The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

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) ●
0.035'' 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 Wires are similar to the predicate guidewires 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, but it does not contain acceptance criteria for the device or a dedicated clinical study report outlining specific performance metrics against such criteria.

The document primarily focuses on:

Device Identification: Trade name, common name, classification, and predicate devices.
Device Description: Components of the system (crossing wires, OCR Unit, RF Generator) and their function.
Intended Use: Facilitating placement of devices in vascular interventions for total occlusions in native iliac and superficial femoral arteries.
Technological Characteristics: Similarity to predicate devices.
Biocompatibility and Performance Data: Mentions that biocompatibility testing, in vitro bench testing, and in vivo animal studies were conducted, and that results "satisfy safety and performance requirements of the device specifications" and "do not raise unanticipated safety issues."
Clinical Studies: States that human clinical studies were conducted to "verify the safety and performance characteristics..." and concluded that the device "performs as intended and does not involve unacceptable risk to the patient."
Conclusion: The system is "substantially equivalent" to predicate devices.
FDA K031842 Clearance Letter: Confirms clearance and reclassification.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide specific details about a study that proves the device meets those criteria, as this information is not present in the provided text.

The document implies that general safety and performance criteria were met through bench, animal, and human clinical studies, but it does not quantify these criteria or provide the results in a comparative format.

Based on the provided text, the following sections cannot be answered with specific details:

1. A table of acceptance criteria and the reported device performance (Not provided).
2. Sample sized used for the test set and the data provenance (Not provided, beyond "human clinical studies" in general).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not provided).
4. Adjudication method (Not provided).
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 provided; this device is a guidewire system, not an AI diagnostic tool involving human readers).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not provided; this device is a guidewire system, not an algorithm).
7. The type of ground truth used (Not specified beyond "safety and performance in human subjects").
8. The sample size for the training set (Not provided).
9. How the ground truth for the training set was established (Not provided).

Summary

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510(K) SUMMARY

SUBMITTER INFORMATION

IntraLuminal Therapeutics, Inc. Company Name: A.
6354 Corte Del Abeto Suite A B. Company Address: Carlsbad, 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 DENTIFICATION

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 principal predicate device is the Safe-Steer™ Guide Wire System, manufactured by Intraluminal Therapeutics and cleared under 510(k) Premarket Notification number K021323. Another predicate device is the Hydrophilic Coated Guidewire by Lake Region Manufacturing, which was cleared under 510(k) Premarket Notification number K003483.

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) ●
0.035'' Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor

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Safe-Cross RF Generator with Footswitch and Interface Cable .
The Safe-Cross RF Crossing Wires are similar to the predicate guidewires 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.

INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

The components of the Safe-Cross System are similar in basic materials, design, construction and performance to the predicate devices. The RF Generator is an additional component of the Safe-Cross System. The performance of the RF Generator 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 exaluate the biological and performance characteristics of the Safe-Cross System. Biocompatibility test results indicate that the patient contact 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 iliac and superficial arteries (SFA) of the lower

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The results of the clinical studies indicate that the device performs as extremities. intended and does not involve unacceptable risk to the patient.

CONCLUSIONS DRAWN FROM STUDIES

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle's perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

SEP 1 8 2013

Re: K031842

Trade/Device Name: Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: September 19, 2003 Received: September 22, 2003

Dear Ms. Misajon:

This letter corrects our substantially equivalent letter of November 21, 2003.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Z.M.Z.

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:	K031842
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 vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

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)

Adlee B. Braun

ióvascular Devices

510(k) Number K031842

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).