(58 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven analysis.
No
The LuMend Frontrunner® CTO Catheter is intended to facilitate the placement of guide wires, not to treat a disease or condition itself.
No
The device is described as a catheter and accessories intended to facilitate the placement of guide wires, not to diagnose a medical condition. Its purpose is for intervention, not diagnosis. This is explicitly stated in the "Intended Use / Indications for Use" section.
No
The device description clearly details a physical catheter with various mechanical components (handle, shaft, tip assembly, etc.) and does not mention any software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions... in the peripheral and coronary vasculature prior to further percutaneous intervention." This describes a device used within the body to aid in a medical procedure.
- Device Description: The description details a catheter with a handle, shaft, tip assembly, and guide wire lumen. This is consistent with a medical device used for accessing and navigating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests outside of the body on biological samples. This device is designed for use inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
Product codes (comma separated list FDA assigned to the subject device)
PDU, DQY
Device Description
The LuMend Frontrunner® CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator und a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, an optional guide wire lumen and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Design analysis, in virro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Routine device evaluation consists of testing specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Dovument (January 1995) and inoluded in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility tests. All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.1250 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).
0
2. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: TBD ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Applicant Information:
| Date Prepared: | November 7, 2003 |
|---|---|
| Name: | LuMend, Inc. |
| Address: | 400 Chesapeake Drive |
| Redwood City, CA 94063 | |
| 650-364-1400 | |
| Contact Person: | Michael A. Daniel |
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | (925) 254-5187 |
Device Information:
| Classification: | Class II Percutaneous Catheter |
|---|---|
| Trade Name: | LuMend Frontrunner® CTO Catheter and Accessories |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Devices:
The LuMend Frontrunner® CTO Catheter and Accessories is substantially equivalent in intended use and method of operation to the following predicate device:
LuMend Frontrunner® CTO Catheter K031005
Device Description:
The LuMend Frontrunner® CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator und a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, an optional guide wire lumen and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and
1
tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.
1033535
Intended Usc:
The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
Comparison to Predicate Device(s):
The LuMend Frontrunner® CTO Catheter and Accessories are substantially equivalent to the previously cleared LuMend Frontrunner® CTO Catheter in terms of embodiment, shape, appearance and function. It has the same indications for use and makes use of the identical mechanism of action: "blunt micro-dissection" to facilitate placement of a guide wire across stenotic vascular lesions including Chronic Total Occlusions (C'l'Os).
In Vitro, In Situ and In Vivo Test Data:
Design analysis, in virro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Routine device evaluation consists of testing specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Dovument (January 1995) and inoluded in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility tests. All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations.
Summarv:
Based upon the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, the LuMend Frontrunner® CTO Catheter has been shown to be substantially equivalent to a currently marketed 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 stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
LuMend, Inc. c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, CA 94063
SEP 1 8 2013
Re: K033535
Trade/Device Name: LuMend Frontrunner CTO Catheter and Accessories Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, DQY Dated: December 10, 2003 Received: December 11, 2003
Dear Mr. Daniel:
This letter corrects our substantially equivalent letter of January 7, 2004.
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 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
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Z.n.Z.
Image /page/3/Picture/8 description: The image contains a handwritten word, "for", in cursive script. The letters are connected, with the "f" having a loop extending above the main body of the letter and a stroke extending below the line. The "o" and "r" are joined together, forming a continuous shape. The writing appears to be done with a pen or marker, and the lines are smooth and flowing.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. INDICATIONS FOR USE FORM
.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
LuMend Frontrunner® CTO Catheter and Accessories Device Name:
Indications For Use:
The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Stealte
Division Shipment)
Division of Cardiovascular Devices
510(K) Number K03352 (SM. IQ
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
(Optional Format 1-2-96)