The ILT Support Catheter with or without the advancing mechanism 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 ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The ILT Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to be used in conjunction with a 0.014" steerable guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The ILT Support Catheter may also be used for The ILT 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 ILT Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 0.037". The distal region incorporates a radiopaque marker band to aid in visualization under fluoroscopy. The inside diameter of the ILT Support Catheter shaft will accommodate a commercially available 0.014" guidewire. The ILT-Support Catheter Advancing Mechanism is a handle with a connecting luer in the proximal region that is mated to the ILT Support Catheter. The handle includes and advancing mechanism that allows for incremental advancement of the guidewire. This advancing mechanism allows for free movements of the guidewire through the catheter shaft. The ILT Support Catheter and the ILT-Support-Catheter-Advancing-Mechanism are packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ILT Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and study proving device performance:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance values. Instead, it describes general claims of performance based on testing.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Biocompatibility	Device materials must be biocompatible.	"Biocompatibility test results indicate that the device materials are biocompatible."
Functional Performance	Device must satisfy functional performance requirements when used as indicated.	"Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
Sterility	Device must be sterile and non-pyrogenic.	"The packaged catheter is sterilized by ethylene oxide gas. The ILT Support Catheter is provided "STERILE" and "Non-pyrogenic"."
Material/Design Equivalence	Modified device (without advancing mechanism) must be substantially equivalent to the predicate device.	"The results of testing demonstrate that the ILT Support Catheter with out the advancing mechanism is substantially equivalent to the predicate device..."
Intended Use Safety/Accuracy	Device must be capable of safely and accurately performing the stated intended use.	"...and is capable of safely and accurately performing the stated intended use."

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the "test set" (i.e., the number of devices or components tested). It generally refers to "Biocompatibility testing and in vitro bench studies."
- Data Provenance: The studies were "in vitro bench studies" performed by IntraLuminal Therapeutics, Inc. The country of origin of the data is not specified beyond the company's location in Carlsbad, CA, USA. The studies appear to be prospective, as they were conducted to evaluate the device prior to clearance.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The studies described are primarily bench and biocompatibility tests, not clinical studies requiring expert ground truth for interpretation.
Adjudication Method for the Test Set:
- This information is not applicable and not provided. The studies reported are not clinical trials requiring adjudication of results by multiple experts.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes bench and biocompatibility studies, not studies involving human readers or comparative effectiveness in a clinical setting.
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 catheter, not an AI/algorithm-based diagnostic or therapeutic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the biocompatibility tests would be established by standardized toxicological assays and material science principles.
- For the in vitro bench studies, the "ground truth" would be the engineering specifications and functional parameters being evaluated (e.g., specific dimensions, material strength, flow rates).
- No expert consensus, pathology, or outcomes data is mentioned as ground truth for these studies.
The sample size for the training set:
- This information is not applicable and not provided. This device is a physical medical catheter, not an AI/algorithm-based system that uses training sets.
How the ground truth for the training set was established:
- This information is not applicable and not provided for the same reason as above.

Summary

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AUG 3 0 2001

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:	ILT Support Catheter and ILT Support CatheterAdvancing Mechanism
B.	Catalog Number:	C114LW1 – ILT Support CatheterA115AM1 – ILT Support Catheter AdvancingMechanism
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 ILT Support Catheter is a similar in design, materials, mode of operation and intended use to the IntraLuminal Therapeutics, Inc. ILT 0.014" Catheters cleared under 510(k) K001992. The modified device separates the catheter from the advancing mechanism.

DEVICE DESCRIPTION

046 ﺎ ﮨﺎ

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The effective length of the ILT Support Catheter is a nominal 135 cm. The nominal The enective longin of the 12 - Saffench (0.037"). The distal region incorporates a maximum outside diamotor to 210 fretton (onder fluoroscopy. The inside diameter of the ILT Support Catheter shaft will accommodate a commercially available 0.014" quidewire.

-The ILT-Support Catheter Advancing Mechanism is a handle with a connecting luer in The ILT Oupport Catholor nated to the ILT Support Catheter. The handle includes and advancing mochanism that allows for incremental advancement of the guidewire. This anovaning moonament the froo movements of the guidewire through the catheter shaft.

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

INTENDED USE

The ILT 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 ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

TECHNOLOGICAL CHARACTERISTICS

The ILT Support Catheter is similar in basic materials, design, construction and mechanical performance to the previously cleared ILT .014" Catheter. The modification separates the advancing mechanism (handle) from the catheter and allows the ability to use the ILT Support Catheter with or without the advancing mechanism..

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing and in vitro bench studies were conducted to evaluate the biological and performance characteristics of the ILT 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 ILT Support Catheter with out the advancing mechanism is substantially equivalent to the predicate device and is 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "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.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

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

K012169 Re:

ILT Support Catheter and ILT Support Catheter Advancing Mechanism Regulation Number: 870.1250 Regulatory Class: II (two) Product Code: DQY Dated: August 10, 2001 Received: August 13, 2001

Dear Ms. Misajon:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally be is substantially equivalent (for the indications for use above and we nave determined the avveeted predicate devices marketed in interstate commerce Stated in the energiane) to legally manage of the Medical Device Amendments, or to devices that prof to May 20, 1970, the chassistence with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (11ct). Tournal) ; actives ; ; increases) ; ; } = } = = = include requirements for annual provisions of the rea. "The Prices, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket / pprovally, while Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Manancial ing Praval regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspoculity, the Read and may result in regulatory action. In addition, FDA may publish compry with the Original concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Pamela Misajon

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to ocemanaling , quivalence of your device to a legally marketed noutication. The I Driving of vice in the 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 and If you desire specific days of the stic devices), please contact the Office of Compliance at additionally 607.10 for in This chaghestions on the promotion and advertising of your device, (201) 594-4560. Runnenary, 2011 - 12:4639. Also, please note the regulation prease conder the Childer reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsion.com Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

KO12169

510(k) Number: Device Name:

ILT Support Catheter (with or without Advancing Mechanism)

Indications For Use:The ILT Support Catheter with or without the advancing mechanism is indicated to be used in conjunction with a steerable guidewire in indicated to be access discreet regions of the vasculature. Once the order to accessed, an exchange of one guidewire for another can occur. The ILT Support Catheter may also be used another san occanduit 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 & Perinatal Services
510(k) Number K021669

016

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).