(27 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
No.
The device facilitates the placement of guide wires for diagnostic or interventional procedures but does not directly treat a disease or condition.
No
The device is intended to facilitate the intra-luminal placement of guidewires, a procedural rather than diagnostic function.
No
The device description clearly outlines a physical catheter with various hardware components (handle, shaft, tip assembly, lever, rotator). There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of guide wires within the coronary or peripheral vasculature in vivo (within a living organism). This is a procedural device used during a medical intervention.
- Device Description: The description details a catheter designed for physical manipulation within the body, not for analyzing biological samples in vitro (outside of a living organism).
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
Therefore, the LuMend Frontrunner™ CTO Coronary Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.
Product codes
74 DQY
Device Description
The LuMend Frontrunner™ CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and 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, 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. The Frontrunner catheter does not have a guide wire lumen. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary or peripheral 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
Design analysis, in vitro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Device evaluation consisted of testing specified in FDA's Coronary and Cerebrovascular Guidance Document (January 1995) and included in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility. All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations.
Key Metrics
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).
0
OCT 2 4 2002
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: September 25, 2002
Name: LuMend, Inc. Address: 400 Chesapeake Drive Redwood City, CA 94063 650-364-1400
| Contact Person: | Michael A. Daniel |
|---|---|
| Phone Number: | Office: 415-407-0228 |
| Facsimile Number: | (925) 254-5187 |
Device Information:
| Classification: | Class II Percutaneous Catheter |
|---|---|
| Trade Name: | LuMend Frontrunner™ CTO Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Devices:
The LuMend Frontrunner™ CTO Catheter is substantially equivalent in intended use and method of operation to the following predicate device:
LuMend Frontrunner™ CTO Coronary Catheter [K013284]
Device Description:
The LuMend Frontrunner™ CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and 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, 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. The Frontrunner catheter does not have a guide wire lumen. Guidance and tracking of the catheter through the coronary or peripheral
1
vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.
Intended Use:
The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.
Comparison to Predicate Device(s):
The LuMend Frontrunner™ CTO Catheter is substantially equivalent to the previously cleared LuMend Frontrunner™ CTO Coronary 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 (CTOs).
In Vitro, In Situ and In Vivo Test Data:
Design analysis, in vitro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Device evaluation consisted of testing specified in FDA's Coronary and Cerebrovascular Guidance Document (January 1995) and included in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility. All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations.
Summary:
Based upon the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, the LuMend Frontrunner™ has been shown to be substantially equivalent to a currently marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and features an abstract design of three wavy lines emanating from a central point. The words "HUMAN SERVICES USA" are arranged around the top of the circle, and "DEPARTMENT OF HEALTH" is arranged around the left side of the circle.
Public Health Service
Food and Drug Administrati 9200 Corporate Boulevard ockville MD 20850
OCT 24 2002
LuMend, Inc. Mr. Michael A. Daniel Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, CA 94063
K023223 Re:
LuMend Frontrunner™ CTO Catheter Regulation Number: 21 CFR 8701250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: 74 DQY Dated: September 25, 2002 Received: September 27, 2002
Dear Mr. Daniel:
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 cquivalence 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 – Mr. Michael A. Daniel
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 (2) CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
KOLATU
Bram D. Zuckerman, M.D.
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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4. INDICATIONS FOR USE FORM
510(k) Number (if known): TBD TBD
Device Name: LuMend TM Frontrunner CTO Catheter
Indications For Use:
The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lessons (including chronic total occlusions) prior to PTCA of stent intervention.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
/~/
Division of Cardiovascular & Respiratory Devices
510(k) Number K-023225
Prescription Use /
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)