The Agilis HisPro Steerable Catheter With Electrodes is indicated to provide a pathway for delivery and support of transvenous devices within the chambers and vasculature of the heart and can be used for electrogram recording and stimulation.

Device Description

The Agilis HisPro Steerable Catheter With Electrodes is a deflectable, slittable catheter with two distal tip electrodes. It serves as a delivery conduit for devices such as cardiac leads. The distal portion can be formed into a "U" shape, when fully deflected, to facilitate positioning of the tip at a desired location in the heart. The 10.5 Fr catheter has a braided shaft with a multi-durometer outer Pebax jacket. The catheter has a 7 Fr diameter lumen that allows for delivery of a 6Fr cardiovascular transvenous device, including a 6Fr pacing lead. The Agilis HisPro catheter's proximal handle consists of a rotating actuator with passive locking mechanism for deflecting the distal portion, a hemostasis valve for leak-proof delivery, and an integrated cable incorporating a 4-pin electrical connection for connecting to external electrical systems via a commercially available electrophysiology cable. The tip electrodes provide the ability to sense intracardiac electrogram (EGM) and pace when connected to the Merlin™ Pacing System Analyzer (PSA) or the WorkMate Claris™ Recording System. The sensing and pacing feature of the Agilis HisPro catheter provides the ability to identify the desired location in the heart. Accessories packaged for use with the Agilis HisPro catheter include dilator, guidewire for vascular access, cable adaptor pins for connection to the Merlin PSA via the electrophysiology cable, valve bypass tools for lead insertion, three-way stopcock and slitter. The catheter and the packaged accessories are provided as a sterile single-use device.

AI/ML Overview

The provided FDA 510(k) summary for the Agilis HisPro Steerable Catheter With Electrodes does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/machine learning or diagnostic performance metrics.

The document describes the device's technical specifications, indications for use, comparison to predicate devices, and a list of performance bench testing, packaging and shelf-life testing, biocompatibility assessment, and some animal testing. However, it does not mention:

Acceptance criteria directly related to diagnostic performance (e.g., sensitivity, specificity, accuracy).
Any study with a "test set" and "training set" of data, ground truth establishment, or expert adjudication that would be typical for validating an AI/ML medical device.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.

The listed tests are primarily focused on the physical, electrical, functional, and biological safety and performance of a medical catheter, not on a diagnostic or prognostic algorithm's performance.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device validation based on the provided text.

The information that is available relates to the overall performance testing for regulatory clearance of a physical medical device. Below is a summary of the performance testing performed, but it doesn't align with the requested format for AI/ML device performance.

Summary of Performance Testing (as described in the document):

The device underwent various performance tests to demonstrate it meets design specifications and is as safe and effective as predicate devices.

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

The document lists categories of tests but does not provide specific numerical acceptance criteria (e.g., "deflection force must be X N ± Y N") or quantified "reported device performance" values for each criterion. It only states that testing "demonstrated that the subject device is as safe and effective as the predicate devices."

Summary of Performance Tests Performed:

Test Category	Description / Outcome
Design Verification
Physical and Dimensional Characteristics	Performed. Outcome: Demonstrated device meets design specification.
Electrical Characteristics	Performed. Outcome: Demonstrated device meets design specification.
Functional Characteristics	Performed. Outcome: Demonstrated device meets design specification.
Connector/Lead/Slitter Compatibility	Performed. Outcome: Demonstrated device meets design specification.
Design Validation
Simulated-use Bench Testing	Performed. Outcome: Demonstrated device meets design specification (implies successful performance in simulated use).
Packaging and Shelf Life
Nominal T=0	Performed.
Accelerated Aging 12-month	Performed. Outcome: Assessed stability and integrity over simulated shelf life.
Biocompatibility
Hemocompatibility	Performed.
Cytotoxicity	Performed.
Systemic Toxicity	Performed.
Sensitization/Irritation	Performed.
Particulate Matter	Performed.
Electromagnetic Compatibility and Electrical Safety	Performed.
Animal Testing
Safety evaluation in comparison to Medtronic SelectSite C304	Performed. Outcome: Presumed comparable safety profile to predicate.
Sensing/Pacing performance via compatibility with PSA and WorkMate Claris	Performed. Outcome: Demonstrated compatibility and functionality for electrogram recording and pacing.

Since the document does not relate to an AI/ML device, the following points cannot be addressed:

2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 3, 2020

Abbott Winnie Yik Senior Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342

Re: K200721

Trade/Device Name: Agilis HisPro Steerable Catheter With Electrodes Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY, DRA Dated: March 17, 2020 Received: March 19, 2020

Dear Winnie Yik:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200721

Device Name

Agilis HisPro Steerable Catheter With Electrodes

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)
----------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

Date Prepared:	June 2, 2020
Submitter:	Abbott (formerly St. Jude Medical), Cardiac Rhythm ManagementDivision
Address:	15900 Valley View Ct.Sylmar, CA 91342USA
Phone:	(818) 362-6822
Contact Person:	Winnie YikSr. Regulatory Affairs Specialist(818) 493-2077wingyan.yik@abbott.com
Trade Name/Proprietary:	Agilis HisPro ™ Steerable Catheter With Electrodes
Common Name:	Catheter, Steerable catheter
Model Number:	DS3H010-38
Product Code:	DQY, DRA
Classification:	Class II - 21 CFR 870.1250Percutaneous catheter
Indications for Use:	The Agilis HisPro ™ Steerable Catheter With Electrodes is indicatedto provide a pathway for delivery and support of transvenousdevices within the chambers and vasculature of the heart and can beused for electrogram recording and stimulation.
Device Description:	The Agilis HisPro Steerable Catheter With Electrodes is adeflectable, slittable catheter with two distal tip electrodes. It servesas a delivery conduit for devices such as cardiac leads.
	The distal portion can be formed into a "U" shape, when fullydeflected, to facilitate positioning of the tip at a desired location inthe heart. The 10.5 Fr catheter has a braided shaft with a multi-durometer outer Pebax jacket. The catheter has a 7 Fr diameterlumen that allows for delivery of a 6Fr cardiovascular transvenousdevice, including a 6Fr pacing lead.

{4}------------------------------------------------

510(k) SUMMARY

	The Agilis HisPro catheter's proximal handle consists of a rotating actuator with passive locking mechanism for deflecting the distal portion, a hemostasis valve for leak-proof delivery, and an integrated cable incorporating a 4-pin electrical connection for connecting to external electrical systems via a commercially available electrophysiology cable. The tip electrodes provide the ability to sense intracardiac electrogram (EGM) and pace when connected to the Merlin™ Pacing System Analyzer (PSA) or the WorkMate Claris™ Recording System. The sensing and pacing feature of the Agilis HisPro catheter provides the ability to identify the desired location in the heart.
	Accessories packaged for use with the Agilis HisPro catheter include dilator, guidewire for vascular access, cable adaptor pins for connection to the Merlin PSA via the electrophysiology cable, valve bypass tools for lead insertion, three-way stopcock and slitter. The catheter and the packaged accessories are provided as a sterile single-use device.
Predicate Devices:	Primary: Medtronic SelectSite™ Model C304510(k) Number: K033989This predicate has not been subject to a design-related recall.
	Secondary: Abbott CPS Luminary Bideflectable Catheter510(k) Number: K052575This predicate has not been subject to a design-related recall.No reference devices were used in this submission.
Comparison toPredicate Devices:	The Agilis HisPro and the two predicate devices are all intended to serve as a conduit to allow delivery of transvenous devices to the heart. The Agilis HisPro Indications for Use is a combination of the primary predicate, Medtronic SelectSite C304 and secondary predicate, Abbott CPS Luminary Bideflectable Catheter. The primary function of the catheter to deliver a transvenous device into the heart is the same as both predicate devices. The expanded use statement of "electrogram recording and stimulation" is based on the CPS Luminary predicate device feature of tip electrodes, that allows for intracardiac signal detection via connection to external recording systems. The differences in indications do not alter the intended use of the device therefore the subject device intended use can be considered substantially equivalent to the predicate devices.

{5}------------------------------------------------

The Agilis HisPro and SelectSite C304 share similar design principles and many of the technological characteristics. Both devices are deflectable/steerable through rotating handle design that controls the distal curve to deflect uni-directionally. Like the SelectSite C304, the Agilis HisPro has radiopaque shaft and tips for visualization via fluoroscopy, and is designed with slittable hub and shaft for catheter removal following cardiac lead delivery. The Agilis HisPro also shares many key technological characteristics with the CPS Luminary predicate device. They are both designed with radiopaque shafts and tips, deflectable distal curves with rotating handles and integrated tip electrodes for intracardiac signal detection.

Some key differences exist between the Agilis HisPro and the two predicates devices. In comparison to the SelectSite, they differ in their tip design in which the Agilis HisPro incorporates dual tip electrodes enabling intracardiac stimulation and signal recording. In the case of the predicate SelectSite catheter, physicians utilize the delivered lead to sense and pace to evaluate sites for lead placement. The sensing/pacing feature of the Agilis HisPro gives physicians an option to enable localization of the intracardiac signals to evaluate pacing sites using the catheter to facilitate lead placement instead of the delivered lead. As mentioned above, the CPS Luminary predicate device shares a similar integrated tip electrode feature for intracardiac signal detection. Therefore, this electrode feature of the Agilis HisPro catheter does not introduce different questions of safety and effectiveness as compared to the predicate devices. When compared against the CPS Luminary, the key difference is that the Agilis HisPro is slittable while CPS Luminary is not; however, slittability is a common feature in transvenous catheter design. Therefore, this difference does not raise different questions of safety and effectiveness.

Substantial Equivalence And Summary of Studies:

The Agilis HisPro Steerable Catheter with Electrodes is substantially equivalent to the predicate devices based on comparisons of the intended use, device functionality and technological characteristics. The following performance testing was performed to demonstrate the device meets its design specification and is as safe and effective as the predicate devices.

Performance Bench Testing

. Design Verification
- Physical and Dimensional Characteristics

510(k) SUMMARY

{6}------------------------------------------------

510(k) SUMMARY

Electrical Characteristics
Functional Characteristics
Connector/Lead/Slitter Compatibility
Design Validation
- Simulated-use Bench Testing
Packaging and Shelf Life testing
- Nominal T=0
- Accelerated Aging 12-month
Biocompatibility ●
- Hemocompatibility
- Cytotoxicity
- Systemic Toxicity
- Sensitization/Irritation
- Particulate Matter
Electromagnetic Compatibility and Electrical Safety ●

Animal Testing

●

Safety evaluation in comparison to Medtronic SelectSite C304
Sensing/Pacing performance via compatibility with PSA and ● WorkMate Claris

The resulting evidence obtained from the design verification testing demonstrated that the subject device is as safe and effective as the predicate devices.

The safety and effectiveness of the Agilis HisPro Catheter to deliver leads to the His Bundle has not been evaluated by the FDA.

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).