The TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm and 20G × 51mm catheter sizes) 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.

Device Description

The TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) are devices consisting of an over-the needle, peripheral catheter made of 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 The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries.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 a Special 510(k) submission for a medical device, the TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against a medical condition.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth generation is not applicable to this document because it describes a 510(k) submission for a modified device, which focuses on demonstrating substantial equivalence to a predicate device rather than on novel performance validation.

Here's a breakdown based on the provided text, indicating why certain information is not present:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence)

This submission relies on demonstrating substantial equivalence to a predicate device (K082362 TERUMO® Surshield® SAFETY I.V. CATHETER). The "performance" section states: "All performance testing conducted on the TERUMO® Surshield® SAFETY IV CATHETER (51mm sizes length) manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate."

Therefore, there are no explicit acceptance criteria or direct performance metrics against a disease condition as would be found in a study for a novel device. The criteria for acceptance are that the new device performs equivalently to the predicate.

Study Details (Not Applicable - Substantial Equivalence)

The filing for a Special 510(k) for a modified device doesn't typically involve new clinical studies that establish de novo performance against a medical condition. The focus is on ensuring the changes to the device do not raise new issues of safety or effectiveness compared to the predicate.

Therefore, the following information is not available in the provided text:

Sample size used for the test set and the data provenance: No new test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a new test set with expert-established ground truth is not part of this type of submission.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this device does not involve an algorithm.
Type of ground truth used: Not applicable.

Training Set Information (Not Applicable - Substantial Equivalence)

Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device Information from Text:

The provided document is a 510(k) summary for a TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter length).

Proprietary Name: TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter)
Classification Name: Intravascular Catheter (880.5200)
Product Code: FOZ
Classification: Class II
Predicate Device: K082362 TERUMO® Surshield® SAFETY I.V. CATHETER
Intended Use: 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. The needle shield feature aids in the prevention of needle stick injuries.
Description: Over-the-needle, peripheral catheter made of a slender, flexible, radio-opaque, plastic catheter with a hub. Stainless steel cannula for rigidity. Passive safety mechanism for needle stick injury prevention.
Principle of Operation: Manually operated.
Materials: Same as the predicate device (K082362).
Performance: All performance testing determined the modified device was substantially equivalent to the predicate. The differences do not raise any new issues of safety or effectiveness.

Key takeaway: This document does not describe a study to prove a device meets specific acceptance criteria in the sense of a clinical trial for a novel product. Instead, it demonstrates substantial equivalence of a modified device to a previously cleared predicate and that the modifications do not alter its safety or effectiveness.

Summary

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Koromb

Terumo Corporation SPECIAL 510(K) - TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

MAY - 1 2009

Section II. 510(k) SUMMARY

A. Device Name

Proprietary Name

TERUMO® Surshield® SAFETY I.V. CATHETER (51mm 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 (51mm catheter) manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance:

K082362 TERUMO® Surshield® SAFETY I.V. CATHETER .
The differences between the devices do not raise any new issues of safety or effectiveness.

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Terumo Corporation

SPECIAL 510(K) - TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

C. Intended Use

The TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter length) 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 (51mm catheter length) is operated manually.

Design / Materials F.

1. The materials are the same materials as used in the TERUMO® Surshield® SAFETY I.V. CATHETER (K082362).

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Terumo Corporation SPECIAL 510(K) - TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

G. Specifications

Product code	Cathetergauge	Color code	Catheterlength	CatheterO.D*	CatheterI.D	Cannulagauge	Flow rate	Lumenvolume**
SR*SFA1851A	18G	Deep Green	2"(51mm)	1.3mm	0.95mm	20G	90mL/min	36 $\mu$ L
SR*SFA2051A	20G	Pink	2"(51mm)	1.1mm	0.80mm	22G	55mL/min	26 $\mu$ L

*Catheter O.D. is fabeled value. ** Catheter only

H. Performance

The testing was conducted in order to adhere to the performance standards and design control requirements. All pcrformance testing conducted on the TERUMO® Surshield® SAFETY IV CATHETER (51mm sizes length) manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate.

I. Substantial Equivalence

The TERUMO® Surshield® SAFETY I.V. CATHETER (51mm length catheter) manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, safety feature, manufacturing process, materials and performance:

K082362 TERUMO® Surshield® SAFETY I.V. Catheter .
The differences between the devices do not raise any new issues of safety or effectiveness.

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Terumo Corporation SPECIAL 510(K) -- TERUMO® Surshicld® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

K. Submitter Information

Date Prepared: 03/01/2009

Lynne Witkowski Prepared by: Sr. 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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Terumo Corporation C/o Ms. Lynne Witkowski Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921

Re: K090973

Trade/Device Name: TERUMO®Surshield®Safety I.V. Catheter (18G x 51mm & 20G x 51mm sizes)

Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 3, 2009 Received: April 6, 2009

Dear Ms. Witkowski:

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 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.

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.

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Page 2- Ms. Witkowski

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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours,

Susan Rose

Susan Runner, D.D.S., MA Acting 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): _

Device Name: TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm & 20G × 51mm sizes)

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) >

: ØGØØ5

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

510(k) Number: K030973

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).