The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices, including leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

Device Description

The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. The CPS Aim, MediGuide Enabled slittable inner catheter (subselector/cannulator) contains a magnetic sensor allowing it to be tracked using the MediGuide™ System. The inner catheter facilitates cannulation of the coronary sinus or subselection of branch veins off of the coronary sinus/great cardiac vein during surgical implantation procedures. It may also be used for the delivery of contrast medium and St. Jude Medical™ devices, including guidewires. When used in conjunction with outer guide catheters, the CPS Aim, MediGuide Enabled slittable inner catheter (subselector/cannulator) can function as a dual-catheter assembly.

AI/ML Overview

The provided text is a 510(k) summary for the St. Jude Medical CPS Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter. It describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain the specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria, especially in the context of AI/ML performance.

This document focuses on the mechanical, functional, and biocompatibility testing of a physical medical device (a catheter). It does not involve any AI/ML components, therefore, aspects related to AI/ML performance such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and are not mentioned.

Therefore, most of the requested information regarding AI/ML device performance and related studies cannot be extracted from this document.

Here's what can be extracted based on the document provided:

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

The document lists types of performance testing but does not provide specific numerical acceptance criteria or detailed quantitative performance results for each test. It only states that the device "met all specified design and performance specifications."

Acceptance Criteria Category	Reported Device Performance
Package Integrity	Met specifications
Seal Strength	Met specifications
Saline and Aspiration Leak Testing	Met specifications
Visual Inspection	Met specifications
Dimensional Testing	Met specifications
Kink Testing	Met specifications
Compatibility Testing	Met specifications
Electrical Integrity	Met specifications
Tensile Testing	Met specifications
Rotation Capacity	Met specifications
Torque Testing	Met specifications
Slit Force	Met specifications
Flex Testing	Met specifications
Radiopacity Testing	Met specifications
Polarity	Met specifications
Static Accuracy	Met specifications

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

This information is not provided in the document. The testing described is for a physical device's mechanical and functional properties, not data-driven AI/ML performance.

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 applicable as the document describes testing of a physical medical device, not an AI/ML system requiring expert-established ground truth from data.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable as the device is a physical catheter, not an AI/ML system designed to assist human readers.

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

This information is not applicable as the device is a physical catheter, not a standalone algorithm.

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

This information is not applicable as the document describes physical and functional testing of a device, not validation against a medical ground truth for an AI/ML system.

8. The sample size for the training set

This information is not applicable as the device is a physical catheter and does not involve AI/ML requiring a training set.

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

This information is not applicable for the reasons stated above.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2014

St. Jude Medical Zachary Price Sr. Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342

Re: K142235

Trade/Device Name: CPS Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Models DS2M051, DS2M052, DS2M053, DS2M054 and DS2M055 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 21, 2014 Received: November 24, 2014

Dear Mr. Price,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Mr. Price

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Melissa A. Torres -S

For

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

CPS Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Device Name: Models DS2M051, DS2M052, DS2M053, DS2M054 and DS2M055

Indications for Use: The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices, including leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

CPS Direct™ MediGuide Enabled™ Inner Catheter Traditional 510(k) St. Jude Medical

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Image /page/3/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left side and the text "St. Jude Medical" on the right side. The text is in a serif font and is black in color. The logo is simple and professional.

510(k) Summary

Submitter :	St Jude Medical, CRMD15900 Valley View CourtSylmar, CA 91324Establishment Registration Number: 2017865
Contact Person :	Zachary PriceSenior Regulatory Affairs SpecialistPhone (818) 493 2903Fax (818) 493 3615
Date Prepared :	August 12, 2014
Trade Name :	CPS Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter ModelsDS2M051, DS2M052, DS2M053, DS2M054, and DS2M055
Classification :	Class II - 21 CFR 870.1250Catheter Percutaneous
Product Code :	DQY
Predicate Device:	The subject device is equivalent to the following St Jude Medical andMediGuide Devices
	St Jude Medical CPS Aim™ SL Slittable Inner Catheter (K090613)cleared on July 7, 2009
	MediGuide Guided Measurement Catheter (GMC) (K091780) cleared onOctober 16, 2009
Device Description:	The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable innercatheter (subselector/cannulator) is used to facilitate left heart leaddelivery procedures. The CPS Aim, MediGuide Enabled slittable innercatheter (subselector/cannulator) contains a magnetic sensor allowing it tobe tracked using the MediGuide™ System. The inner catheter facilitatescannulation of the coronary sinus or subselection of branch veins off of thecoronary sinus/great cardiac vein during surgical implantation procedures.It may also be used for the delivery of contrast medium and St. JudeMedical™ devices, including guidewires.
	When used in conjunction with outer guide catheters, the CPS Aim,MediGuide Enabled slittable inner catheter (subselector/cannulator) canfunction as a dual-catheter assembly.

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Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid with a tilted square in the center, followed by the text "ST. JUDE MEDICAL" in a sans-serif font. The word "MEDICAL" is followed by the registered trademark symbol.

The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner Intended Use: catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices, including leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

Comparison to

Predicate Devices The St Jude Medical CPS Aim™ MediGuide Enabled™ slittable inner guide catheter and accessories have a similar intended use and the same fundamental scientific technology as the predicate devices. All technological characteristics of CPS Aim™ MediGuide EnabledTM slittable inner catheter and accessories are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where differences exist between the subject device and the predicate devices performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device.

Performance Testing

(non-clinical) Product verification was performed on the CPS Aim™ MediGuide EnabledTM slittable inner catheter to confirm that it meets the design requirements and applicable industry standards. Testing included evaluations of (1) package integrity, (2) seal strength, (3) saline and aspiration leak testing, (4) visual inspection, (5) dimensional testing, (6) kink testing, (7) compatibility testing, (8) electrical integrity, (9) tensile testing, (10) rotation capacity, (11) torque testing, (12) slit force, (13) flex testing. (14) radiopacity testing. (15) polarity, and (16) static accuracy. This evaluation of the mechanical, functional, and biocompatibility testing with the CPS Aim™ MediGuide Enabled™ slittable inner catheter demonstrated that it met all specified design and performance specifications.
Conclusion : St Jude Medical considers the CPS Aim™ MediGuide Enabled™ slittable inner catheter and accessories to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in

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Image /page/5/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left and the words "ST. JUDE MEDICAL" in a serif font on the right. The grid is made up of smaller squares, with one square slightly tilted.

K142235

design, technological characteristics, principle of operation, materials and indications for use.

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).