The IntraLuminal Therapeutics Torquer is a plastic device that allows for manipulating and directional control of a guide wire. The Torquer will accommodate commercially available quide wires ranging in size from 0.014" to 0.035". The Torquer can be sideloaded onto the quide wire after the wire is in place within the catheter. When the finger tabs of the ILT Torquer are squeezed and the iaws of the ILT Torquer open, the quide wire can be placed inside. Releasing the finger tabs allows the jaws to close, capturing and firmly gripping the guide wire.

The ILT Torquer is packaged in a Tyvek®/mylar pouch that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", 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 Torquer." This document focuses on demonstrating that the device is substantially equivalent to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a clinical trial for an AI/ML device would.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. This 510(k) is for a mechanical medical device, not an AI/ML diagnostic or prognostic tool.

However, I can extract the relevant information regarding performance and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Performance Requirements	In vitro bench studies were conducted to evaluate the performance characteristics. Performance test results indicate the device satisfies functional performance requirements when used as indicated.
Accommodate Guide Wires	The Torquer will accommodate commercially available guide wires ranging in size from 0.014" to 0.035".
Ability to Sideload	The Torquer can be sideloaded onto the guide wire after the wire is in place within the catheter.
Grip Guide Wire	Releasing the finger tabs allows the jaws to close, capturing and firmly gripping the guide wire.
Sterility	The device is provided "STERILE" and sterilized with ethylene oxide gas.
Biocompatibility	Not required as there is no patient contact.
Substantial Equivalence	The results of testing demonstrate that the ILT Torquer is substantially equivalent to the predicate device [Boston Scientific Corporation wireClip™ cleared under 510(k) K003398].

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

Sample Size: Not specified. The document only mentions "In vitro bench studies" were conducted.
Data Provenance: Not applicable/specified. Bench testing is typically performed in a laboratory setting, not with patient data.

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 mechanical device, and ground truth in the context of expert review for diagnostic accuracy is not relevant here. Performance was assessed via bench tests.

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

Not Applicable.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable directly. The "ground truth" for this mechanical device's performance would be engineering specifications and successful operation during in vitro bench testing (e.g., ability to grip wires of specified sizes, withstand torque, maintain sterility).

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

Study That Proves the Device Meets Acceptance Criteria:

The document states:

"In vitro bench studies were conducted to evaluate the performance characteristics of the ILT Torquer. Performance test results indicate that the device satisfies functional performance requirements when used as indicated."

And concludes:

"The results of testing demonstrate that the ILT Torquer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use."

While the specific details of the bench studies (e.g., number of tests, specific parameters measured, statistical analysis) are not provided in this summary, the submission relies on these in vitro bench studies as the evidence that the device meets its functional performance requirements and is substantially equivalent to the predicate device. The FDA's 510(k) clearance indicates they found this evidence sufficient for substantial equivalence.

Summary

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'JUL 11 2002

Ko21243

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 andQuality Assurance
DEVICE IDENTIFICATION

A.	Trade Name:	ILT Torquer
B.	Catalog Number:	A114TR1
C.	Common Name:	Torquer
D.	Classification Name:	Catheter Guide Wire Accessory
E.	Device Class:	Class II (per 21 CFR 870.1330)

INDENTIFICATION OF PREDICATE DEVICE

The ILT Torquer is substantially equivalent to the Boston Scientific Corporation wireClip™ cleared under 510(k) K003398.

DEVICE DESCRIPTION

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INTENDED USE

221247

The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.

TECHNOLOGICAL CHARACTERISTICS

The ILT Torquer is similar in basic materials, design, construction and mechanical performance to the predicate device.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing is not required for ILT Torquer because there is no patient contact. In vitro bench studies were conducted to evaluate the performance characteristics of the ILT Torquer. 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 Torquer 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

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Food and Drug Administration 9200 Corporate Boulevard Rockville · MD 20850

JUL 11 2002

IntraLuminal Therapeutics, Inc. c/o Ms. Pamela Misajon 6354 Corte del Abeto, Suite A Carlsbad, CA 92009

Re: K021243

ILT Torquer Regulation Number: 870.1330 Regulation Name: Catheter Cannula Regulatory Class: II (two) Product Code: DQX Dated: April 18, 2002 Received: April 19, 2002

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);

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Page 2 - Ms. Pamela Misajon

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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). 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sath Tum

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Original 510(k) Premarket Notification ILT Torquer

22243

INDICATIONS FOR USE

510(k) Number:

ILT Torquer Device Name:

Indications for Use:

The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.

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

DeM

on Sian-Off of Cardiovascular and Respiratory Dev

510(k) Number K021243

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.