(177 days)
No
The device description and performance studies focus on the physical properties and testing of a standard syringe and needle, with no mention of AI or ML.
No.
The Terumo Syringe is intended for the aspiration of fluids and blood or for the injection of fluids, which are diagnostic or administration functions, not therapy.
No
The device is a syringe used for aspiration or injection of fluids; it does not perform any diagnostic function.
No
The device description clearly indicates it is a physical hypodermic syringe made of plastic and stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of fluids and blood, or for the injection of fluids. This describes a device used on or in the body for direct medical procedures, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a standard hypodermic syringe and needle, which are tools for administering or withdrawing substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information. IVD devices are designed for testing and analysis in vitro (in glass, or outside the living organism).
Therefore, the Terumo Syringe with/without needle is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket.
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 Terumo syringe with/without needle was tested in accordance with EN ISO 7886-1 (1993).
For the needle properties, reference is made to the cleared Neolus Needles compared to in the submitted file K001572. In accordance with the new requirements stipulated in EN ISO 10993-4 (2002) and its amendment (2006) the hypodermic needles were also subjected to additional hemocompatibility testing. A declaration for compliance with the requirements of these tests can be found on page 177.
None of the obtained data raises any new issues of safety and effectiveness.
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.
K023271, K052034, K063613, K070264
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.
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
ﺎﻟﻔ
510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
Submitter Information
| Prepared for: | TERUMO EUROPE N.V.
Researchpark Zone 2,
Interleuyenlaan 40,
3001 Leuven,
BELGIUM |
|----------------|-------------------------------------------------------------------------------------------------|
| Prepared by: | Mrs. M.J. Aerts – Manager Regulatory Affairs
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
| Date prepared: | November 2008 |
-
- Device Name
Proprietary Name
Terumo® Syringe with/without Needle
Classification Name
Piston syringe (80FMF)
21CFR, Section 880.5860
Classification: Class II
Common Name
Sterile hypodermic syringe with/without needle
2. Reason for Submission New Device
3. Intended Use
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
4. Description & Materials
The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.
| Syringe sizes | Needle gauges | Exposed needle lengths |
|---|---|---|
| 1, 2 (including special | ||
| graduations), 5, 10, 50 ml | 20 - 26G | 12 mm (1/2") - 40 mm (1 1/2") |
MAY 22 2009
1
5. Technology/Principles of operation
The Terumo Syringe with/without needle is operated manually.
6. Performance
ﻟﻨﻘ
The Terumo syringe with/without needle was tested in accordance with EN ISO 7886-1 (1993).
For the needle properties, reference is made to the cleared Neolus Needles compared to in the submitted file K001572. In accordance with the new requirements stipulated in EN ISO 10993-4 (2002) and its amendment (2006) the hypodermic needles were also subjected to additional hemocompatibility testing. A declaration for compliance with the requirements of these tests can be found on page 177.
None of the obtained data raises any new issues of safety and effectiveness.
7. Substantial Equivalence
The "Terumo Syringe with/without Needle", manufactured by Terumo Europe N.V., is submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following devices:
-
- 50 ml Terumo Syringe for administration of UV sensitive medicines, manufactured by Terumo Europe N.V. (K070264)
Any differences raise no new issues of safety and effectiveness.
8. Additional Safety Information
The sterility of the Terumo Syringe with/without needle is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide sterilization" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 10 as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices".
Ethylene oxide residual levels and Ethylene Chlorohydrin residual levels resulting from EtO sterilization are in compliance with ISO 10993-7: "Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals".
The device is tested for biocompatibility requirements in accordance with the tests stipulated in EN ISO 10993-1, "Biological Evaluation of Medical Devices. Part-1: Evaluation and testing." The results of the testing demonstrate that the device is biocompatible.
The expiration dating for the Terumo Syringe with/without needle has been established at 5 years.
2
III. DRAFT LABELLING
- Blister paper unit packaging III.1.
- Ш.2. Unit box
ﺮ ﻟﻤ
- Label unit box Ш.3.
- III 4.
III 5. - Shipping carton
Label shipping carton
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. M.J. Aerts Regulatory Affairs Manager Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 LEUVEN - BELGIE BELGIUM
MAY 2 2 2009
Re: K083514
Trade/Device Name: Terumo® Syringe With/Without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 7, 2009 Received: May 11, 2009
Dear Ms. Aerts:
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 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.
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
4
Page 2- Ms. Aerts
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Penner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known):
Device Name: Terumo® Syringe with/without needle
Indication For Use:
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
Prescription Use x (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)__ and the other side is the signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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