The LuMend Frontrunner™ CTO Catheter is intended to facilitate the intra-luminal 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™ 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.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and study information for the LuMend Frontrunner™ CTO Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Standard	Reported Device Performance
In vitro tests:	All data continued to fall well within internal specification requirements.
- Tensile strength	All data continued to fall well within external standard requirements and predicate performance expectations.
- Torque strength	All data continued to fall well within internal specification requirements.
- Torqueability	All data continued to fall well within external standard requirements and predicate performance expectations.
- Tip flexibility	All data continued to fall well within internal specification requirements.
- Coating adherence/integrity	All data continued to fall well within external standard requirements and predicate performance expectations.
Biocompatibility	All data continued to fall well within internal specification requirements.
	All data continued to fall well within external standard requirements and predicate performance expectations.
Catheter compatibility	All data continued to fall well within internal specification requirements.
	All data continued to fall well within external standard requirements and predicate performance expectations.
Substantial Equivalence (Overall based on technical details & intended use)	The LuMend Frontrunner™ has been shown to be substantially equivalent to a currently marketed predicate device (LuMend Frontrunner™ CTO Coronary Catheter [K013284]). It is identical in terms of embodiment, shape, appearance, function, and mechanism of action ("blunt micro-dissection").

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the "in vitro, in situ, and in vivo" tests. It mentions "routine device evaluation" and that the testing "continued" from previous assessments, implying ongoing quality control rather than a single limited test set.

The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes engineering and biocompatibility testing, not studies involving expert assessment of images or clinical outcomes.

4. Adjudication method for the test set

This information is not provided in the document. As the tests are largely engineering and biocompatibility focused, an adjudication method in the context of expert review would not typically apply.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC comparative effectiveness study involving human readers or AI in this document. The device is a physical catheter, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the in vitro tests (tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity), the ground truth was based on internal specification requirements and external standard requirements specified in FDA's Coronary and Cerebrovascular Guidewire Guidance: Document (January 1995).

For the biocompatibility and catheter compatibility tests, the ground truth would also be related to established biocompatibility standards and compatibility specifications for medical devices.

8. The sample size for the training set

This is not applicable. The device is a physical catheter, not an AI model that requires a training set. The "testing" described refers to engineering and performance verification, not algorithm training.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for an AI model. For the device itself, the "ground truth" for its performance is aligned with the internal and external device specifications and standards.

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 KO23114

Applicant Information:

Date Prepared:	September 11, 2002
Name:	LuMend, Inc.
Address:	400 Chesapeake Drive
	Redwood City, CA 94063
	650-364-1400

Contact Person:	Michael A. Daniel
Phone Number:	Office: 415-407-0223
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:

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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:

Comparison to Predicate Device(s):

The LuMend Frontrunner™ CTO Catheter is identical to the previously cleared LuMend Frontrunner M CTO Coronary Catheter in terms of embodiment, shape, appearance and function, It 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: 1. 1 1. 1 1.

In Vitro, In Situ and In Vivo Test Data:

4.0.

LuMend's Quality system, including design control procedures assure that the Frontrunner device continues to meet all appropriate internal and external design input requirements. Routine device evaluation continues to consisted of testing specified in FDA's Coronary and Cerebrovascular Guidewire Guidance: Document (January 1995) and included in viro 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. dies : .. . .

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.

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

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 18 2013

Re: K023114

Trade/Device Name: LuMend Frontrunner CTO Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, DQY Dated: January 13, 2003 Received: January 14, 2003

Dear Mr. Daniel:

This letter corrects our substantially equivalent letter of January 23, 2003.

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 (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.

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/Resourcesfor You/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Zim.Zi

Image /page/3/Picture/8 description: The image contains a handwritten word "for" in cursive. The word is written in black ink on a white background. The letter "f" has a loop at the top and extends below the line, while the letter "o" is a closed circle, and the letter "r" has a curved top.

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 TM Frontrunner CTO Catheter 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 Sign-Off)
Division of Cardiovascular
510(k) Number Ko 23/14

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).