The TERUMO® SurGuard 2™ SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Device Description

The SurGuard 2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes are 18gauge to 25gauge and the needle lengths are 5/8" to 1 ½". The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SurGuard 2™ Safety Needle will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe (as cleared under K771205 and K980181).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the TERUMO® SurGuard 2™ Safety Needle, based on the provided document.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission seeking substantial equivalence, the acceptance criteria are not explicitly defined as pass/fail thresholds in the same way they would be for a de novo or PMA application. Instead, the "acceptance criteria" are implied by the comparison to predicate devices and the demonstration that the new device performs similarly and does not raise new safety or effectiveness issues. The reported device performance is presented as a list of tests conducted, with the overarching conclusion that these tests support substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Performance similar to predicate devices for safety features	Activation Force, Deactivation Force, Puncture Resistance, Sheath Removal Force, Collar Removal Force, Sheath Radial Force, Protector Fit, Simulated Use Study
Biocompatibility of blood-contacting materials	Biocompatibility testing per FDA G95-1 (ISO-10993 Part 1)
Sterility Assurance Level (SAL) per recognized standard	SAL of 10^-6 validated according to ANSI/AAMI/ISO 11137-1994
No new issues of safety and effectiveness compared to predicates	Risk analysis conducted; "None of the data raises any new issues of safety and effectiveness."

Study Details

This 510(k) submission primarily relies on bench testing/performance testing rather than a clinical study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test set, experts for ground truth, MRMC study, training set) are not applicable in their typical sense for this type of device.

1. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each performance criterion. The document states "The following tests were performed on the SurGuard 2TM Safety Needle," implying that a sufficient number of devices were tested to draw conclusions.
Data Provenance: The tests were performed internally by Terumo Medical Corporation (the manufacturer). The country of origin for the data is implied to be the USA, given the submission is to the FDA in the US. The data is prospective as it was generated specifically for this 510(k) submission.

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

Not Applicable. For a mechanical safety device undergoing bench testing, "ground truth" is established by direct measurement and standardized test methods, not expert consensus on interpretations.

3. Adjudication method for the test set:

Not Applicable. As per point 2, ground truth is based on direct measurement, not assessment by humans requiring adjudication.

4. 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 medical device (safety hypodermic needle), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not Applicable. This device does not incorporate an AI algorithm.

6. The type of ground truth used:

For the performance tests (e.g., Activation Force, Puncture Resistance), the "ground truth" is the measured physicochemical and mechanical properties of the device, assessed against pre-defined engineering specifications or comparative data from predicate devices.
For biocompatibility, the ground truth is established by laboratory testing results compliant with ISO-10993 Part 1.
For sterility, the ground truth is established by sterilization validation results compliant with ANSI/AAMI/ISO 11137-1994.

7. The sample size for the training set:

Not Applicable. There is no training set as no AI/machine learning algorithm is involved.

8. How the ground truth for the training set was established:

Not Applicable. As there is no training set.

Summary

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K031453

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Device Name A.

Proprietary Name

TERUMO® SurGuard 2™ Safety Needle or similar proprietary name

Classification Name

Hypodermic Single Lumen Needle (880.5570)

Classification: Class II 80 FMI

Common Name

Hypodermic needle with safety sheath or needle with needle protection device

B. Intended Use

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C. Device Description

D. Substantial Equivalence

The SurGuard 2™ Safety Needle without or with syringe attached is substantially equivalent to:

1. K923127 SurGuard Needle/Syringe with Needle Protection device manufactured by Portex, Inc.
1. K771203 Terumo Hypodermic Needle
1. K771205 & K980181 Terumo Hypodermic Syringe

All of these cleared devices serve as predicates for the device which is subject of this 510k.

Principle of Operation and Technology E.

The Terumo SurGuard 2™ Safety Needle, the Surguard device manufactured by Portex, Inc (K923127), the Terumo Hypodermic Needles (K771203) and Terumo Hypodermic Syringes (K771205 and K980181) are all operated manually.

F. Materials

The materials used for the hypodermic needle and syringe portion of the SurGuard 2TM Safety Needle are identical to the materials used for the cleared Terumo Hypodermic Needles (K771203) and Terumo Hypodermic Syringe (K771205 and

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K980181). The material selected for the safety feature is the same type of material used for the sheath of the Surguard predicate (K923127). Any differences in materials between the SurGuard 2™ Safety Needle and the Surguard predicate raise no new issues of safety and effectiveness.

G. Specifications

Product Descriptions
18 gauge x 1" safety needle
18 gauge x 1 ½" safety needle
19 gauge x 1" safety needle
19 gauge x 1 ½" safety needle
20 gauge x 1" safety needle
20 gauge x 1 ½" safety needle
21 gauge x 1" safety needle
21 gauge x 1 ½" safety needle
22 gauge x 1" safety needle
22 gauge x 1 ½" safety needle
23 gauge x 1" safety needle
23 gauge x 1 ½" safety needle
25 gauge x 5/8" safety needle
25 gauge x 1" safety needle
25 gauge x 1 ½" safety needle
1cc/ml syringe with 25 gauge x 5/8" safety needle
3cc/ml syringe with 20 gauge x 1" safety needle
3cc/ml syringe with 20 gauge x 1 ½" safety needle
3cc/ml syringe with 21 gauge x 1" safety needle
3cc/ml syringe with 21 gauge x 1 ½" safety needle
3cc/ml syringe with 22 gauge x 1" safety needle
3cc/ml syringe with 22 gauge x 1 ½" safety needle
3cc/ml syringe with 23 gauge x 1" safety needle
3cc/ml syringe with 25 gauge x 5/8" safety needle
3cc/ml syringe with 25 gauge x 1" safety needle
5cc/ml syringe with 20 gauge x 1" safety needle
5cc/ml syringe with 20 gauge x 1 ½" safety needle
5cc/ml syringe with 21 gauge x 1 ½" safety needle
10cc/ml syringe with 20 gauge x 1" safety needle
10cc/ml syringe with 20 gauge x 1 ½" safety needle
10cc/ml syringe with 21 gauge x 1" safety needle

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H. Performance

The following tests were performed on the SurGuard 2TM Safety Needle:

Activation Force .
. Deactivation Force
Puncture Resistance .
Sheath Removal Force .
Collar Removal Force .
Sheath Radial Force .
. Protector Fit
Simulated Use Study .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

The performance of the SurGuard 2TM Safety Needle submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the legally marketed predicate devices.

I. 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 ANSI/AAMI/ISO 11137-1994 Medical Devices - Validation and Routine Control of Radiation Sterilization. The SurGuard 2TM Safety Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10-6.

The Terumo SurGuard 2™ Safety Needle is classified as Externally Communicating Device, Blood Path Indirect, Limited Duration of Contact (< 24 hr). 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.

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J. Conclusion

The SurGuard 2™ Safety Needle without or with syringe attached is substantially equivalent to:

1. K923127 SurGuard Needle/Syringe with Needle Protection device manufactured by Portex, Inc.
1. K771203 Terumo Hypodermic Needle
1. K771205 & K980181 Terumo Hypodermic Syringe

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:	May 2, 2003
Prepared By:	Barbara SmithSr. Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation125 Blue Ball Rd.Elkton, MD 21921Phone: 410-392-7241Fax: 410-398-6079

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Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces, and a flowing, ribbon-like element below.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2003

Ms. Barbara Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland, 21921

Re: K031453

Trade/Device Name: TERUMO® Surguard 2 TMSafety Needle Regulation Number: 21 CFR 880.5570, 21 CFR 880.5860 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI, MEG Dated: May 2, 2003 Received: May 8, 2003

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Susa Runo

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

KO31453

TERUMO® SurGuard 2™ Safety Needle Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use________

(Optional Format 1-2-96)

Patricio Cererita

. General Hospital

510(k) Number: K031453

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).