Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical catheter device and its performance characteristics, with no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device, a support catheter, is intended to assist in accessing vasculature and delivering substances, not to treat a disease or condition.

Diagnostic

No

The device is a support catheter for guide wires and delivery of agents, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical catheter with a lubricous coating, radiopaque marker bands, and a Luer connector, indicating it is a hardware device.

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 clearly states the device is for guide wire support, exchange, and delivery of saline/contrast agents within the peripheral vasculature. This is an interventional procedure performed directly on the patient's body.
Device Description: The description details a catheter designed for intravascular use, providing support and allowing for guide wire exchange. This aligns with a medical device used in a clinical setting, not a diagnostic test performed on samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely procedural and supportive during a medical intervention.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.

Product codes

DQY

Device Description

The GlideCross Support Catheters are single lumen intravascular catheters designed for use in the peripheral vasculature. The catheters provide support to guide wires during access of the vasculature and allow for exchange of guide wires while maintaining vessel access. The GlideCross Support Catheters are available in 9 models compatible with various guide wire sizes and have a lubricous hydrophilic coating on the distal shaft and a female Luer on the proximal end. The catheters have 3 encapsulated radiopaque marker bands evenly spaced along the distal shaft, with the distal band 3 mm from the tip, to aid in positioning of the catheter tip and in estimating distances.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

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

The Terumo GlideCross Support Catheter submitted in this 510(k), and the Spectranetics QUICK CROSS CATHETERS cleared under K033678 have similar performance characteristics. The following performance tests were conducted on these catheters. Testing was performed on the Terumo GlideCross Support Catheters and the Spectranetics QUICK CROSS CATHETERS.

1. Trackability
1. Wire Support

Pushability/Crossability

1. Lubricity
  The performance of the Terumo GlideCross Support Catheter is substantially equivalent to the performance of the predicate devices.

In addition, the following tests were performed on the Terumo GlideCross Support Catheter to assure proper performance. All test results met the pre-approved specifications.

1. Simulated use
1. Length
1. Penetration
1. Visual inspections-Catheter Tip
1. Visual inspections- Marker bands
1. Visual appearance / foreign matter
1. Outer diameter: Catheter tip
1. Outer diameter: Proximal shaft
1. Flow rate
1. Catheter burst
1. Inner diameter: Hub
12)Inner diameter: Catheter tip
1. Luer taper
1. Luer assembly
1. Luer resistance to overriding
1. Force at break
1. Kink resistance
1. Catheter leakage
1. Marker spacing
1. Coating length
1. Coating Integrity and Particulate Release Verification
1. Torque Testing

Biocompatibility testing was conducted:

Physicochemical profile: Meets Requirements
Cytotoxicity- L929 Neutral Red Uptake-ISO: Not considered to have cytotoxic potential
Hemolysis: Non-hemolytic
In vitro Hemocompatibility Assay - ISO Direct Contact: Pass
Thrombogenicity Study in Dogs: Thrombosis was not considered significant
Complement Activation: Meets Requirements
Unactivated Partial Thromboplastin time: Meets Requirements
Prothrombin Time: No adverse effect on the prothrombin time of human plasma
Sensitization: Meets requirements
Intracutaneous Reactivity: Meets requirements
Acute Systemic Toxicity: Negative
Pyrogenicity: Meets Requirements
Genotoxicity: Not considered to be mutagenic

Limited screening tests were conducted on the accelerated aged, 2x EO sterile device to demonstrate that aging does not affect the device's biocompatibility. The results are summarized in the table below.

Physicochemical profile: Meets Requirements
Cytotoxicity: Not considered to have cytotoxic potential
Hemolysis: Non-hemolytic

Key Metrics

Not Found

Predicate Device(s)

K033678

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

0

JUL 2 9 2011

SECTION II. 510(K) SUMMARY

A. Device Name

Proprietary Name:	GlideCross Support Catheter
Classification Name:	Percutaneous catheter
21 CFR 870.1250
Class II
Common Name:	Percutaneous catheter
Product Code:	DQY
Panel:	Cardiovascular

B. Intended Use

The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.

C. Device Description

The GlideCross Support Catheters are single lumen intravascular catheters designed for use in the peripheral vasculature. The catheters provide support to guide wires during access of the vasculature and allow for exchange of guide wires while maintaining vessel access. The GlideCross Support Catheters are available in 9 models compatible with various guide wire sizes and have a lubricous hydrophilic coating on the distal shaft and a female Luer on the proximal end. The catheters have 3 encapsulated radiopaque marker bands evenly spaced along the distal shaft, with the distal band 3 mm from the tip, to aid in positioning of the catheter tip and in estimating distances.

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KHI556 page 7 of 10

Device Specifications:
Model #	54-143	54-145	54-189	54-183	54-185	54-156	54-159	54-153	54-155
Maximum
Guidewire,
inch/mm	0.014 /0.36	0.014 /0.36	0.018 /0.46	0.018 /0.46	0.018 /0.46	0.035 /0.89	0.035 /0.89	0.035 /0.89	0.035 /0.89
Working
Length, cm	135	150	90	135	150	65	90	135	150
Minimum
Guidewire
length, cm	180	180	150	180	180	150	150	180	180
Marker Band
Spacing, mm	15	15	15	15	15	50	50	50	50
Proximal Shaft
Diameter,
inch/mm	0.063 /1.60	0.063 /1.60	0.063 /1.60	0.063 /1.60	0.063 /1.60	0.063 /1.60	0.063 /1.60	0.063 /1.60	0.063 /1.60
Distal Shaft
Diameter,
inch/mm	0.029 /0.74	0.029 /0.74	0.033 /0.84	0.033 /0.84	0.033 /0.84	0.051 /1.30	0.051 /1.30	0.051 /1.30	0.051 /1.30
Tip Outside
Diameter,
inch/mm	0.019 /0.48	0.019 /0.48	0.024 /0.61	0.024 /0.61	0.024 /0.61	0.040 /1.02	0.040 /1.02	0.040 /1.02	0.040 /1.02
Hydrophilic
Coating
Length, cm	60	60	60	60	60	40	60	60	60
Minimum
Introducer
Sheath, French	5	5	5	5	5	5	5	5	5

Image /page/1/Figure/3 description: The image shows a diagram of a catheter. The diagram labels the "luer", "strain relief", and "catheter working length" of the catheter. The diagram also shows the "marker spacing" and indicates that the spacing is 3 mm. The diagram provides a visual representation of the catheter's components and dimensions.

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K111556 page 3 of 10

D. Reason for Premarket Notification

This premarket notification is being submitted for the GlideCross Support Catheter which is a new device being manufactured by Terumo Medical Corporation.

E. Statement of Equivalence

The GlideCross Support Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the Spectranetics QUICK CROSS CATHETERS cleared under K033678 1.

F. Principle Of Operation / Technology

The GlideCross Support Catheter is operated manually or by a manual process.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then a guiding catheter or sheath would be advanced over the guide wire. Next, the GlideCross Support Catheter would be inserted over the guide wire and through the hemostasis valve of the guiding catheter or sheath. The guide wire and GlideCross Support Catheter would then be advanced to the target vessel. The GlideCross Support Catheter can then be used for injection of contrast media or for support and exchange of guide wires.

1 A statement of substantially equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits'' 42 Fed. Reg. 42,520, et seq. (1977)

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K111556 page 4 of 10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

G. Design / Materials

The GlideCross Support Catheter in this submission uses similar materials as the predicate devices. Differences in materials between the devices do not raise any new issues of safety and effectiveness. Below is a table with a comparison of the materials used in the GlideCross Support Catheter and the predicate devices:

| | | QUICK CROSS
CATHETERS | Terumo GlidCross
Support Catheter |
|----------|------------------------------------|--------------------------|-------------------------------------------------------------|
| | | K033678 | – |
| Design | Construction | Single layer | Two layers distal section, One layer
on proximal section |
| | Number of
Radiopaque
markers | 3 | 3 |
| Material | Inner layer | Polyethylene | Polyester elastomer (Pebax) |
| | Outer layer | – | Polyester elastomer (Pebax) |
| | Radiopaque
marker | Platinum | Platinum alloy |

4

K111556 page 5 of 10

H. Specifications

The Terumo GlideCross Support Catheter submitted in this 510(k) and the Spectranetics QUICK CROSS CATHETERS cleared under K033678 have similar device specifications. Differences in specifications between the devices do not raise any new issues of safety and effectiveness.

| Item | QUICK CROSS
CATHETERS K033678 | Terumo GlideCross
Support Catheter |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Effective lengths | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm |
| Number of radiopaque
markers | 3 | 3 |
| Distance from distal tip to
first radiopaque marker | 3mm | 3mm |
| Radiopaque marker spacing | 15mm (for 0.014 &0.018
wire compatible catheters)
50mm (for 0.035 wire
compatible catheter) | 15mm (for 0.014 &0.018
wire compatible
catheters)
50mm (for 0.035 wire
compatible catheter) |
| Guidewire Compatibility | 0.014, 0.018, 0.035 inch | 0.014, 0.018, 0.035 inch |
| Maximum Injection Pressure | 300psi | 300psi |
| Minimum Introducer Sheath
Compatible With | 4Fr-5Fr depending on
model number | 5Fr |
| Tip design/shape | Straight | Straight |
| Hydrophilic Coating | Distal 40cm | Distal 40-60cm |

5

K111556 page 6 of 10

I. Performance

The Terumo GlideCross Support Catheter submitted in this 510(k), and the Spectranetics QUICK CROSS CATHETERS cleared under K033678 have similar performance characteristics. The following performance tests were conducted on these catheters. Testing was performed on the Terumo GlideCross Support Catheters and the Spectranetics QUICK CROSS CATHETERS.

1. Trackability
1. Wire Support

Pushability/Crossability

1. Lubricity
  The performance of the Terumo GlideCross Support Catheter is substantially equivalent to the performance of the predicate devices.

In addition, the following tests were performed on the Terumo GlideCross Support Catheter to assure proper performance. All test results met the pre-approved specifications.

1. Simulated use
1. Length
1. Penetration
1. Visual inspections-Catheter Tip
1. Visual inspections- Marker bands
1. Visual appearance / foreign matter
1. Outer diameter: Catheter tip
1. Outer diameter: Proximal shaft
1. Flow rate
1. Catheter burst
1. Inner diameter: Hub
12}Inner diameter: Catheter tip
1. Luer taper
1. Luer assembly
1. Luer resistance to overriding
1. Force at break
1. Kink resistance
1. Catheter leakage
1. Marker spacing
1. Coating length
1. Coating Integrity and Particulate Release Verification
1. Torque Testing

6

K111556 page 7 of 10

J. Additional Safety Information

Biocompatibility testing was conducted in accordance with 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" and ISO 10993-1:2009, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process."

GlideCross Support Catheter is classified as Externally Communication Device, Circulating Blood, Limited Contact (up to 24 hours). The Terumo Support Catheter successfully passed all of the following biocompatibility tests:

7

KUI556 page 8 of 10

Biocompatibility Testing on non-aged, 2x EO sterile GlideCross Support Catheter
Test/Details	Details (if applicable)	Standard	Result
Physicochemical profile		USP	Meets Requirements
Cytotoxicity- L929
Neutral Red Uptake-ISO	L929 Neutral Red Uptake	ISO 10993-5	Not considered to have cytotoxic potential
Hemolysis	Direct Contact	ASTM F756	Non-hemolytic
In vitro
Hemocompatibility Assay - ISO Direct
Contact	Direct Contact	ISO 10993-4	Pass
Thrombogenicity Study in Dogs		ISO 10993-4	Thrombosis was not considered significant
Complement
Activation	C3a & SC5b-9, Direct Contact	ISO 10993-4	Meets Requirements
Unactivated Partial
Thromboplastin time	Direct Contact	ISO 10993-4	Meets Requirements
Prothrombin Time	Direct Contact	ISO 10993-4	No adverse effect on the prothrombin time of human plasma
Sensitization	Kligman Maximization, NaCl and CSO extracts	ISO 10993-10	Meets requirements
Intracutaneous
Reactivity	Intracutaneous Injection, NaCl and CSO extracts	ISO 10993-10	Meets requirements
Acute Systemic
Toxicity	Systemic Injection, NaCl and CSO extracts	ISO 10993-11	Negative
Pyrogenicity	Rabbit Pyrogen, Material Mediated	ISO 10993-11	Meets Requirements
Genotoxicity	Reverse mutation assay, Salmonella typhimurium and Escherichia coli	ISO 10993-3	Not considered to be mutagenic

8

In addition, limited screening tests were conducted on the accelerated aged, 2x EO sterile device to demonstrate that aging does not affect the device's biocompatibility. The results are summarized in the table below.

Biocompatibility Testing on aged, 2x EO sterile GlideCross Support Catheter
Test	Details (if applicable)	Standard	Result
Physicochemical
profile		USP	Meets Requirements
Cytotoxicity	L929 Neutral Red
Uptake	ISO 10993-5	Not considered to have
cytotoxic potential
Hemolysis	Direct Contact	ASTM
F756	Non-hemolytic

The sterilization conditions have been validated according to ISO 11135, Sterilization of Health Care Products-Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10 °.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.

The GlideCross is certified to be non-pyrogenic in the unopened and undamaged package. Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) test is performed on each lot of production accordance to the United States Pharmacopoeia (USP) Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices"; 1987.

9

I. Substantial Equivalence

The Terumo GlideCross Support Catheter submitted in this 510(k) is substantially equivalent in the general intended use, design, technology/principles of operation, materials, and performance to the Spectranetics QUICK CROSS CATHETERS cleared under K033678. Differences between the devices do not raise any issues of safety or effectiveness.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

J. Submitter Information

| Prepared By: | Mr. Mark Unterreiner
Sr. Regulatory Affairs Specialist |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
Registration No.: 111 888 0
Phone: (410) 392-7213
Fax: (410) 398-6079
Email: mark.unterreiner@terumomedical.com |
| Date Prepared: | June 3, 2011 |

10

Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and a wavy line underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Terumo Medical Corp. % Mark Unterreiner 950 Elkton Blvd Elkton, MD 21921

JUL 2 9 2011

Re: K111556

Trade/Device Name: GlideCross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous catheter Regulatory Class: Class II Product Code: DQY Dated: June 3, 2011 Received: June 6, 2011

Dear Mr. Unterreiner:

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.

11

Page 2 - Mr. Mark Unterreiner

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.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

12

K111556 page 1 of 1

Indications for Use
510(k) Number (if known):	K111556
Device Name:	GlideCross Support Catheter
Indications For Use:	The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.
Prescription Use (Part 21 CFR 801 Subpart D)	X
	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)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K111556