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 Connector accessory is a flexible, insulated cable that is used to connect the CPS Excel™ MediGuide Enabled " guidewire to the MediGuide Technology. The guidewire is inserted into the connector until it bottoms out. Once the guidewire cannot be pushed any further, the nut on the connector end is tightened to fixate the guidewire in the connector. Inside the molded connector housing is a printed circuit board (PCB) which is wrapped with magnetic shielding. The PCB has contact slots that connect with the electrical contacts of the guidewire for electrical functionality. The other end of the MediGuide guidewire connector is a ODU-compatible connector that connects to the MediGuide Technology catheter connect box.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (CPS Excel™ MediGuide Enabled™ Guidewire and accessories). It states that this submission is a "special 510(K) to gain clearance" for the device, and that there are "no design changes to the Guidewire Models DS2M027, and DS2M029." It also states that the "Connector accessory DS2M033 have only undergone minimal design changes to connect directly to the MediGuide technology as compared to the predicate."

This type of submission often focuses on demonstrating that the modified device remains substantially equivalent to a previously cleared predicate device, rather than performing a new, extensive clinical study to establish new performance criteria. It relies heavily on non-clinical testing and comparison to the predicate.

Therefore, many of the typical acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithmic performance) that would be present for a novel AI/software device are not applicable or available in this document because the submission focuses on demonstrating equivalence through non-clinical testing and minimal design changes.

The document does not describe a study in the sense of a large-scale clinical trial with human subjects for novel performance claims. Instead, it describes non-clinical verification and validation testing to ensure the modified device meets its design and performance specifications and remains substantially equivalent to the predicate.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:

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

The document does not provide a table of precise acceptance criteria with specific numerical thresholds and corresponding reported device performance values in a format typical for new performance claims. Instead, it lists the types of non-clinical tests performed and states that they were "Successful completion of all verification and validation activities...demonstrated that the candidate devices meet their predetermined design and performance specifications and that the products are substantially equivalent to the predicate devices."

The acceptance criterion for each test would generally be that the device successfully passes the specified test according to the guiding standard. The reported device performance is implicitly that it passed these tests.

Acceptance Critera (Type of Test)	Guiding Standard	Reported Device Performance
Bubble leak testing	ASTM F2096	Successful completion
Peel testing for seal strength	ASTM F88	Successful completion
Visual inspection testing	ISO 10555-1:2009	Successful completion
Dimensional testing	ISO 11070:1999	Successful completion
Cable joint flex testing	ANSI/AAMI EC53:1995/"2008	Successful completion
Label testing	BS EN-45502-1	Successful completion

2. Sample size 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 tests performed are non-clinical, mechanical, and integrity tests, not studies involving patient data or clinical datasets.

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. The tests are non-clinical and do not involve expert interpretation of medical data to establish ground truth.

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

This information is not applicable. The tests are non-clinical and do not involve expert adjudication of medical data.

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. This is a medical device for real-time tip positioning and navigation, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or performed for this specific 510(k) submission.

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

The device is a guidewire and connector, intended for use with the MediGuide™ System to enable real-time tip positioning and navigation. It is not an algorithm or AI product that would have a standalone performance study in the context typically described (e.g., for diagnostic algorithms). Its "performance" relates to its structural integrity, electrical functionality, and ability to connect to the MediGuide system.

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

For the non-clinical tests described, the "ground truth" is typically defined by the specifications and requirements outlined in the referenced ASTM, ISO, and ANSI/AAMI standards. For example, for a bubble leak test, the "ground truth" is the absence of bubbles under specified conditions. For dimensional testing, it's meeting the specified dimensions. There is no expert consensus, pathology, or outcomes data involved in these non-clinical tests.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device (guidewire and connector), not an AI algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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

November 20, 2014

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

Re: K142254

Trade/Device Name: CPS Excel MediGuide Enabled Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 13, 2014 Received: November 13, 2014

Dear Mr. Price:

This letter corrects our substantially equivalent letter of November 13, 2014.

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 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

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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 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" (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 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 yours,

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For Bram 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) K142254

Device Name

CPS Excel™ MediGuide Enabled™ Guidewire Models DS2M027, DS2M028, DS2M029

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

510(k) Summary

The purpose of this special 510(K) is to gain clearance for the CPS Excel™ MediGuide Enabled™ Guidewire Models DS2M027, DS2M028, DS2M029 and accessories. There are no design changes to the Guidewire Models DS2M027, and DS2M029. The design features of the CPS Excel™ MediGuide Enabled™ Guidewire Connector accessory DS2M033 have only undergone minimal design changes to connect directly to the MediGuide technology as compared to the predicate, MediGuide Enabled™ Guidewire Connector DS2M032 (K120298).

Submitter:	St. Jude Medical, CRMD
Address:	15900 Valley View CtSylmar, CA 91342
Phone:	818 493 2903
Fax:	818 493 3615
Contact Person:	Zachary Price
Trade Name/ProprietaryName:	CPS Excel™ MediGuide Enabled™ Guidewire and accessories
Common Name:	Catheter, GuidewireModel Numbers: DS2M027, DS2M028, DS2M029, DS2M030,DS2M033
Legally marketed deviceto which your firm isclaiming equivalence:	CPS Excel™ MediGuide Enabled™ Guidewire and accessories(K120298)

Device Description:

The device description of the CPS Excel™ MediGuide Enabled™ Guidewire Connector accessory DS2M033 is as follows.

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The indication for use is as follows:

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.

Technological Characteristics of the Device Compared to the Predicate Device:

The device has the same technological characteristics as the currently marketed CPS Excel™ MediGuide Enabled™ Guidewire connector, with only minimal changes to the cable length, connector type, connector construction to accommodate change to connect directly to the MediGuide Technology

Non-clinical Test Summary:

The risk analysis method used to assess the impact of the modification of the CPS Excel™ MediGuide Enabled™ Guidewire Connector accessory DS2M033 documents the investigation of hazards and the mitigation of risks associated with its use and reports the results of the investigation. The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA/FMECA). It was determined that overall residual risk is acceptable.

Verification and validation testing of the Connector accessory included the following testing and associated guiding standards: (1) bubble leak testing (ASTM F2096), (2) peel testing for seal strength (ASTM F88), (3) visual inspection testing (ISO 10555-1:2009), (4) dimensional testing (ISO 11070:1999), (5) cable joint flex testing (ANSI/AAMI EC53:1995/"2008), and (6) label testing (BS EN-45502-1). Successful completion of all verification and validation activities, (as shown in Table 4) demonstrated that the candidate devices meet their predetermined design and performance specifications and that the products are substantially equivalent to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left, with one square tilted. To the right of the grid is the text "St. Jude MEDICAL" in a simple, sans-serif font.

Conclusion (Statement of Equivalence):

The results of the verification and validation tests and the risk analysis have demonstrated the CPS Excel™ MediGuide Enabled™ Guidewire and accessories functions in accordance with product specifications that were previously cleared for the predicate device, , the CPS Excel™ MediGuide Enabled™ Guidewire connector DS2M032 cleared in 510(k) K120298.

Therefore, St. Jude Medical considers the CPS Excel™ MediGuide Enabled™ Guidewire and accessories to be substantially equivalent to the legally marketed predicate device, the CPS Excel™ MediGuide Enabled™ Guidewire connector DS2M032 cleared in 510(k) 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.