(57 days)
No
The device description focuses on mechanical and radio frequency components, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device facilitates the placement of other devices during percutaneous interventions by helping to cross total occlusions; it does not directly treat a disease or condition itself.
No
The device is indicated for use in facilitating the placement of devices in percutaneous interventions, not for diagnosing conditions. It assists in crossing total occlusions in arteries using RF energy for navigation and movement, rather than providing diagnostic information.
No
The device description explicitly lists hardware components such as RF Crossing Wires, a System Console with Display and Footswitch, and a Y-Site hub. This indicates it is a hardware-based medical device with potential software control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of devices in percutaneous interventions in native peripheral arteries. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device components are wires, a console, and a footswitch, all designed for physical manipulation within the body and delivery of energy.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening. The visualization mentioned is for navigation within the vessel during the procedure, not for analyzing biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is clearly designed for a therapeutic intervention.
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 peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
Product codes
PDU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native peripheral 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 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.
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
Not Found
§ 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).
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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 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:
- 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 .
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.
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 peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
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.
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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.
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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 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 percutaneous interventions | |
| in native peripheral arteries with total occlusions. The | |
| device 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_