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 Wire 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 proximal end of the RF 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 input on the console to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF output on the console. 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 with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

AI/ML Overview

Acceptance Criteria and Device Performance

This 510(k) summary focuses on modifications to a previously cleared device. Therefore, the acceptance criteria are primarily demonstrated through verification that the modified device maintains the safety and performance of the predicate device and meets established design specifications. Specific numerical performance metrics or acceptance criteria are not explicitly detailed in the provided text as they would be in a submission for a novel device.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Materials in the modified RF Crossing Wires are biologically safe.
Benchtop Performance	Modified RF Crossing Wires satisfy safety and performance requirements of the device specifications. No additional safety issues raised.
In Vivo Performance	Components of the system function properly together and satisfy intravascular performance requirements in an animal model.

Study Details

The provided document describes studies conducted to support the substantial equivalence claim for the modified Safe-Cross® Radio Frequency Total Occlusion Crossing System.

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

Test Set (Bench Testing): Not explicitly stated. The document mentions "Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications." This implies a set of tests were conducted, but the number of devices or iterations tested is not provided.
Test Set (In Vivo Animal Studies): Not explicitly stated. The document mentions "In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model." The number of animals or specific experimental design details are not given.
Data Provenance: The studies were conducted by IntraLuminal Therapeutics, Inc., likely at their facilities or through contracted labs. The data would be prospective, as it was generated specifically for this 510(k) submission. No country of origin for the data is specified beyond the company's location in Carlsbad, CA, USA.

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

Not applicable/Not explicitly stated. For biocompatibility, bench testing, and animal studies, "ground truth" is typically established by objective measurements, scientific standards, and observation by qualified scientific personnel (e.g., toxicologists, engineers, veterinarians, or principal investigators) according to established protocols. The document does not specify the number or qualifications of experts beyond the company's internal R&D and QA teams.

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

Not applicable/Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human interpretation of data (e.g., image reading). For the types of studies described (biocompatibility, bench, animal), results are generally objective and determined by predefined pass/fail criteria or statistical analysis, not by human adjudication of nuanced findings in the same way.

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 comparative effectiveness study was not performed. This device is a medical instrument (catheter guide wire system), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in data interpretation.

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

No. This device is a medical instrument, not an algorithm or software-only device. Its function intrinsically requires human operation.

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

Biocompatibility: Ground truth is established by adherence to recognized standards (e.g., ISO 10993 series) and biological safety assessments based on specific tests (e.g., cytotoxicity, sensitization, irritation).
Bench Testing: Ground truth is established by design specifications, engineering tolerances, and mechanical/electrical performance standards. Measurements are compared against these predefined criteria.
In Vivo Animal Studies: Ground truth is established through direct observation of device function, physiological responses, and potentially histological examination in animal models, evaluated against expected normal biological function and safety parameters.

8. The sample size for the training set:

Not applicable. The devices described are hardware medical devices, not AI models that require a "training set" in the computational sense. The "training" of the device is through design, manufacturing, and quality control processes.

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

Not applicable, as there is no "training set" in the context of an AI model for this hardware medical device.

Summary

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JUN 7 - 2005

Ko509/5

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:	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) K040037.

DEVICE DESCRIPTION

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

175cm Working Length 0.014" Safe-Cross RF Crossing Wire 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 modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF 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 input on the console to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF output on the console. 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 with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene 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, construction and performance to the predicate device. The RF Crossing Wires have been modified to improve performance characteristics (i.e., tip flexibility, tip shaping and shape retention). The safety and performance of the modified Safe-Cross System has been verified through biocompatibility testing, bench testing and in vivo animal studies.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing has been conducted to verify that the materials in the modified RF Crossing Wires are biologically 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 raise 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three horizontal lines curving upwards, resembling a symbol or abstract representation of a flag.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 7 - 2005

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

K050915 Re:

Trade/Device Name: Safe-Cross® Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: May 5, 2005 Received: May 9, 2005

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR) (2006) (2006) (2006) (21 CFR (21 (2) 642 - 6th Anti) 21 CFR 1000forth in the quality systems (QS) regulation (21 -51 -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 95 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA imulig of substantial equivalies by .
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
r the light and the many of the 10, 276, Alles were the regulation entitled If you desire specific advice for your ac not one of a lise, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the re contact the Office of Comphalec at (240) 276 or Frant 807.97). You may obtain
"Misbranding by reference to premarket notification (21CFR Part 807.97). You may obtain "Misbranding by reference to premarkst notificancer the Act from the Division of Small
other general information on your responsibilities under that the gumber (800) 638-200 other general information on your responsion.com in total-free number (800) 638-2041 or Manufacturers, Imemational and Consumer Assistance a no vol an an an an an an an and and and and and and a

Sincerely yours,

Duna R. Vicines

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): K 6 50915

Device Name:

Safe-Cross® Radio Frequency Total Occlusion Crossing System

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

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Donna P. Vachal

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K050915

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.