Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.

Device Description

Roll-X™ Guidewires are steerable guidewires constructed of a stainless steel core wire with a coiled wire spring design at the distal end. The core wire is PTFE coated. Roll-X™ Guidewires have a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopague. The guidewires are provided sterile and non-pyrogenic.

AI/ML Overview

This St. Jude Medical 510(k) summary (K100710) describes the Roll-X™ Interventional Guidewire Portfolio. The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and technological characteristics, as well as non-clinical testing. It does not contain information related to software algorithms, AI, or human reader performance.

Here's a breakdown of the requested information based on the provided text, and where specific details are not available, it's noted:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted but does not provide specific acceptance criteria values or detailed reported performance data in a tabular format. The summary states that "Results of the testing demonstrate that the quidewire design meets product specifications and intended uses," but the actual "specifications" or "results" are not enumerated.

Item	Tests Performed	Reported Device Performance (as stated in document)
Device Performance	• Tensile Strength• Torque Strength• Torqueability• Tip Flexibility• Catheter Compatibility• Coating Adherence/Integrity• Flexing Test• Fracture Test• Corrosion Resistance• Radiopacity• Steering Response• Tip Load Test	"Results... demonstrate that the guidewire design meets product specifications and intended uses." (No specific values provided)
Biocompatibility	• Cytotoxicity• Sensitization• Irritation• Acute Systemic Toxicity• Hemolysis• Partial Thromboplastin Time• Complement Activation• In vivo Thromboresistance	"Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results)
Sterilization/Microbiology	• Ethylene Oxide Sterilization Evaluation• Bioburden• EO residuals• Endotoxin	"Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results)
Packaging	• Pouch Peel Test• Visual Inspection• Pouch Seal Integrity	"Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results)
Shelf Life	• Same as device performance and packaging tests	"Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results)

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

Sample Size: Not explicitly stated for any of the non-clinical tests. The document lists the types of tests but does not provide the number of units tested.
Data Provenance: All testing appears to be conducted by St. Jude Medical as part of their premarket notification. It describes "bench and animal testing." No information is provided regarding the country of origin for the data (beyond being part of a US regulatory submission) or whether it was retrospective or prospective.

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

This information is not applicable. The tests performed are engineering and biological tests on the device itself (e.g., tensile strength, biocompatibility), not diagnostic tests requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the types of tests described.

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

No. This type of study is not mentioned or relevant for a guidewire device submission, which focuses on physical and biological performance rather than diagnostic accuracy or human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is a medical guidewire, not a software algorithm or AI system. Therefore, standalone performance of an algorithm is not applicable.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be the established scientific and engineering standards for device performance (e.g., specific tensile strength values, accepted biocompatibility limits, sterility requirements). The document states that results "demonstrate that the quidewire design meets product specifications and intended uses," implying adherence to these standards.

For Animal Testing, the document mentions:
- Study #1 – assess performance as compared to currently marketed guidewire. This implies a comparative animal model where the performance of the new device is compared against a known, marketed predicate.
- Study #2 – development of hydrophilic coating scheme. This likely involved assessing the performance and characteristics of different coating schemes in an animal model.

8. The Sample Size for the Training Set

This information is not applicable. There is no software algorithm or AI model requiring a training set for this device.

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

This information is not applicable, as there is no training set for a software algorithm/AI model.

Summary

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1400710

Image /page/0/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the company name is the phrase "MORE CONTROL. LESS RISK."

MORE CONTROL. LESS RISK.

510(K) SUMMARY

APR 2 8 2010

1. Administrative Information

Name:	St. Jude Medical
Address:	14901 DeVeau PlaceMinnetonka, MN 55345
Phone:	651-756-6522
Fax:	651-756-3049
Contact Person:	Jennifer ZwiefelhoferSenior Regulatory Affairs Specialist
Date:	February 19, 2009

2. Device Information

Name of Device:	Roll-X™ Interventional Guidewire Portfolio
Common Name:	Guidewire
Classification Name:	Catheter Guidewire (870.1330)
Product Code:	DQX

3. Predicate Device Information

Roll-X™ Guidewire (St. Jude Medical) - K082304 cleared Aug 2008 Asahi Prowater PTCA Coronary Guidewire (Abbott) - K052339 cleared Nov 2005 Hi-Torque Balance Middleweight Universal (Abbott) - K013833 cleared Jan 2002 Hi-Torque Balance Heavyweight Guidewire (Abbott) - K982083 cleared Sep 1998

Device Description 4.

Page 1 of 3 Roll-X™ Interventional Guidewire Portfolio 510(k) Premarket Notification

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Image /page/1/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of squares on the left, with one square rotated. To the right of the grid is the text "ST. Jude Medical" in a serif font. Below the text is the tagline "More control. Less risk."

5. · Intended Use

Technological Characteristics 6.

The Roll-X Guidewires as compared to the Roll-X. Asahi Prowater, Hi-Torque BMW and Hi-Torque BHW guidewires are substantially equivalent in many ways, including intended use, design, material types, and technology as outlined below.

Intended Use:

Roll-X, Prowater, BMW and BHW guidewires have the same intended ● indication which is to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures.
Product Design, Material Types and Technology:
Sized 0.014" .
Available in similar lengths (180, 185 or 190cm and 300 cm) ●
Contain a SST core wire .
� Contain a distal radiopaque coil
Have flexible tip designs that can be shaped by the user .
Are joined by a combination of solders, welds, and/or adhesives �
Proximal SST cores wires are PTFE coated �
Contain a hydrophilic coating on the distal end

Summary of Non-clinical Testing 7.

Performance testing of the Roll-X Guidewires consists of bench and animal testing. Results of the testing demonstrate that the quidewire design meets product specifications and intended uses. A summary of the bench and performance testing conducted is listed below:

Page 2 of 3 · Roll-X™ Interventional Guidewire Portfolio 510(k) Premarket Notification

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Item	Tests
Device performance	• Tensile Strength• Torque Strength• Torqueability• Tip Flexibility• Catheter Compatibility• CoatingAdherence/Integrity	• Flexing Test• Fracture Test• Corrosion Resistance• Radiopacity• Steering Response• Tip Load Test
Biocompatibility	• Cytotoxicity• Sensitization• Irritation• Acute Systemic Toxicity• Hemolysis• Partial Thromboplastin Time• Complement Activation• In vivo Thromboresistance
Sterilization/Microbiology	• Ethylene Oxide Sterilization Evaluation• Bioburden• EO residuals• Endotoxin
Packaging	• Pouch Peel Test• Visual Inspection• Pouch Seal Integrity
Shelf Life	• Same as device performance and packaging
Animal Testing	• Study #1 – assess performance as compared tocurrently marketed guidewire• Study #2 – development of hydrophilic coatingscheme

Darfarmanca Tactina Cummo

Substantial Equivalence Conclusion 8.

The Roll-X™ Guidewires described in this 510(k) are substantially equivalent to the St. Jude Medical Roll-X™ Guidewire (K082304), the Abbott Vascular ASAHI Prowater Coronary Guidewire (K052339), the Abbot Vascular (previously Guidant Vascular Intervention) Hi-Torque Balance Middleweight™ Universal Guidewire (K013833) and the Abbot Vascular (previously Guidant Vascular Intervention) Hi-Torque® Balance Heavy Weight Guidewire (K982083). The intended use, design, material types, technology, and performance of the Roll-X™ Guidewires are equivalent to the predicate devices. There are no differences between devices which would raise issues of safety or effectiveness.

Page 3 of 3 Roll-XTM Interventional Guidewire Portfolio 510(k) Premarket Notification

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

St. Jude Medical c/o Mr. Mark Job Responsible Third Party Official Regulatory Technologies Services LLC 1394 25th Street NW Buffalo, MN 55313

APR 2 8 2010

Re: K100710

Trade/Device Name: Roll-XTM Interventional Guidewire Portfolio Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: March 11, 2010 Received: March 12, 2010

Dear Mr. Job:

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. Insting 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 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 - Mr. Mark Job

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Duna R. V. Aunes

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): |८ | DO 7 | 0

Device Name: Roll-X™ Interventional Guidewire Portfolio

Indications For Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunna (Division Slan-Off) Division of Cardiovascular Devices

Page 1 of 1

510(k) Number_K100710

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.