The Safe Cross® Support Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe Cross Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The Safe Cross® Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to use in conjunction with a .014" and .018" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. The Safe Cross® Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The effective length of the Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 2.8 French (0.037"). The distal region incorporates a radiopaque material to aid in visualization under fluoroscopy. The inside diameter of the Support Catheter shaft will accommodate a commercially available .014" and .018" quide wire.

The Safe Cross® Support Catheter is packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The Safe Cross Coated Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.

AI/ML Overview

The provided text is related to a 510(k) Premarket Notification for a medical device called the "ILT Safe Cross® Support Catheter". This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study that would typically establish detailed acceptance criteria and performance against those criteria through extensive clinical trials.

Therefore, the information required to populate the requested table and answer the specific study-related questions (sample size, experts, adjudication, MRMC, standalone performance, ground truth details) is not present in the provided document. The 510(k) summary explicitly states that the device modification was evaluated through "Biocompatibility testing and in vitro bench studies" to demonstrate substantial equivalence, not a clinical study involving human patients, ground truth establishment by experts, or AI performance metrics.

Here's an explanation and an attempt to address the relevant points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain a table of explicit acceptance criteria or specific quantitative performance metrics beyond general statements of "biocompatible" and "satisfies functional performance requirements." This is typical for a 510(k) submission demonstrating substantial equivalence based on bench testing.

Acceptance Criteria	Reported Device Performance
Biocompatibility	Device materials are biocompatible (concluded from testing).
Functional Performance	Device satisfies functional performance requirements when used as indicated (concluded from in vitro bench studies).
Substantial Equivalence	Modifications are substantially equivalent to the predicate device and capable of safely and accurately performing the stated intended use (conclusion from overall testing).
Accommodates Guide Wires	Accommodates commercially available .014" and .018" guide wires (design specification).
Radiopacity	Distal region incorporates a radiopaque material to aid in visualization under fluoroscopy (design specification).
Sterility & Non-pyrogenic	Provided "STERILE" and "Non-pyrogenic" (packaging and sterilization claim).

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

Sample Size: Not specified. The document mentions "Biocompatibility testing and in vitro bench studies" but does not detail the number of samples or test runs.
Data Provenance: Not specified, but generally, bench testing and biocompatibility studies are conducted in a controlled lab environment. There is no mention of country of origin for data or whether it's retrospective or prospective, as it's not a clinical study in that sense.

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

Not Applicable. This device is a physical catheter, and its performance evaluation for this 510(k) was based on engineering bench tests and biocompatibility assessments, not on subjective expert interpretation or ground truth establishment relevant to AI/diagnostic performance.

4. Adjudication method for the test set:

Not Applicable. As mentioned above, there was no expert-based adjudication in the context of this 510(k) submission.

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 is a physical medical device (catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

No. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used:

Bench Testing Standards/Specifications & Biocompatibility Standards: The "ground truth" for this type of device evaluation would be established engineering specifications, industry standards for catheter performance (e.g., burst pressure, tensile strength, pushability, trackability), and recognized standards for biocompatibility (e.g., ISO 10993 series). The document states that "Performance test results indicate that the device satisfies functional performance requirements."

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI algorithm, so there is no training set in the context of machine learning.

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

Not Applicable. As above, no training set for an AI algorithm.

Summary

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APR 2 4 2003

K030984

Special 510(k) Premarket Notification
ILT Safe Cross® Support Catheter

510(k) Summary of Safety and Effectiveness

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) 918-1823
E.	Contact Person:	Pamela MisajonVice President of Regulatory Affairs and QualityAssurance

DEVICE IDENTIFICATION

A.	Device Trade Name:	Safe Cross® Support Catheter
B.	Catalog Number:	C114AN1 – Safe Cross® .014" Angled Support Catheter
		C114SN1 – Safe Cross® .014" Straight Support Catheter
		C118AN1 – Safe Cross® .018" Angled Support Catheter
		C118SN1 – Safe Cross® .018" Straight Support Catheter
C.	Device Common Name:	Percutaneous Catheter
D.	Classification Name:	Percutaneous Catheter
E.	Device Class:	Class II (per 21 CFR 870.1250)

IDENTIFICATION OF MODIFIED DEVICE

The Safe Cross® Support Catheter is a similar in design, materials, mode of operation and intended use to the IntraLuminal Therapeutics, Inc. 0.014" Support Catheter cleared under 510(k) K012169. The device modification includes the devices to be coated with a hydrophilic coating and a new .018" Support Catheter Model. The new .018" Support Catheter is a single lumen intravascular catheter with same intended use. But will accommodate a .018" guide wire.

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16030984

DEVICE DESCRIPTION

INTENDED USE

The Safe Cross® Support Catheter is indicated to be used in conjunction with a steerable quidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one quidewire for another can occur. The Safe Cross® Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

TECHNOLOGICAL CHARACTERISTICS

The Safe Cross Support Catheter is similar in basic materials, design, construction and mechanical performance to the previously cleared .014" Catheter. The device modification includes the devices to be coated with a Bio-coat Hydak® hydrophilic coating and an additional .018" Support Catheter Model.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing and in vitro bench studies were conducted to evaluate the biological and performance characteristics of the Support 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 modifications to the Safe Cross Support Catheter are substantially equivalent to the predicate device and are capable of safely and accurately performing the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IntraLuminal Therapeutics, Inc. Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6354 Corte Del Abeto - Suite A Carlsbad, CA 92009

Re: K030984

Trade/Device Name: Safe Cross® Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 15, 2003 Received: April 16, 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 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

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Page 2 - Ms. Pamela Misajon

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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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1.6 INDICATIONS FOR USE FORM

INDICATIONS FOR USE

Kb30984 510(k) Number: Safe Cross® Support Catheter Device Name:

The Safe Cross® Support Catheter is indicated to be used in Indications For Use: conjunction with a steerable guidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe Cross Support 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 i

(Per 21 CFR 801.109)

Over-The-Counter Use _____________

N. Derler Th

510(k) Number K033482

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).