K Number

Device Name

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

Manufacturer

TERUMO EUROPE N.V.

Date Cleared

2014-02-05

(47 days)

Product Code

FPA

Regulation Number

880.5440

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K052887, K072894, K100946

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is used for accessing the peripheral vascular system for fluid administration or blood withdrawal, and for needle protection, none of which are considered therapeutic actions but rather diagnostic or supportive.

Diagnostic

Explanation: The device is an infusion set used to administer fluids or withdraw blood, and it includes features for needle protection. Its primary function is for access to the vascular system and fluid/blood management, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly details physical components like a needle, winged hub, tubing, adapter, cap, and a hinged shield cover. The performance studies also focus on physical characteristics and integrity tests of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to access the peripheral vascular system for administering fluids and withdrawing blood specimens. This is a direct interaction with the patient's body for therapeutic or diagnostic sample collection purposes.
Device Description: The description details a physical device used for accessing veins and protecting against needle sticks. It does not describe any components or processes for analyzing biological samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing blood or other biological samples, detecting specific analytes, or providing diagnostic information based on sample analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for obtaining the specimen or administering treatment, not for analyzing the specimen itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FPA

Device 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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: Visual inspection, ACCEPTANCE CRITERIA: 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
TEST: Effective tubing length, ACCEPTANCE CRITERIA: The effective tubing length is 350 ± 20mm
TEST: Dead space volume, ACCEPTANCE CRITERIA: Dead space volume for sets with standard tubing: ≤ 0.40 ml; Dead space volume for sets with microbore tubing: ≤ 0.20 ml
TEST: Air leakage (= integrity of set), ACCEPTANCE CRITERIA: No leakage
TEST: Air leakage luer adaptor, ACCEPTANCE CRITERIA: No leakage at the luer connection (according to ISO 594-1 and ISO 594-2)
TEST: Liquid leakage luer adaptor, ACCEPTANCE CRITERIA: No leakage at the luer connection (according to ISO 594-1 and ISO 594-2)
TEST: Conical fitting, ACCEPTANCE CRITERIA: The conical fitting shall be within level 1-3 (according to ISO 594-1 and ISO 594-2)
TEST: Separation force of Luer slip tip connection, ACCEPTANCE CRITERIA: The fitting remains attached (according to ISO 594-1)
TEST: Separation force of Luer lock connection, ACCEPTANCE CRITERIA: The fitting remains attached (according to ISO 594-2)
TEST: Stress cracking on Luer conical fitting, ACCEPTANCE CRITERIA: No stress cracking on the conical fitting (according to ISO 594-1 and ISO-594-2)
TEST: Unscrewing torque of Luer lock fittings, ACCEPTANCE CRITERIA: The fitting remains attached when the fitting between the hub and a reference fitting is tested according to ISO 594-2
TEST: Ease of assembly, ACCEPTANCE CRITERIA: A satisfactory fit is achieved when tested according to ISO 594-2
TEST: Overriding resistance of Luer lock systems, ACCEPTANCE CRITERIA: 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)
TEST: Torque resistance cap - adapter, ACCEPTANCE CRITERIA: The torque force required to unscrew the cap from the adapter does not exceed 9 N.cm
TEST: Bonding strength tube - adapter, ACCEPTANCE CRITERIA: The force required for separating the tube from the adapter is 15 N minimum.
TEST: Bonding strength tube - wing hub, ACCEPTANCE CRITERIA: The force required for separating the tube from the wing hub is 15 N minimum.
TEST: Air flow choke test, ACCEPTANCE CRITERIA: 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.
TEST: Flow rate, ACCEPTANCE CRITERIA: 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
TEST: Bonding strength Surshield protector, ACCEPTANCE CRITERIA: The bonding strength between the Surshield protector and the SV-set is minimum 4 N
TEST: Misalignment of Surshield Protector, ACCEPTANCE CRITERIA: The angle measured axially from the cannula between the horizontally positioned wings and the vertically positioned Surshield protector does not exceed 15°.
TEST: Peel behaviour of blister, ACCEPTANCE CRITERIA: The blister is peeled by hand with minimal fibres and no paper splitting
TEST: Peel strength, ACCEPTANCE CRITERIA: The peel strength of the pack seal is minimum 0.15 kN/m
TEST: Package integrity, ACCEPTANCE CRITERIA: The integrity of the unit pack is minimum 4 kPa
TEST: Kink stability of tubing, ACCEPTANCE CRITERIA: Free of deformation and kinking

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.

Key Metrics

Not Found

Predicate Device(s)

K052887, K072894, K100946

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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 Affairs
Tel. (+32) 16 38 13 53
Fax (+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

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 with
Needle Protection (Surshield)
(K052887) & (K072894)
(SV-S23BL35VS & SV-S25BL35VS)	SV-S23BL35 & SV-S25BL35:
a) Change of code
b) Change of adapter design
c) Change of adapter material from PP to PMMA (material PMMA adapter
already cleared under K100946)
d) Change of adapter cap design
e) Change of adapter cap material from PE to PP.
f) Connection wing hub - tube from glue to solvent bonding
g) Connection Surshield protector from cyano-acrylate glue to UV curing glue
h) Change of specification for dead space volume
i) Update of labeling
Surflo Winged Infusion Set with
Needle Protection (Surshield)
(K100946)
(SV-S23WL35 & SV-S25WL35)	SV-S23WL35 & SV-S25WL35:
a) Change of tube supplier (material remains identical)
b) Change of adapter design
c) Change of adapter cap design
d) Change of adapter cap material from PP to different grade of PP.
e) Connection wing hub - tube from tetrahydrofurane solvent bonding to
cyclohexanone solvent bonding
f) Connection tube - adapter: from solvent to glue bonding
g) Connection Surshield protector from cyano-acrylate glue to UV curing glue

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	Update of labeling
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7. Summary of Verification Activities:

TEST	ACCEPTANCE CRITERIA
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
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 ml
Dead 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 tip
connection	The fitting remains attached (according to ISO 594-1)
9. Separation force of Luer lock
connection	The fitting remains attached (according to ISO 594-2)
10. Stress cracking on Luer conical
fitting	No stress cracking on the conical fitting (according to ISO 594-1 and ISO-594-2)
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
12. Ease of assembly	A satisfactory fit is achieved when tested according to ISO 594-2
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)
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 - wing
hub	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 20
kPa (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/min
Flow rate for sets with microbore tubing: 23G: ≥ 1.7 ml/min & 25G: ≥ 1.5 ml/min
19. Bonding strength Surshield
protector	The bonding strength between the Surshield protector and the SV-set is minimum 4 N
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°.
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

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.

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.

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

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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