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 is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, a female connector with a multi-sample luer adapter attached for blood collection. The Surshield Safety Winged Blood Collection Set is the same as the Surshield Safety Winged Infusion Set (K010104) except for the attached luer adapter (K983490).

A hinged safety shield, previously cleared under K010103, is attached to the wing just below the needle-to-wing junction. The safety shield 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 single-handed technique. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needlestick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the TERUMO® SURSHIELD™ Safety Winged Blood Collection Set. This submission is for a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's an analysis of the provided text in relation to the prompt:

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

The document states that "The following performance tests were performed on the Surshield Safety Winged Blood Collection Set:

Leakage at connector to luer adapter junction
Blockage
Connection strength of luer adapter to connector
Valve Protector Fit"

It also explicitly states, "Additionally, a risk analysis was conducted and any potential issues were addressed through design modification, and/or labeling as appropriate. None of the data raises any new issues of safety and effectiveness."

This indicates that the device met the acceptance criteria for these tests, implicitly defined by "not raising any new issues of safety and effectiveness." However, specific numerical acceptance criteria or performance metrics for these tests are not detailed in the provided text. For example, it doesn't state "Leakage less than X mL/hr" or "Connection strength greater than Y Newtons."

Acceptance Criteria (Implicit)	Reported Device Performance
No new issues of safety and effectiveness for:	Met, as "None of the data raises any new issues of safety and effectiveness."
- Leakage at connector to luer adapter junction	Met (Implied by the overall statement)
- Blockage	Met (Implied by the overall statement)
- Connection strength of luer adapter to connector	Met (Implied by the overall statement)
- Valve Protector Fit	Met (Implied by the overall statement)

2. Sample size 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 the sample sizes used for the performance tests mentioned (Leakage, Blockage, Connection strength, Valve Protector Fit). It also does not explicitly state the country of origin of the test data or whether the tests were retrospective or prospective. Given that the manufacturer, Terumo Corporation, is in Tokyo, Japan, it is highly likely the testing was conducted there.

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):

This question is not applicable as the submission is for a physical medical device (blood collection set), not an AI/ML diagnostic or predictive algorithm that relies on expert interpretation for ground truth. The performance tests described are physical engineering tests.

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

Not applicable for a physical device's engineering performance tests. Adjudication methods are typically relevant for human interpretation of data, as in clinical studies or AI algorithm evaluations.

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. The device is a physical blood collection set, not an AI system.

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

Not applicable. The device is a physical blood collection set, not an AI algorithm.

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

The "ground truth" for the device's performance tests would be defined by engineering specifications and standards (e.g., maximum allowable leakage, minimum required connection strength). These are objective measurements rather than subjective human interpretations or clinical outcomes in the context of an AI/ML study.

8. The sample size for the training set:

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm that requires a training set.

Summary

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OCT 1 5 2001

K013164

SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET Section II - Summary & Certification

SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

A. Device Name

Proprietary Device Name: TERUMO® SURSHIELD™ Safety Winged Blood Collection Set

Classification Name: Tubes, vials, systems, serum separators, blood collection and Intravascular Administration Sets

Product Code(s): 75 JKA and 80 FPA

B. Reason for Submission:

This premarket notification (510(k)) is being submitted for the SURSHIELD™ SAFEY WINGED BLOOD COLLECTION SET, which is blood collection device comprised of two cleared devices both manufactured by Terumo Corporation in Tokyo, Japan. The base predicate device is the SURSHIELD™ SAFETY WINGED INFUSION SET cleared under 510(k) number K010103 and the attached device is the TERUMO® VENOJECT® LUER ADAPTER cleared under 510(k) number K983490. The focus of this submission is to address any potential issues of safety and effectiveness of the device being formed after joining the two cleared devices.

C. 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.

Note: This is the same intended use as the predicate device, Surshield Winged Infusion Set -K010103.

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D. Description

E. Substantial Equivalence

The SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is substantially equivalent in intended use, design, technology/principals of operation, materials, and performance to the following cleared devices:

TERUMO® SURSHIELD SAFETY WINGED INFUSION SET K010103 1.
TERUMO® VENOJECT® LUER ADAPTER K983490 2.
VACUTAINER® SAFETY-LOK™ BLOOD COLLECTION SET K980414 3.

Differences between the devices do not raise any significant issues of safety and effectiveness.

F. Principals of Operation/Technology

The Surshield Safety Winged Blood Collection Set, Surshield Safety Winged Infusion Set, Venoject Luer Adapter, and Vacutainer Safety-Lok Blood collection set are all operated manually.

G. Materials

The Surshield Safety Winged Blood Collection Set is comprised of the same materials as the cleared Surshield Safety Winged Infusion Set (K010103) and Venoject Luer Adapter (K983490).

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H. Specifications

Cannulagauge	Color code	Product code	Tubinglength
19G	Cream	MN*SVS19B303/4"(19mm)	300mm±10%
		MN*SVS19B183/4"(19mm)	180mm±10%
21G	Green	MN*SVS21B303/4"(19mm)	300mm±10%
		MN*SVS21B183/4"(19mm)	180mm±10%
23G	Light blue	MN*SVS23B303/4"(19mm)	300mm±10%
		MN*SVS23B183/4"(19mm)	180mm±10%
25G	Orange	MN*SVS25B303/4"(19mm)	300mm±10%
		MN*SVS25B183/4"(19mm)	180mm±10%

Note: The 180mm length tubing is new for this blood collection device but is bracketed by the 90 and 300mm lengths cleared under K010103.

I. Performance

The following performance tests were performed on the Surshield Safety Winged Blood Collection Set:

Leakage at connector to luer adapter junction
. Blockage
t Connection strength of luer adapter to connector
. Valve Protector Fit

Additionally, a risk analysis was conducted and any potential issues were addressed through design modification, and/or labeling as appropriate. None of the data raises any new issues of safety and effectiveness.

J. Additional Safety Information

a. Sterilization
The EtO sterilization conditions are validated according to ISO11135/EN550 to provide a Sterility Assurance Level (SAL) of 10-6.

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
Ethylene Glycol	250 ppm

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b. Biocompatibility

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. Therefore, no further testing was deemed necessary.

c. Expiration Dating

Expiration Dating for the Surshield Safety Winged Blood Collection Set will be 36 months (3 years).

d. Pyrogen Testing

The Surshield Safety Winged Blood Collection Set is pyrogen free. Testing is performed on each lot of the product using the Limulus Amebocyte Lysate (LAL) gel clot test according to the US Pharmacopoeia XXIV.

K. Conclusion

In summary, the Surshield Safety Winged Blood Collection Set is substantially equivalent in intended use, design, technology/principals of operation, materials, and performance to the following cleared devices:

1. TERUMO® SURSHIELD SAFETY WINGED INFUSION SET K010103
TERUMO® VENOJECT® LUER ADAPTER K983490 2.
1. VACUTAINER® SAFETY-LOKTM BLOOD COLLECTION SET-K980414

Differences between the devices do not raise any significant issues of safety and effectiveness.

Terumo's statement that this device is substantially equivalent to any other device 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: September 20, 2001

Prepared by: Barbara Smith Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921 Phone#: 410-392-7241 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings or feathers. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2001

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

Re: K013164

Trade/Device Name: Surshield™ Safety Winged Blood Collection Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 20, 2001 Received: September 21, 2001

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.

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.

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Page 2 - Ms. Smith

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou interest 011); 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

$\substack{f \ y}$ $\substack{S \ Ti}$

noves Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K013/64

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)
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Division Sign-Off)	B. Brede
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K013164

(Optional Format 1-2-96)
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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.