The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular 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 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 OCK mpat on the connector is alles. The RF connector is connected to the RF output on the vessol of havigation practical 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 The Ice orosing 'Are wided in a separate peel pouch. The packaged RF Crossing Wire 1 on. 71 Torquer is provided oxide) and non-pyrogenic, and is intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the Safe-Cross® Radio Frequency Total Occlusion Crossing System. This type of document is for regulatory clearance based on substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through clinical studies. Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance) is not available in these FDA submission documents.

Here's a breakdown of what can be extracted from the document based on the request:

Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: The key "acceptance criterion" for this 510(k) submission is that the modified Safe-Cross RF System is substantially equivalent to its predicate device (Safe-Cross Radio Frequency Total Occlusion Crossing System, K033929). This implies that the device performs as intended and is as safe and effective as the predicate.	Equivalence to Predicate: The submitter concludes, "The Safe-Cross System is substantially equivalent to the predicate device." This is based on: - Same components and technological characteristics as the predicate device. - Bench testing and software verification/validation conducted to qualify changes. - Intended Use: Facilitating placement of devices in vascular interventions in native peripheral arteries with total occlusions (not for carotid arteries). This is the same as the predicate.

Acceptance Criteria

Reported Device Performance

Substantial Equivalence: The key "acceptance criterion" for this 510(k) submission is that the modified Safe-Cross RF System is substantially equivalent to its predicate device (Safe-Cross Radio Frequency Total Occlusion Crossing System, K033929). This implies that the device performs as intended and is as safe and effective as the predicate.

Equivalence to Predicate: The submitter concludes, "The Safe-Cross System is substantially equivalent to the predicate device." This is based on: - Same components and technological characteristics as the predicate device. - Bench testing and software verification/validation conducted to qualify changes. - Intended Use: Facilitating placement of devices in vascular interventions in native peripheral arteries with total occlusions (not for carotid arteries). This is the same as the predicate.

Study Information:

Sample size used for the test set and the data provenance: Not applicable. This submission relies on bench testing and software verification/validation, not a clinical test set with human data for performance evaluation in a clinical context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for clinical performance studies (e.g., expert consensus on medical images) is not relevant here, as there isn't a clinical test set being evaluated in that manner.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no clinical test set requiring adjudication.
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. The device is a physical catheter system, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter system), not an algorithm. Bench testing and software verification/validation were performed on the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated in terms of clinical ground truth. The "ground truth" for this submission would be defined by engineering specifications and functional performance metrics established during bench testing and software validation. These are evaluated against predetermined thresholds or against the performance of the predicate device.
The sample size for the training set: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that sense.
How the ground truth for the training set was established: Not applicable, for the same reason as above. If "training set" were interpreted as the data used for the design and development of the device, then the "ground truth" for design would be derived from clinical needs, engineering principles, and performance requirements for a device of this type.

Summary

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

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 QualityAssurance

DEVICE IDENTIFICATION

A.	Device Trade Name:Frequency Total Occlusion Crossing System	Safe-Cross®
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 Number K033929.

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 .

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

The modified Safe-Cross RF System is equivalent 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 OCK mpat on the connector is alles. The RF connector is connected to the RF output on the vessol of havigation practical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.

INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

The components and technological characteristics of the Safe-Cross System are the same as the predicate device.

BIOCOMPATIBILITY AND PERFORMANCE DATA

Bench testing and software verification/validation testing has been conducted to qualify the changes to the device and its software/firmware.

CONCLUSIONS DRAWN FROM STUDIES

The Safe-Cross System is substantially equivalent to the predicate device.

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

Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text that is difficult to read due to the image quality. Inside the circle is a stylized bird-like symbol composed of three curved lines, resembling the emblem of the U.S. Department of Health and Human Services. The logo appears to be a simplified representation of a government agency or organization related to health or human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

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

K041973 Re:
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: July 21, 2004 Received: July 22, 2004

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 vour 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 ( FR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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

Page 2 -- Ms. Pamela Misajon

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) of crowisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro helems (Seting your device as described in your Section 510(K) I ms letter with anow you to ough mating of substantial equivalence of your device to a legally prematication: "The Driver and sification 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 if you dosire of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

D.mme. R. Vachner

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

Enclosure

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

Indications for Use

510(k) Number (if known):	K041973
Device Name:	Safe-Cross® Radio Frequency Total Occlusion 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 in native peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.

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)

Duna R. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko41973

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.