CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE by ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI

The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy

Device Description

The St. Jude Medical CPS Excel ™ , MediGuide Enabled ™ guidewire is a MediGuide enabled guidewire with a hydrophilic coating. The CPS Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing it to be visualized using the MediGuide system

AI/ML Overview

This document is a 510(k) summary for a medical device called the "CPS Excel™ MediGuide Enabled™ Guidewire and accessories." It does not describe a study involving algorithms, AI, or human readers, but rather a traditional medical device (a guidewire) seeking FDA clearance based on substantial equivalence to existing predicate devices.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance cannot be extracted from this document.

However, I can provide the information that is present, interpreted for a traditional medical device:

Acceptance Criteria and Device Performance (for a traditional medical device)

The document asserts "substantial equivalence" as the primary acceptance criteria. For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" are generally that the device is as safe and effective as a legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.

Key statements:

"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."
"This conclusion is based upon the device similarities in design, technological characteristics, principles of operation, materials and indications for use."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Actual Acceptance Criterion (Implicit/Explicit for Device Equivalence)	Reported Device Performance and Evidence from Document
Overall Substantial Equivalence	The device must be substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, principles of operation, materials, safety, and effectiveness. Any differences should not raise new questions of safety or effectiveness.	"The St Jude Medical CPS Excel MediGuide Enabled guidewire has a similar intended use and the same fundamental scientific technology as the predicate devices." "All technological characteristics of CPS Excel MediGuide Enabled guidewire kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling." "Where differences exist... performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device." "St Jude Medical considers the CPS Excel MediGuide Enabled guidewire kit to be equivalent to the predicate devices listed above."
Intended Use	Must be similar to predicate devices.	"The St. Jude Medical™ CPS Excel™ MediGuide Enabled™ guidewire is intended for use with the MediGuide system to enable real-time tip positioning and navigation within the coronary and peripheral vasculature. The MediGuide system is intended for use as an adjunct to fluoroscopy." (Similar to predicate devices, though specific predicate intended uses are not detailed in this excerpt)
Fundamental Scientific Technology	Must be the same or similar to predicate devices.	"The St Jude Medical CPS Excel MediGuide Enabled guidewire has a similar intended use and the same fundamental scientific technology as the predicate devices."
Technological Characteristics	Must be substantially equivalent to predicate devices (packaging, biocompatibility, sterilization, labeling).	"All technological characteristics of CPS Excel MediGuide Enabled guidewire kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling."
Safety and Effectiveness (where differences exist)	If there are differences from predicate devices, performance testing must demonstrate that these differences do not adversely affect the safety and effectiveness of the device. (Specific benchmarks for safety/effectiveness are not provided in this public summary, but would be part of the full 510(k) submission).	"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." (No specific performance data or metrics are provided in this summary, only the statement that testing was done and met the criteria).

Regarding the specific questions about an AI/algorithm study:

As stated previously, this document is about a physical guidewire. Therefore, the following information is not applicable or available from the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no "test set" in the AI sense. The "performance testing" referred to for the guidewire would be mechanical, chemical, and biological, not based on data sets of images or algorithms.
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): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and effectiveness for a guidewire would be demonstrated through various tests (e.g., tensile strength, kink resistance, pushability, torqueability, biocompatibility, sterility) and potentially animal or bench testing relevant to its physiological environment and mechanism of action, compared against predicate devices.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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长120298
中小2 Pago 15

MAY - 8 2012

Section 5- 510(k) Summary

Submitter :	St Jude Medical, CRMD15900 Valley View CourtSylmar, CA 91324Establishment Registration Number: 2017865
Contact Person :	Colleen CananStaff Regulatory Affairs SpecialistPhone (818) 493 2960Fax (818) 493 3615
Date Prepared :	January 27, 2012
Trade Name :	CPS Excel TM MediGuide Enabled TM Guidewire and accessories
Classification :	Class II-21 CFR 870.1330Catheter, Guidewire
Product Code :	DQX
Predicate Device:	The subject device is equivalent to the following St Jude Medical andMediGuide Devices
	St Jude Medical CPS Courier TM Guidewire (K073082) cleared on January9, 2008
	MediGuide Guided Measurement Catheter (GMC) (K091781) cleared onOctober 16, 2009
Device Description :	The St. Jude Medical CPS Excel TM , MediGuide Enabled TM guidewire is aMediGuide enabled guidewire with a hydrophilic coating. The CPSExcel, MediGuide Enabled guidewire contains a magnetic sensor allowingit to be visualized using the MediGuide system
Intended Use:	The St. Jude Medical TM CPS Excel TM MediGuide Enabled TM guidewire isintended for use with the MediGuide system to enable real-time tippositioning and navigation within the coronary and peripheral vasculature.The MediGuide system is intended for use as an adjunct to fluoroscopy
Comparison toPredicate Devices	The St Jude Medical CPS Excel MediGuide Enabled guidewire has asimilar intended use and the same fundamental scientific technology as the

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predicate devices. All technological characteristics of CPS Excel MediGuide Enabled guidewire kit 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.

Conclusion : St Jude Medical considers the CPS Excel MediGuide Enabled guidewire kit to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in design, technological characteristics, principles of operation, materials and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and tail. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the bird.

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

JUN 13 2012

St. Jude Medical c/o Ms. Colleen Canan Staff Regulatory Submission Specialist 15900 Valley View Court Sylmar, CA 91342

K120298 CPS Excel™ MediGuide Enabled™ Guidewire and accessories Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: 74 DQX Dated (Date on orig SE ltr): April 6, 2012 Received (Date on orig SE Itr): April 10, 2012

Dear Ms. Canan:

Re:

This letter corrects our substantially equivalent letter of May 8, 2012.

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 (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 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. Colleen Canan

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 (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.

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/CDRH0ffices/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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

CPS Excel™ MediGuide Enabled™ Guidewire Device Name: Models DS2M027, DS2M028, DS2M029

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-The-Counter Use(21 CFR 801 Subpart C)
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K120298

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.