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.

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.

AI/ML Overview

The provided text describes the Terumo Micro tapered pen needle and its FDA 510(k) clearance, but it does not contain a specific performance study with detailed acceptance criteria and reported results. Instead, it states that the device was "tested in accordance with ISO 11608-2: 2000" and that "None of the data raises any new issues of safety and effectiveness." It also mentions "injection force and penetration resistance" as other tested parameters.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment cannot be extracted directly from the provided text for a device that is not an AI/ML diagnostic system.

However, I can infer some information based on the context of a medical device submission and ISO standards.

Here's a breakdown of the available information and what cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Inferred from ISO 11608-2:2000)	Reported Device Performance
Needle Dimensions	Adherence to specified gauges (28G vial end, 33G patient end), tapered length (3.5mm), exposed length (3/16" / 5mm).	The device is described as having these dimensions.
Needle Sharpness/Penetration Force	Within acceptable limits to ensure patient comfort and proper injection. (ISO 11608-2 covers this for pen needles).	"Penetration resistance" was tested. No specific values or criteria reported.
Injection Force	Within acceptable limits for ease of use. (ISO 11608-2 covers this for pen needles).	"Injection force" was tested. No specific values or criteria reported.
Compatibility with Pen Injectors	Fits type A universal insulin pen injectors securely. (ISO 11608-2 would cover this).	"Designed to fit type A universal insulin pen injectors." No specific test results reported.
Sterility	Meets sterility requirements as a single-use, disposable device.	Stated as "individually packaged and sterilized." No specific test results reported.
Leakage	No leakage during use. (ISO 11608-2 would cover this).	Not explicitly mentioned but would be a part of general performance testing under ISO.
Material Biocompatibility	Materials are biocompatible for medical use.	Materials (stainless steel needle, plastic hub/caps/packaging) are mentioned as "similar to the predicate devices." No specific test results reported.
Risk Analysis	No new or different issues of safety and effectiveness for usage by adults or children.	"A risk analysis was conducted and there were no new or different issues of safety and effectiveness identified."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified.
Data Provenance: Not specified. The device is manufactured by Terumo Corporation in Japan, but where the testing was conducted or the origin of any clinical data (if applicable, which isn't clear here) is not stated. The submission was prepared by Terumo Medical Corporation in Maryland, USA.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This device is a pen needle, not an AI/ML diagnostic device that requires expert ground truth for classification tasks. Performance testing likely involved engineering measurements and potentially usability testing, but not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant. The comparison is against predicate devices based on design and performance standards, not human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. See point 3. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be established by engineering specifications, direct physical measurements, and adherence to established international standards (ISO 11608-2:2000) for pen needles. This includes criteria for dimensions, force, sterility, material properties, and compatibility. It also relies on the safety and effectiveness profile of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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Ko5256|

A. Device Name

Proprietary Name:	TERUMO® Micro tapered Pen Needle or other proprietaryname
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

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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Regulation Number and Section

§ 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).