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 Total Occlusion Crossing System consists of 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-Cross RF System Console .
The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. 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 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. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

AI/ML Overview

This 510(k) summary (K033708) describes a medical device, the Safe-Cross® Radio Frequency Total Occlusion Crossing System, which is a modified version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through performance and bench testing, rather than a clinical study involving human patients.

Therefore, many of the requested categories, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not directly applicable or reported in this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (General)	Reported Device Performance
Satisfy safety and performance requirements of device specifications	Benchtop performance test results indicate that the components of the Safe-Cross System satisfy safety and performance requirements of the device specifications.
Do not raise additional safety issues via modifications	Benchtop performance test results indicate that the components of the Safe-Cross System do not raise additional safety issues.
Substantially equivalent to predicate device	Concluded to be substantially equivalent to the predicate device based on testing.
Verification through software testing (for combined console)	Performance of the modified Safe-Cross System has been verified through software testing.
Verification through bench testing	Performance of the modified Safe-Cross System has been verified through bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable / Not specified for human testing. The testing was primarily in vitro bench testing and software testing.
Data Provenance: Not applicable for human data. The testing was conducted by the manufacturer, IntraLuminal Therapeutics, Inc., likely at their facilities (Carlsbad, CA, USA). The nature of the testing (bench and software) is prospective for the device under evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies on in vitro bench testing and software testing, not expert-adjudicated clinical data to establish ground truth.

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

Not applicable. No clinical adjudication method was used as this was not a human study.

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 applicable. This device is a physical medical device (catheter guide wire system), not an AI/software product, and therefore, no MRMC study was conducted.

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

Not applicable. This is not an algorithm-only device. The performance data refers to the physical device's characteristics and functionality. The "standalone" performance here refers to the device's ability to function according to specifications in a controlled, non-human environment. The "bench testing" represents this form of standalone evaluation.

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

The "ground truth" for this submission is based on the device's predetermined engineering specifications and performance requirements. The bench testing and software testing confirmed that the modified device met these specifications, which serve as the "ground truth" for its safety and performance claims in this context.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable. No training set or ground truth for a training set was used.

Summary

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K033708

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
C.	Device Common Name:	Catheter Guide Wire
D.	Classification Name:	Catheter Guide Wire
E.	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) K031842.

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) .
0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
Safe-Cross RF System Console .

The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. 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

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1033708

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. 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 Generator and OCR Unit have been combined into a single console. The performance of the modified Safe-Cross System has been verified through software testing and bench testing.

PERFORMANCE DATA

In vitro bench testing was conducted to evaluate the performance characteristics of the modified Safe-Cross System. Benchtop performance test results indicate that the components of the Safe-Cross System satisfy safety and performance requirements of the device specifications and do not raise additional safety issues.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

DEC 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033708

Safe-Cross® Radio Frequency Total Occlusion Crossing System [Peripheral] Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: November 25, 2003 Received: November 26, 2003

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.

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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 issuance of a substitution of the requirements of the Act
that FDA has made a determination that your device as a love a needes. You must that FDA has made a delefinitiation administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listing or any Federal statutes and regulations and united to: registration and listing (2)
comply with all the Act's requirements, including, but not limited to set comply with all the Act's requirements, including, occurer and many of the electronics as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the elect CFR Part 807); labeling (21 CFR Fail 601); good manatasan); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 21 CFR 1000-1050 forth in the quality systems (Sections 53) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (bections of the minderse of your Section 5 10(k)
This letter will allow you to begin marketing your and creation of your device to a lev This letter will allow you to begin marketing your active of your device of your device to a legally premarket notification. The FDA Inding of substantial equivaliation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the may and 1648 - 11 1648 - the coulstion and readers not the regula If you desire specific advice for your act 1001) 594-4648. Also, please note the regulation entitled, contact the Office of Compliance at (301) 57 - 10 - (21CFR Patt 807.97). You may obtain "Misbranding by relerence to premarkst nothreation der the Act from the Division of Small
other general information on your responsibilities under the Act from www.er/900) 63 other general information on your responsion.com and and the oll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

(301)445-0577 or at its intrimed in http://www.fdsmamain.html

Sincerely yours,

Ashley B. Beam

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

Kb33708 510(k) Number:

Safe-Cross® Radio Frequency Total Occlusion Crossing System Device Name:

The Safe-Cross® Radio Frequency Total Occlusion Crossing Indications For Use: 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
(Per 21 CFR 801.109)

	Over-The-Counter Use
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(Division Sign-off)
Division of Cardiovascular Devices

510(K) Number	K033708
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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.