The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Device Description

The TERUMO® Surshield® Safety I.V. Catheter are devices consisting of an over-the needle, peripheral catheter made of an a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

AI/ML Overview

The provided text describes the TERUMO® Surshield® SAFETY I.V. CATHETER. The performance section indicates that several tests were performed on the device. However, the document does not explicitly state acceptance criteria for these tests, nor does it provide a detailed study that proves the device meets specific acceptance criteria with quantifiable results. The information mainly lists the types of tests conducted and specifies the materials and sterilization methods used.

Therefore, for aspects like "reported device performance" against "acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "ground truth type," "training set size," and "ground truth establishment for training set," the information is not available in the provided document.

Here's an attempt to structure the answer based on the available information, indicating where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Reactive force to close shutter (Safety mechanism)	Not specified	Not specified
Force to detach safety cover from catheter hub (Safety feature activation)	Not specified	Not specified
Initial sliding friction (Catheter and Needle attachment)	Not specified	Not specified
Tensile strength of safety cover and needle (Safety mechanism break strength)	Not specified	Not specified
Force to needle breaking safety cover (Puncture resistance of needle shield)	Not specified	Not specified
Flow rate	Not specified	Not specified (Table G provides typical flow rates for different gauges, but not performance against a specific criterion for this test)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

This type of information is not relevant or applicable for the device described, as it is a physical medical device and not an AI/diagnostic software. No ground truth was established by experts in this context.

4. Adjudication method for the test set

Not applicable as no expert adjudication for ground truth was involved.

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. This is a physical medical device, not an AI/diagnostic system.

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 AI/diagnostic system.

7. The type of ground truth used

Not applicable. For this type of physical medical device, "ground truth" would be objective measurements and functional tests according to established standards (e.g., force measurements, flow rate, biocompatibility tests). The document indicates such tests were performed but does not detail the "ground truth" methodology beyond listing the test types.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI training sets.

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

Not applicable. This is a physical medical device and does not involve AI training sets or ground truth establishment in that context.

Summary of available performance claims related to acceptance:

The document states that the listed tests (Reactive force to close shutter, Force to detach safety cover, Initial sliding friction, Tensile strength, Force to needle breaking safety cover, Flow rate) were performed. It also specifies material equivalence to predicate devices and validated sterilization methods (ISO 11135-2007 to a SAL of 10-6, and EtO residual limits per ISO 10993-7). These aspects imply compliance with relevant standards and safety requirements, which effectively serve as "acceptance criteria" for regulatory clearance, even if explicit performance results against those criteria are not detailed in this specific summary. The 510(k) clearance itself (K082362) indicates that the FDA found the device "substantially equivalent" to predicate devices based on the submitted information, which would have included data demonstrating safety and effectiveness.

Summary

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SEP 1 7 2008

K082362 (P. 1 of 4)

Section II. 510(k) SUMMARY

A. Device Name

Proprietary Name

TERUMO® Surshield® SAFETY I.V. CATHETER or similar proprietary name

Classification Name

Intravascular Catheter (880.5200) Panel & Product Code: FOZ Classification: Class II

Common Name

Intravascular catheter with needle protection device

B. Predicate Device

The TERUMO® Surshield® SAFETY I.V. CATHETER manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance:

1. K891087 TERUMO® SURFLO® I.V. Catheter for the catheter portion only
1. K991406 TERUMO® SURFLASH® I.V. Catheter for the needle portion only
1. K020785 B.BRAUN Introcan Safety" I.V. Catheter

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

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K 482362 (P. 2 of 4)

C. Intended Use

The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

D. Description

E. Principle of Operation / Technology

The TERUMO® Surshield® SAFETY IV CATHETER is operated manually.

Design / Materials F.

The materials are the same materials as used in the TERUMO® SURFLO® I.V. Catheter (K891087) and the TERUMO® SURFLASH® I.V. Catheter (K991406).

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Terumo Corporation TERUMO® Surshield® SAFETY I.V. CATHETER II. 510(k) Summary

K482362 (P.3 of 4)

G Specifications

Product code	Cathetergauge	Color code	Catheterlength	CatheterO.D	CatheterI.D	Cannulagauge	Flow rate	Lumenvolume*
SR*SFA1832A	18G	Deep Green	1-1/4"(32mm)	1.3mm	0.95mm	20G	100mL/min	23 µL
SR*SFA2032A	20G	Pink	1-1/4"(32mm)	1.1mm	0.80mm	22G	60mL/min	16 µL
SR*SFA2225A	22G	Deep Blue	1"(25mm)	0.9mm	0.60mm	24G	35mL/min	7 µL
SR*SFA2419A	24G	Yellow	3/4"(19mm)	0.7mm	0.47mm	27G	15mL/min	3 µL

*Catheter only

H. Performance

The following tests were performed on the TERUMO® Surshield® SAFETY IV CATHETER manufactured by Terumo Corporation:

1. Reactive force to close shutter (Reaction force generated by the safety mechanism)
1. Force to detach safety cover from catheter hub (Force to activate safety feature)
1. Initial sliding friction (Catheter and Needle attachment)
1. Tensile strength of safety cover and needle (Break strength of safety mechanism)
1. Force to needle breaking safety cover (Puncture resistance of the needle shield)
1. Flow rate

I. Additional Safety Information

The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135-2007. The Surshield® Safety IV Catheter is sterilized to provide a Sterility Assurance Level (SAL) of 10-6.

Ethylene oxide residual levels (EtO and ECH) resulting from EtO sterilization will not exceed the maximum residue limits in accordance with ISO 10993-7: Biological Evaluation of Medical Devices -- Part 7: Ethylene Oxide Sterilization Residuals and AAMI TIR19 Guidance for ANSI / AAMI / ISO 10993-7:1995, Biological Evaluation for Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (and amendment).

The addition of the safety devices requires no additional biocompatibility testing, because there is no blood/fluid contact.

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Terumo Corporation TERUMO® Surshield® SAFETY I.V. CATHETER II. 510(k) Summary

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J. Substantial Equivalence

1. K891087 TERUMO® SURFLO® I.V. Catheter for the catheter portion only
1. K991406 TERUMO® SURFLASH® I.V. Catheter for the needle portion only
1. K020785 B.BRAUN Introcan Safety™ I.V. Catheter

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

K. Submitter Information

Date Prepared: 08/06/2008

Prepared by: Eileen Dorsey Regulatory Affairs Specialist Terumo Medical Corporation 950 Blue Ball Road Elkton, MD 21921 Phone: (410) 392-7241 Fax: (410) 398-6079

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized representation of a human figure embracing another person, symbolizing care and protection.

SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corporation C/O Mr. Mark Job Responsible Third Party Officer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K082362

Trade/Device Name: TERUMO® Surshield® SAFETY I.V. CATHETER Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 3, 2008 Received: September 4, 2008

Dear Mr. Job:

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 Eederal Register.

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Page 2 – Mr. Job

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 clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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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Indications for Use

510(k) Number (if known): K432362

TERUMO® Surshield® SAFETY I.V. CATHETER Device Name:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Artur Lem

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).