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 peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.

Device Description

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

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

The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The The modified Bate-Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and 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 mible on the console to anow and more connector is connected to the RF output on the vessel for navigation purposes. al 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

The provided text describes the Safe-Cross® Radio Frequency Total Occlusion Crossing System (K050916), a catheter guide wire system. The summary focuses on its substantial equivalence to a predicate device and safety testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations.

Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth types for AI performance evaluation is not available in the provided document, as it pertains to a mechanical medical device rather than an AI/ML system.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a mechanical device, the "acceptance criteria" are related to safety and performance requirements rather than statistical metrics against a benchmark. The document states:

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Biocompatibility testing has been conducted to verify that the materials in the modified 0.014" RF Crossing Wires are safe.
Benchtop Performance Characteristics	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. (Specific metrics of "safety and performance requirements of the device specifications" are not detailed in this summary document.)
In Vivo Functionality (System Components)	In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model. (Specific intravascular performance requirements are not detailed.)
Overall Safety and Performance Requirements (Conclusion)	"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." (This is a summary conclusion rather than specific criteria and measured performance.)

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

Sample Size: Not specified for biocompatibility, bench testing, or animal studies. The text only mentions "modified 0.014" RF Crossing Wires" for biocompatibility and "an animal model" for in vivo.
Data Provenance: Not specified (e.g., country of origin). Both bench and animal studies are mentioned as "in vitro" and "in vivo," respectively, but whether they are retrospective or prospective is not stated, though animal studies are typically prospective.

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

Not applicable/Not specified. This information is typically relevant for AI/ML studies where human experts establish ground truth. For this mechanical device, "ground truth" would be the direct measurement of physical properties or biological response in laboratory or animal settings, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth labeling in AI/ML studies. For device testing involving physical and biological measures, standard scientific protocols for data collection and analysis would be followed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic technologies, particularly AI systems, with human readers. The Safe-Cross® system is an interventional device, not a diagnostic one.

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

Not applicable. The device is a physical, interventional medical device and does not involve an AI algorithm operating "standalone."

7. The Type of Ground Truth Used:

Bench Testing: Engineering specifications and physical measurements are the "ground truth" for bench testing.
Biocompatibility: Standardized biological tests (e.g., cytotoxicity, sensitization, irritation) results compared against acceptance criteria for biological safety.
Animal Studies: Observed physiological and pathological responses in an animal model—e.g., successful crossing of occlusions, lack of vessel damage, proper system function.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, there is no training set.

Summary

{0}------------------------------------------------

510(K) SUMMARY

SUBMITTER INFORMATION

A.	Company Name:	IntraLuminal Therapeutics, Inc.
B.	Company Address:	6354 Corte Del Abeto – Suite A
		Carlsbad, CA 92009

(760) 918-1820 C. Company Phone:
Company Facsimile: (760) 603-9615 D.
Contact Person: Pamela Misajon E. 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) K040037.

DEVICE DESCRIPTION

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

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) (175cm Working Length)
0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)

{1}------------------------------------------------

0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) ◆ (275cm Working Length)
Safe-Cross RF System Console with Display and Footswitch .

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 0.014" 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 raise additional safety issues. In vivo animal studies have shown that the components of the system function properly logether and satisfy intravascular performance requirements in an animal model.

{2}------------------------------------------------

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 condided with the Econovenions for Use for the indicated patient population. The modified Safe-Cross System is substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

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 Vice President of Regulatory Affairs and Quality Assurance 6354 Corte del Abeto, Suite A Carlsbad, CA 92009

SEP 1 8 2013

Re: K050916

Trade/Device Name: Safe-Cross Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: May 5, 2005 Received: May 9, 2005

Dear Ms. Misajon:

This letter corrects our substantially equivalent letter of June 8, 2005.

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

{4}------------------------------------------------

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

L.M.Z.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):	K050916
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 peripheral arteries with total occlusions. Thedevice is not to be used in the carotid arteries.

X Prescription Use (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)

R. Vachner

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number_Ko 509/6_

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).