The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The Safe-Cross® Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross® Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guide wires.

The Safe-Cross® Deflecting Catheter is packaged in a Tyvek® covered custom PETG trav that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.

AI/ML Overview

This document is a 510(k) summary for a medical device called the Safe-Cross® Deflecting Catheter. It focuses on establishing substantial equivalence to a predicate device, not on AI/ML-driven performance or standalone algorithm efficacy. Therefore, much of the requested information regarding AI device evaluation is not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device Performance)	Reported Device Performance (Safe-Cross® Deflecting Catheter)
Biocompatibility	Meets established biocompatibility standards for intravascular devices.	"Biocompatibility test results indicate that the device materials are biocompatible."
Functional Performance	Satisfies functional requirements (e.g., guide wire access, exchange, delivery of solutions).	"Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
Material/Design Similarity	Similar basic materials, design, construction to predicate.	"The Safe-Cross® Deflecting Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device."
Physical Dimensions	Effective length, OD, ID comparable to predicate/clinically acceptable.	"The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip...is a nominal 0.016" and...accommodate commercially available 0.014" guide wires."
Sterility	Sterilized and non-pyrogenic.	"The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic"."

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

Sample Size: Not explicitly stated as a "test set" in the context of AI/ML evaluation. The document refers to "Biocompatibility testing and bench studies," but the number of devices or iterations tested is not provided.
Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin for images). These are bench tests and biocompatibility studies.

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

Not applicable. This is a traditional medical device submission, not an AI/ML device. Ground truth as typically defined for AI models (e.g., expert labels on medical images) is not relevant here.

4. Adjudication method for the test set

Not applicable. This is a traditional medical device submission, not an AI/ML 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

No. This document describes a traditional medical device (catheter), not an AI/ML-powered device. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

No. This document describes a traditional medical device (catheter), not an AI/ML-powered device with a standalone algorithm.

7. The type of ground truth used

For biocompatibility: Adherence to recognized biological safety standards (e.g., ISO 10993).
For performance: Engineering specifications and functional requirements as determined by the manufacturer and assessed through bench testing (e.g., ability to accommodate guide wires, withstand pressure).
For substantial equivalence: Comparison against the characteristics of the legally marketed predicate device (IntraLuminal Therapeutics, Inc. ILT Deflecting Catheter cleared under 510(k) K010531).

8. The sample size for the training set

Not applicable. This is a traditional medical device submission, not an AI/ML device that requires a training set.

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

Not applicable. This is a traditional medical device submission, not an AI/ML device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER INFORMATION

A.	Company Name:	IntraLuminal Therapeutics, Inc
B.	Company Address:	6354 Corte del AbetoSuite ACarlsbad, CA 92009
C.	Company Phone:	(760) 918-1820
D.	Company Facsimile:	(760) 918-1823
E.	Contact Person:	Pamela MisajonVice President of Regulatory Affairs and QualityAssurance
	DEVICE IDENTIFICATION
A.	Trade Name:	Safe-Cross® Deflecting Catheter
A.	Trade Name:	Safe-Cross® Deflecting Catheter
B.	Catalog Number:	C114ND1
C.	Common Name:	Support Catheter
D.	Classification Name:	Percutaneous Catheter
E.	Device Class:	Class II (per 21 CFR 870.1250)

IDENTIFICATION OF PREDICATE DEVICE

The Safe-Cross® Deflecting Catheter is similar in design, materials, and intended use to the IntraLuminal Therapeutics, Inc. ILT Deflecting Catheter cleared under 510(k) K010531.

DEVICE DESCRIPTION

ﺮﻧ

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INTENDED USE

The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the peripheral vasculature and facilitate placement of the guide wire. Once the region has been accessed, an exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

TECHNOLOGICAL CHARACTERISTICS

The Safe-Cross® Deflecting Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing and bench studies were conducted to evaluate the biological and performance characteristics of the Safe-Cross® Deflecting Catheter. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.

CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the Safe-Cross® Deflecting Catheter is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

IntraLuminal Therapeutics, Inc. c/o Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6254 Corte del Abeto, Suite A Carlsbad, CA 92009

Re: K031692

Trade Name: Safe-Cross Deflecting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 30, 2003 Received: June 27, 2003

Dear Ms. Misajon:

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 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

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Page 2 – Ms. Pamela Misajon

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Arlene B. Brown

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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INDICATIONS FOR USE

510(k) Number:	K031692
Device Name:	ILT Safe-Cross® Deflecting Catheter
Indications for Use:	The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

510(k) Number:

K031692

Device Name:

ILT Safe-Cross® Deflecting Catheter

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Ashley B. Beams
(Division Sign Off)

(Division Sign-Off) (Division Sign-Qili)
Division of Cardiovascular Devices

510(k) Number K031692

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).