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 Total Occlusion Crossing System consists of the following:

175cm Working Length 0.014" Safe-Cross RF Crossing Wirc Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
Safe-Cross RF System Console with Display and Footswitch .

The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The I he modified Sale-Cross RF Bystein is simmal nt a Y-Site hub that houses the optic proximal end of the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the imput on the console to anow the medical proceed to the RF couput on the digit vessel for havigation purposes. The re-over to provide discrete RF energy to the distal console: - This anoving the wire tip through the occlusion in the vessel.

The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Kr Crossing Wire is packaged warate peel pouch. A rorquer is provided the oxide) and non-pyrogenic, and is intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Safe-Cross® Radio Frequency Total Occlusion Crossing System:

It's important to note that the provided text is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting full clinical trial results with specific acceptance criteria in the way a PMA (Pre-Market Approval) or novel device application might. Therefore, the information available is focused on comparison to a previously cleared device and internal testing, which may not align with the standard format for reporting clinical study results to establish acceptance criteria for a new, unique claim.

Based on the provided document, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device)	Reported Device Performance
Biocompatibility	Materials in modified RF Crossing Wires are safe (as per predicate device's safety profile).	"Biocompatibility testing has been conducted to verify that the materials in the modified RF Crossing Wires are safe."
Benchtop Performance	Functional performance characteristics of modified RF Crossing Wires (matching or improving upon predicate device). Satisfy safety and performance requirements of device specifications.	"In vitro bench testing was conducted to evaluate the performance characteristics of the modified RF Crossing Wires. Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications and do not raise additional safety issues."
In Vivo (Animal) Performance	System components function properly together in an intravascular environment. Satisfy intravascular performance requirements.	"In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model."
Software Validation	(Implicit: Software in the combined console functions correctly and safely).	"software validation testing." (No specific details of results provided here, only that testing was conducted).
Safety	No additional safety issues compared to the predicate device.	"Benchtop performance test results indicate... do not raise additional safety issues." "On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population."
Performance (Overall)	Satisfies safety and performance requirements when used as indicated, indicating substantial equivalence to predicate.	"On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The modified Safe-Cross System is substantially equivalent to the predicate device."

Important Note on "Acceptance Criteria": In a 510(k), explicit "acceptance criteria" are often internal to the manufacturer's design controls and testing protocols. The public summary typically states that these criteria were met rather than detailing the specific numerical targets. The primary "acceptance criterion" for the FDA in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.

Detailed Study Information:

The document describes several types of studies performed, but it focuses on demonstrating substantial equivalence to a predicate device (K032031, also the Safe-Cross Radio Frequency Total Occlusion Crossing System). It does not present a traditional clinical study with explicitly defined acceptance criteria, sample sizes for test sets in human patients, or ground truth established by independent experts for a novel device claim.

Here's a breakdown based on the categories requested:

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

Test Set (Human Data): Not applicable for a typical "test set" as understood in machine learning or a de novo clinical trial. This 510(k) relies on non-clinical data and comparison to a predicate device.
Data Provenance:
- Bench Testing: In vitro, conducted by the manufacturer (IntraLuminal Therapeutics, Inc.).
- Animal Studies: In vivo, conducted by the manufacturer. No country of origin is specified for the animal studies, but the company is US-based.
- Retrospective/Prospective: The testing described (biocompatibility, bench, animal, software validation) would be considered prospective for the purpose of demonstrating substantial equivalence for this modification, but it's not a prospective human clinical trial.

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

This information is not provided as the submission does not detail an independent expert review process for a "test set" in the context of human data. The "ground truth" for this submission is based on engineering specifications, biocompatibility standards, and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as there's no "test set" of human cases with independent expert interpretation forming a ground truth.

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. An MRMC study was not performed. This device is a catheter guide wire system aiding in physical navigation, not an AI-powered diagnostic or assistive tool for human readers interpreting medical images.

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

Not applicable. This is a medical device (catheter guide wire system) that requires human operation; it is not a standalone algorithm. The "software validation testing" mentioned is for the integrated console, not for an independent diagnostic algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Performance Standards: For bench and animal testing, the "ground truth" would be successful adherence to predefined engineering specifications, performance targets, and safety criteria relevant to the device's intended function and comparison to the predicate.
Predicate Device Performance: The overarching ground truth is the established safety and effectiveness profile of the predicate device (Safe-Cross Radio Frequency Total Occlusion Crossing System cleared under K032031). The modified device aims to maintain or improve upon this.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device and its modifications, not a machine learning model requiring a "training set."

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

Not applicable, as there is no training set for an algorithm in this context.

Summary

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MAR - 3 2004

K040037

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 Misajon

Vice President of Regulatory Affairs and Quality Assurance

DEVICE IDENTIFICATION

A.	Device Trade Name:	Safe-Cross® Radio Frequency Total OcclusionCrossing System
B.	Device Common Name:	Catheter Guide Wire
C.	Classification Name:	Catheter Guide Wire
D.	Device Class:	Class II (per 21 CFR 870.1330)

IDENTIFICATION OF PREDICATE DEVICE

The predicate device is the Safe-Cross Radio Frequency Total Occlusion Crossing System, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K032031.

DEVICE DESCRIPTION

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

175cm Working Length 0.014" Safe-Cross RF Crossing Wirc Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
Safe-Cross RF System Console with Display and Footswitch .

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The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Kr Crossing Wire is packaged warate peel pouch. The packaged RF Crossing Wire i oot. A rorquer is provided the oxide) 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, constition and performance to the predicate device. The RF Generator and OCR Unit have been combined into a single console. The RF Crossing Wires have been modified to improve handling and add a 175cm length model. The performance of the modified Safe-Cross System has been verified through biocompatibility testing, bench testing, animal testing and software validation testing.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing has been conducted to verify that the materials in the modified RF Crossing Wires are safe. In vitro bench testing was conducted to evaluate the performance characteristics of the modified RF Crossing Wires. Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications and do not raisc additional safety issues. In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model.

CONCLUSIONS DRAWN FROM STUDIES

On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The modified Safe-Cross System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized eagle-like symbol with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

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

Re:

K040037
Trade/Device Name: Safe-Cross® Radio Frequency Total Occlusion Crossing System
Trade/Device Name: Safe-Cross® 1920 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 8, 2004 Received: January 9, 2004

Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQK J prematic is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices mendments. for use stated in the enclosure) to regally manced the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the organision of the Federal Food. Drue commerce prior to May 28, 1976, the enaculient with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the A.M. (PMA).
and Cosmetic Act (Act) that do not required to seems as annovalisions of the A.t. Th and Cosmetic Act (Act) that do not require approvations provisions of the Art. The Art. The Art. The Art. The You may, therefore, market the device, subject to the general cannual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirements to
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 If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controls: Listers in as a 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Pederal Regarations, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issuance of a subscribe complies with other requirements of the Act
that FDA has made a determination that your device Foderal agencies. You mus that FDA has made a determination mat your areas by other Federal agencies. You must or any Federal statutes and regulations administers, but not limited to: registration and listing (2)
comply with all the Act's requirements, including, but not times asset comply with all the Act s requirements, merading, out all relative requirements as set

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Page 2 – Ms. Pamela Misajon

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (2001); for the state (2001) (2005) = 500 = 500 = 500 = 640 = 540 = 1000-1 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Acction 5 product radiation control provisions (Scottons of the easines in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin maketing your actives waters of your device to a legally premarket notification. The FDA inding of substantal equive 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 ior your do 1100%. Also, please note the regulation entitled, and contact the Office of Comphaneous (30 rysification" (21CFR Part 807.97). You may obtain "Misbranding by reletence to promantee to promantee the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638, 00 other general information on your responsible to toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of Address (domemore http:// Manufacturers, International and Combanets 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 (if known):	K040037
Device Name:	Safe-Cross® Radio Frequency Total Occlusion CrossingSystem
Indications For Use:	The Safe-Cross® Radio Frequency Total OcclusionCrossing System is indicated for use in facilitating theplacement of devices used in percutaneous interventionsin native coronary arteries with total occlusions.

Prescription Use X (Part 21 CFR 801 Subpart D)

and the control of the control of the control of the control of the contribution of the first of the first of the first of the first of the first of the first of the first of

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovasc'
510(k) Number	K040057

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.