(56 days)
Not Found
No
The description focuses on the mechanical and electrical components of the system (wires, console, RF energy) and visualization via optic fiber. There is no mention of AI, ML, or any computational analysis of data for decision-making or image processing.
Yes
The device is used in percutaneous interventions to facilitate the placement of devices, and it also uses radiofrequency energy to assist in moving the wire tip through occlusions in vessels, which implies direct treatment or modification of the body.
No
The device is used to facilitate the placement of devices in percutaneous interventions for total occlusions, and to assist in moving a wire tip through an occlusion by providing RF energy. It is not used to diagnose a condition.
No
The device description explicitly lists hardware components such as the RF Crossing Wire, RF System Console with Display and Footswitch, and associated tools. It is a system that includes both hardware and software (likely embedded in the console).
Based on the provided information, the Safe-Cross® Radio Frequency Total Occlusion Crossing System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Function: The Safe-Cross system is described as a device used within the body (in vivo) to facilitate the placement of other devices in coronary arteries. It uses a wire and radio frequency energy to cross total occlusions.
- Intended Use: The intended use clearly states it's for "facilitating the placement of devices used in percutaneous interventions in native coronary arteries." This is a procedural device, not a diagnostic test performed on a sample.
- Device Description: The description details a system with a wire, console, and footswitch, designed for direct interaction with the patient's anatomy.
Therefore, the Safe-Cross Radio Frequency Total Occlusion Crossing System is a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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 arteries with total occlusions.
Product codes
DQX
Device Description
The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:
- 175cm Working Length 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)
- Safe-Cross RF System Console with Display and Footswitch ●
The modified Safe-Cross RF System is similar 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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing has been conducted to verify that the materials in the modified RF Crossing Wires are biologically 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 together and satisfy intravascular performance requirements in an animal model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUN 7 - 2005
Ko509/5
510(K) SUMMARY
SUBMITTER INFORMATION
| A. | Company Name: | IntraLuminal Therapeutics, Inc. |
|---|---|---|
| B. | Company Address: | 6354 Corte Del Abeto - Suite A |
| 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 IDENTIFICATION
| A | Device Trade Name: | Safe-Cross® Radio Frequency Total Occlusion
Crossing 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:
- 175cm Working Length 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)
- Safe-Cross RF System Console with Display and Footswitch ●
1
The modified Safe-Cross RF System is similar 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 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 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.
INTENDED USE
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 arteries with total occlusions.
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 RF Crossing Wires are biologically 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 together and satisfy intravascular performance requirements in an animal model.
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three horizontal lines curving upwards, resembling a symbol or abstract representation of a flag.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 - 2005
Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance Intraluminal Therapeutics, Inc. 6354 Corte del Abeto, Suite A Carlsbad, CA 92009
K050915 Re:
Trade/Device Name: Safe-Cross® Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: May 5, 2005 Received: May 9, 2005
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.
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
3
Page 2 – Ms. Pamela Misajon
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR) (2006) (2006) (2006) (21 CFR (21 (2) 642 - 6th Anti) 21 CFR 1000forth in the quality systems (QS) regulation (21 -51 -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 95 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA imulig of substantial equivalies by .
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
r the light and the many of the 10, 276, Alles were the regulation entitled If you desire specific advice for your ac not one of a lise, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the re contact the Office of Comphalec at (240) 276 or Frant 807.97). You may obtain
"Misbranding by reference to premarket notification (21CFR Part 807.97). You may obtain "Misbranding by reference to premarkst notificancer the Act from the Division of Small
other general information on your responsibilities under that the gumber (800) 638-200 other general information on your responsion.com in total-free number (800) 638-2041 or Manufacturers, Imemational and Consumer Assistance a no vol an an an an an an an and and and and and and a
Sincerely yours,
Duna R. Vicines
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): K 6 50915
Device Name:
Safe-Cross® Radio Frequency Total Occlusion Crossing System
The Safe-Cross® Radio Frequency Total Occlusion Indications For Use: Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.
Prescription Use X (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)
Donna P. Vachal
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K050915