The TERUMO® SurGuard2™ 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 withdrawal 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 SurGuard2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. 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 fall within the 18 to 30gauge range and the needle lengths are 3/8" 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 SurGuard2™ Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 1. 3,5, and 10cc/ml.

AI/ML Overview

The provided document is a 510(k) premarket notification for the TERUMO® SurGuard2™ Safety Needle. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and performance data for the new device.

Therefore, many of the requested elements (sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, specific ground truth types) are not applicable or extractable from this type of regulatory submission, as it relies on the established performance of predicate devices.

However, I can extract the acceptance criteria as implied by the testing performed and describe how the document implies the device meets these criteria through substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria (Based on Substantial Equivalence)

The TERUMO® SurGuard2™ Safety Needle, as described in this 510(k) submission (K051865), demonstrates its compliance by proving substantial equivalence to existing legally marketed predicate devices. This means that the acceptance criteria are implicitly met if the new device performs equivalently to the predicates in key areas. The study demonstrating this is essentially a comparison study against the predicates across various specifications and performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Achieved via Equivalence)
Mechanical/Physical Performance:
Activation Force (Safety Mechanism)	Performed. No new issues of safety and effectiveness.
Deactivation Force (Safety Mechanism)	Performed. No new issues of safety and effectiveness.
Puncture Resistance (Needle)	Performed. No new issues of safety and effectiveness.
Sheath Removal Force	Performed. No new issues of safety and effectiveness.
Collar Removal Force	Performed. No new issues of safety and effectiveness.
Sheath Radial Force	Performed. No new issues of safety and effectiveness.
Protector Fit	Performed. No new issues of safety and effectiveness.
Adhesive Hold	Performed. No new issues of safety and effectiveness.
Functional Performance (Syringe - 1cc/ml):
Leakage (Aspiration and Injection)	Performed. No new issues of safety and effectiveness.
Plunger Gasket Fit	Performed. No new issues of safety and effectiveness.
Nominal Graduation Capacity	Performed. No new issues of safety and effectiveness.
Deadspace	Performed. No new issues of safety and effectiveness.
Conical Fitting	Performed. No new issues of safety and effectiveness.
Safety Features:
Prevention of accidental needlestick	Manual activation after use to minimize risk, equivalent to predicates.
Biocompatibility:
Blood contacting materials biocompatibility	Tested in accordance with ISO-10993: results demonstrate biocompatibility.
Sterility:
Sterility Assurance Level (SAL) of $10^{-6}$	Validated in accordance with ANSI/AAMI/ISO 11137-1994.
Overall Equivalence:
Substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to predicates.	Stated as achieved. Differences do not raise any significant issues of safety or effectiveness.

Study Description:

The study to "prove the device meets the acceptance criteria" is implicitly the 510(k) submission itself, which functions as a comparative effectiveness study against predicate devices to establish substantial equivalence. The manufacturer asserts that the performance of the SurGuard2™ Safety Needle is substantially equivalent to the legally marketed predicate devices (K031453, K040531, K023271, K771205).

The performance tests listed (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study, etc.) were conducted, and the document states, "None of the data raises any new issues of safety and effectiveness." This implies that the results of these tests were within acceptable ranges, or comparable to the predicate devices, thereby meeting the unstated acceptance criteria.

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

Sample Size: Not explicitly stated for each test. The document mentions "The following tests were performed on the SurGuard2™ Safety Needle" and "The following tests were performed on the Terumo Philippines 1cc/ml syringe," but does not provide specific quantities of devices tested for each parameter.
Data Provenance: The manufacturing entity is Terumo (Philippines) Corporation, and the submission is prepared by Terumo Medical Corporation (USA). The origin of the test data is implied to be from testing performed on devices produced by Terumo (Philippines) Corporation. The data is reported as part of a retrospective comparison to previously cleared predicate devices.

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

Not Applicable. This is a 510(k) submission for a medical device (hypodermic needle and syringe), not a diagnostic or AI-driven system requiring expert ground truth for image interpretation or similar. The "truth" is established by physical measurement, engineering standards, and biological testing, not expert consensus in a clinical sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. As above, this type of adjudication method is generally for clinical endpoints or diagnostic interpretations, which are not relevant to the physical and functional tests described for this device.

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 document pertains to a physical medical device (needle/syringe), not a digital health or AI software product.

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 (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests would be defined by established engineering standards, material science properties, and validated test methods for medical devices (e.g., force measurements against specific thresholds, leak rates against defined limits, visual inspections against specifications). For biocompatibility, it's defined by ISO-10993 standards and their associated testing protocols. For sterility, ANSI/AAMI/ISO 11137-1994 provides the ground truth for validation.

8. The sample size for the training set:

Not Applicable. This refers to a manufactured medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As there is no training set, this question is irrelevant.

In summary, the provided document leverages the substantial equivalence pathway for regulatory clearance. It asserts that the TERUMO® SurGuard2™ Safety Needle meets acceptance criteria because it is identical or critically similar in materials, design, intended use, technology, and performance to previously cleared predicate devices, and any differences raise no new issues of safety or effectiveness. The various tests listed confirm that the device's measured parameters align with expectations for devices of its type and prior clearances.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Device Name A.

Proprietary Name

TERUMO® SurGuard2™ Safety Needle or similar proprietary name

Classification Name

Hypodermic Single Lumen Needle (880.5570) with antistick

Product Code: 80 FMI / 80 MEG

Classification: Class II

Common Name

Hypodermic needle with safety sheath or needle with needle protection device

B. Intended Use

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C. Device Description

The specification of the needle and safety feature portions are identical to the SurGuard2TM Safety Needle cleared under K031453 and K040531. manufactured by Terumo Medical Corporation, Elkton, MD, USA. The attached 3, 5, and 10cc/ml syringes are identical to those syringe cleared under K023271. manufactured by Terumo Philippines Corporation. Information provided in this 510k will show that the 1cc/ml syringe manufactured by Terumo Philippines Corporation is substantially equivalent to the 1cc/ml manufactured by Terumo Medical Corporation, USA, cleared under K 771205.

D. Substantial Equivalence

The SurGuard2TM Safety Needle manufactured by Terumo Philippines Corporation is substantially equivalent to:

1. K031453 TERUMO® SURGUARD2™ SAFETY NEEDLE (18 to 25g) with or without syringe manufactured by Terumo Medical Corporation, Elkton, Maryland.
1. K040531 TERUMO® SURGUARD2™ SAFETY NEEDLE (26 to 30g) with or without syringe manufactured by Terumo Medical Corporation. Elkton, Maryland.
1. K023271 TERUMO® SYRINGE manufactured by Terumo (Philippines) Corporation, Binan, Laguna, Philippines
K771205 TERUMO® HYPODERMIC SYRINGE (1cc/ml) manufactured by ধ: Terumo Medical Corporation, Elkton, Maryland

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

E. Principle of Operation and Technology

The Terumo SurGuard2™ Safety Needle device with and without syringe manufactured by Terumo (Philippines) Corporation and Terumo Medical Corporation, USA (K040531 and K031453) and all referenced predicate devices are operated manually.

F. Materials

The type of materials used for the hypodermic needle, safety feature and syringe of the SurGuard2™ Safety Needle device are identical to the materials used for the cleared SurGuard2TM Safety Needle cleared under K031453 and K040531. Any differences in materials between the SurGuard27M Safety Needle manufactured by Terumo (Philippines) Corporation and the SurGuard2TM predicate manufactured by Terumo Medical Corporation, USA, raise no new issues of safety and effectiveness.

G. Specifications

Product Descriptions
18gauge x 1" (25mm) safety needle
18gauge x 1 1/2" (38mm) safety needle
19gauge x 1" (25mm) safety needle
19gauge x 1 1/2" (38mm) safety needle
20gauge x 1" (25mm) safety needle
20gauge x 1 1/2" (38mm) safety needle
21gauge x 1" (25mm) safety needle
21gauge x 1 1/2" (38mm) safety needle
22gauge x 1" (25mm) safety needle
22gauge x 1 1/2" (38mm) safety needle
23gauge x 1" (25mm) safety needle
23gauge x 1 1/2" (38mm) safety needle
25gauge x 5/8" (16mm) safety needle
25gauge x 1" (25mm) safety needle
25gauge x 1 1/2" (38mm) safety needle
26gauge x 1/2" (13mm) safety needle
27gauge x 1/2" (13mm) safety needle

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30 gauge x 1/2" (13mm) safety needle
1cc/mL syringe with 25gauge x 5/8" (16mm) safety needle
1cc/mL syringe with 26gauge x 3/8" (9mm) safety needle
1cc/mL syringe with 27gauge x 1/2" (13mm) safety needle
3cc/mL syringe with 20gauge x 1" (25mm) safety needle
3cc/mL syringe with 20gauge x 1 1/2" (38mm) safety needle
3cc/mL syringe with 21gauge x 1" (25mm) safety needle
3cc/mL syringe with 21 gauge x 1 1/2" (38mm) safety needle
3cc/mL syringe with 22gauge x 1" (25mm) safety needle
3cc/mL syringe with 22gauge x 1 1/2" (38mm) safety needle
3cc/mL syringe with 23gauge x 1" (25mm) safety needle
3cc/mL syringe with 25gauge x 5/8" (16mm) safety needle
3cc/mL syringe with 25gauge x 1" (25mm) safety needle
5cc/mL syringe with 20gauge x 1" (25mm) safety needle
5cc/mL syringe with 20gauge x 1 1/2" (38mm) safety needle
5cc/mL syringe with 21gauge x 1 1/2" (38mm) safety needle
10cc/mL syringe with 20gauge x 1" (25mm) safety needle
10cc/mL syringe with 20gauge x 1 1/2" (38mm) safety needle
10cc/mL syringe with 21gauge x 1" (25mm) safety needle

H. Performance

The following tests were performed on the SurGuard2™ Safety Needle:

Activation Force .
Deactivation Force ●
Puncture Resistance .
Sheath Removal Force .
Collar Removal Force ◆
. Sheath Radial Force
Protector Fit ◆
Adhesive Hold .
Simulated Use Study .

The following tests were performed on the Terumo Philippines 1cc/ml syringe:

Leakage (Aspiration and Injection) ●
Plunger Gasket Fit .
Nominal Graduation Capacity .

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KOSIECT
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. Deadspace
. Conical Fitting

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 SurGuard27M 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.

l. 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 SurGuard2TM Safety Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10th.

The Terumo SurGuard2TM 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.

J. Conclusion

The SurGuard2™ Safety Needle manufactured by Terumo Philippines Corporation is substantially equivalent to:

I . K031453 TERUMO® SURGUARD2™ SAFETY NEEDLE (18 to 25g) with or without syringe manufactured by Terumo Medical Corporation. Elkton, Maryland.
K040531 TERUMO® SURGUARD2™ SAFETY NEEDLE (26 to 30g) with or 2. without syringe manufactured by Terumo Medical Corporation. Elkton, Maryland.
K023271 TERUMO® SYRINGE manufactured by Terumo (Philippines) rri
Corporation, Binan, Laguna, Philippines
1. K771205 TERUMO® HYPODERMIC SYRINGE (1cc/ml) manufactured by Terumo Medical Corporation, Elkton, Maryland

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K051865

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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:	July 8, 2005
Prepared By:	Barbara SmithSr. Regulatory Affairs SpecialistTerumo Medical CorporationPhone: 410-392-7241Fax: 410-398-6079
Prepared For:	Terumo (Philippines) Corporation#124 East Main AvenueLaguna TechnoparkBinan, Laguna 4026PhilippinesPhone: 011-63-49-541-2111

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Image /page/6/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a traditional symbol of medicine and healthcare.

SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051865

K021662
Trade/Device Name: Terumo Surguard 2 Safety Needle or Similar Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MEG Dated: July 6, 2005 Received: July 11, 2005

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becalent 910(x) promised is substantially equivalent (for the referenced above and have determined and to legally marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed projects indications for use stated in the enactment date of the Medical Device interstate collinered prof to triay 20, 1778, and existed in accordance with the provisions of Amendments, of to devices that have oben recident do not require approval of a premarket the Federal Food, Drug, and Cosmene Tree (110) therefore, subject to the general approval application (1117). 1 our . general controls provisions of the Act include confors provisions of the rec. "The genting 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) of class III If your device is classifica (sec above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional controllar controllations, Title 21, Parts 800 to 898. In the Foorel your device can be found in the Code of Pederal regional of 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 Please oe advised that PDA s Issualles of a sacomments with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regarments, including, but not limited to: registration You must comply with an the Fict b requires (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labeling (21 crss (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality of sections (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) This letter will anow you to ocean mailer.ing your substantial equivalence of your device to a premarket notification. The PDF Imaling or colusiin 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), il you desire specific advice for your de 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 may obtain other general micrimation of the mational and Consumer Assistance at its toll-free Division of Binas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center of Devices and Radiological Health

Enclosure

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K051865
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Indications For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_______TERUMO® SurGuard2™ Safety Needle

Indications For Use:

The TERUMO® SurGuard 2™ SAFETY NEEDLE device is intended for use in the The TEROMO® Surouard 2 - ORRETTFREDDurposes. The Terumo Safety Needle is aspiration and injoction standard luer slip and luer lock syringes.

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

× 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)

Anthen D. nuk

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

510(k) Number: K951865

Page 1 of

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).