The Pegasus 10 steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The wire employs a stainless steel proximal core shaft joined to a nitinol distal ground core portion. 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. The guidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Pegasus™ Guidewire.

Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device (guidewire). Such summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed clinical study proving strict acceptance criteria for a novel device. Therefore, the information you're requesting, particularly details on sample sizes, expert qualifications, and specific AI-related metrics, is largely not present in this type of document because it's not typically required for a 510(k) for a guidewire.

This document describes a non-clinical, benchtop comparison to a predicate device.

Acceptance Criteria and Study to Prove Device Performance:

Due to the nature of a 510(k) Premarket Notification for a guidewire, the "acceptance criteria" are primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" referenced is a series of non-clinical, benchtop qualification tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of specific, quantitative acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it states the following:

Acceptance Criteria Category	Reported Device Performance
Equivalence to Predicate Device	Functionality and performance characteristics are comparable to currently marketed devices (predicate: Titan™).
Visual/Tactile Attributes	Met established specific inspection criteria.
Dimensional Attributes	Met established specific inspection criteria.
Mechanical Attributes	Met established specific inspection criteria.
Biocompatibility	Found to be acceptable per ISO 10993 series.
Risk Analysis (FMEA)	All verification and validation activities resulted in meeting predetermined acceptance criteria.
Quality Systems (for manufacturing changes)	Product remains equivalent to predicate products; changes will not have an adverse effect on safe and effective use.

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

Sample Size: Not specified quantitatively. The document states "Test pieces were tested," implying a defined number, but the exact count is not provided.
Data Provenance: The testing was "Non-Clinical Tests" performed by LRM (Lake Region Manufacturing, Inc.) and Stereotaxis. This indicates laboratory/benchtop testing, not human subject data. The country of origin for the data is implicitly the USA, where Lake Region is located. The study is not retrospective or prospective in the clinical sense, as it's non-clinical bench testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not Applicable: This type of non-clinical testing for a guidewire does not involve "experts" establishing a "ground truth" in the clinical diagnostic sense. The comparison is against established engineering specifications and the performance of a predicate device.

4. Adjudication Method for the Test Set:

Not Applicable: Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology images). This guidewire testing involves objective measurements and comparisons against engineering specifications and predicate device performance, not subjective human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No: A MRMC study is not mentioned because this is a non-clinical submission for a guidewire. Such studies are typically conducted for diagnostic imaging devices or AI-powered clinical decision support tools where human readers are interpreting medical cases.
Effect Size of Human Readers with/without AI Assistance: Not applicable, as no AI component for human assistance is described in this device or associated testing.

6. Standalone (Algorithm Only) Performance Study:

Yes, in the context of non-clinical performance: The device itself (guidewire) is being tested for its standalone physical and mechanical performance characteristics (e.g., steerability, tip strength, lubricity, biocompatibility) without a human-in-the-loop performance metric being specifically detailed, beyond proving equivalence to the predicate. There is no "algorithm" in the AI sense for a guidewire.

7. Type of Ground Truth Used:

Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission are the established engineering design specifications for the device, and the known, acceptable performance characteristics of the legally marketed predicate device (Titan™ guidewire). Biocompatibility has its own 'ground truth' in the form of ISO 10993 standards.

8. Sample Size for the Training Set:

Not Applicable: This device is a physical guidewire and does not involve AI algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not Applicable: As there is no AI training set, this question is not relevant.

Summary

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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

December 21, 2007

Kor3655

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. d/b/a Lake Region Medical (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: Pegasus™ Guidewire (Moderate Support and Assert)

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 established for these devices under Section 514 of the Medical Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. ILRM has also determined that there are no applicable voluntary standards.

Device Description:

The guidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.

Technological Characteristics:

The design specifications are substantially similar for the Peqasus™ iterations as they are for the Titan " predicate device with the exception of the blended core material that is joined with a hypotube.

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 activities 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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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Qualification Testing:

Non-Clinical Tests:

In order to demonstrate equivalence of the Pegasus™ iterations, LRM and Stereotaxis performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices.

Biocompatibility Testing:

Biocompatibility testing per ISO 10993 series has been performed on the Pegasus™ device and has been found to be acceptable.

の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時

Substantial Equivalence Data:

Lake Region believes the Pegasus™ iterations are substantially equivalent to the Titan™ predicate devices cleared under 510(k) K060454. Performance specification changes to the Pegasus™ iterations are directly related to the blended material core design. All non-clinical test results support the claim of substantial equivalence to the predicate devices.

Intended Use Statement:

Pegasus™ steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three human profiles facing right, stacked on top of each other, with a flowing element beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 2 5 2008

Re: K073655

Trade Name: Pegasus™ Steerable (PTCA) Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DOX Dated: December 21, 2007 Received: December 26, 2007

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, Orug, 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, EDA way 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); good manufacturing proctice requirements as set

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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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Duna R. Wachner

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): Ko'73655 Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary 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)

Suma R. V. James

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K073655

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.