The Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire 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.

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 guidewires 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, guidewires 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" guidewires.

The 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 describes a 510(k) premarket notification for a medical device called the "ILT Safe-Cross® Deflecting Catheter." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive performance studies against pre-defined acceptance criteria for efficacy or diagnostic performance. Instead, the "acceptance criteria" here refer to the functional performance requirements of the device and its biocompatibility, which are typically met through bench testing and standard biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI-based device's performance. Instead, it discusses the device's functional characteristics and how its performance was evaluated against these.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Biocompatibility	Device materials must be biocompatible (to ensure safety when in contact with body tissues). (Implicit)	"Biocompatibility test results indicate that the device materials are biocompatible."
Functional Performance	Device must satisfy functional performance requirements for its intended use (e.g., ability to facilitate guidewire access and exchange, suitable for delivering saline/contrast). (Implicit)	"Performance test results indicate that the device satisfies functional performance requirements when used as indicated." Specific dimensions are provided as characteristics, implying they meet design specifications: - Effective length: 135-140 cm - Shaft nominal O.D.: 2.5 F (0.033") - Max O.D. of deflecting segment: 3.5 F (0.045") at 10 atm - I.D. at tip: 0.016" - Accommodates 0.014" guidewires
Sterility	Device must be sterile. (Implicit)	"The packaged units are sterilized with ethylene oxide gas. The device is provided 'STERILE'."
Pyrogenicity	Device must be non-pyrogenic. (Implicit)	"'Non-Pyrogenic'"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "bench studies" and "biocompatibility testing." These types of studies typically involve a set number of manufactured devices tested against engineering specifications and biological safety standards. However, the exact sample sizes for these tests are not specified in the provided text. The data provenance is also not specified, though it would originate from the manufacturer's testing facilities. These were likely prospective tests performed on newly manufactured devices.

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 as the device is a medical catheter, not a diagnostic device relying on expert interpretation of data or images to establish ground truth for performance. The "ground truth" for this device's performance would be objective measurements against engineering specifications and standard biocompatibility assay results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation of medical data where there's a need to resolve discrepancies between multiple readers.

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

An MRMC study was not done. This device is a physical catheter, not an AI or imaging-based diagnostic system. Therefore, there's no concept of human readers or AI assistance in its direct use or evaluation in the context of this 510(k) submission.

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 catheter, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on:

Engineering Specifications: Measurements of physical dimensions, flexibility, pushability, torqueability, and other mechanical properties against pre-defined design criteria.
Standard Biocompatibility Test Results: Objective results from assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) performed according to international standards (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

Summary

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K032784

NOV 1 8 2003

510(k) SUMMARY

SUBMITTER INFORMATION

A.	Company Name:	IntraLuminal Therapeutics, Inc.
----	---------------	---------------------------------

B. Company Address:

C. Company Phone:

Company Facsimile: D.

ய் Contact Person:
nc

6354 Corte del Abeto Suite A Carlsbad, CA 92009

(760) 918-1820

(760) 918-1823

Pamela Misajon Vice President of Requlatory Affairs and Quality Assurance

DEVICE IDENTIFICATION

A. Trade Name: B. Catalog Number: C114ND1 C. Support Catheter Common Name: D. Classification Name: Percutaneous Catheter
Device Class: E.

ILT Safe-Cross® Deflecting Catheter

Class II (per 21 CFR 870.1250)

IDENTIFICATION OF MODIFIED DEVICE

The ILT Safe-Cross® Deflecting Catheter is identical in design, materials and mode of operation to the IntraLuminal Therapeutics, Inc. ILT Safe-Cross Deflecting Catheter cleared under 510(k) K031692.

DEVICE DESCRIPTION

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INTENDED USE

The Safe-Cross Deflecting Catheter is indicated to be used with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire 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 Safe-Cross Deflecting Catheter is identical 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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Image /page/2/Picture/11 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a bird or eagle, with three curved lines forming its body and wings, symbolizing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2003

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

Re: K032784

ILT Safe-Cross® Deflecting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: October 17, 2003 Received: October 20, 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.

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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.gov/cdrh/dsma/dsmamain.html

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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INDICATIONS FOR USE

510(k) Number: K032784

ILT Safe-Cross® Deflecting Catheter Device Name:

The Safe-Cross® Deflecting Catheter is indicated to Indications for Use: be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K032784

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).