The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

Device Description

The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following:

0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
Safe-Cross RF Generator with Footswitch and Interface Cable .
The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.
The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.

AI/ML Overview

The provided text describes the Safe-Cross Radio Frequency Total Occlusion Crossing System, a medical device, and its regulatory submission. It mentions human clinical studies were conducted to verify the device's safety and performance, but it does not provide specific acceptance criteria or detailed results of those studies in a quantifiable manner.

Therefore, I cannot populate the table or answer all of your questions directly from the provided text.

However, I can extract the information that is present and indicate where information is missing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not specified in document	Not specified in document
(e.g., Specific success rate for crossing occlusions, rate of adverse events within defined limits)	"the device performs as intended and does not involve unacceptable risk to the patient"

Note: The document only states a general conclusion that the device performs as intended and does not pose unacceptable risks, but it does not provide the specific numerical acceptance criteria (e.g., "successful crossing of occlusion in X% of cases") or the achieved performance metrics (e.g., "successful crossing in Y% of cases").

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only states "Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System."
Data Provenance: Prospective human clinical studies. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document does not detail how the outcomes of the clinical studies were assessed or by whom.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study Done?: Not applicable. This device is a guidewire system, not an imaging or diagnostic AI requiring human reader comparison. The "clinical studies" mentioned are likely efficacy and safety trials demonstrating the device's ability to cross occlusions.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Study Done?: Not applicable in the context of an "algorithm only" study. This is a physical medical device (guidewire system) operated by a human, not a standalone AI algorithm. The device's performance inherently involves human interaction.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for performance and safety would be established through clinical outcomes observed during the human clinical studies, likely including successful occlusion crossing, procedural success rates, and the incidence of adverse events, as assessed by the treating physicians and study investigators.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The development and testing would involve bench testing and animal studies prior to human clinical trials.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable as there is no "training set" in the AI sense. For the development and pre-clinical stages, "ground truth" for design and performance would be established through engineering specifications, bench testing results (e.g., force required to cross simulated occlusions, RF power output, durability), and animal study observations (e.g., successful crossing in animal models, tissue effects). These would typically be compared against predetermined design requirements and safety parameters.

Summary

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JAN - 7 2004

1632031

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 Radio Frequency Total OcclusionCrossing System
B.	Device Common Name:	Guidewire
D.	Classification Name:	Catheter Guidewire
E.	Device Class:	Class II (per 21 CFR 870.1330)

IDENTIFICATION OF PREDICATE DEVICE

The predicate device is the Safe-Steer™ Guide Wire System, manufactured by Intraluminal Therapeutics and cleared under 510(k) Premarket Notification number K021323.

DEVICE DESCRIPTION

The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following:

0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
Safe-Cross RF Generator with Footswitch and Interface Cable .

The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub

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that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.

The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.

INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

The components of the Safe-Cross System are similar in basic materials, design, construction and performance to the predicate device. The RF Generator is an additional component of the Safe-Cross System. The performance of the RF Cenerator has been verified through bench, animal, and human clinical studies.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing, in vitro bench testing and in vivo animal studies were conducted to cvaluate the biological and performance characteristics of the Safe-Cross System. Biocompatibility test results indicate that the patient components of the Safe-Cross Crossing Wire are biocompatible. Benchtop performance test results indicate that the components of the Safe-Cross System satisfy safety and performance requirements of the device specifications. In Vivo animal studies demonstrate that the various components of the Safe Cross System function together, as intended, in the animal model and do not raise unanticipated safety issues.

CLINICAL STUDIES

Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System when used in human subjects for the indicated use of crossing total occlusions in native coronary arteries. The results of the clinical studies indicate that the device performs as intended and docs not involve unacceptable risk to the patient.

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CONCLUSIONS DRAWN FROM STUDIES

The results of nonclinical and clinical testing demonstrate that Safe-Cross System is substantially equivalent to the predicate device and satisfies the requirements of the device specifications.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

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

K032031 Rc:

Safe-Cross Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Codc: DQX Dated: October 10, 2003 Received: October 14, 2003

Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave te riewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prices 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 adultcration.

If your device is classified (scc 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. Pamela Misajon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles or a succession complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delemmation that your as room of rederal agencies. You must or any Federal statutes and regulations administered by out not limited to: registration and listing (21 comply with all the Act S requirements, more 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good manat 820); and if applicable, the electronic form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (Doctors of Persons of Personal in your Section 510(k) i his letter will anow you to begin manxeting your substantial equivalence of your device to a legally premarket notification. The PDA miding of bassanaal vqur 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 If you desire specific advice for your act (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain Misolalling by reference to promanters in the Act from the Division of Small other general information on your respenser Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address

(501) : 15 057 : 6 da.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Elson Diaz for

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:	To Be Assigned By FDA K632031
Device Name:	Safe-Cross® RF TO Crossing System
Indications For Use:	The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Olesa Dike for Anne Parker

510(K) Numbe

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.