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.

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.

AI/ML Overview

The provided text describes the LuMend Frontrunner™ CTO Coronary Catheter. It outlines the device's description, intended use, and comparison to predicate devices, but it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance metrics.

However, the document states:

"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."

Based on this information, I can answer some of your questions and explain why others cannot be fully addressed from the provided text.

1. A table of acceptance criteria and the reported device performance

The document explicitly states: "All data fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations."

However, specific numerical acceptance criteria (e.g., "tensile strength > X N") and the corresponding precise reported device performance values are not provided in this summary. The summary only gives a high-level statement of compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "a series of clinical studies" but does not provide details on the sample size for these studies, their design (retrospective or prospective), or the country of origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The text refers to "clinical studies" but doesn't detail the methodology for establishing ground truth within those studies, nor does it mention expert review processes for a "test set" in the context of AI or diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. The study summary doesn't describe an adjudication process, which is typically relevant for studies involving subjective interpretations or differing expert opinions, often found in diagnostic imaging studies.

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

No MRMC comparative effectiveness study is mentioned. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable here.

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

This question is not applicable as the device is a physical medical instrument (catheter), not a standalone algorithm.

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

For the "clinical studies" mentioned, the ultimate ground truth would likely be clinical outcomes data, possibly supplemented by angiographic assessments or other objective measures of successful lesion crossing and subsequent intervention. However, the document does not specify the exact nature of the ground truth used. For the in vitro and in vivo testing, the "ground truth" would be the measured physical properties or biological responses against predefined specifications.

8. The sample size for the training set

This question is not applicable as the device is a physical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

This question is not applicable for the same reason as point 8.

Summary

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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 DriveRedwood City, CA 94063650-364-1400

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:

1. Spectranetics Support Catheter Spectranetics Corp. - 510(k) K991059
1. Magnum-Meier™ Recanalization Guidewire Schneider AG / Pfizer Hospital Prod. -510(k) K911547
1. Clyde™ Coronary Guidewire Schneider (Europe) AG / Pfizer Hospital Prod. Group -510(k) K970528
1. 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

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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:

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.

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(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.

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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

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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

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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) ✓

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).