The LuMend Frontrunner™ GW 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™ GW 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, 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 a 510(k) submission for the LuMend Frontrunner™ GW CTO Catheter. Based on the information, here's a breakdown of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate device and guidance)	Reported Device Performance (Summary from text)
Functional Equivalence	Substantially equivalent in embodiment, shape, appearance, function, and mechanism of action to predicate device.	"The LuMend Frontrunner™ GW CTO Catheter is substantially equivalent to the previously cleared LuMend Frontrumer™ CTO Catheter in terms of embodiment, shape, appcarance and function."
Intended Use Equivalence	Same indications for use as predicate device.	"It has the same indications for use..."
Mechanism of Action	Utilizes "blunt micro-dissection" for guide wire placement across stenotic lesions.	"...makes use of the identical mechanism of action: 'blunt micro-dissection' to facilitate placement of a guide wire across stenotic vascular lessions including Chronic Total Occlusions (CTOs)."
Device Specifications	Fall within internal specifications and external standard requirements.	"All data continued to fall well within internal specification requirements..."
Predicate Performance	Meet predicate performance expectations.	"...as well as external standard requirements and predicate performance expectations."
Biocompatibility	Acceptable biocompatibility.	Included in evaluation.
Catheter Compatibility	Acceptable catheter compatibility.	Included in evaluation.
Physical Properties	Tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity.	All tested "within internal specification requirements, as well as external standard requirements and predicate performance expectations."

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

The provided text does not specify a sample size for a test set in the context of clinical or human performance data related to AI/algorithm assessment. The testing mentioned is for the physical and functional characteristics of the catheter, falling under in vitro, in situ, and in vivo tests. The data provenance is not explicitly stated beyond "in vitro, in situ and in vivo data," but it refers to technical performance rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or not provided in the context of an AI/algorithm study. The acceptance criteria and testing described pertain to the physical device's characteristics and its equivalence to a predicate device, not to an expert-driven assessment of an AI model's output.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as there is no mention of a human-reviewed test set requiring adjudication for an AI/algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, not on evaluating human reader performance with or without AI assistance. This device is a physical catheter, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

For the device's performance, the "ground truth" was established by internal specification requirements, external standard requirements (such as those specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Document), and predicate performance expectations. This is based on objective measurements of physical and functional properties, rather than expert consensus, pathology, or outcomes data in a clinical trial setting for a diagnostic aid.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since this is a physical medical device and not an AI algorithm, there is no "training set" in the sense of data used to train a machine learning model.

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

This information is not applicable or not provided for the reasons stated in point 8.

Summary

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KO31005-

JUN 1 8 2003

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:	June 17, 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™ GW CTO Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 74 DQY / 21 CFR 870.1250

Predicate Devices:

The LuMend Frontrunner™ GW CTO Catheter is substantially equivalent in intended use and method of operation to the following predicate device:

LuMend Frontrunner™ CTO Catheter K023223 / K023114

Device Description:

The LuMend Frontrunner™ GW CTO Catheter is a sterile single-use perculancous 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, an optional guide wire lumen and a radiopaque blunt-shaped distal variablesize tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rolator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and

LuMend, Inc. Frontrunner™ CTO Catheter 510(k) Submission. 03/28/03 Page 5 of 38

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tracking of the catherer through the coronary or verinheral 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.

Intended Use:

The LuMend Frontrunner™ GW CTO Catheter is intended to facilitate the intra-Jurninul 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™ GW CTO Catheter is substantially equivalent to the previously cleared LuMend Frontrumer™ CTO Catheter in terms of embodiment, shape, appcarance 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 lessions 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. Routine device evaluation consists of testing specified in FDA's Coronary and Cercbrovascular Guidewire Guidance Document (January 1995) and included in vitro tensile, torque strength, torqueability, tip flexibility, coaling 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™ GW CTO Catheter has been shown to be substantially equivalent to a currently marketed predicate device.

LuMend, Inc. Frontrunner™ CTO Catheter 510(k) Submission. 03/28/03

Page 6 of 38

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.

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: K031005

Trade/Device Name: LuMend Frontrunner GW CTO Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, DQY Dated: May 17, 2003 Received: May 19, 2003

Dear Mr. Daniel:

This letter corrects our substantially equivalent letter of June 18, 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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Z.M.Z.

for

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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HI' L HISH H J = =

4. INDICATIONS FOR USE FORM

TBD K631065 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

LuMend TM Frontrunner GW CTO Catheter Device Name:

Indications For Usc:

The LuMend Frontrunner™ GW CTO Catheter is intended to facilitate the intra-luminal placcancat of conventional guide wires beyond stenotic lesions (including cluonic total occlusions) in the peripheral and coronary vasculature prior to further perculaneous intervention.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Image /page/4/Figure/7 description: The image shows a document related to the Concurrence of GDRH, Office of Device Evaluation (ODE). It includes a section for indicating whether the device is for prescription use, with a checkmark next to "Prescription Use (Per 21 CFR 801.109)". The document also contains a 510(k) Number, which is listed as K031005. There is also a signature on the document.

(Optional Formal 1 -2-96)

LuMend, Inc. Frontrumer™ CTO Catheter 510(k) Submission. 03/28/03 Page 11 of 38

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).