The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system for intravenous administration of fluids using a syringe, or other compatible/appropriate devices and 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 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 needle stick.

Device Description

The Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, microbore tubing, adapter with integrated 20 um filter and adapter cap, and a hinged shield cover that attaches 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. 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 Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield) are available with a cannula with a needle size of 23 gauge (0.6 mm) or 25 gauge (0.5 mm) and a length of 19 mm (3/4"). The device possesses 350 mm length tubing.

AI/ML Overview

Here's an analysis of the provided text regarding the "SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™)":

It's important to note that the provided 510(k) summary does not contain details about specific acceptance criteria or a dedicated study proving performance against those criteria in the way one might expect for a software or AI/ML device. This document is for a physical medical device (an infusion set), and the "study" mentioned is primarily focused on demonstrating substantial equivalence to previously cleared devices through material compatibility, sterilization validation, and shelf-life testing, rather than an AI-driven performance study.

Therefore, many of the requested fields regarding AI/ML-specific performance metrics (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this document.

However, I can extract the information that is present and explain why other requested details are absent.

Analysis of SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™) 510(k) Summary

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present explicit performance acceptance criteria in the format typically seen for novel diagnostic or AI devices (e.g., sensitivity, specificity thresholds). Instead, the "performance" demonstrated is through substantial equivalence and compliance with relevant standards.

Acceptance Criterion (Implied by Regulatory Compliance)	Reported Device Performance
Sterility Assurance Level (SAL)	Achieved 10⁻⁶ SAL per EN 550 and ISO 11135
Ethylene Oxide Residual Levels	In compliance with ISO 10993-7
Biocompatibility of Blood Contacting Materials	Materials demonstrated to be biocompatible per ISO 10993-1
Shelf-Life/Expiration Dating	Established at 5 years
Needle Protection Feature Functionality	Substantially equivalent to predicate device (K052887)
Overall Functionality (Infusion Set)	Substantially equivalent to predicate device (K033350)

2. Sample Size for the Test Set and Data Provenance

Not Applicable in the context of an AI/ML device's "test set."
For the physical device, "testing" would involve laboratory evaluations for sterility, material properties, and shelf-life. The sample sizes for these types of tests are not specified in this summary but would typically follow established validation protocols for manufacturing and quality control.
Data Provenance: The studies (sterilization, biocompatibility, shelf-life) are conducted by the manufacturer, Terumo Europe N.V. The country of origin of the data is implicitly Belgium (where Terumo Europe N.V. is located). These are more akin to prospective laboratory or manufacturing validation studies rather than retrospective clinical data analysis.

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

Not Applicable. This is not a device that relies on expert interpretation for its "ground truth" performance in a clinical context (like image analysis). Ground truth relates to objective measurements for sterility, chemical residuals, and material compatibility standards.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" in the sense of resolving discrepancies between expert opinions on a test set, as this is not an interpretive device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for diagnostic devices where human readers interpret outputs (e.g., radiologists reading images with and without AI assistance). This device is an intravenous administration set, not a diagnostic tool requiring human interpretation for its primary function.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for relevant testing includes:

Standardized Sterility Assurance Level (SAL): Defined by international standards (EN 550, ISO 11135) to be 10⁻⁶.
Reference Limits for Chemical Residues: Defined by international standards (ISO 10993-7) for ethylene oxide residuals.
Biocompatibility Standards: Defined by international standards (ISO 10993-1).
Performance Specifications: The core "ground truth" for the device's functionality and safety features is its ability to meet the design specifications and be substantially equivalent to predicate devices that have already demonstrated safety and effectiveness for their intended use.

8. The Sample Size for the Training Set

Not Applicable. This refers to AI/ML model training, which is not relevant for this device.

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

Not Applicable. See point 8.

Summary of Device and Regulatory Context:

The 510(k) for the SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™) is a submission for a Class II physical medical device. The primary goal of this type of submission is to demonstrate substantial equivalence to predicate devices already on the market. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The "studies" referenced are primarily:

Comparison to Predicate Devices: Demonstrating similarity in design and function to previously cleared infusion sets.
Compliance with International Standards: Validation of manufacturing processes (sterilization), material safety (biocompatibility, chemical residuals), and performance (shelf-life).

This is distinctly different from the type of information requested for a software as a medical device (SaMD) or AI/ML-powered diagnostic device, where performance metrics like sensitivity, specificity, and results from clinical studies (often involving human readers) are central to the submission.

Summary

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

ﺎ . Device Name
MAY 2 5 2007

Proprietary Name

SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™)

Classification Name

Intravascular Administration Set (80FPA)

21CFR, Section 880.5440

Classification: Class II

1. Reason for Submission
  New Device

3. Intended Use

4. Description

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 Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield) are available with a cannula with a needle size of 23 gauge (0.6 mm) or 25 gauge (0.5 mm) and a length of 19 mm (3/4"). The device possesses 350 mm length tubing.

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న. Substantial Equivalence

The "Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)", 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 following cleared devices:

1. BD Vacutainer Safety-Lok Administration Set with Filter (K033350), manufactured by Becton Dickinson Company, which is used as a predicate for the functionality of the set
Surflo Winged Infusion Set with Needle Protection (K052887), manufactured by 2. Terumo Europe N.V., which is used as a predicate for the identical needle protection feature

Additional Safety Information 6.

The sterility of the Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) 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 10th 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 with Filter and Needle Protection (Surshield) has been established at 5 years.

7. Conclusion

The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) 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 following cleared devices:

BD Vacutainer Safety-Lok Administration Set with Filter (K033350), manufactured by 1. Becton Dickinson Company, which is used as a predicate for the functionality of the set
1. Surflo Winged Infusion Set with Needle Protection (K052887), manufactured by Terumo Europe N.V., which is used as a predicate for the identical needle protection feature

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 & Human Services. The logo consists of a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2007

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

Re: K070547

Trade/Device Name: Surflo® Winged Infusion Set with Filter and Needle Protection (Surshield™) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 23, 2007 Received: February 26, 2007

Dear Mrs. 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 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 - Mrs. 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. 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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K07-0547

Indications for Use

510(k) Number (if known):

Device Name: Surflo® Winged Infusion Set with Filter and Needle Protection (Surshield™)

Indications for Use:

Prescription Use x (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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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.