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.

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.

AI/ML Overview

The provided text describes the 510(k) summary for the TERUMO® Needle, a hypodermic single lumen needle. The focus of this document is to demonstrate substantial equivalence to previously cleared devices rather than to present a de novo study with detailed acceptance criteria and performance metrics for a new device.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria and performance studies, such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable to this type of submission. This document primarily relies on the equivalency of the new device to existing devices based on several performance tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in the format typically seen for novel device efficacy studies. Instead, it states that:

Performance Tests Performed:
- Protector Pit
- Adhesive Hold
- Conical Fitting
- Seal Strength
Outcome Statement: "None of the data raises any new issues on safety and effectiveness." This implies that the device met the internal specifications and standards set by Terumo (Philippines) Corporation for these tests, which are presumably deemed equivalent to those of the predicate devices. However, the specific numerical acceptance thresholds and the quantitative results are not disclosed in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document only mentions that performance tests were "performed on the TERUMO® Needle manufactured by Terumo (Philippines) Corporation."
Data Provenance: The device is manufactured by Terumo (Philippines) Corporation. The data would therefore originate from their internal testing. It's a prospective internal test for the new device variant to confirm its manufacturing quality and performance against established specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The performance tests listed are mechanical and material engineering tests (e.g., strength of adhesive, fit of conical parts, seal integrity). These do not typically involve human expert interpretation or "ground truth" establishment in the way that diagnostic imaging or clinical decision support AI devices would. The "ground truth" for such tests would be defined by engineering specifications and objective measurements.

4. Adjudication method

Not applicable, for the same reasons as #3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (a hypodermic needle), not an AI algorithm or a diagnostic imaging system. Therefore, MRMC studies are not relevant.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

For the listed performance tests (Protector Pit, Adhesive Hold, Conical Fitting, Seal Strength), the "ground truth" would be established by engineering specifications and objective measurements against industry standards (e.g., ISO standards for Luer connectors) and the manufacturer's internal quality control criteria, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device's design and manufacturing processes are informed by established engineering principles and prior experience with similar devices, not by a data-driven training process.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

In summary, the 510(k) process for a device like a hypodermic needle heavily relies on demonstrating equivalence to predicate devices through design, materials, intended use, and a set of standard performance and safety tests. The detail of these tests, while crucial for the submission, is often summarized at a high level in the public 510(k) summary, with the most critical information being the confirmation that "None of the data raises any new issues on safety and effectiveness," thereby establishing substantial equivalence.

Summary

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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

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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

ProductCode	HubColor	Needle Ø(Gauge andmm)	NeedleLength(inch - mm)	Wallthickness	NeedleBevel
NN-1825R	Pink	18G - 1.20mm	1" – 25mm	Thin Wall	RegularBevel
NN-1838R	Pink	18G - 1.20mm	1 ½" – 38mm	Thin Wall	RegularBevel
NN-1925R	Cream	19G - 1.10mm	1" – 25mm	Thin Wall	RegularBevel
NN-1938R	Cream	19G - 1.10mm	1 ½" – 38mm	Thin Wall	RegularBevel
NN-2025R	Yellow	20G - 0.90mm	1" – 25mm	Ultra ThinWall	RegularBevel
NN-2025V	Yellow	20G - 0.90mm	1" – 25mm	RegularWall	RegularBevel
NN-2038R	Yellow	20G - 0.90mm	1 ½" – 38mm	Ultra ThinWall	RegularBevel
NN-2125R	Green	21G - 0.80mm	1" – 25mm	Ultra ThinWall	RegularBevel
NN-2138R	Green	21G - 0.80mm	1 ½" – 38mm	Ultra ThinWall	RegularBevel
NN-2225R	Black	22G - 0.70mm	1" – 25mm	Ultra ThinWall	RegularBevel
NN-2238R	Black	22G - 0.65mm	1 ½" – 38mm	Ultra ThinWall	RegularBevel

00013

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ProductCode	HubColor	Needle Ø(Gauge andmm)	NeedleLength(inch - mm)	Wallthickness	NeedleBevel
NN-2325R	Blue	23G - 0.65mm	1" - 25mm	Ultra ThinWall	RegularBevel
NN-2338R	Blue	23G - 0.65mm	1 ½" - 38mm	Ultra ThinWall	RegularBevel
NN-2516R	Orange	25G - 0.50mm	5/8" - 16mm	Ultra ThinWall	RegularBevel
NN-2522R	Orange	25G-0.50mm	7/8" - 22mm	Ultra ThinWall	RegularBevel
NN-2525R	Orange	25G - 0.50mm	1" - 25mm	Ultra ThinWall	RegularBevel
NN-2538R	Orange	25G - 0.50mm	1 ½" - 38mm	RegularWall	RegularBevel
NN-2613R	Brown	26G - 0.45mm	½" - 13mm	RegularWall	RegularBevel
NN-2713R	Gray	27G - 0.40mm	½" - 13mm	RegularWall	RegularBevel
NN-2732R	Gray	27G - 0.40mm	1 ¼" - 32mm	RegularWall	RegularBevel
NN-3025R	Yellow	30G -0.30mm	1" - 25mm	RegularWall	RegularBevel
NN-3013R	Yellow	30G-0.30mm	½" - 13mm	RegularWall	RegularBevel

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:

1. K001572 TERUMO® NEOLUS® Necdle manufactured by Terumo Europe, Leuven, Belgium
1. K771203 TERUMO® Hypodermic Needle manufactured by Tcrumo Medical Corporation, Elkton, Maryland
K012646 (30G) TERUMO® Needle manufactured by Terumo Medical Corp, Elkton, MD mi

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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

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.

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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:

1. K001572 TERUMO® NEOLUS® Needle manufactured by Terumo Europe, Leuven, Belgium
1. K771203 TERUMO® Hypodermic Needle manufactured by Terumo Medical Corporation, Elkton, Maryland
1. 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.

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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.

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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

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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

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K121607

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).