These steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 180 cm and 300 cm. The wire is configured with a radiopaque gold cup at the distal end and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, specifically the Titan™ Guidewire. Such submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria and performance metrics for a new, innovative device's clinical efficacy. Therefore, a direct answer to your request, formatted as a table of acceptance criteria and reported device performance with all the specified details, is not fully extractable from the provided text.

The document states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." However, it does not explicitly list these acceptance criteria or the specific quantitative results for the Titan™ Guidewire. Instead, it relies on demonstrating equivalence to predicate devices through "Qualification Testing" (Non-Clinical Tests and Biocompatibility Testing).

Here's what can be inferred and explicitly stated from the provided text based on your request, with significant limitations due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantified acceptance criteria and specific performance results for the Titan™ Guidewire itself are not provided in this 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to predicate devices, implying that its performance meets the established safety and effectiveness profiles of those predicates.

The text does state that:

"Test pieces were Stereotaxis performed tooling to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."
"The requirements for visual/tactile, functionality and performance results of these guidewires are comparable to the currently marketed devices."
"All non-clinical test embedded magnet being assemmal equivalence to the predicate devices." (Likely a typo, meant to convey "all non-clinical tests re-affirmed substantial equivalence").

In lieu of a specific table, the "acceptance criteria" can be broadly interpreted as meeting the performance and safety profiles of the predicate devices. No specific numerical values for these criteria are given.

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

Test Set Sample Size: Not specified. The document mentions "test pieces" for non-clinical testing but does not provide details on the number of units tested.
Data Provenance: The testing described (visual/tactile, dimensional, mechanical attributes, biocompatibility) are non-clinical (bench) tests. The document does not refer to clinical test sets with patient data.

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

Not applicable. The "ground truth" concept usually applies to clinical studies where experts evaluate outcomes. For these non-clinical tests, the "ground truth" would be established by the testing methodology and the specification requirements themselves, not by expert consensus in a clinical context.

4. Adjudication method for the test set

Not applicable. This applies to clinical studies or assessments requiring human interpretation. The non-clinical tests would have pass/fail criteria based on specifications.

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. This is a 510(k) submission for a guidewire, which is a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

For the non-clinical tests, the "ground truth" was based on engineering specifications and established test methods designed to ensure the device's physical attributes, functionality, and biocompatibility are comparable to predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the Titan™ Guidewire itself in this submission document beyond relying on the predicate device's established safety and efficacy.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable. See point 8.

Summary

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K052-347

alle Region Manufacturing, Inc. 340 Lake Hazeltine Drive Chuska, MN 55318-1029 USA TEL: (952) 448-5111 FAX: (952) 448-3441

Image /page/0/Picture/2 description: The image shows a logo for "Lake Region". The logo consists of a stylized square with the letters "L" and "R" intertwined within it. Below the symbol, the words "Lake Region" are written in a simple, bold font. The entire logo is in black and white.

FEB 1 7 2006

SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

August 25, 2005

This summary is being included in the Premarket Notification submission in lieu of a statement of availability.

Company Name, Address, and Telephone Number:
Lake Region Manufacturing, Inc. (LRM)
340 Lake Hazeltine Drive
Chaska, MN 55318
Telephone: (952) 448-5111 Fax: (952) 448-3441
Contact Name: Karen MortensenManager, Regulatory Affairs
Establishment Registration Number: 2126666

Device Trade Name/Proprietary Name:

Titan™ Guidewire

Device Common Names/Usual Names and Classification Names:

These devices are commonly known as guides, guidewires, or spring The current classification names, and product codes are guidewires. Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ).

Classification of Devices:

The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels, respectively.

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SECTION 2.0 – SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Applicability of Performance Standards:

LRM has determined that no mandatory performance standards have been Erin has determinou that is under Section 514 of the Medical Amendments established for those of the or by any subsequent regulatory to i ederal i ood, Brag, and conned that there are no applicable voluntary standards.

Device Description:

These steerable guidewires have a nominal diameter of 0.014" and nominal These stoorable galability on. The wire is configured with a radiopaque longthe of Tree on embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A the wire through raccurers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

The guidewires will be packaged in the standard Lake Region single pack rno gaias mobility (one wire in a dispenser, placed in a pouch, labeled packaging conngarations). There will be no changes to the sterilization process for these guidewires.

Technological Characteristics:

The design specifications are the same for the proposed device as they are from the LRM predicate device with the exception of the additional magnet inside the gold cup at the distal end of the guidewire which will accommodate magnetic actuation and control.

Quality System Controls:

Design Control:

LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation raniate resulted in the ability to demonstrate that the predetermined acceptance criteria were met.

Material/Supplier/Product/Process Controls:

LRM has formal quality systems in place to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.

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Qualification Testing:

Non-Clinical Tests:

Nort-Clinical rests.
In order to demonstrate equivalence of the proposed device, LRM and In "order" to "demondtate" oquirements. TTest pieces were Stereotaxis performed tooling to established specific inspection criterial requirements for visual/tactile, dimensional and mechanical attributes. The requirements for visuallacile, antionality and performality and performance results of these guidewires are comparable to the currently marketed devices.

Biocompatibility Testing:

Biocompatibility testing has been performed on the predicate products and has been found to be applicable to the modified device. This testing, along has been found to be applicable biocompatibility, establishes acceptable biocompatibility for this device.

Substantial Equivalence Data:

Substantial Equirant this device is substantially equivalent to the predicate Eake Region believes and device, cleared under 510(K) K041624, is the device. - The Eake Rogion as not and started under K042854 is the primary predicate to show that material additions (gold cup/spacer and secondary prodioute to chex end in a previously cleared predicate device in magnet at the distance intended use. Performance specification the same classimoution for the can directly related to the addition of the changes to the proposed action are are arrestation system. All non-clinical test embedded magnet being assemmal equivalence to the predicate devices.

Intended Use Statement:

Lake Region's steerable guidewires are intended for use in angiographic Eake rogier o etoduce and position catheters and interventional devices i within the coronary and peripheral vasculature.

NOTE: The modification of this device does not alter its intended use.

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Image /page/3/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.

FEB 1 7 2006

Lake Region Manufacturing, Inc. c/o Ms. Karen Mortensen Manager, Regulatory Affairs 340 Lake Hazeltine Drive Chaska, MN 55318

Re: K052347 Titan Steerable (PTCA) Guidewire Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DOX Dated: January 25, 2006 Received: January 26, 2006

Dear Ms Mortensen:

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.

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Page 2 - Ms. Karen Mortensen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease or advised that I DA issuanted or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally I cuchal statutes and regulations ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, not 801); good manufacturing practice requirements as set CFK Fart 807), adomig (21 CFR Part 820); and if applicable, the electronic (2004) 1050 forth in the quality byteening (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provinces. (Seeing your device as described in your Section 510(k) I ins icticle will anow you to organization of substantial equivalence of your device to a legally prematics notification: "The PDF First on 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 darroliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

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):

Device Name:__Steerable (PTCA) Guidewire(Trade Name: Titan™)

Indications For Use:

For use in angiographic procedures to introduce and position catheters and i or use in anglographic proche prochary and peripheral vasculature.

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

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)

signature

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052347

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.