(132 days)
Not Found
No
The description focuses on mechanical manipulation and manual control of the device, with no mention of AI/ML capabilities or data processing for decision making.
No.
The device facilitates the placement of guide wires, which are used to gain access to stenotic lesions for subsequent PTCA or stent intervention. It does not directly provide a therapeutic effect itself.
No
The device is described as a catheter intended to physically facilitate the placement of guidewires, not to diagnose conditions.
No
The device description clearly outlines a physical catheter with a handle, shaft, and distal tip assembly, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, the LuMend Frontrunner™ CTO Coronary Catheter 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 vasculature prior to PTCA or stent intervention. This is a procedural device used in vivo (within the body) to aid in a medical procedure.
- Device Description: The description details a physical catheter designed for insertion into the coronary arteries. It describes mechanical components like a handle, rotator, and tip assembly.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The LuMend Frontrunner™ does not perform any such analysis of biological samples.
The device is clearly intended for use within the patient's body during a medical procedure, which is the defining characteristic of an in vivo medical device, 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™ is a sterile single-use percutaneous coronary catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal and a radiopaque blunt-shaped distal variable-size tip assembly. 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 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 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
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 fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations.
In addition to the above testing, a series of clinical studies have demonstrated substantial equivalence in terms of device safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K991059, K911547, K970528, K884647
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
ﺴﺴﺴﻠ
FEB 1 1 2002
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: _______________________________________________________________________________________________________________________________________________________________
Applicant Information:
- September 26, 2001 Date Prepared:
| Name: | LuMend, Inc. |
|---|---|
| Address: | 400 Chesapeake Drive |
| Redwood City, CA 94063 | |
| 650-364-1400 |
| Contact Person: | Michael A. Daniel: |
|---|---|
| Phone Number: | (415) 407-0223 |
| Facsimile Number: | (925) 932-5706 |
Device Information:
| Classification: | Class II Percutaneous Catheter |
|---|---|
| Trade Name: | LuMend Frontrunner™ CTO Coronary Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Devices:
The LuMend Frontrunner™ CTO Coronary Catheter is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
-
- Spectranetics Support Catheter Spectranetics Corp. - 510(k) K991059
-
- Magnum-Meier™ Recanalization Guidewire Schneider AG / Pfizer Hospital Prod. -510(k) K911547
-
- Clyde™ Coronary Guidewire Schneider (Europe) AG / Pfizer Hospital Prod. Group -510(k) K970528
-
- USCI Adjustable Tip Guide Wire C.R. Bard, Inc. - 510(k) K884647
Device Description:
The LuMend Frontrunner™ is a sterile single-use percutaneous coronary catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal
1
510(k) SUMMARY
(Continued)
and a radiopaque blunt-shaped distal variable-size tip assembly. 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 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 Coronary Catheter is substantially equivalent to a combination of the Spectranetics Support Catheter (K991059), the Schneider AG / Pfizer Hospital Products Magnum-Meier™ Recanalization Guidewire (K911547) and Clyde™ Coronary Guidewire (K970528) and the C.R. Bard, Inc. USCI Adjustable Tip Guide Wire (K884647).
The LuMend Frontrunner™ is substantially equivalent to the Clyde™ Coronary Guidewire (K970528) in terms of intended use. The Clyde Guide wire is intented to reach ond cross stenotic lesions prior to use of PTCA and / or stent therapeutic devices. The LuMend Frontrunner is intended to facilitate the intra-luminal placement of guide-wires beyond stenotic lesions. In the case of the Clyde™ device, once the lesion has been crossed, a balloon silation catheter may be immediately introduced along the guide wire. In the cose of the LuMend Frontrumer™, the device must be removed and replaced with a conventional guide wire prior to insertion of a PTCA device.
The LuMend Frontrunner™ device is substantially equivalent to the USCI Adjustable Tip Guide Wire in terms of the incorporation of a "pull wire" in the internal lumen used to deflect the distal tip of the catheter. Both the USCI Adjustable Tip Guide Wire and the LuMer of Grontrumer devices provide the ability to deflect the distal tip in situ.
The Frontrumer™ device is substantially equivalent to the Magnum Meier™ Recanalization Guide Wire in that it provides a spherically shaped distal tip to bluntly dissect steenotic tissue. The Magnum Meier instructions for use explicitly discusses the use of the guide wire in conjunction with a supporting catheter and advancing the recanalization wire either by itself or along with the catheter. The option of expanding the size of the Frontrumer distal tip is similar in affect to exchanging smaller guide wires for larger diameter wires.
The LuMend Frontrunner™ is similar in terms of shape, size, materials and construction to common coronary catheters used to provide guide wire support.
2
(Continued)
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 devices 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 fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations.
In addition to the above testing, a series of clinical studies have demonstrated substantial equivalence in terms of device safety and effectiveness .
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 currently marketed predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized emblem resembling an abstract human form or a caduceus. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Michael A. Daniel LuMend, Inc. 400 Chesapeake Drive Redwood City, CA 94063
Re: K013284
LuMend Frontrunner™ CTO Coronary Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: December 24, 2001 Received: December 26, 2001
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 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
Page 2 - Mr. Michael A. Daniel
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 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 (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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,
Dan Ben Tilleh
Bram Zuckerman, M.D.
am Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): __ TBD
LuMend FrontrunnerTM CTO Coronary Catheter Device Name:
Indications For Use:
The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-I he Luvicha I romanitional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.
KO13284
( )
on of Carolovascular, Respiratory, Jeurological Devices K013284 ½) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _________
(Optional Format 1-2-96)