The Outback® Catheter is intended to facilitate placement and positioning of guide wires / catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

Device Description

The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved ip is positioned coaxially within the nosecone. In this configuration the catherer may be tracked over a guide wire to the sclected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.

AI/ML Overview

The provided text describes a 510(k) summary for the Outback® Catheter, a percutaneous catheter intended to facilitate placement and positioning of guide wires/catheters within the peripheral vasculature. The document clarifies that this device is not for use in coronary or cerebral vasculature.

However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and study results in the manner requested. The 510(k) process primarily relies on showing that a new device is as safe and effective as a legally marketed predicate device, often by citing similarities in design, materials, intended use, and performance claims. Performance testing is usually done to verify that the device meets its design specifications and functions as intended, but these studies may not be presented with the same level of detail as a de novo or PMA submission.

Therefore, the requested information, such as detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a human-in-the-loop or standalone AI study, is not available in the provided text. The document does not describe any studies that would involve AI or human reader performance.

Based on the provided text, here is what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Functional equivalence to predicate device (K040771, K032298)	Achieved substantial equivalence to predicate device. Principle of operation, intended use, fundamental design, and function remain basically the same as the predicate. Additional material options added.
Sterility	"sterile, single use device" - (Implied to meet sterility requirements, but no specific performance data given).
Proper functioning of guide tip and deployment mechanism	"Upon proximal retraction of the guide via the control knob, the guide's curved ip is positioned coaxially within the nosecone." & "The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port." (Implied functionality, no specific performance data given).
Radiopacity for fluoroscopic guidance	"The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance." (Implied visibility, no specific quantitative performance data given).
Biocompatibility (implied for medical devices)	Not mentioned, but assumed to be tested as part of device design.
Material specifications	"Additional material options have been added." (Implied met, but no details of types or testing).
Intended Use: Facilitate placement and positioning of guide wires/catheters within the peripheral vasculature	Device is intended for this use and deemed substantially equivalent to a device with the same intended use. (Implied, no specific performance data given to demonstrate this facilitation).

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

Not Applicable. The document describes a medical device (catheter) submitted for 510(k) clearance, not an AI or diagnostic imaging device that would typically involve a "test set" in the context of AI performance. The studies mentioned are likely engineering and functional tests to demonstrate equivalence, but details are not provided.

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

Not Applicable. This information is for AI or diagnostic performance studies, which are not described in the document.

4. Adjudication method for the test set:

Not Applicable. This information is for AI or diagnostic performance studies, which are not described in the document.

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. An MRMC comparative effectiveness study is not mentioned. This document pertains to a physical medical device (catheter), not an AI-based diagnostic tool.

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

No. This document pertains to a physical medical device (catheter), not an AI algorithm. "Standalone performance" in this context would refer to internal validation of the catheter's components and overall function (e.g., strength, flexibility, material compatibility), but no specific study details are provided.

7. The type of ground truth used:

Not Applicable in the traditional sense of AI/diagnostic imaging. For this catheter, "ground truth" would be related to whether the device physically performs its intended function (e.g., successful guide wire placement, material integrity, sterility). These are typically assessed through bench testing, simulated use, and potentially animal or cadaver studies, but details are not provided in this summary. The primary "ground truth" for 510(k) is demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, and intended use.

8. The sample size for the training set:

Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

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

Not Applicable. There is no mention of a "training set."

Summary of the Study (as described in the 510(k) summary):

The "study" described in the 510(k) summary is a design and engineering data review to demonstrate substantial equivalence to existing predicate devices (LuMend Outback® Catheter cleared via 510(k) K040771 and K032298).

The core of the "study" is a comparison:

Device Under Review: Outback® Catheter (K043534)
Predicate Devices: K040771 and K032298

The summary states: "A few minor changes have been made (see detailed device description), however, the principle of operation, intended use, fundamental design, and function of the product remains basically the same. Additional material options have been added. This version of the Outback® Catheter is clearly substantially equivalent to the previously cleared Outback device."

This means the "study" likely involved:

Engineering verification and validation (V&V) testing to ensure the minor changes and new materials did not adversely affect performance and that the device still met its design specifications. These tests would involve bench testing for mechanical properties, functional performance (e.g., deploying the guide tip, allowing guidewire passage), and biocompatibility.
A comprehensive comparison of the new device's specifications (intended use, technological characteristics, materials, design, performance data) against those of the predicate devices.

Data Provenance: The document does not specify the origin of the data (e.g., country of origin, retrospective/prospective). It would typically be generated by the manufacturer (LuMend, Inc.) through internal testing and design documentation.

Summary

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3. 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 K043534
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Applicant Information:

Date Prepared: December 20, 2004
Name: LuMend, Inc. Address: 400 Chesapeake Drive Redwood, CA. 94063 Office: 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
Trade Name:	Outback® Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 74 DQY / 21 CFR 870.1250

Predicate Devices:

The Outback® Catheter is substantially equivalent in intended use and method of operation to the following predicate devices:

LuMend Outback® Catheter cleared via 510(k) K040771 on 4/23/04 and K032298 on 8/26/03

Device Description:

LuMend, Inc. Outback Catheter 510(k) Submission. December 20, 2004

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Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.

Intended Use:

Comparison to Predicate Device(s):

The LuMend Outback® Catheter is very similar to the previously cleared LuMend Outback Catheter cleared via 510(k) K0407771. A few minor changes have been made (see detailed device description), however, the principle of operation, intended use, fundamental design, and function of the product remains basically the same. Additional material options have been added. This version of the Outback® Catheter is clearly substantially equivalent to the previously cleared Outback device.

Summary:

Based upon the indication for use and the design and engineering data provided in this premarket notification, the Outback® Catheter has been shown to be substantially equivalent to a currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LuMend, Inc. c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, CA 94063

Re: K043534

Trade Name: Outback® Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 20, 2004 Received: December 22, 2004

Dear Mr. Daniel:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 910(x) premantee nearly equivalent (for the indications referenced above and nave uctchined the acresed predicate devices marketed in interstate for use stated in the encrosure) to regary manatism of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactified in accordance with the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the United devices that have been recured in accordance while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or of the and Cosment Act (Act) that do not require appro the seneral controls provisions of the Act. The You may, therefore, market the devreet, books requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (Sec above) into ettier on a or regulations affecting your device can be may be subject to such additional controls. Extrong may on 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

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Page 2 – Mr. Michael A. Daniel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issualled of a babevice complies with other requirements of the Act that FDA has made a determination that your stered by other Federal agencies. You must of any rederal statutes and regalations and admited to: registration and listing (21 comply with an the Act 3 requirements, moraling, were and acturing practice requirements as set a CFK Part 807), adomig (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (sveting your device as described in your Section 510(k) This letter with anow you to begin maxical equivalence of your device to a legally premaired notineadon. The PDF mailing sification 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), please If you desire specific davice 10. Jour as 1) 594-4646. Also, please note the regulation entitled, connact the Office of Comphanes as (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Diana R. Vachner

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a combination of letters or a unique design. The character is drawn with curved lines and has a flowing, interconnected structure.

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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Indications for Use

510(k) Number (if known): K043534

Qutback® Catheter Device Name:

Indications For Use:

The Outback® Catheter is intended to facilitate placement and positioning of guide wires/ The Outback "Catherer is Inchieva to laciniano provinces "Catheter is not intended for use in the coronary or cerebral vasculature.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dma D. bachner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K04 3534

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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).