Reprocessed Electrophysiology Diagnostic Catheters

K150357 · Sterilmed, Inc. · NLH · Aug 27, 2015 · Cardiovascular

Device Facts

• Record ID: K150357
• Device Name: Reprocessed Electrophysiology Diagnostic Catheters
• Applicant: Sterilmed, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended 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.

Device Story

Steerable, multi-electrode diagnostic catheter; used for intracardiac sensing, recording, and pacing during electrophysiology studies. Features high-torque shaft; braided uni-directional deflectable tip; ten platinum electrodes (including 2 mm tip dome). Operated by physician via proximal hand piece with thumb-operated sliding piston to control tip deflection and rotation. Facilitates accurate positioning within coronary sinus for cardiac mapping. Reprocessed device; Sterilmed performs cleaning, sterilization, and functional testing. Maximum four reprocessing cycles; tracked via marking system. Output is electrical signal data from heart tissue, interpreted by external electrophysiology recording system to guide clinical decision-making regarding cardiac arrhythmias.

Clinical Evidence

Bench testing only. Includes cleaning validation, sterilization validation (ISO 11135, USP <71>), biocompatibility (ISO 10993-1), EO residual testing (ISO 10993-7), packaging validation (ASTM D 4169, F 88, F 2096), and shelf life validation (ASTM F 1980). Functional performance validated via simulated use, visual inspection, and fatigue testing.

Technological Characteristics

6 French, 115 cm length; high-torque shaft; braided uni-directional deflectable tip; 10 platinum electrodes. Sterilization: Ethylene Oxide. Reprocessed device; max 4 cycles. No changes from predicate design or materials.

Indications for Use

Indicated for patients undergoing electrophysiology studies requiring intracardiac sensing, recording, and pacing for mapping and evaluation of cardiac structures and arrhythmias; designed for use in the coronary sinus.

Regulatory Classification

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.

Predicate Devices

• Webster® Coronary Sinus Uni-Directional Catheters with Auto ID Technology (K090898)
• Webster® Coronary Sinus Uni-Directional Catheters with Auto ID Technology (K101345)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

| Original<br>Manufacturer | Model # | Description |
|--------------------------|---------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Biosense Webster | D135303 | Webster® Coronary Sinus Uni-Directional Catheters with<br>Auto ID Technology, 6F, CS-D Curve, 115 cm useable<br>length, 2 mm tip electrode |
| Biosense Webster | D135304 | Webster® Coronary Sinus Uni-Directional Catheters with<br>Auto ID Technology, 6F, CS-F Curve, 115 cm useable<br>length, 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 Kaufman<br>5010 Cheshire Pkwy N, Suite 2<br>Plymouth, MN 55446<br>Phone: [phone]<br>Fax: [phone] |
| | 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 |
| Predicate<br>Devices: | The reprocessed EP diagnostic catheters are substantially equivalent to the Biosense Webster<br>Webster® Coronary Sinus Uni-Directional Catheters with Auto ID Technology (K090898 and<br>K101345). | |
| Device<br>Description: | The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to<br>facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a<br>braided uni-directional deflectable tip section containing an array of ten platinum electrodes that<br>includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 6<br>French with a usable length of 115 cm. The braided tip is controlled by a proximal hand piece that<br>features a thumb operated sliding piston, and is offered in various curve types. The high-torque shaft<br>allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at<br>the desired site. | |
| Indications for<br>Use: | The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology<br>studies for intracardiac sensing, and pacing for the electrophysiological mapping and<br>evaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronary<br>sinus. | |
| Technological<br>Characteristics: | The reprocessed EP diagnostic catheters are identical to the predicate devices in design, materials of<br>construction, and intended use. There are no changes to the clinical applications, patient population,<br>performance specifications, or method of operation. | |
| Functional and<br>Safety Testing: | Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriate<br>functional characteristics. Process validation testing was performed to validate the cleaning and<br>sterilization procedures as well as device packaging. In addition, the manufacturing process includes<br>visual and validated functional testing of 100% of products reprocessed. The reprocessed EP<br>diagnostic catheters are reprocessed no more than four (4) times. Each device is marked and tracked<br>through each reprocessing cycle. After the device has reached the maximum number of reprocessing<br>cycles, the device is rejected from further reprocessing is performed only by the<br>manufacturer Sterilmed. Sterilmed restricts its reprocessings to exclude devices previously<br>reprocessed by other reprocessors. | |
| Summary of<br>Non-clinical<br>Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO<br>11135, USP <71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO<br>10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life<br>validation (ASTM F 1980). In addition, validation of functional performance (bench testing) was<br>performed through simulated use, visual inspection, fatigue testing, and function testing. Performance<br>testing shows the reprocessed EP diagnostic catheters to perform as originally intended. | |
| Conclusion: | Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantially<br>equivalent to the predicate devices, Webster® Coronary Sinus Uni-Directional Catheters with Auto<br>ID Technology (K090898 and K101345) , as described in this premarket notification submission. | |

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