The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.

The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.

Additionally, after withdraw of the needle from the patient's vein, 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 Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, female connector with a multi-sample luer adapter attached for blood collection.

A hinged shield cover is attached to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TERUMO® SURSHIELD™ Safety Winged Blood Collection Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test. Instead, it states that the performance tests were performed and the conclusion is that the device is "substantially equivalent" to a predicate device, which implies the test results either met the predicate's performance or fell within acceptable manufacturing tolerances. For some tests, the document describes the design intent or functionality, which implicitly forms the basis of acceptance.

Test Performed	Implied Acceptance Criteria (Based on Substantial Equivalence and Design)	Reported Device Performance
Shield cover/Needle Locking Strength	The shield cover must effectively and securely lock the needle after activation, preventing accidental exposure.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Break strength of the shield cover joint	The joint must withstand normal handling during activation without breaking, ensuring the safety mechanism remains intact.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Force to lock the needle in the shield cover (Force to activate safety feature)	The activation force should be reasonable for user operation while ensuring positive locking.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Puncture Resistance of Shield Cover	The shield cover must adequately resist needle puncture once locked, preventing accidental needlesticks.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Flow Rate	The device should allow for efficient blood collection and fluid administration.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Wing to Tubing Connection Strength	Connections must be robust to prevent leaks or detachment during use.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Tubing to Connector Connection Strength	Connections must be robust to prevent leaks or detachment during use.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Needle to Wing Connection Strength	Connections must be robust to prevent leaks or detachment during use.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Needle Penetration Resistance	Not explicitly defined for the safety feature (likely applies to the needle itself, ensuring proper venipuncture efficacy).	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Wing Needle Protector Fit	The protector must fit securely on the wing, likely referring to the design and integration of the safety feature.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Leak Test	The device must not leak during normal use for blood collection or fluid administration.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Blockage Test	The device must remain unblocked, allowing for proper fluid flow.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Connection Strength of Winged Infusion Set and Luer Adaptor Joint	The connection between the set and luer adaptor must be secure.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Valve Protector Fit	Likely refers to the fit and function of any valve mechanisms, ensuring proper seal and operation.	Not explicitly quantified, but considered "substantially equivalent" to predicate.
Sterility Assurance Level (SAL)	SAL of 10^-6 (implied by EN550 validation to 10^-9 means it meets this common standard).	Validated to provide a Sterility Assurance Level (SAL) of 10^-9.
Ethylene Oxide Residual Levels	Ethylene Oxide: 25 ppm; Ethylene Chlorohydrin: 25 ppm.	Ethylene Oxide: Does not exceed 25 ppm; Ethylene Chlorohydrin: Does not exceed 25 ppm.
Biocompatibility	Materials must be biocompatible according to ISO-10993 Part-1.	Blood contacting materials are biocompatible.

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

Sample Size: The document does not specify the sample size for any of the performance tests.
Data Provenance: The tests were performed on the "Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China." The data is thus prospective for this specific device model from that manufacturing location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The study described is primarily a device performance and substantial equivalence assessment, not one relying on expert interpretation of results. Physical and chemical tests were performed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (mechanical, chemical, flow rates), an adjudication method as typically used for clinical or imaging data (e.g., 2+1) would not be applicable. The tests likely involved standardized methods with objective pass/fail criteria or measurements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a physical medical device (blood collection set), not an AI-powered diagnostic or interpretive system. Therefore, the concept of "human readers" or "AI assistance" is not relevant to this submission.

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

No, this is not an algorithm-only or AI-based device. It 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 was based on engineering specifications, industry standards (e.g., EN550, ISO-10993), and the performance characteristics of the predicate device. For example, the ground truth for "Shield cover/Needle Locking Strength" would be defined by the predicate device's measured locking strength or a specific force threshold required by relevant standards for safety features.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

Not Applicable. As above, no training set was used.

Summary

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MAY 3 0 2003

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TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY BLOOD COLLECTION SET Section II - Summary and Certification

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

DEVICE NAME

Proprietary Name

SURSHIELD™ Safety Winged Blood Collection Set

Classification Name

Tubes, vials, systems, serum separators, blood collection (75JKA) 21CFR. Section 862.1675 Classification: Class II

Intravascular Administration Set (80FPA) 21CFR. Section 880.5440 Classification: Class II

Common Name

Blood specimen collection device and Intravascular Administration Set

INTENDED USE

The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.

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DESCRIPTION

SUBSTANTIAL EQUIVALENCE

PRINCIPLE OF OPERATION/TECHNOLOGY

Both devices are operated manually.

MATERIALS

The materials used in the Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China are the same as the predicate devices, which do not raise any new issues of safety or effectiveness.

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SPECIFICATIONS

Cannula gauge	Color code	Product code	Winged type hub	Cannula length	Tube Length
19G	Cream	MN*SVS19B30	C type	3/4"(19mm)	300mm
21G	Green	MN*SVS21B30	C type	3/4"(19mm)	300mm
23G	Light blue	MN*SVS23B30	C type	3/4"(19mm)	300mm
		MN*SVS23B18	C type	3/4" (19mm)	180mm
25G	Orange	MN*SVS25B30	C type	3/4"(19mm)	300mm
		MN*SVS25B18	C type	3/4"(19mm)	180mm

PERFORMANCE

The following tests were performed on the Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China:

Shield cover/Needle Locking Strength ●
Break strength of the shield cover joint ●
Force to lock the needle in the shield cover (Force to activate safety feature) .
Puncture Resistance of Shield Cover
Flow Rate
Wing to Tubing Connection Strength
. Tubing to Connector Connection Strength
Needle to Wing Connection Strength
Needle Penetration Resistance
Wing Needle Protector Fit
Leak Test
Blockage Test
Connection Strength of Winged Infusion Set and Luer Adaptor Joint
Valve Protector Fit ●

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Additionally, a risk analysis was conducted and no new issues were identified since the Surshield China device is the same as the cleared Surshield Kofu. None of the data raises any new issues of safety and effectiveness.

The Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou. China is substantially equivalent to the Surshield Safety Winged Blood Collection set manufactured by Terumo Corporation in Kofu, Japan and cleared under K013164.

ADDITIONAL SAFETY INFORMATION

The sterilization conditions are validated according to EN550 to provide a Sterility Assurance Level (SAL) of 10-9.

Ethylene Oxide residual levels resulting from EtO sterilization will not exceed the maximum residue levels proposed for Part 821 of Title 21 in the Federal Register Notice issued June 23, 1978, and indicated as follows:

Ethylene Oxide	25 ppm
Ethylene Chlorohydrin	25 ppm

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.

CONCLUSION

The Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China is substantially equivalent to the Surshield Safety Winged Blood Collection set manufactured by Terumo Corporation in Kofu, Japan and cleared under K013164 with respect to intended use, design, technology/principles of operation, materials and performance. Differences between the devices do not raise any new issues of safety or effectiveness.

Date Prepared: 04/18/03

Prepared by: Kazuhito Inoue Regulatory Affairs Specialist 125 Blue Ball Rd Elkton, MD 21921 Phone: 1-800-283-7866 Ex. 7001 · Fax: (410) 398-6079

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting hair or clothing.

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

*Terumo Medical Products Hangzhou Company C/O Mr. Kazuhito Inoue Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921

Re: K031279

Trade/Device Name: SURSHIELD™ Safety Winged Blood Collection Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 21, 2003 Received: April 22, 2003

Dear Mr. Inoue:

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.

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

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Page 2 - Mr. Inoue

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,

Susan Burnes

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):

SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET Device Name:

Indications For Use:

The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.

(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) OR

Over-The-Counter Use

Patricia Cucentiz

(Optional Format 1-2-96)

vision Sian-Off vision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.