The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimans using a syringe, luer adapter, or other compatible/appropriate devices.

Device Description

The Terumo Surflo Winged Infusion Set is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap. The device possesses 300 mm length tubing.

AI/ML Overview

This 510(k) premarket notification (K070362) for the SURFLO® Winged Infusion Set does not contain the level of detail typically found in a clinical study report for AI/software-based medical devices. This submission pertains to a physical medical device (an infusion set) and focuses on demonstrating substantial equivalence to a predicate device rather than evaluating the performance of an algorithm or AI system.

Therefore, many of the requested categories like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable or not provided in this document.

However, I will extract and present applicable information based on the provided text, primarily focusing on the regulatory and performance aspects that are discussed for this physical device.

Acceptance Criteria and Device Performance (SURFLO® Winged Infusion Set)

This submission is a 510(k) for a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" discussed are primarily related to general performance, safety, and manufacturing standards for such devices. The "reported device performance" refers to the demonstration of compliance with these standards and substantial equivalence to a predicate device.

Acceptance Criteria Category	Reported Device Performance/Evidence
Intended Use	Meets Intended Use: Intended to access the peripheral vascular system for intravenous fluid administration and/or blood specimen withdrawal. The submission states the device is "substantially equivalent in intended use" to the predicate device.
Sterility	Sterile: Sterility is assured by a validated sterilization method (Ethylene Oxide) qualified in accordance with EN 550 and ISO 11135 to a Sterility Assurance Level (SAL) of 10⁻⁶, as required by EN 556-1.
Ethylene Oxide (EtO) Residuals	Compliant: EtO residual levels comply with ISO 10993-7 ("Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals").
Biocompatibility	Biocompatible: Blood-contacting materials were tested in accordance with FDA General Program Memorandum #G95-1 (5/1/95) and EN ISO-10993 Part-1. Results demonstrate that the blood-contacting materials are biocompatible.
Expiraton Dating / Shelf Life	Established Shelf Life: An expiration dating of 5 years has been established for the device.
Substantial Equivalence (Overall Device)	Substantially Equivalent: The device is concluded to be "substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance" to the cleared predicate device (K891063, "Surflo Winged Infusion Set" manufactured by Terumo Medical Corporation). The submission states "Differences between the devices do not raise any new issues of safety or effectiveness." This is the primary "acceptance criterion" for a 510(k) submission.

Study Details (Not Applicable for AI/Software)

As this submission is for a physical medical device and not an AI/software product, the following requested information regarding AI/algorithm performance studies is not provided or not relevant to this document.

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

Not Applicable / Not Provided: This information is not relevant for the type of device and submission. Performance is demonstrated through compliance with standards (sterility, biocompatibility) and comparison of physical characteristics to a predicate device, rather than a data-driven test set.

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

Not Applicable / Not Provided: No "ground truth" in the context of expert labels for data is established in this type of submission. Performance is assessed through engineering testing and regulatory compliance.

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

Not Applicable / Not Provided: No adjudication method for a test set is used.

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 / Not Provided: This is not an AI-assisted device.

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

Not Applicable / Not Provided: This is not an algorithm.

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

Not Applicable / Not Provided: No "ground truth" in the context of data labeling is used. Performance relies on established engineering and biological standards.

8. The sample size for the training set

Not Applicable / Not Provided: Not an AI/ML device requiring a training set.

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

Not Applicable / Not Provided: Not an AI/ML device.

Summary

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K070362

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510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information

I . Device Name

Proprietary Name

SURFLO® Winged Infusion Set

Classification Name

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

1. Reason for Submission
  New Device
1. Intended Use
  The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a symng, luer adapter, or other compatible/appropriate devices.
1. Description
  The Terumo Surflo Winged Infusion Set is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap.

The device possesses 300 mm length tubing.

5. Substantial Equivalence

The "Surflo Winged Infusion Set", manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the cleared "Surflo Winged Infusion Set", manufactured by Terumo Medical Corporation, which is the subject of 1111553

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K070362

6. Additional Safety Information

The sterility of the Surflo Winged Infusion Set is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 104 as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices"

Ethylene oxide residual levels resulting from EtO sterilization are in compliance with ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals".

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 EN ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing, Results of the testing demonstrate that the blood contacting materials are biocompatible.

The expiration dating for the Surflo Winged Infusion Set has been established at 5 years.

1. Conclusion
  The Surflo Winged Infusion Set manufactured by Terumo Europe N.V. and submitted in this 510(k) file is substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance to the cleared "Surflo Winged Infusion Set'', manufactured by Terumo Medical Corporation, which is the subject of K891063.

Differences between the devices do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a bold, abstract style, and the text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. M.J. Aerts Manager Regulatory Affairs Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 Leuven BELGIUM

MAY - 2007

Re: K070362

Trade/Device Name: Surflo® Winged Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 31, 2007 Received: February 7, 2007

Dear Ms. Aerts:

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 vour 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. Aerts

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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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K070362

Indications for Use

510(k) Number (if known):

Device Name: Surflo® Winged Infusion Set

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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cinesioloov, General Hospital, Control, Dental Devices

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Page

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.