The Surshield Safety Winged Infusion Set is intended for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. The winged infusion set may be used for any patient population with consideration given to patient size. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needlestick.

Device Description

The Surshield Safety Winged Infusion Set is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, connector and connector cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China is the same as the Surshield Winged Infusion Set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103. 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. An audible click is noted upon activation. 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. The device possesses both 90 and 300mm length tubing.

AI/ML Overview

The provided text describes a medical device, the SURSHIELD™ Safety Winged Infusion Set, and its substantial equivalence to a previously cleared device. However, the text does not contain information about specific acceptance criteria or a detailed study that proves the device meets those criteria in a quantitative sense as might be expected for an AI/software device or a study with statistical performance metrics.

Instead, the document details physical and functional tests performed to demonstrate that the new device (manufactured in China) is identical to the predicate device (manufactured in Japan) already cleared by the FDA. The safety and effectiveness are established by showing substantial equivalence, meaning the design, materials, manufacturing, and performance are the same as or very similar to the predicate device, and thus raise no new safety or effectiveness concerns.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. A table of acceptance criteria and the reported device performance

The document lists "Performance" tests but does not provide specific quantitative acceptance criteria or detailed results. It simply states that the "following tests were performed."

Performance Test	Reported Device Performance	Acceptance Criteria (Not Explicitly Stated in Document)
Shield cover/Needle Locking Strength	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Break strength of the shield cover joint	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Force to lock the needle in the shield cover (Force to activate safety feature)	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Puncture Resistance of Shield Cover	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Flow Rate	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Priming Volume	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Wing to Tubing Connection Strength	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Tubing to Connector Connection Strength	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Needle to Wing Connection Strength	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Needle Penetration Resistance	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Wing Needle Protector Fit	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Leak Test	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)
Blockage Test	Performed (Implied satisfactory outcome for substantial equivalence)	(Likely internal specifications matching predicate device)

Key takeaway: The document focuses on demonstrating that the new device is the same as the predicate device by performing physical and functional tests, rather than setting and meeting novel acceptance criteria.

The remaining questions are largely not applicable or cannot be answered from the provided text, as they pertain to clinical or AI algorithm studies, which are not described here. This document is a 510(k) submission for a physical medical device demonstrating substantial equivalence, not a clinical trial report or AI performance study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the performance tests.
Data provenance is implicitly for the device manufactured by Terumo Medical Products in Hangzhou, China, but no specific "data" in the clinical sense is presented. The tests are likely laboratory bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert-established ground truth.

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

Not applicable.

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 not a study involving human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is likely adherence to engineering specifications and functional equivalence to the predicate device, as demonstrated through product performance testing. There isn't a "ground truth" derived from clinical outcomes or expert consensus in the way one would for diagnostic tools.

8. The sample size for the training set

Not applicable. There is no "training set" for this physical device.

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

Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device, primarily demonstrating substantial equivalence. It describes a series of mechanical and functional tests rather than clinical studies or AI performance evaluations, and therefore, most of the requested information about acceptance criteria and study details (especially those related to ground truth, expert review, or AI performance) is not present.

Summary

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KO31266

TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY WINGED INFUSION SET Section II - Summary and Certification

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

DEVICE NAME

Proprietary Name

SURSHIELD™ Safety Winged Infusion Set

Classification Name

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

Common Name

Intravascular Administration Set

INTENDED USE

DESCRIPTION

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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. An audible click is noted upon activation. 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.

The device possesses both 90 and 300mm length tubing.

SUBSTANTIAL EQUIVALENCE

PRINCIPLE OF OPERATION/TECHNOLOGY

Both devices are operated manually.

MATERIALS

The materials used in the Surshield Safety Winged Infusion 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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TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY WINGED INFUSION SET Section II - Summary and Certification

SPECIFICATIONS

Cannulagauge	Color code	Product code	Wingedtypehub	Cannulalength	Tubelength
19G	Cream	SV*S19BL	C type	3/4"(19mm)	300mm
		SV*S19DL	D type	5/8"(16mm)
		SV*S19BLS	C type	3/4"(19mm)	90mm
21G	Green	SV*S21BL	C type	3/4"(19mm)	300mm
		SV*S21DL	D type	5/8"(16mm)
		SV*S21BLS	C type	3/4"(19mm)	90mm
23G	Light blue	SV*S23BL	C type	3/4"(19mm)	300mm
		SV*S23DL	D type	5/8"(16mm)
		SV*S23BLS	C type	3/4"(19mm)	90mm
25G	Orange	SV*S25BL	C type	3/4"(19mm)	300mm
		SV*S25DL	D type	5/8"(16mm)
		SV*S25BLS	C type	3/4"(19mm)	90mm

PERFORMANCE

The following tests were performed on the Surshield Safety Winged Infusion 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
Priming Volume
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

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TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY WINGED INFUSION SET Section II - Summary and Certification

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

ADDITIONAL SAFETY INFORMATION

The sterilization conditions are validated according to EN550 to provide a Sterility Assurance Level (SAL) of 104.

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 Infusion Set manufactured by Terumo Medical Products in Hangzhou. China is substantially equivalent to the Surshield Winged Infusion set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103 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: 04/17/03

Prepared by: Barbara Smith Sr. Regulatory Affairs Specialist 125 Blue Ball Rd Elkton, MD 21921 Phone: 410-392-7241

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031266

Trade/Device Name: SURSHIELD™ Safety Winged Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 18, 2003 Received: April 22, 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 (OS) 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,

Suvor Russer

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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K 03/2 66

510(k) Number (if known):

SURSHIELD™ SAFETY WINGED INFUSION SET 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) OR

Over-The-Counter Use

Pattuce Cucenit

(Optional Format 1-2-96)

n of Anesthesiology. General Hospital

510(k) Number: K031266

003

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.