The TERUMO® SURFLO® FLEX I.V. Catheters and the TERUMO® SURFLASH™ I.V. Catheters are devices consisting of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.

Device Description

The TERUMO SURFLO FLEX I.V. CATHETER AND THE TERUMO SURFLASH I.V. CATHETER are sterile, single use devices consisting of a slender tube (catheter) made of polyurethane. The devices are inserted into the patient's vascular system for short-term use to withdraw samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors.

Each device consists of a catheter assembly-catheter, caulking pin, catheter hub; a needle assembly-cannula, needle hub; and a filter cap with an air filter

The catheters are made of polyurethane, which allows appropriate stiffness for proper insertions into the vein, and flexibility during retention in the vein. Each catheter contains barium sulfate radio-opaque stripes along the length of the catheter to allow radio detectability. A stainless steel caulking pin fastens the catheter to the catheter hub.

Each catheter hub is color coded according to the outside diameter as specified in ISO 10555-5, "Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters".

The needle assembly has the same specifications as the Terumo® Surflo® I.V. Catheter, which is the subject of K891087. The transparent needle hubs permit flashback detection when the cannula enters the vessel.

The filter cap with an air filter is provided as a vent fitting.

The Terumo Surflo Flex I.V. Catheter is available in 14 sizes with different combinations of 6 catheter diameters and 5 catheter lengths (see following specifications table). The Terumo Surflash I.V. Catheter is available in 24G by 19mm currently. Additional sizes will be implemented at a later date.

The cannula of the Surflash I.V. Catheter are grooved from the heel of the cannula tip bevel to the end of the catheter tip, which allows flashback detection at the catheter tip after the catheter tip enters the vessel.

The only difference between the TERUMO SURFLO FLEX and the TERUMO SURFLASH I.V. catheters is the grooved cannula feature of the SURFLASH. All other specifications are the same.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (intravascular catheters) seeking substantial equivalence to already cleared devices. This type of submission does not typically involve the kind of elaborate clinical studies or AI performance metrics that the requested questions imply.

Therefore, many of the requested sections about acceptance criteria, detailed study designs, expert involvement, and AI performance cannot be answered from the provided document. The purpose of this 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through performance testing and material comparisons, rather than a comparative clinical trial with human and AI readers.

Here's an attempt to answer the questions based only on the provided text, and explicitly noting when information is not present:

Description of Acceptance Criteria and Device Performance Study

The TERUMO® SURFLO® FLEX I.V. Catheters and TERUMO® SURFLASH™ I.V. Catheters demonstrated substantial equivalence to predicate devices (Becton Dickinson (B-D®) Insyte® I.V. Catheter, B-D Insyte (N) I.V. Catheter, and Terumo® Surflo® I.V. Catheter) through a series of performance tests. The acceptance criterion for these tests was that the performance of the proposed devices be equivalent to that of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate equivalence. However, it does not provide specific quantitative acceptance criteria or detailed numerical results for the proposed device's performance, nor does it explicitly detail the predicate device's performance for direct comparison in the format below. The "reported device performance" is implicitly stated as meeting the equivalence standard.

Performance Test	Acceptance Criteria (Implicit: Equivalence to Predicate)	Reported Device Performance
Catheter body tensile strength (force at break of catheter)	Equivalent to predicate devices	Demonstrated substantial equivalence
Stiffness	Equivalent to predicate devices	Demonstrated substantial equivalence
Elongation	Equivalent to predicate devices	Demonstrated substantial equivalence
Burst pressure	Equivalent to predicate devices	Demonstrated substantial equivalence
Collapse	Equivalent to predicate devices	Demonstrated substantial equivalence
Flexural fatigue tolerance	Equivalent to predicate devices	Demonstrated substantial equivalence
Radio detectability	Equivalent to predicate devices	Demonstrated substantial equivalence
Flow rate	Equivalent to predicate devices	Demonstrated substantial equivalence
Corrosion resistance of caulking pin	Equivalent to predicate devices	Demonstrated substantial equivalence
Catheter body to catheter hub tensile strength (force at break of catheter/hub)	Equivalent to predicate devices	Demonstrated substantial equivalence
Catheter/needle attachment (fitting strength)	Equivalent to predicate devices	Demonstrated substantial equivalence
Vent fitting	Equivalent to predicate devices	Demonstrated substantial equivalence
Detection of flashback at catheter tip and needle hub	Equivalent to predicate devices	Demonstrated substantial equivalence
Detection of flashback at needle hub	Equivalent to predicate devices	Demonstrated substantial equivalence
Strength of union between needle hub and needle	Equivalent to predicate devices	Demonstrated substantial equivalence
Sterility (SAL of 10^-6)	Sterility assurance level (SAL) of 10^-6	Validated to provide SAL of 10^-6 (via EN 550)
Ethylene oxide residual levels	Ethylene oxide: < 25 ppm Ethylene chlorhydrin: < 25 ppm Ethylene glycol: < 250 ppm	Will not exceed specified maximum residue levels
Biocompatibility	In accordance with AAMI/ANSI/ISO 10993-1	Tested in accordance with recommended tests

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

The document does not specify the sample sizes used for each of the performance tests. The data provenance is implied to be from laboratory testing conducted by Terumo Medical Corporation (USA). The nature of these tests suggests they are prospective laboratory bench tests rather than retrospective or prospective clinical studies involving patient data from a specific country of origin.

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

This information is not applicable to this type of device and submission. The "ground truth" here is based on engineering specifications and physical property measurements, not expert interpretation of clinical data or images.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in image interpretation or clinical outcomes, which is not relevant to the physical performance tests conducted for this device.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical medical instrument and does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the performance tests would be established through defined physical and chemical measurement standards and established engineering specifications for parameters like tensile strength, flow rate, stiffness, and chemical residue levels. For biocompatibility, it's adherence to the recommended tests in FDA G95-1 (AAMI/ANSI/ISO 10993-1). For sterility, it's achieving an SAL of 10^-6 based on the EN 550 standard.

8. The sample size for the training set

This is not applicable as there is no AI or algorithm involved in this device, and thus no "training set."

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

This is not applicable as there is no AI or algorithm involved in this device, and thus no "training set."

Summary

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JUN 16 1999

K99/406

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: TERUMO® SURFLO® FLEX I.V. Catheter TERUMO® SURFLASH™ I.V. Catheter, or similar proprietary name

Classification Name: Intravascular Catheter

INTENDED USE

DESCRIPTION

Each device consists of a catheter assembly-catheter, caulking pin, catheter hub; a needle assembly-cannula, needle hub; and a filter cap with an air filter

Each catheter hub is color coded according to the outside diameter as specified in ISO 10555-5, "Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters".

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The filter cap with an air filter is provided as a vent fitting.

The only difference between the TERUMO SURFLO FLEX and the TERUMO SURFLASH I.V. catheters is the grooved cannula feature of the SURFLASH. All other specifications are the same.

SPECIFICATIONS/DIMENSIONS

Catheter gauge	Color code	Product code	Catheter length	Catheter O.D.	Catheter I.D.	Cannula gauge	Flow rate
14G	Orange	SR*OF1451	2" (51mm)	2.17mm	1.73mm	16G	316ml/min
		SR*OF1464	2-1/2" (64mm)				282ml/min
16G	Medium Grey	SR*OF1632	1-1/4"(32mm)	1.70mm	1.30mm	18G	202ml/min
		SR*OF1651	2"(51mm)				184ml/min
		SR*OF1664	2-1/2" (64mm)				177ml/min
18G	Deep Green	SR*OF1832	1-1/4"(32mm)	1.30mm	0.95mm	20G	99ml/min
		SR*OF1851	2" (51mm)				88ml/min
		SR*OF1864	2-1/2" (64mm)				80ml/min
20G	Pink	SR*OF2025	1"(25mm)	1.10mm	0.80mm	22G	73ml/min
		SR*OF2032	1-1/4"(32mm)				67ml/min
		SR*OF2051	2"(51mm)				59ml/min
22G	Deep Blue	SR*OF2225	1"(25mm)	0.85mm	0.60mm	24G	38ml/min
		SR*OF2232	1-1/4"(32mm)				30ml/min
24G	Yellow	SR*OF2419	3/4" (19mm)	0.67mm	0.47mm	27G	15ml/min

SURFLO FLEX Specification

SURFLASH Specification

Catheter gauge	Color code	Product code	Catheter length	Catheter O.D.	Catheter I.D.	Cannula gauge	Flow rate
24G	Yellow	SR*FF2419	3/4" (19mm)	0.67mm	0.47mm	27G	15ml/min

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SUBSTANTIAL EQUIVALENCE

The TERUMO® SURFLO® FLEX I.V. Catheters and the TERUMO® SURFLASH™ I.V. Catheters, submitted in this 510k, are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Becton Dickinson (B-D®) Insyte® I.V. Catheter and the B-D Insyte (N) I.V. Catheter, which are the subject of K971339 (unable to confirm); and to the Terumo® Surflo® I.V. Catheter which is the subject of K891087.

PRINCIPLE OF OPERATION/TECHNOLOGY

The Terumo SURFLO FLEX and SURFLASH I.V. catheters, the B-D® Insyte and Insyte (N) I.V. catheters, and the Terumo Surflo I.V. catheters are all operated manually .

COMPONENT	PROPOSED(SURFLO FLEX &SURFLASH)	PREDICATETERUMO SURFLO	PREDICATE INSYTE& INSYTE (ND)
Cannula	Stainless steel	Stainless steel	Stainless steel
Catheter	Polyurethane	Teflon®	Polyurethane
Radio opaquemedium	Barium sulfate	Barium sulfate	Barium sulfate
Catheter hub	Polypropylene	Polypropylene	Unknown
Caulking pin	Stainless steel	Stainless steel	Unknown
Filter cap	Polystyrene	Polystyrene	Unknown
Air filter	Polyester	Polyester	Unknown

MATERIALS

PERFORMANCE

The performance of the TERUMO® SURFLO® FLEX and the SURFLASH I.V. Catheters is equivalent to the performance of the cleared Becton-Dickinson® (B-D) Insyte® I.V. Catheter, the cleared Becton-Dickinson® (B-D) Insyte® (N) I.V. Catheter (K971339-unable to confirm), and the cleared Terumo Medical Corporation Surflo I.V. Catheter (K891087).

2007 - 100 - 100 - 100

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The following tests were performed demonstrating the substantial equivalence of the TERUMO SURFLO FLEX and the SURFLASH I.V. Catheters submitted in this 510k to the B-D Insyte I.V. Catheter, the B-D Insyte (N) I.V. Catheter and the Terumo Surflo I.V. Catheter.

Catheter body tensile strength (force at break of catheter) 1.
Stiffness 2.
Elongation 3.
Burst pressure 4.
Collapse ડ.
Flexural fatigue tolerance Q.
Radio detectability 7.
1. Flow rate
Corrosion resistance of caulking pin 9.
1. Catheter body to catheter hub tensile strength (force at break of catheter/hub)
1. Catheter/needle attachment (fitting strength)
1. Vent fitting
1. Detection of flashback at catheter tip and needle hub
1. Detection of flashback at needle hub
1. Strength of union between needle hub and needle

ADDITIONAL SAFETY INFORMATION

The sterility of the product is assured using a sterilization method validated in accordance with the European Standard, EN 550 (1994): "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization", to provide a sterility assurance level (SAL) of 10°.

Ethylene oxide residual levels resulting from EtO sterilization will not exceed the maximum residue levels proposed in the Federal Register Notice issued June 23, 1978, and indicated as follows:

Ethylene oxide	25 ppm
Ethylene chlorhydrin	25 ppm
Ethylene glycol	250 ppm

Manufacturing test methods include functional, chemical stability and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard AAMI/ANSI/ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Guidance on Selection of Tests".

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The SURFLO FLEX and SURFLASH I.V. Catheters are classified as external communicating device, circulating blood, prolonged exposure (24 hrs to 30 days).

The expiration dating for the TERUMO® SURFLO® FLEX and the TERUMO® SURFLASH™ will be 60 months.

CONCLUSION

Terumo's statement that these devices are substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

Date Prepared	April 19, 1999
Prepared by	Kristine WagnerRegulatory Affairs Specialist
Prepared for	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone (410) 392-7241 or (410) 392-7231Fax (410) 398-6079

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with three intertwined snakes. The logo is rendered in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1999

Ms. Kristine Wagner Regulatory Affairs Specialist Terumo Medical Corporation Requlatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921

Re : K991406 TERUMO® SURFLO® FLEX I.V. CATHETER and Trade Name: TERUMO® SURFLASH™ I.V. CATHETER Requlatory Class: II FOZ Product Code: Dated: April 19, 1999 Received: April 22, 1999

Dear Ms. Wagner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Ms. Wagner

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991406

TERUMO® SURFLO® FLEX I.V. CATHETER and TERUMO® Device Name: SURFLASH I.V. CATHETER

Indications For Use:

The TERUMO® SURFLO® FLEX I.V. Catheters and the TERUMO® SURFLASH™ I.V. Catheters are devices consisting of a slender, flexible, radioopaque, plastic catheter with a hub. The plastic catheter is inserted into the patient's vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrice Cucenti

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use

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).