The ILT Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guide wire in order to access discrete regions of the vasculature. 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 0.018" 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 0.018" Safe-Cross Deflecting Catheter is 135cm. The shaft deflecting segment maximum outside diameter is 4.3Fr at a use pressure of 10atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires.

The 0.018" Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray 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

The provided text is a 510(k) summary for a medical device (Safe-Cross® Deflecting Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with precise acceptance criteria and performance metrics. Therefore, many of the requested data points (e.g., sample sizes for test and training sets, expert qualifications, specific performance metrics against acceptance criteria, MRMC studies, standalone algorithm performance) are not included within this type of regulatory submission.

However, based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the device performs similarly to the predicate device and meets established safety and performance requirements for its intended use. Specific quantitative performance targets are not explicitly stated for parameters like sensitivity, specificity, or reader improvement, as would be common for AI/diagnostic software. Instead, the focus is on the device's physical and functional characteristics.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate and Device Specifications)	Reported Device Performance (Summary)
Biocompatibility	Meets established standards for patient safety in contact with blood/tissue.	"Biocompatibility... indicate that the 0.018" Safe-Cross Deflecting Catheter satisfies safety... requirements..."
Mechanical Performance	Similar tensile strength, flexibility, lubricity, burst pressure, and other physical characteristics to the predicate device, specifically adapted for the 0.018" guidewire. Ability to accommodate 0.018" guidewires. Ability to deflect.	"...mechanical performance to the predicate device.""I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires."
Material Composition	Similar materials to the predicate device, including the hydrophilic coating.	"...similar in basic materials, design, construction...""coated with a Biocoat Hydak® hydrophilic coating..."
Sterility	Sterility assurance level (SAL) achieved (e.g., 10^-6). Non-pyrogenic.	"The device is provided 'STERILE', 'Non-Pyrogenic'..."
Intended Use Compatibility	Effectively functions in accessing peripheral vasculature, facilitating guidewire exchange, and delivering saline/contrast.	"performance testing indicate that the 0.018" Safe-Cross Deflecting Catheter satisfies... performance requirements of the device specifications..."

2. Sample Sizes and Data Provenance for Test Set

Sample Size: Not specified. The document mentions "Biocompatibility and performance testing," but does not detail the number of units tested or whether human subjects were involved (unlikely for this type of 510(k) for a catheter enhancement). These tests are typically benchtop or in vitro, and sometimes an in vivo animal study, but the specifics are not provided.
Data Provenance: Not specified. Given the nature of a 510(k) for mechanical changes to a catheter, the data would primarily be from internal laboratory/bench testing. It is not clinical data from patients or countries of origin in the way typical of AI models. It is entirely retrospective on the device itself.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts/Qualifications: Not applicable in the context of this device. Ground truth for a physical medical device like a catheter is established through validated engineering specifications, material science, and performance testing against industry standards, not through expert consensus on images or clinical outcomes.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. There is no concept of "adjudication" in the sense of reconciling expert opinions for establishing ground truth for a physical device's specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is a physical medical device (catheter), not an AI algorithm or diagnostic imaging tool that would involve human readers interpreting cases with or without AI assistance.

6. Standalone Performance Study

Standalone Performance: Yes, in an engineering and functional sense. The "performance testing" described in the document is a standalone evaluation of the device's physical and functional characteristics (e.g., integrity, flow capacity, deflection mechanism, guidewire compatibility) according to its design specifications. It is not an "algorithm-only" performance in the context of AI.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device is based on engineering specifications and established industry standards for catheters (e.g., material strength, dimensions, coating integrity, sterility validation) and comparison to the performance of the predicate device. It is not pathology, expert consensus on imaging, or patient outcomes data directly.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set" of data.

9. How Ground Truth for Training Set was Established

Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary

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K040481

510(K) SUMMARY

SUBMITTER INFORMATION

A.	Company Name:	IntraLuminal Therapeutics, Inc.
B.	Company Address:	6354 Corte Del Abeto – Suite ACarlsbad, CA 92009
C.	Company Phone:	(760) 918-1820
D.	Company Facsimile:	(760) 603-9615
E.	Contact Person:	Pamela MisajonVice President of Regulatory Affairs and Quality Assurance

DEVICE IDENTIFICATION

A.	Device Trade Name:	Safe-Cross® Deflecting Catheter (0.018")
B.	Catalog Number:	C118ND1
C.	Device Common Name:	Support Catheter
D.	Classification Name:	Percutaneous Catheter
E.	Device Class:	Class II (per 21 CFR 870.1250)

IDENTIFICATION OF PREDICATE DEVICE

The predicate device is the 0.014" Safe-Cross Deflecting Catheter, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K032784.

DEVICE DESCRIPTION

The effective length of the 0.018" Safe-Cross Deflecting Catheter is 135cm. The shaft deflecting segment maximum outside diameter is 4.3Fr at a use pressure of 10atm. The

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I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires.

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 Safe-Cross Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

TECHNOLOGICAL CHARACTERISTICS

The 0.018" Safe-Cross Deflecting Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device. The guidewire lumen and outside diameter have been increased to be compatible with commercially available 0.018* guidewires.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility and performance testing indicate that the 0.018" Safe-Cross Deflecting Catheter satisfies safety and performance requirements of the device specifications and do not raise additional safety issues.

CONCLUSIONS DRAWN FROM STUDIES

On the basis of the testing conducted on the 0.018" Safe-Cross Deflecting Catheter it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The 0.018" Safe-Cross Deflecting Catheter is substantially equivalent to the predicate device.

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

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2004

IntraLuminal Therapeutics, Inc. c/o Pamela Misajon c/o Fallera Misajon
Vice President of Regulatory Affairs and Quality Assurance 6354 Corte del Abeto, Suite A Carlsbad, Ca 92009

K040481 Re: ILT 0.018" Safe-Cross® Deflecting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 24, 2004 Received: February 25, 2004

Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > IV(x) premater is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivale in i referenced above and have decemblicated medicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior in May 20, 1970, the charge with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance with as peo arket approval applications (PMA).
and Cosmetic Act (Act) that do not require approval or arousions of the Act . and Cosmetic Act (Act) that to not require the general controls provisions of the Act. The You may, meretore, market the devreet, solice to annual registration, listing of
general controls provisions of the Act include requirements for anyages misbranding and general controls provisions of the Fret merade required.
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 If your device is classified (sec above) in claim a control and many of the can in addition. EDA may may be subject to such additional controllar Existing may on 898. In addition, FDA may be found in the Code of I concerning your device in the Federal Register.

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Page 2 - Ms. Pamala Misajon

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); 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. 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) 594-4648. 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duma R. Kuhnes

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

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Indications for Use

Safe-Cross® Deflecting Catheter (0.018")

KA0481 510(k) Number (if known):

Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

Duma R. La Lune

(Division Sign-Off) Division of Cardiovascular Devices

KOA 1,4 8 510(k) Number

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).