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.

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.

AI/ML Overview

The provided document describes a medical device, the GlideCross Support Catheter, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria in a human study. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert ground truth, sample sizes for training/test sets, etc.) is not applicable in this context.

Instead, acceptance criteria and performance are demonstrated through engineering testing, material comparisons, and biocompatibility assessments to show that the new device is as safe and effective as its predicate.

Here's an analysis of the provided information, framed to address the spirit of your request where applicable, even if direct answers for AI/ML device studies are not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GlideCross Support Catheter are largely derived from ensuring its specifications and performance are similar to its predicate device (Spectranetics QUICK CROSS CATHETERS, K033678) and that it meets established industry standards for medical devices of its type. The "reported device performance" refers to the results of various engineering and biocompatibility tests.

Acceptance Criteria Category	Specific Criteria / Test	Performance Outcome (Reported Device Performance)
Device Specifications	Effective lengths	65, 90, 135, 150 cm (Similar to predicate)
	Number of radiopaque markers	3 (Similar to predicate)
	Distance from distal tip to first radiopaque marker	3 mm (Similar to predicate)
	Radiopaque marker spacing (0.014 & 0.018 wire)	15 mm (Similar to predicate)
	Radiopaque marker spacing (0.035 wire)	50 mm (Similar to predicate)
	Guidewire Compatibility	0.014, 0.018, 0.035 inch (Similar to predicate)
	Maximum Injection Pressure	300 psi (Similar to predicate)
	Minimum Introducer Sheath Compatible With	5 Fr (Predicate: 4Fr-5Fr depending on model number; GlideCross meets 5Fr)
	Tip design/shape	Straight (Similar to predicate)
	Hydrophilic Coating	Distal 40-60 cm (Predicate: Distal 40 cm; GlideCross covers this range)
Functional Performance	Trackability	Substantially equivalent to predicate devices
	Wire Support	Substantially equivalent to predicate devices
	Pushability/Crossability	Substantially equivalent to predicate devices
	Lubricity	Substantially equivalent to predicate devices
	Simulated use	All test results met pre-approved specifications
	Length	All test results met pre-approved specifications
	Penetration	All test results met pre-approved specifications
	Visual inspections - Catheter Tip	All test results met pre-approved specifications
	Visual inspections - Marker bands	All test results met pre-approved specifications
	Visual appearance / foreign matter	All test results met pre-approved specifications
	Outer diameter: Catheter tip	All test results met pre-approved specifications
	Outer diameter: Proximal shaft	All test results met pre-approved specifications
	Flow rate	All test results met pre-approved specifications
	Catheter burst	All test results met pre-approved specifications
	Inner diameter: Hub	All test results met pre-approved specifications
	Inner diameter: Catheter tip	All test results met pre-approved specifications
	Luer taper	All test results met pre-approved specifications
	Luer assembly	All test results met pre-approved specifications
	Luer resistance to overriding	All test results met pre-approved specifications
	Force at break	All test results met pre-approved specifications
	Kink resistance	All test results met pre-approved specifications
	Catheter leakage	All test results met pre-approved specifications
	Marker spacing	All test results met pre-approved specifications
	Coating length	All test results met pre-approved specifications
	Coating Integrity and Particulate Release Verification	All test results met pre-approved specifications
	Torque Testing	All test results met pre-approved specifications
Biocompatibility	Physicochemical profile	Meets Requirements (USP <661>)
	Cytotoxicity	Not considered to have cytotoxic potential (ISO 10993-5)
	Hemolysis	Non-hemolytic (ASTM F756)
	In vitro Hemocompatibility Assay	Pass (ISO 10993-4)
	Thrombogenicity Study in Dogs	Thrombosis was not considered significant (ISO 10993-4)
	Complement Activation	Meets Requirements (ISO 10993-4)
	Unactivated Partial Thromboplastin time	Meets Requirements (ISO 10993-4)
	Prothrombin Time	No adverse effect on the prothrombin time of human plasma (ISO 10993-4)
	Sensitization	Meets requirements (ISO 10993-10)
	Intracutaneous Reactivity	Meets requirements (ISO 10993-10)
	Acute Systemic Toxicity	Negative (ISO 10993-11)
	Pyrogenicity	Meets Requirements (ISO 10993-11)
	Genotoxicity	Not considered to be mutagenic (ISO 10993-3)
Sterilization	Sterility Assurance Level (SAL)	10⁻⁶ (Validated per ISO 11135)
	Residual Ethylene Oxide (EO)	Not exceeding 4 mg per device (Meets ISO 10993-7 for limited exposure)
	Residual Ethylene Chlorohydrin (ECH)	Not exceeding 9 mg per device (Meets ISO 10993-7 for limited exposure)
	Non-pyrogenic certification	Certified non-pyrogenic; LAL test performed each lot (per USP <85>) and validated per FDA guideline.

2. Sample Size Used for the Test Set and Data Provenance

For a traditional medical device (not AI/ML), the "test set" primarily refers to the number of individual devices or components subjected to each specific physical, mechanical, or biological test. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for trackability or burst pressure). However, it implies that sufficient samples were tested to demonstrate conformity to specifications and substantial equivalence to the predicate.

The data provenance is from Terumo Medical Corporation's in-house testing facilities, likely following established laboratory procedures and standards (e.g., ISO, ASTM, USP) for medical device evaluation. This is a prospective generation of data specifically for this 510(k) submission, comparing the new device's performance against its own pre-approved specifications and in comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not directly applicable to a traditional medical device 510(k) submission concerning physical and mechanical properties. "Ground truth" in this context is established by:

Engineering specifications and standards: These are the objective benchmarks (e.g., maximum pressure, specific lengths, material properties) that the device must meet.
Predicate device's performance: The Spectranetics QUICK CROSS CATHETERS (K033678) serves as the established benchmark for "safe and effective" performance through its prior clearance.
Regulatory standards: ISO, ASTM, and USP standards for biocompatibility and sterilization are the "ground truth" for these aspects.

The expertise lies in the engineers, scientists, and quality assurance personnel who design the tests, conduct them, and interpret the results against these established standards. Their qualifications would typically involve degrees in engineering, materials science, biology, and chemistry, with experience in medical device testing and regulatory affairs. Their 'number' is not specified globally but would involve teams for each testing area.

4. Adjudication Method for the Test Set

Again, this is not applicable in the context of a physical medical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (e.g., imaging reads) to resolve disagreements. For engineering tests, the "adjudication" is inherent in:

Objective measurements: A tensile strength test yields a numerical result. Either it meets the specification or it doesn't.
Pre-defined pass/fail criteria: Each test has clear parameters for what constitutes a successful outcome.
Comparison to predicate: Direct comparison of measurements or observations with the predicate device's characteristics.
Standard compliance: Meeting the requirements of relevant ISO or ASTM standards.

Any discrepancies or failures would lead to investigation, redesign, or retesting, rather than an "adjudication" in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. MRMC studies are clinical effectiveness studies typically used for diagnostic devices (like imaging software) to assess how human reader performance changes with or without AI assistance across multiple cases and readers. The GlideCross Support Catheter is an interventional/support device, and its safety and effectiveness are demonstrated through engineering tests, biocompatibility, and comparison to a predicate device, not through human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an AI algorithm. Its performance is entirely dependent on the physical properties of the catheter and its interaction with physiological systems and clinicians.

7. The Type of Ground Truth Used

The ground truth used for this device can be categorized as:

Engineering Specifications/Standards: Detailed quantitative and qualitative requirements for the device's physical and mechanical properties (e.g., dimensions, strength, flexibility, flow rates, coating integrity).
Predicate Device Performance Profile: The known and accepted performance characteristics of the legally marketed predicate device (Spectranetics QUICK CROSS CATHETERS, K033678). The "substantial equivalence" claim relies on the new device performing similarly.
International and National Standards: Compliance with recognized standards for biocompatibility (ISO 10993 series, ASTM F756), sterilization (ISO 11135, ISO 10993-7), and endotoxin testing (USP <85>, FDA guidelines). These standards themselves represent established "ground truths" for safety.

8. The Sample Size for the Training Set

No "training set" in the context of machine learning was used. This device is a physical product, not an AI/ML model. Therefore, the concept of a training set is not applicable. The design and manufacturing processes are refined through engineering development and quality control, not iterative training on data.

9. How the Ground Truth for the Training Set Was Established

Since there was no "training set" for an AI/ML model, this question is not applicable. For physical device development, the "ground truth" (i.e., desired performance and specifications) for the design phase is established through:

Clinical needs assessment: Understanding the requirements for guide wire support and delivery in peripheral vasculature.
Benchmarking against existing products: Analyzing the predicate device (Spectranetics QUICK CROSS CATHETERS) and other similar devices to inform design goals.
Material science: Selecting materials with known properties suitable for the intended use.
Engineering principles: Applying principles of mechanical engineering and fluid dynamics to design the catheter.
Regulatory requirements: Ensuring the design inherently meets relevant safety and performance standards.

Summary

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JUL 2 9 2011

SECTION II. 510(K) SUMMARY

A. Device Name

Proprietary Name:	GlideCross Support Catheter
Classification Name:	Percutaneous catheter21 CFR 870.1250Class II
Common Name:	Percutaneous catheter
Product Code:	DQY
Panel:	Cardiovascular

B. Intended Use

C. Device Description

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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
MaximumGuidewire,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
WorkingLength, cm	135	150	90	135	150	65	90	135	150
MinimumGuidewirelength, cm	180	180	150	180	180	150	150	180	180
Marker BandSpacing, mm	15	15	15	15	15	50	50	50	50
Proximal ShaftDiameter,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 ShaftDiameter,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 OutsideDiameter,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
HydrophilicCoatingLength, cm	60	60	60	60	60	40	60	60	60
MinimumIntroducerSheath, 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

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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 CROSSCATHETERS	Terumo GlidCrossSupport Catheter
		K033678	–
Design	Construction	Single layer	Two layers distal section, One layeron proximal section
	Number ofRadiopaquemarkers	3	3
Material	Inner layer	Polyethylene	Polyester elastomer (Pebax)
	Outer layer	–	Polyester elastomer (Pebax)
	Radiopaquemarker	Platinum	Platinum alloy

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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 CROSSCATHETERS K033678	Terumo GlideCrossSupport Catheter
Effective lengths	65, 90, 135, 150 cm	65, 90, 135, 150 cm
Number of radiopaquemarkers	3	3
Distance from distal tip tofirst radiopaque marker	3mm	3mm
Radiopaque marker spacing	15mm (for 0.014 &0.018wire compatible catheters)50mm (for 0.035 wirecompatible catheter)	15mm (for 0.014 &0.018wire compatiblecatheters)50mm (for 0.035 wirecompatible catheter)
Guidewire Compatibility	0.014, 0.018, 0.035 inch	0.014, 0.018, 0.035 inch
Maximum Injection Pressure	300psi	300psi
Minimum Introducer SheathCompatible With	4Fr-5Fr depending onmodel number	5Fr
Tip design/shape	Straight	Straight
Hydrophilic Coating	Distal 40cm	Distal 40-60cm

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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

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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:

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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 <661>	Meets Requirements
Cytotoxicity- L929Neutral Red Uptake-ISO	L929 Neutral Red Uptake	ISO 10993-5	Not considered to have cytotoxic potential
Hemolysis	Direct Contact	ASTM F756	Non-hemolytic
In vitroHemocompatibility Assay - ISO DirectContact	Direct Contact	ISO 10993-4	Pass
Thrombogenicity Study in Dogs		ISO 10993-4	Thrombosis was not considered significant
ComplementActivation	C3a & SC5b-9, Direct Contact	ISO 10993-4	Meets Requirements
Unactivated PartialThromboplastin 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
IntracutaneousReactivity	Intracutaneous Injection, NaCl and CSO extracts	ISO 10993-10	Meets requirements
Acute SystemicToxicity	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

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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
Physicochemicalprofile		USP <661>	Meets Requirements
Cytotoxicity	L929 Neutral RedUptake	ISO 10993-5	Not considered to havecytotoxic potential
Hemolysis	Direct Contact	ASTMF756	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) <85> 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.

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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 UnterreinerSr. Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Registration No.: 111 888 0Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com
Date Prepared:	June 3, 2011

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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.

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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

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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

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).