(160 days)
No
The device description and intended use describe a standard hypodermic needle, and there are no mentions of AI, ML, image processing, or any related technologies in the provided text.
No.
The device description indicates it is a hypodermic needle for injecting or withdrawing fluids, which is a delivery or collection tool, not a therapeutic agent or device itself.
No
The device is described as a hypodermic needle intended for injecting or withdrawing fluids, with no mention of analyzing or interpreting data for diagnostic purposes.
No
The device description clearly states it is a physical hypodermic needle made of stainless steel, which is a hardware component.
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 body for therapeutic or diagnostic purposes in vivo (within a living organism).
- Device Description: The description details a hypodermic needle designed for connecting to syringes or administration sets, which are used for delivering or withdrawing substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside of a living organism) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the body, not for direct interaction with the body itself for injection or withdrawal of fluids.
N/A
Intended Use / Indications for Use
The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Product codes
FMI
Device Description
The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected 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® Needle manufactured by Terumo (Philippines) Corporation:
- . Protector Pit
- Adhesive Hold .
- Conical Fitting .
- . Seal Strength
None of the data raises any new issues on safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
1121607
NOV
8 2012
: TERUMO (PHILIPPINES) CORPORATION Prepared for 124 East Main Avenue, Laguna Technopark, Binan, Laguna,Philippines
Prepared by
: Ma. Cristina Faderagao - Supervisor, Regulatory Affairs Tel. (+63) 49 541 2111 Fax (+63) 49 541 2121
Date prepared : February 10, 2012
Contact Person : Sandi Hartka
Regulatory Affairs Manager Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 Phone#: (410) 392-7243 Fax#: (410) 398-6079 E-mail: sandi.hartka@terumomedical.com
A. DEVICE NAME
Proprietary Name TERUMO® NEEDLE
Classification Name Hypoderinic Single Lumen Needle (880.5570)
Product Code: FMI
Classification: Class II
Common Name: Hypodermic Needle
1
B. INTENDED USE
The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
C. DEVICE DESCRIPTION
The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe or an intravascular administration set.
| Product
Code | Hub
Color | Needle Ø
(Gauge and
mm) | Needle
Length
(inch - mm) | Wall
thickness | Needle
Bevel |
|-----------------|--------------|-------------------------------|---------------------------------|--------------------|------------------|
| NN-1825R | Pink | 18G - 1.20mm | 1" – 25mm | Thin Wall | Regular
Bevel |
| NN-1838R | Pink | 18G - 1.20mm | 1 ½" – 38mm | Thin Wall | Regular
Bevel |
| NN-1925R | Cream | 19G - 1.10mm | 1" – 25mm | Thin Wall | Regular
Bevel |
| NN-1938R | Cream | 19G - 1.10mm | 1 ½" – 38mm | Thin Wall | Regular
Bevel |
| NN-2025R | Yellow | 20G - 0.90mm | 1" – 25mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2025V | Yellow | 20G - 0.90mm | 1" – 25mm | Regular
Wall | Regular
Bevel |
| NN-2038R | Yellow | 20G - 0.90mm | 1 ½" – 38mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2125R | Green | 21G - 0.80mm | 1" – 25mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2138R | Green | 21G - 0.80mm | 1 ½" – 38mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2225R | Black | 22G - 0.70mm | 1" – 25mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2238R | Black | 22G - 0.65mm | 1 ½" – 38mm | Ultra Thin
Wall | Regular
Bevel |
00013
2
| Product
Code | Hub
Color | Needle Ø
(Gauge and
mm) | Needle
Length
(inch - mm) | Wall
thickness | Needle
Bevel |
|-----------------|--------------|-------------------------------|---------------------------------|--------------------|------------------|
| NN-2325R | Blue | 23G - 0.65mm | 1" - 25mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2338R | Blue | 23G - 0.65mm | 1 ½" - 38mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2516R | Orange | 25G - 0.50mm | 5/8" - 16mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2522R | Orange | 25G-0.50mm | 7/8" - 22mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2525R | Orange | 25G - 0.50mm | 1" - 25mm | Ultra Thin
Wall | Regular
Bevel |
| NN-2538R | Orange | 25G - 0.50mm | 1 ½" - 38mm | Regular
Wall | Regular
Bevel |
| NN-2613R | Brown | 26G - 0.45mm | ½" - 13mm | Regular
Wall | Regular
Bevel |
| NN-2713R | Gray | 27G - 0.40mm | ½" - 13mm | Regular
Wall | Regular
Bevel |
| NN-2732R | Gray | 27G - 0.40mm | 1 ¼" - 32mm | Regular
Wall | Regular
Bevel |
| NN-3025R | Yellow | 30G -0.30mm | 1" - 25mm | Regular
Wall | Regular
Bevel |
| NN-3013R | Yellow | 30G-0.30mm | ½" - 13mm | Regular
Wall | Regular
Bevel |
D. SUBSTANTIAL EQUIVALENCE
The TERUMO® NEEDLE manufactured by Terumo Philippines Corporation is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the following cleared devices:
-
- K001572 TERUMO® NEOLUS® Necdle manufactured by Terumo Europe, Leuven, Belgium
-
- K771203 TERUMO® Hypodermic Needle manufactured by Tcrumo Medical Corporation, Elkton, Maryland
- K012646 (30G) TERUMO® Needle manufactured by Terumo Medical Corp, Elkton, MD mi
3
Intended Use
The TERUMO® Needle manufactured from Terumo (Philippines) Corporation and predicate devices cleared under K001572, K771203 and K012646 (30G) are hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Principles of Operation / Technology
The TERUMO® Needle manufactured by Terumo (Philippines) Corporation and the predicate devices cleared under K001572 manufactured by Terumo Europe N.V. Belgium, and K771573 and K012646 (30G) manufactured by Terumo Medical Corporation, USA are all operated manually.
Design and Materials
The TERUMO® Needle manufactured by Terumo (Philippines) Corporation and the predicate devices cleared under K001572 manufactured by Terumo Europe N.V. Belgium, and K771573 and K012646 (30G) manufactured by Terumo Medical Corporation, USA are made up of stainless steel needle that is sharpened at one end and at the other end was attached to a plastic polypropylene hub by means of adhesive.
Performance
The following performance tests were performed on the TERUMO® Needle manufactured by Terumo (Philippines) Corporation:
- . Protector Pit
- Adhesive Hold .
- Conical Fitting .
- . Seal Strength
None of the data raises any new issues on safety and effectiveness.
4
E. 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 ANSUAAMI/ISO 11137 - Medical Devices - Validation and Routine Control of Radiation Sterilization. The TERUMO® Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10-5.
The TERUMO® Needle is classified as Externally Communicating Device, Circulating Blood. Limited Duration of Contact (≤24hr.). 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, "Biological Evaluation of Medical Devices part 1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible.
F. Conclusion
In summary, the TERUMO® Needle manufactured by Terumo Philippines Corporation is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the following cleared devices:
-
- K001572 TERUMO® NEOLUS® Needle manufactured by Terumo Europe, Leuven, Belgium
-
- K771203 TERUMO® Hypodermic Needle manufactured by Terumo Medical Corporation, Elkton, Maryland
-
- K012646 (30G) TERUMO® Needle manufactured by Terumo Medical Corporation, Elkton, Maryland
There is no significant change that raises any new issues on safety and effectiveness.
Terumo's statement of substantial equivalence 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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Date: November 8, 2012
Terumo Medical Corporation Ms. Sandi Hartka Manager, Regulatory Affairs 950 Elkton Boulevard Elkton, Maryland 21921
Re: K121607
Trade/Device Name: Terumo® Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 2, 2012 Received: November 5, 2012
Dear Ms. Hartka:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Eederal Register.
6
Page 2 - Ms. Hartka
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Digitally signed by Anthony D. Watson DN: c=US. o=U.S. Government ou=HiHS, ou= Anthony D. Watson eople, cn=Anthony D. Watson, 342.19200300.100.1.1=1300092402 2012.11.08 11:16:45 -05'00
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K121607
Device Name: TERUMO® Needle
Indications for Use:
The TERUMO® Needle is a hypodermic single lumen needle intended to inject The TERUMO Necule is a nypousiness and the body below the surface of the skin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of
N
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121607