepared by: Barbara Smith Sr. Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921
- Prepared for: Terumo (Philippines) Corporation #124 East Main Ave., Laguna Technopark, Biñan, Laguna, Philippines 4026
Date Prepared: July 26, 2005
2
AUG 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Rd. Elkton, Maryland 21921
Re: K052034
Trade/Device Name: Terumo Syringe with/without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Hypodermic Syringe with/without needle Regulatory Class: II Product Code: FMF Dated: July 27, 2005 Received: July 29, 2005
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Smith
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/industry/support/index.html.
Sincerely yours,
Cure
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOSZO34 ાં રી (
Indications for Use
510(k) Number (if known): ... . . . . . . . .
Device Name:
Indications For Use:
The Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Set Roll for now
(Division Sign-Off) Division of Anesthesiology. General Mospital, Infection Control, Dental Devices
:
510(k) Number: Kos 3 034
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