The Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information.

Device Description

The Reprocessed Advisor™ FL Circular Mapping Catheters, Sensor Enabled™ are steerable, flexible, insulated electrophysiology catheters constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented counter-clockwise as viewed from the handle.

This device is compatible with the EnSite Precision™ System which is a three dimensional (3-D) cardiac mapping system that combines impedance and magnetic field technology.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a reprocessed medical device, the "Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled." It primarily focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing, rather than an AI/ML-based system. As such, many of the requested criteria regarding AI model performance, multi-reader studies, and ground truth establishment for AI training/test sets are not applicable to this submission.

However, I can extract information related to the device's performance against its own acceptance criteria, as well as the testing methodology.

Here's a breakdown based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance (Based on the nature of this medical device submission)

The document primarily focuses on demonstrating that the reprocessed device performs "as safe and effective as the predicate and operate as originally intended." The acceptance criteria are implicitly met by successful completion of the listed tests, ensuring the reprocessed device maintains the functional and safety characteristics of the original.

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

The document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. Instead, it lists the types of performance tests conducted to demonstrate the device's safety and effectiveness and its equivalence to the predicate device. The conclusion states these tests demonstrated that the reprocessed devices are "as safe and effective as the predicate and operate as originally intended."

Here's an interpretation of the performance tests as implicitly meeting acceptance:

Acceptance Criterion (Implied)	Reported Device Performance (Implied)
Biocompatibility	Tests conducted and successfully met.
Validation of Reprocessing	Tests conducted and successfully met.
Sterilization Validation	Tests conducted and successfully met.
EEPROM verification	Tests conducted and successfully met.
Location sensor testing	Tests conducted and successfully met.
Visual inspection	Tests conducted and successfully met.
Dimensional testing	Tests conducted and successfully met.
Electrode continuity/isolation	Tests conducted and successfully met.
Curve and in-plane deflection	Tests conducted and successfully met.
Rigidity testing	Tests conducted and successfully met.
Freedom from leakage	Tests conducted and successfully met.
Tensile testing	Tests conducted and successfully met.
Locking mechanism testing	Tests conducted and successfully met.
Electrical Safety Testing	Tests conducted and successfully met.

Note: The document states "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended," implying all listed tests were passed successfully to meet the acceptance of substantial equivalence.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact sample size (number of reprocessed catheters) used for each of the bench and laboratory tests. It only states "Bench and laboratory testing was conducted."
Data Provenance: Not explicitly stated (e.g., country of origin, specific labs). It indicates these were "bench and laboratory testing," suggesting they were controlled experimental environments. The nature of reprocessing validation typically involves prospective testing of reprocessed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This submission is for a reprocessed electrophysiology catheter, not an AI/ML diagnostic system. The "ground truth" for this device's performance is established through objective physical, electrical, and mechanical measurements and validations (e.g., successful sterilization, appropriate dimensions, electrical continuity, sensor function). It does not involve human expert interpretation of images or signals for establishing a "ground truth" for a diagnostic outcome.

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

Not Applicable. As this is not an AI/ML diagnostic system based on human interpretation, there is no need for expert adjudication of results for a test set. Device performance is determined by objective measurements compared to specifications.

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

Not Applicable. This is not an AI-assisted diagnostic system. No MRMC study was conducted.

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

Not Applicable. This is a hardware medical device; it does not have an "algorithm-only" or "standalone" performance in the context of AI/ML. Its performance is inherent to its physical and electrical properties.

7. The type of ground truth used

The "ground truth" for this reprocessed device is established through:
- Objective Engineering Specifications: The device must meet the original design specifications for dimensions, electrical properties (continuity, isolation), mechanical properties (curve, deflection, rigidity, tensile strength, locking mechanism), and sensor function (EEPROM and location sensor verification).
- Validation Standards: Compliance with validated reprocessing procedures (cleaning, sterilization) and biocompatibility standards is the "ground truth" for safety.
- Essentially, the ground truth is that the reprocessed device performs indentically to a new, original device according to its established specifications and regulatory standards.

8. The sample size for the training set

Not Applicable. This is not an AI/ML system that utilizes a "training set" in the machine learning sense. The "training" in the context of a reprocessed medical device would refer to the optimization/validation of the reprocessing procedure itself, but not in the data science meaning.

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

Not Applicable. (See point 8).

In summary, the provided document details the regulatory clearance of a reprocessed medical device through extensive bench and laboratory testing to demonstrate substantial equivalence to its predicate. The framework of questions provided is highly tailored to AI/ML software, which is not the subject of this 510(k) submission.

Summary

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

Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

May 13, 2020

Stryker Sustainability Solutions Mia McCorkel Senior Regulatory Affairs Specialist 18101 W Drake Drive Tempe, Arizona 85283

Re: K200205

Trade/Device Name: Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: April 14, 2020 Received: April 15, 2020

Dear Mia McCorkel:

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. 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

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

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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,

Mark Fellman 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}------------------------------------------------

Model numbers intended for reprocessing:

Model Number	Description	Curve	Number ofLoopElectrodes	ElectrodeSpacing	LoopDiameter
D-AVSE-DF10-F15	Bi-DirectionalCircular MappingCatheter	DF	10	3-3-3	15
D-AVSE-DF10-F20	Bi-DirectionalCircular MappingCatheter	DF	10	5-5-5	20

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

Indications for Use

510(k) Number (if known)

K200205

Device Name

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

Indications for Use (Describe)

The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information.

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."

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

Image /page/4/Picture/0 description: The image shows the logo for Stryker Sustainability Solutions. The word "stryker" is in bold, black, sans-serif font on the top line. Below that, the words "Sustainability Solutions" are also in bold, black, sans-serif font, but in a smaller size.

SECTION 5: 510(k) SUMMARY

Submitter:

Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283

Contact:

Mia McCorkel Senior Regulatory Affairs Specialist 480-343-1855 (c) 480-763-2965 (f) mia.mccorkel@stryker.com

Date of Preparation: January 27, 2020

Name of Device:

	Trade/Proprietary Name:	Reprocessed Advisor FL™ Circular Mapping Catheter,Sensor Enabled™
	Common Name:	Diagnostic Electrophysiology Catheter, Electrode RecordingCatheter or Electrode Recording Probe
		Classification Information: Cardiovascular (21 CFR § 870.1220, NLH, Class II)
	Model Numbers:	D-AVSE-DF10-F15, D-AVSE-DF10-F20

Predicate Device:

Model Numbers	510(k) Number	510(k) Title	Original Manufacturer
D-AVSE-DF10-F15D-AVSE-DF10-F20	K160335	Advisor FL Circular MappingCatheter, Sensor Enabled	St. Jude Medical

Device Description:

K200205

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

Image /page/5/Picture/0 description: The image shows the logo for Stryker Sustainability Solutions. The word "stryker" is written in a bold, sans-serif font in black. Below the word "stryker" is the phrase "Sustainability Solutions," also written in a bold, sans-serif font in black. The logo is simple and modern, and it conveys a sense of strength and innovation.

This device is compatible with the EnSite Precision™ System which is a three dimensional (3-D) cardiac mapping system that combines impedance and magnetic field technology.

Model Numbers	Description	Curve	Loop Diameter
D-AVSE-DF10-F15	Reprocessed Advisor FL CircularMapping Catheter, Sensor Enabled	DF	15mm
D-AVSE-DF10-F20	Reprocessed Advisor FL CircularMapping Catheter, Sensor Enabled	DF	20mm

The model numbers included in the scope of this submission are as follows:

Intended Use:

The Reprocessed Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is a sensorenabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information.

Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ are equivalent to the predicate device. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of the device includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations.

Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Advisor™ FL Circular Mapping Catheter, Sensor Enabled™. This included the following tests:

Biocompatibility ●
Validation of Reprocessing ●
Sterilization Validation
Functional Performance Testing ●
- о EEPROM verification
- Location sensor testing o
- Visual inspection O
- Dimensional testing O
- Electrode continuity and isolation testing O
- Curve and in-plane deflection testing O
- Rigidity testing o
- Freedom from leakage O

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

Image /page/6/Picture/0 description: The image shows the logo for Stryker Sustainability Solutions. The word "Stryker" is in a bold, sans-serif font, with the letters slightly overlapping. Below "Stryker" is the phrase "Sustainability Solutions" in a smaller, bold, sans-serif font. The logo is black on a white background.

o Tensile testina
Locking mechanism testing
. Electrical Safety Testing

The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.

The Reprocessed Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is reprocessed no more than one (1) time. Each reprocessed device is tracked with a serial number label which is affixed to the catheter shaft. Once the device reaches the maximum number or reprocessing cycles, it is rejected and taken out of service. Reprocessing is conducted only by Stryker Sustainability Solutions. Stryker Sustainability Solutions restricts its reprocessing to exclude devises previously reprocessed by other reprocessors.

Conclusion:

The results of bench and laboratory testing demonstrate that the Reprocessed Advisor™ FL Circular Mapping Catheters, Sensor Enabled™ are at least as safe and effective and perform as well as the identified legally marketed predicate device as described herein.

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).