(190 days)
Not Found
No
The document describes a system using radio frequency energy and optical coherence reflectometry for visualization and crossing of coronary artery total occlusions. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used to facilitate the placement of devices in percutaneous interventions by assisting the medical practitioner in moving a guidewire through total occlusions in coronary arteries using RF energy, which directly interacts with and impacts the physiological condition of the patient by addressing the occlusion.
No
The device is indicated for facilitating the placement of devices used in percutaneous interventions by crossing total occlusions, which is a therapeutic intervention, not a diagnostic one. While it uses Optical Coherence Reflectometry (OCR) for visualization, this visualization is for navigation purposes during the therapeutic procedure, not for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a crossing wire, OCR unit with display monitor, and an RF generator with footswitch and interface cable.
Based on the provided text, the Safe-Cross® Radio Frequency Total Occlusion Crossing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate the placement of devices within native coronary arteries with total occlusions. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The device components (crossing wire, OCR unit, RF generator) are designed for direct interaction with the patient's anatomy (coronary arteries) during a medical procedure.
- Anatomical Site: The device is used in native coronary arteries, which are part of the human body.
- Input Imaging Modality: While it uses Optical Coherence Reflectometry (OCR), this is used for visualization within the vessel during the procedure, not for analyzing samples taken from the body.
- Performance Studies: The studies mentioned include in vivo animal studies and human clinical studies, which are typical for devices used directly on patients.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Safe-Cross System does not fit this description. It is a medical device used during a procedure on a patient.
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 (RF) Total Occlusion (TO) Crossing System consists of a the following:
- 0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
- Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
- Safe-Cross RF Generator with Footswitch and Interface Cable .
The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. 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 Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. 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 sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" 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
Optical Coherence Reflectometry (OCR)
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)
Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System when used in human subjects for the indicated use of crossing total occlusions in native coronary arteries. The results of the clinical studies indicate that the device performs as intended and docs not involve unacceptable risk to the patient.
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
§ 870.1330 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
JAN - 7 2004
1632031
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: | Guidewire |
| D. | Classification Name: | Catheter Guidewire |
| E. | Device Class: | Class II (per 21 CFR 870.1330) |
IDENTIFICATION OF PREDICATE DEVICE
The predicate device is the Safe-Steer™ Guide Wire System, manufactured by Intraluminal Therapeutics and cleared under 510(k) Premarket Notification number K021323.
DEVICE DESCRIPTION
The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following:
- 0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
- Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
- Safe-Cross RF Generator with Footswitch and Interface Cable .
The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub
1
that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. 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 sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" 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 Generator is an additional component of the Safe-Cross System. The performance of the RF Cenerator has been verified through bench, animal, and human clinical studies.
BIOCOMPATIBILITY AND PERFORMANCE DATA
Biocompatibility testing, in vitro bench testing and in vivo animal studies were conducted to cvaluate the biological and performance characteristics of the Safe-Cross System. Biocompatibility test results indicate that the patient components of the Safe-Cross Crossing Wire are biocompatible. Benchtop performance test results indicate that the components of the Safe-Cross System satisfy safety and performance requirements of the device specifications. In Vivo animal studies demonstrate that the various components of the Safe Cross System function together, as intended, in the animal model and do not raise unanticipated safety issues.
CLINICAL STUDIES
Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System when used in human subjects for the indicated use of crossing total occlusions in native coronary arteries. The results of the clinical studies indicate that the device performs as intended and docs not involve unacceptable risk to the patient.
2
CONCLUSIONS DRAWN FROM STUDIES
The results of nonclinical and clinical testing demonstrate that Safe-Cross System is substantially equivalent to the predicate device and satisfies the requirements of the device specifications.
Image /page/2/Figure/3 description: The image is mostly white with some black specks and markings scattered throughout. There are a few small clusters of these markings in the upper left and center left areas of the image. The markings appear to be random and do not form any recognizable shapes or patterns.
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3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
IntraLuminal Therapcutics, Inc. c/o Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6354 Corte Del Abeto - Suite A Carlsbad, CA 92009
K032031 Rc:
Safe-Cross Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Codc: DQX Dated: October 10, 2003 Received: October 14, 2003
Dear Ms. Misajon:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave te riewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prices 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 adultcration.
If your device is classified (scc 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.
4
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 issualles or a succession complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delemmation that your as room of rederal agencies. You must or any Federal statutes and regulations administered by out not limited to: registration and listing (21 comply with all the Act S requirements, more 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good manat 820); and if applicable, the electronic form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (Doctors of Persons of Personal in your Section 510(k) i his letter will anow you to begin manxeting your substantial equivalence of your device to a legally premarket notification. The PDA miding of bassanaal vqur 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 desire specific advice for your act (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain Misolalling by reference to promanters in the Act from the Division of Small other general information on your respenser Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address
(501) : 15 057 : 6 da.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Elson Diaz 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
| 510(k) Number: | To Be Assigned By FDA K632031 |
|---|---|
| Device Name: | Safe-Cross® RF TO 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 coronary arteries with total occlusions. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
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OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Olesa Dike for Anne Parker
510(K) Numbe