Reprocessed Electrophysiology Diagnostic Catheters by STERILMED, INC.

The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronary sinus.

Device Description

The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided uni-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 6 French with a usable length of 115 cm. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Reprocessed Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a novel device meets specific performance criteria in a typical clinical study involving AI or diagnostic accuracy.

Therefore, many of the requested points related to AI, clinical studies, ground truth, expert consensus, and sample sizes for training/test sets are not applicable to this type of regulatory submission. The "acceptance criteria" here are primarily about demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than meeting specific diagnostic accuracy thresholds.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where it doesn't apply:

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

Acceptance Criteria (Inferred from testing performed)	Reported Device Performance (Summary from text)
Cleaning Validation: Removal of bioburden and residues.	Process validation testing was performed to validate the cleaning procedures. Specific non-clinical tests included "cleaning validation." (Implies successful validation as part of SE determination).
Sterilization Validation: Sterility Assurance Level (SAL).	"Sterilization validation (ISO 11135, USP <71>)." (Implies successful validation to meet industry standards).
Biocompatibility: No adverse biological reactions.	"Biocompatibility testing (ISO 10993-1)." (Implies successful testing to demonstrate that the reprocessed device is biocompatible).
Ethylene Oxide Residuals: Levels below safety thresholds.	"Ethylene oxide residual testing (ISO 10993-7)." (Implies successful testing to ensure residuals are within acceptable limits).
Packaging Validation: Maintain sterility and integrity.	"Packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096)." (Implies successful validation to protect the device until use).
Shelf Life Validation: Maintain performance over time.	"Shelf life validation (ASTM F 1980)." (Implies successful validation of the reprocessed device's shelf life).
Functional Performance (Bench Testing): Equivalent to original device under simulated use.	"Validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed EP diagnostic catheters to perform as originally intended." (Concludes successful performance, implying equivalence to the predicate). Additionally, "The manufacturing process includes visual and validated functional testing of 100% of products reprocessed."
Reprocessing Cycle Limit: Device integrity maintained for stated number of reprocesses.	"The reprocessed EP diagnostic catheters are reprocessed no more than four (4) times. Each device is marked and tracked through each reprocessing cycle. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing." (Implies demonstration that the device remains safe and effective for up to 4 reprocessing cycles).
Substantial Equivalence: All characteristics (design, materials, intended use, performance, safety) are substantially the same as the predicate or differences do not raise new questions of safety/effectiveness.	"Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantially equivalent to the predicate devices... as described in this premarket notification submission." (The entire submission is dedicated to proving this.)

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

The document mentions "Representative samples of reprocessed EP diagnostic catheters were tested." It does not specify the exact sample size for the various non-clinical and functional tests.
"Data provenance" is not directly applicable in the sense of patient data. The tests are laboratory-based and simulated use, conducted by the manufacturer (Sterilmed, Inc., from Plymouth, Minnesota, USA).

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 is not applicable. This submission is for a reprocessed medical device, not a diagnostic AI device requiring expert ground truth for image or data interpretation. The "ground truth" for the reprocessed device is its ability to meet performance specifications, safety standards, and functional equivalence to the original device, which is evaluated through engineering and laboratory testing.

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

This is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations in diagnostic studies, which is not the nature of this device's evaluation.

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 is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.

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

This is not applicable. This device does not involve an algorithm.

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

The "ground truth" for this submission is established through objective engineering performance specifications, industry standards (ISO, ASTM, USP), and validated testing protocols. The desired outcome (e.g., sterility, biocompatibility, functional performance like the original device) is the "truth" that the tests aim to confirm.

8. The sample size for the training set

This is not applicable. This is not an AI device, so there is no "training set."

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

This is not applicable for the same reason as 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

August 27, 2015

Sterilmed. Inc. Patricia F. Kaufman Regulatory Affairs Specialist 5010 Cheshire Parkway Suite 2 Plymouth, Minnesota 55446

Re: K150357

Trade/Device Name: Reprocessed Electrophysiology Diagnostic Catheters (See Attached List of Models) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: July 17, 2015 Received: July 20, 2015

Dear Patricia F. Kaufman:

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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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 yours,

Mitchell Stei

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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Page 3 - Patricia F. Kaufman

OriginalManufacturer	Model #	Description
Biosense Webster	D135303	Webster® Coronary Sinus Uni-Directional Catheters withAuto ID Technology, 6F, CS-D Curve, 115 cm useablelength, 2 mm tip electrode
Biosense Webster	D135304	Webster® Coronary Sinus Uni-Directional Catheters withAuto ID Technology, 6F, CS-F Curve, 115 cm useablelength, 2 mm tip electrode

K150357 List of Reprocessed Models Found SE:

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Indications for Use

510(k) Number: K150357

Device Name: Reprocessed Electrophysiology Diagnostic Catheters

Indications for Use: The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronary sinus.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

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Section II. SUMMARY AND CERTIFICATION

A.	510(k) Summary	K150357
	Submitter:	Sterilmed, Inc.
	Contact Person:	Patricia Kaufman5010 Cheshire Pkwy N, Suite 2Plymouth, MN 55446Phone: 763.488.3211Fax: 763.488.3350
	Date Prepared:	11 February 2015
	Trade Name:	Reprocessed Electrophysiology Diagnostic Catheters
	Classification Name:	Electrode Recording Catheter or Electrode Recording Probe
	Classification Number:	Class II, 21 CFR 870.1220
	Product Code:	NLH
PredicateDevices:	The reprocessed EP diagnostic catheters are substantially equivalent to the Biosense WebsterWebster® Coronary Sinus Uni-Directional Catheters with Auto ID Technology (K090898 andK101345).
DeviceDescription:	The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed tofacilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with abraided uni-directional deflectable tip section containing an array of ten platinum electrodes thatincludes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 6French with a usable length of 115 cm. The braided tip is controlled by a proximal hand piece thatfeatures a thumb operated sliding piston, and is offered in various curve types. The high-torque shaftallows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip atthe desired site.
Indications forUse:	The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiologystudies for intracardiac sensing, and pacing for the electrophysiological mapping andevaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronarysinus.
TechnologicalCharacteristics:	The reprocessed EP diagnostic catheters are identical to the predicate devices in design, materials ofconstruction, and intended use. There are no changes to the clinical applications, patient population,performance specifications, or method of operation.
Functional andSafety Testing:	Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriatefunctional characteristics. Process validation testing was performed to validate the cleaning andsterilization procedures as well as device packaging. In addition, the manufacturing process includesvisual and validated functional testing of 100% of products reprocessed. The reprocessed EPdiagnostic catheters are reprocessed no more than four (4) times. Each device is marked and trackedthrough each reprocessing cycle. After the device has reached the maximum number of reprocessingcycles, the device is rejected from further reprocessing is performed only by themanufacturer Sterilmed. Sterilmed restricts its reprocessings to exclude devices previouslyreprocessed by other reprocessors.
Summary ofNon-clinicalTestsConducted:	Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO11135, USP <71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf lifevalidation (ASTM F 1980). In addition, validation of functional performance (bench testing) wasperformed through simulated use, visual inspection, fatigue testing, and function testing. Performancetesting shows the reprocessed EP diagnostic catheters to perform as originally intended.
Conclusion:	Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantiallyequivalent to the predicate devices, Webster® Coronary Sinus Uni-Directional Catheters with AutoID Technology (K090898 and K101345) , as described in this premarket notification submission.

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).