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.

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.

AI/ML Overview

The provided text describes the LuMend Frontrunner® CTO Catheter and Accessories, a Class II Percutaneous Catheter 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.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific, quantifiable acceptance criteria with numerical targets. Instead, it relies on a comparison to a predicate device and general compliance with internal specifications and external standards.

Acceptance Criteria Category	Reported Device Performance
Overall Performance	Substantially equivalent to the predicate device (LuMend Frontrunner® CTO Catheter K031005) in terms of embodiment, shape, appearance, function, indications for use, and mechanism of action ("blunt micro-dissection").
Functional Characteristics	Confirmed by design analysis, in vitro, and in vivo data to be substantially equivalent to the predicate device.
Specific Tests (In Vitro)	Tesile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility, and catheter compatibility tests were performed.
Test Results	All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations.
Compliance	Routine device evaluation consisted of testing specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Document (January 1995).

2. Sample Size for the Test Set and Data Provenance:

The document mentions "in vitro and in vivo data" but does not specify the sample size for any of the tests. It also does not mention the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention any experts being used to establish ground truth for a test set. The evaluation relies on engineering tests and comparison to a predicate device's established performance.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there's no indication of human interpretation or a "ground truth" derived from expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was NOT mentioned or performed. This is a device for facilitating guidewire placement, not an imaging or diagnostic device that typically involves human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable to this medical device submission. The LuMend Frontrunner® CTO Catheter is a physical medical device and does not involve an algorithm or AI that would operate in a "standalone" or "human-in-the-loop" manner. Its function is physical manipulation by a clinician.

7. Type of Ground Truth Used:

The "ground truth," in the context of this device's evaluation, is based on engineering specifications, compliance with FDA guidance documents (FDA's Coronary and Cerebrovascular Guidewire Guidance Document - January 1995), and the established performance characteristics of the predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" for the device's technical performance.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this type of medical device submission. Training sets are typically associated with machine learning algorithms, which are not involved here. The testing described is for a physical device.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reasons as #8.

Summary

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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:

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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:

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.

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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

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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

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4. INDICATIONS FOR USE FORM

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

LuMend Frontrunner® CTO Catheter and Accessories Device Name:

Indications For Use:

(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)

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Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).