The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vasular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, fuer adapter, or other compatible/ appropriate devices. Additionally, after withdrawal of 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 23G and the 25G Terumo Surflo Winged Infusion Sets with Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, standard or microbore tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing 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 the 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 a 350 mm length standard or microbore tubing.

AI/ML Overview

The document provides information on the Surflo Winged Infusion Set with Needle Protection (Surshield). It details the acceptance criteria and summarizes verification activities to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

TEST	ACCEPTANCE CRITERIA	Reported Device Performance
1. Visual inspection	When examined by normal vision or under 2.5 fold magnification, all components of the set are smooth, clean and free of flash, surface irregularities, detachable particles, and moulding or processing defects	Meets acceptance criteria (implicit, as stated below table)
2. Effective tubing length	The effective tubing length is 350 ± 20mm	Meets acceptance criteria (implicit, as stated below table)
3. Dead space volume	Dead space volume for sets with standard tubing: ≤ 0.40 ml; Dead space volume for sets with microbore tubing: ≤ 0.20 ml	Meets acceptance criteria (implicit, as stated below table)
4. Air leakage (= integrity of set)	No leakage	Meets acceptance criteria (implicit, as stated below table)
5. Air leakage luer adaptor	No leakage at the luer connection (according to ISO 594-1 and ISO 594-2)	Meets acceptance criteria (implicit, as stated below table)
6. Liquid leakage luer adaptor	No leakage at the luer connection (according to ISO 594-1 and ISO 594-2)	Meets acceptance criteria (implicit, as stated below table)
7. Conical fitting	The conical fitting shall be within level 1-3 (according to ISO 594-1 and ISO 594-2)	Meets acceptance criteria (implicit, as stated below table)
8. Separation force of Luer slip tip connection	The fitting remains attached (according to ISO 594-1)	Meets acceptance criteria (implicit, as stated below table)
9. Separation force of Luer lock connection	The fitting remains attached (according to ISO 594-2)	Meets acceptance criteria (implicit, as stated below table)
10. Stress cracking on Luer conical fitting	No stress cracking on the conical fitting (according to ISO 594-1 and ISO-594-2)	Meets acceptance criteria (implicit, as stated below table)
11. Unscrewing torque of Luer lock fittings	The fitting remains attached when the fitting between the hub and a reference fitting is tested according to ISO 594-2	Meets acceptance criteria (implicit, as stated below table)
12. Ease of assembly	A satisfactory fit is achieved when tested according to ISO 594-2	Meets acceptance criteria (implicit, as stated below table)
13. Overriding resistance of Luer lock systems	When the fitting between the hub and a reference fitting is tested, the reference fitting shall not override the threads or lugs of the fitting under test (according to ISO 594-2)	Meets acceptance criteria (implicit, as stated below table)
14. Torque resistance cap - adapter	The torque force required to unscrew the cap from the adapter does not exceed 9 N.cm	Meets acceptance criteria (implicit, as stated below table)
15. Bonding strength tube - adapter	The force required for separating the tube from the adapter is 15 N minimum.	Meets acceptance criteria (implicit, as stated below table)
16. Bonding strength tube - wing hub	The force required for separating the tube from the wing hub is 15 N minimum.	Meets acceptance criteria (implicit, as stated below table)
17. Air flow choke test	Air bubbles escape out of the set when immersed under water and connected to an airline of 20 kPa (0.2 bar) effective pressure, to create an airflow through the set.	Meets acceptance criteria (implicit, as stated below table)
18. Flow rate	Flow rate for sets with standard tubing: 23G: ≥ 2.9 ml/min & 25G: ≥ 1.6 ml/min; Flow rate for sets with microbore tubing: 23G: ≥ 1.7 ml/min & 25G: ≥ 1.5 ml/min	Meets acceptance criteria (implicit, as stated below table)
19. Bonding strength Surshield protector	The bonding strength between the Surshield protector and the SV-set is minimum 4 N	Meets acceptance criteria (implicit, as stated below table)
20. Misalignment of Surshield Protector	The angle measured axially from the cannula between the horizontally positioned wings and the vertically positioned Surshield protector does not exceed 15°.	Meets acceptance criteria (implicit, as stated below table)
21. Peel behaviour of blister	The blister is peeled by hand with minimal fibres and no paper splitting	Meets acceptance criteria (implicit, as stated below table)
22. Peel strength	The peel strength of the pack seal is minimum 0.15 kN/m	Meets acceptance criteria (implicit, as stated below table)
23. Package integrity	The integrity of the unit pack is minimum 4 kPa	Meets acceptance criteria (implicit, as stated below table)
24. Kink stability of tubing	Free of deformation and kinking	Meets acceptance criteria (implicit, as stated below table)

Device Performance Note: The document explicitly states: "The Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, meet all acceptance criteria as indicated in table above. None of the obtained data raises any new issue of safety and effectiveness."

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual verification test. It generally refers to "all necessary verification and validation tests" having been performed.
Data Provenance: The document was prepared by Terumo Europe N.V. in Belgium. The tests were performed to demonstrate substantial equivalence to predicate devices cleared by the FDA (K052887, K072894, K100946). The nature of these tests (e.g., physical, mechanical, functional) suggests they were conducted prospectively to evaluate the modified device's performance.

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

This information is not applicable as the verification activities are focused on the physical, mechanical, and functional performance of a medical device (infusion set) against defined engineering and safety standards (e.g., ISO standards), rather than diagnostic accuracy or interpretation by human experts. Therefore, there is no "ground truth" in the clinical diagnostic sense established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. The testing involves objective measurements against predefined acceptance criteria, not subjective interpretation requiring adjudication among experts.

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:

This information is not applicable. The device is an intravenous administration set, not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the verification activities comprises pre-defined acceptance criteria based on established engineering standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN ISO 10993-7) and internal specifications. These criteria are objective and measurable, ensuring the device's physical, mechanical, and sterile properties.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reasons as point 8.

Summary

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化133867

FEB - 5 2014

510(k) SUMMARY

Prepared for:

TERUMO EUROPE N.V. Interleuvenlaan 40, 3001 Leuven, BELGIUM

Prepared by/Contact Person:

Mrs. M.J. Aerts - Manager Regulatory Affairs Tel. (+32) 16 38 13 53 Fax (+32) 16 40 02 49

Date prepared:

December 2013

Note: Class III Summary & Certification is not applicable for the submission of a Class II device

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11. 510(k) SUMMARY

l. Device Name
1. Reason for Submission
1. Intended Use
1. Description
న. Substantial Equivalence
1. Additional Safety Information
1. Summary of Verification Activities

1. Additional Safety Information
1. Conclusion

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

Submitter information

Prepared for:	TERUMO EUROPE N.V.Interleuvenlaan 40,3001 Leuven,BELGIUM
Prepared by/Contact person:	Mrs. M.J. Aerts – Manager Regulatory AffairsTel. (+32) 16 38 13 53Fax (+32) 16 40 02 49
Date prepared:	December 2013

1. Device Name

Proprietary Name

SURFLO® Winged Infusion Set with Needle Protection (Surshield®)

Classification Name

Intravascular Administration Set (-FPA)

21 CFR, Section 880.5440

Classification: Class II

2. Reason for Submission

This premarket notification [510(k)] is being submitted for the 23G Surflo Winged Infusion Set with Needle Protection (Surshield), with standard and microbore tubing, to provide supporting information that despite of some changes in material, design, process and labeling to the devices cleared under K052887, K072894 and K100946, the proposed devices are safe and effective and substantially equivalent to the devices cleared under K052887. K072894 and K100946.

3. Intended Use

The Surflo Winged Infusion Sets with Needle Protection (Surshield) are intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. 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.

Note: This is the same intended use as the predicate device, Surflo Winged Infusion Set with Needle Protection (Surshield), cleared under K052887, K072894 and K100946.

4. 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 the 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 a 350 mm length standard or microbore tubing.

રું . Substantial Equivalence

The 23G and the 25G Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, manufactured by Terumo Europe N.V., submitted in this 510(k) file are substantially equivalent in intended use, description/specifications, technology/principles of operation. materials and performance to the following cleared devices:

1. Surflo Winged Infusion Set with Needle Protection (Surshield) (K052887) (SV-S23BL35VS), manufactured by Terumo Europe N.V.
1. Surflo Winged Infusion Set with Needle Protection (Surshield) (K072894) (SV-S25BL35VS), manufactured by Terumo Europe N.V.
1. Surflo Winged Infusion Set with Needle Protection (Surshield) (K100946) (SV-S23WL35 & SV-S25WL35), manufactured by Terumo Europe N.V

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

Summary of Technological Modifications compared to Predicate Devices: 6.

The technological modifications made to the subjected device compared to the predicate devices are summarized in the following table:

Predicate device	Modification summary (Proposed device)
Surflo Winged Infusion Set withNeedle Protection (Surshield)(K052887) & (K072894)(SV-S23BL35VS & SV-S25BL35VS)	SV-S23BL35 & SV-S25BL35:a) Change of codeb) Change of adapter designc) Change of adapter material from PP to PMMA (material PMMA adapteralready cleared under K100946)d) Change of adapter cap designe) Change of adapter cap material from PE to PP.f) Connection wing hub - tube from glue to solvent bondingg) Connection Surshield protector from cyano-acrylate glue to UV curing glueh) Change of specification for dead space volumei) Update of labeling
Surflo Winged Infusion Set withNeedle Protection (Surshield)(K100946)(SV-S23WL35 & SV-S25WL35)	SV-S23WL35 & SV-S25WL35:a) Change of tube supplier (material remains identical)b) Change of adapter designc) Change of adapter cap designd) Change of adapter cap material from PP to different grade of PP.e) Connection wing hub - tube from tetrahydrofurane solvent bonding tocyclohexanone solvent bondingf) Connection tube - adapter: from solvent to glue bondingg) Connection Surshield protector from cyano-acrylate glue to UV curing glue

Predicate device

Modification summary (Proposed device)

Surflo Winged Infusion Set withNeedle Protection (Surshield)(K052887) & (K072894)(SV-S23BL35VS & SV-S25BL35VS)

SV-S23BL35 & SV-S25BL35:a) Change of codeb) Change of adapter designc) Change of adapter material from PP to PMMA (material PMMA adapteralready cleared under K100946)d) Change of adapter cap designe) Change of adapter cap material from PE to PP.f) Connection wing hub - tube from glue to solvent bondingg) Connection Surshield protector from cyano-acrylate glue to UV curing glueh) Change of specification for dead space volumei) Update of labeling

Surflo Winged Infusion Set withNeedle Protection (Surshield)(K100946)(SV-S23WL35 & SV-S25WL35)

SV-S23WL35 & SV-S25WL35:a) Change of tube supplier (material remains identical)b) Change of adapter designc) Change of adapter cap designd) Change of adapter cap material from PP to different grade of PP.e) Connection wing hub - tube from tetrahydrofurane solvent bonding tocyclohexanone solvent bondingf) Connection tube - adapter: from solvent to glue bondingg) Connection Surshield protector from cyano-acrylate glue to UV curing glue

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7. Summary of Verification Activities:

All necessary verification and validation tests have been performed for the Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, to assure substantial equivalence to the predicate devices. Summary of all verification activities including acceptance criteria is given in the following table:

TEST	ACCEPTANCE CRITERIA
1. Visual inspection	When examined by normal vision or under 2.5 fold magnification, all components of the set aresmooth, clean and free of flash, surface irregularities, detachable particles, and moulding orprocessing defects
2. Effective tubing length	The effective tubing length is 350 ± 20mm
3. Dead space volume	Dead space volume for sets with standard tubing: ≤ 0.40 mlDead space volume for sets with microbore tubing: ≤ 0.20 ml
4. Air leakage (= integrity of set)	No leakage
5. Air leakage luer adaptor	No leakage at the luer connection (according to ISO 594-1 and ISO 594-2)
6. Liquid leakage luer adaptor	No leakage at the luer connection (according to ISO 594-1 and ISO 594-2)
7. Conical fitting	The conical fitting shall be within level 1-3 (according to ISO 594-1 and ISO 594-2)
8. Separation force of Luer slip tipconnection	The fitting remains attached (according to ISO 594-1)
9. Separation force of Luer lockconnection	The fitting remains attached (according to ISO 594-2)
10. Stress cracking on Luer conicalfitting	No stress cracking on the conical fitting (according to ISO 594-1 and ISO-594-2)
11. Unscrewing torque of Luer lockfittings	The fitting remains attached when the fitting between the hub and a reference fitting is testedaccording to ISO 594-2
12. Ease of assembly	A satisfactory fit is achieved when tested according to ISO 594-2
13. Overriding resistance of Luerlock systems	When the fitting between the hub and a reference fitting is tested, the reference fitting shall notoverride the threads or lugs of the fitting under test (according to ISO 594-2)
14. Torque resistance cap - adapter	The torque force required to unscrew the cap from the adapter does not exceed 9 N.cm
15. Bonding strength tube - adapter	The force required for separating the tube from the adapter is 15 N minimum.
16. Bonding strength tube - winghub	The force required for separating the tube from the wing hub is 15 N minimum.
17. Air flow choke test	Air bubbles escape out of the set when immersed under water and connected to an airline of 20kPa (0.2 bar) effective pressure, to create an airflow through the set.
18. Flow rate	Flow rate for sets with standard tubing: 23G: ≥ 2.9 ml/min & 25G: ≥ 1.6 ml/minFlow rate for sets with microbore tubing: 23G: ≥ 1.7 ml/min & 25G: ≥ 1.5 ml/min
19. Bonding strength Surshieldprotector	The bonding strength between the Surshield protector and the SV-set is minimum 4 N
20. Misalignment of SurshieldProtector	The angle measured axially from the cannula between the horizontally positioned wings and thevertically positioned Surshield protector does not exceed 15°.
21. Peel behaviour of blister	The blister is peeled by hand with minimal fibres and no paper splitting
22. Peel strength	The peel strength of the pack seal is minimum 0.15 kN/m
23. Package integrity	The integrity of the unit pack is minimum 4 kPa
24. Kink stability of tubing	Free of deformation and kinking

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The Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, meet all acceptance criteria as indicated in table above. None of the obtained data raises any new issue of safety and effectiveness.

8. Additional Safety Information

The sterility of the Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, is assured by using a validated sterilization method qualified in accordance with the requirements of EN ISO 11135-1 "Sterilization of health care products - Ethylene oxide - Part 1:Requirements for development, validation and routine control of a sterilization process for medical devices" to a sterility assurance level (SAL) of 10° 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 EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals".

The 23G and the 25G Surflo Winged Infusion Sets with Needle Protection (Surshield) are Externally Communicating devices, Circulating Blood, Limited Exposure (24 hrs). The devices' 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".

The expiration dating for the 25G Surflo Winged Infusion Sets with Needle Protection (Surshield) have been established at 5 years which is the same as the cleared Surflo Winged Infusion Sets with Needle Protection (Surshield) (K052887, K072894 and K100946).

9. Conclusion

The Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, manufactured by Terumo Europe N.V. and submitted in this 510(k) file are substantially equivalent in intended use, description, specifications, and technology/principles of operation, materials and performance to the following cleared devices:

1. Surflo Winged Infusion Set with Needle Protection (Surshield) (K052887), manufactured by Terumo Europe N.V.
Surflo Winged Infusion Set with Needle Protection (Surshield) (K072894), manufactured by 2. Terumo Europe N.V.
1. Surflo Winged Infusion Set with Needle Protection (Surshield) (K100946), manufactured by Terumo Europe N.V

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2014

Terumo Europe N.V C/O Mrs. M.J. Aerts Regulatory Affairs Manager Interleuvenlaan 40 Leuven, Belgium 3001

Re: K133867

Trade/Device Name: Surflo Winged Infusion Set with Needle Protection (Surshield) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 10, 2014 Received: January 13, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

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for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133867

Device Name

ﺜﻨﻴﺔ ﺍﻟ

Surflo Winged Infusion Set with Needle Protection (Surshield)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Digitally signed by Richard C. Chapman Date: 2014.02.05 09:32:18 -05'00'
------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

ﺔ ﺍﻟﺘﻲ

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.