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 and 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 provides Optical Coherence Reflectometry for navigation through vessels allowing visualization of the Safe-Cross Crossing Wire tip. Radio Frequency energy is provided to the wire's distal tip in order to ablate tissue to create a passage for wire advancement through difficult sections of arterial occlusions. The System was modified to add a High Dynamic Range Console to the product line, which allows more light to penetrate and reflect off tissue improving the overall range of the system; and to modify the Crossing Wires to reinforce the distal tip.

The Safe-Cross Crossing Wires are provided EtO sterile for single use in the following sizes:

.014" x 275 cm, straight or angled tip packaged with Safe Torquer and tip shaping tool; Coronary . and Peripheral use.
.035" x 275 cm, straight or angled tip packaged with Safe-Cross Torquer; Peripheral use only. .

AI/ML Overview

The provided text describes a 510(k) summary for the Safe-Cross® Radio Frequency Total Occlusion Crossing System. This submission focuses on modifications to an existing device, specifically adding a High Dynamic Range Console and reinforcing the distal tip of the crossing wires.

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or a direct comparison table as would be typical for an AI/ML device. Instead, the "acceptance criteria" are implied by the types of non-clinical tests performed to demonstrate the safety and effectiveness of the modifications to an already legally marketed predicate device. The "reported device performance" refers to the successful completion of these tests, demonstrating substantial equivalence to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Console optics module verification: Functionality and performance of the new High Dynamic Range Console.	Verification of Console optics module completed successfully.
Software validation: Functionality and safety of the updated software.	Software validation completed successfully.
Crossing Wire biocompatibility: Safety of materials in contact with body tissues.	Biocompatibility testing of crossing wires completed successfully.
Crossing Wire tensile strength: Ability of the wire to withstand pulling forces.	Tensile strength testing of crossing wires completed successfully.
Crossing Wire friction: Smoothness of wire movement within vessels.	Friction testing of crossing wires completed successfully.
Crossing Wire torque response/strength: Ability of the wire to transmit rotational forces and resist breakage.	Torque response and strength testing of crossing wires completed successfully.
Crossing Wire package integrity: Assurance of sterility and product protection until use.	Package integrity testing completed successfully.
Overall safety and effectiveness: The modifications do not negatively impact the device's ability to facilitate placement of percutaneous intervention devices in total occlusions.	Testing provides reasonable assurance of safety and effectiveness for its intended use, maintaining substantial equivalence to the predicate.

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

The provided text describes non-clinical testing (e.g., bench testing, material characterization). It does not mention a "test set" in the context of patient data or clinical studies. Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective) related to patient data. The tests were performed presumably in a laboratory setting.

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

This information is not applicable as the submission describes non-clinical engineering and material tests, not clinical studies requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the submission describes non-clinical engineering and material tests, not clinical studies requiring adjudication of patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical testing for device modifications and substantial equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study as described for an AI algorithm was not done. The device in question is a physical medical device (catheter/guidewire system), not an AI algorithm. Its "navigation" capabilities involving "Optical Coherence Reflectometry" are physical and optical, not AI-driven.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and industry standards for material properties and device performance. For example, a tensile strength test would have a specified breaking point or load capacity as a "ground truth" to meet.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI/ML system that utilizes a "training set" of data.

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

This information is not applicable, as there is no training set for an AI/ML algorithm mentioned in the submission. The "ground truth" for the non-clinical tests would have been based on established engineering principles and benchmarks, as mentioned in point 7.

Summary

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K073162

510(k) Summary

Submitted by:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341
Prepared by:	Jennifer J. Bosley, Regulatory Affairs Manager
Contact Person:	Robin Fatzinger, VP Clinical & Regulatory AffairsPh: (484) 713-2100 Fax: (484) 713-2903
Date Prepared:	November 7, 2007
Device Trade Name:Common/Usual Name:Proposed Classification:	Safe-Cross® Radio Frequency Total Occlusion Crossing SystemWire, Guide, CatheterCatheter Guide Wire21CFR § 870.1330 Class II, DQX—74 Cardiovascular

Device Description:

The Safe-Cross Crossing Wires are provided EtO sterile for single use in the following sizes:

.014" x 275 cm, straight or angled tip packaged with Safe Torquer and tip shaping tool; Coronary . and Peripheral use.
.035" x 275 cm, straight or angled tip packaged with Safe-Cross Torquer; Peripheral use only. .

Intended Use:

Predicate Devices:

K050915 - Safe-Cross® Radio Frequency Total Occlusion Crossing System (Intraluminal Therapeutics) K050916 - Safe-Cross® Radio Frequency Total Occlusion Crossing System (Intraluminal Therapeutics)

Substantial Equivalence:

The modified Safe-Cross System is substantially equivalent to the legally marketed predicate Safe-Cross devices now manufactured by Kensey Nash Corporation. Devices have same basic design and same materials, processing, intended use and fundamental scientific technology.

Non-Clinical Testing:

The Safe-Cross System has undergone the following testing: Console optics module verification and software validation: Crossing Wire biocompatibility, tensile, friction, torque response/strength and package integrity. Testing provides reasonable assurance of safety and effectiveness for its intended use.

1-484-713-2100

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

FEB -8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kensey Nash Corporation c/o Ms. Robin Fatzinger Vice President, Clinical & Regulatory Affairs 735 Pennsylvania Drive Exton, PA 19341

Re: K073162

Safe-Cross® Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: January 10, 2008 Received: January 11, 2008

Dear Ms. Fatzinger:

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. Robin Fatzinger

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 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duma R. Wachner

ABram 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 Statement

510(k) Number (if known): KO73l 2_

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

Indications For Use:

X Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nuna R. W. chmer
(Division Sign-Off)

Dision of Cardiovascular Devices

510(K) Number_K673162

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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.