(65 days)
Not Found
No
The device description and performance studies focus solely on the mechanical and physical properties of a pen needle for insulin injection. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
A therapeutic device actively treats or rehabilitates a medical condition. This device is a pen needle used for injecting insulin, which is a drug, not a therapeutic device itself.
No
This device is a pen needle intended for the subcutaneous injection of insulin, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, sterile, disposable pen needle comprised of stainless steel and plastic components, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The TERUMO® Micro tapered pen needle is used for the subcutaneous injection of insulin. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states "for use with a pen injector device for the subcutaneous injection of insulin." This describes a delivery mechanism, not a diagnostic test.
The device is a delivery system for medication, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
80 FMI
Device Description
The Terumo® Micro tapered pen needle is comprised of a stainless steel needle pointed at both ends with a 28gauge outer diameter at the vial end and tapers to a 33gauge outer diameter at the needle tip i.e. patient end. The tapered length is 3.5mm from the tip. The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device). It is designed to fit type A universal insulin pen injectors. The exposed patient-end needle length is 3/16" (5mm). The needle tip is covered by a colored plastic protective cap which is covered by a clear outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is completed. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and sterilized. It is a disposable device intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
general use and for pediatric patients
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 Micro tapered pen needle was tested in accordance with ISO11608-2: 2000. Other testing included injection force and penetration resistance.
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new or different issues of safety and effectiveness identified for usage by adults or by children.
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
§ 880.5570 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
Ko5256|
A. Device Name
| Proprietary Name: | TERUMO® Micro tapered Pen Needle or other proprietary
name |
|----------------------|---------------------------------------------------------------|
| Common Name: | Pen Needle |
| Classification Name: | Hypodermic Single Lumen Needle (880.5570) |
| Product Code: | 80 FMI |
| Classification: | Class II |
B. Intended Use
The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.
C. Device Description
The Terumo® Micro tapered pen needle is comprised of a stainless steel needle pointed at both ends with a 28gauge outer diameter at the vial end and tapers to a 33gauge outer diameter at the needle tip i.e. patient end. The tapered length is 3.5mm from the tip. The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device). It is designed to fit type A universal insulin pen injectors. The exposed patient-end needle length is 3/16" (5mm). The needle tip is covered by a colored plastic protective cap which is covered by a clear outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is completed. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and sterilized. It is a disposable device intended for single use only.
D. Principle of Operation and Technology
The Terumo Micro tapered pen needle and the legally marketed BD predicate pen needle devices are operated manually.
E. Materials
The Terumo Micro tapered pen needle is comprised of a stainless steel needle, plastic hub, plastic needle inner/outer cap and plastic/paper outer packaging similar to the predicate devices.
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F. Performance
The Terumo Micro tapered pen needle was tested in accordance with ISO11608-2: 2000. Other testing included injection force and penetration resistance.
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new or different issues of safety and effectiveness identified for usage by adults or by children.
G. Substantial Equivalence
The Terumo 33g Micro tapered Pen Needle manufactured by Terumo Corporation in Japan is substantially equivalent to the legally marketed Becton Dickinson Ultra-fine 31g x 3/16" (5mm) pen needle cleared under K002938 and the Becton Dickinson Ultra-fine 31g x 5/16" (8mm) pen needle cleared under K955235.
Differences between the devices do not raise any significant issues of safety or 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.
Date Prepared: September 16, 2005
Prepared By:
Barbara Smith Sr. Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921 Phone: 410-392-7241 Fax: 410-398-6079
- Prepared For: Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo JAPAN
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Ms. Barbara Smith Senior, Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921
Re: K052561
Trade/Device Name: TERUMO Micro Tapered Pen Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 16, 2005 Received: September 22, 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.
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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,
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
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Indications for Use
510(k) Number (if known):
KOS 2561
_TERUMO® Micro tapered Pen Needle Device Name:
Indications For Use:
The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.
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)
Antony V. Matan
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Islon of Anesthesiology, General Hospital, ......scontrol, Dental Devices
210(%) Number: K452561
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