Livewire Electrophysiology Catheter

K151617 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NLH · Jan 22, 2016 · Cardiovascular

Device Facts

• Record ID: K151617
• Device Name: Livewire Electrophysiology Catheter
• Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
• Product Code: NLH · Cardiovascular
• Decision Date: Jan 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Story

Reprocessed diagnostic electrophysiology catheter; used for electrogram recording and cardiac stimulation during diagnostic EP studies. Placed at high right atrium, right ventricular apex, His bundle, and coronary sinus. Features steerable design with user-adjustable tip curve and various electrode spacings. Used by clinicians in clinical settings. Reprocessed a maximum of two times; marked and retired after cycle limit. Device provides electrical interface for cardiac mapping; output used by physician to diagnose arrhythmias.

Clinical Evidence

Bench testing only. Evaluated via functional performance (simulated use, bond/torsional strength, leakage current, deflection, fatigue, tip flexibility, buckling, electrical resistance/impedance, corrosion), cleaning validation (protein, TOC, endotoxins, visual inspection), biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility), and sterilization/packaging validation (bioburden, EO/ECH residuals).

Technological Characteristics

Steerable diagnostic electrophysiology catheter with multiple electrode spacings. Features include adjustable tip curve, shaft/handle flexibility, and electrical continuity. Reprocessed using validated cleaning and ethylene oxide sterilization processes. Maximum of two reprocessing cycles allowed.

Indications for Use

Indicated for patients requiring evaluation of cardiac arrhythmias via endocardial and intravascular electrogram recording and cardiac stimulation.

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

• St. Jude Medical Livewire Electrophysiology Catheter (K022380)

Submission Summary (Full Text)

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

January 22, 2016

Medline ReNewal Brandi Panteleon Director, Quality Assurance/Regulatory Affairs Medline ReNewal 2747 SW 6th St Redmond. Oregon 97756

Re: K151617

Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: December 17, 2015 Received: December 18, 2015

Dear Brandi Panteleon:

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device 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,

Arthell Stein

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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Image /page/2/Picture/0 description: The image contains the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it.

Traditional 510(k) Notification Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter

## 4.0 Indications for Use

| | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|--------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K151617 | |
| TBD | | |

Device Name

Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter

Indications for Use (Describe)

The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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 [e-mail] "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." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services [phone] EF

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Image /page/3/Picture/0 description: The image shows the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, followed by the Renewal logo in green and blue. Below the Renewal logo is the text "Full Circle Reprocessing".

## 510(k) Summary – K151617

| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon<br>Director, QA/RA<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] | | |
| Date Prepared | June 19, 2015 | | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Livewire<br>Electrophysiology Catheter<br>Common Name: Diagnostic Electrophysiology Catheter, Reprocessed | | |
| Classification | Classification: Class II<br>Regulation Number: 870.1220<br>Product Code: NLH | | |
| Predicate<br>Device | K022380 St. Jude Medical Livewire Electrophysiology Catheter | | |
| Device<br>Description | Medline ReNewal Reprocessed St. Jude Livewire Electrophysiology<br>Catheters are commonly placed at the high right atrium, right ventricular<br>apex and His bundle, and in the coronary sinus, and are used for<br>electrogram recording and cardiac stimulation during diagnostic<br>electrophysiology studies. | | |
| Statement of<br>Intended Use | Medline ReNewal Reprocessed Electrophysiology catheters can be used in<br>the evaluation of a variety of cardiac arrhythmias from endocardial and<br>intravascular sites. | | |
| Technological<br>Characteristics | The Medline ReNewal Reprocessed Electrophysiology Catheters contain<br>various electrode spacing and a steerable design with a tip that can be<br>shaped into a user-desired curve. The technological characteristics of the<br>proposed devices are substantially equivalent to the predicate devices<br>listed in this submission. The proposed devices are a reprocessed version<br>of the predicate devices. Only Medline ReNewal reprocesses the Medline<br>ReNewal Reprocessed St. Jude Livewire Electrophysiology Catheters.<br>Catheters are reprocessed a maximum of two times. Catheters are marked<br>and taken out of service after the maximum number of cycles is reached. | | |
| Performance<br>Testing | The functional characteristics of the subject device have been evaluated<br>and found to be substantially equivalent to the predicate device based on<br>the following tests:<br>Functional performance studies: | ●<br>O<br>O<br>O<br>O | simulated use and artificial soiling;<br>bond strength (tensile testing);<br>torsional strength;<br>leakage current;<br>steerable deflection and continuity; |
| | ○ | catheter/handle joint flexibility and continuity (flex fatigue); | |
| | ○ | electrode adherence; | |
| | ○ | applied force deflection (tip flexibility); | |
| | ○ | shaft flexibility; | |
| | ○ | tip buckling; | |
| | ○ | direct current resistance; | |
| | ○ | impedance at 5 kHz; and | |
| | ○ | corrosion resistance. | |
| ● | | Cleaning: | |
| | ○ | protein, total organic carbon, and endotoxins; | |
| | ○ | visual inspection under magnification; and | |
| | ○ | cleaning performance qualification. | |
| ● | | Biocompatibility: | |
| | ○ | cytotoxicity; | |
| | ○ | sensitization; | |
| | ○ | irritation; | |
| | ○ | acute systemic toxicity; | |
| | ○ | pyrogenicity; | |
| | ○ | hemocompatibility (hemolysis, thrombogenicity; and | |
| | | complement activation). | |
| ● | | Packaging and shelf life validation; sterilization validation: | |
| | ○ | bioburden testing; and | |
| | ○ | ethylene oxide and ethylene chlorohydrin residuals testing. | |
| ● | | Product stability | |
| | Based on comparisons of the indications for use, intended use, | | |
| Conclusion | technological characteristics, and performance data to the predicate<br>devices, Medline ReNewal Reprocessed St. Jude Medical Livewire<br>Electrophysiology Catheters are substantially equivalent to the predicate<br>device. | | |

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Image /page/4/Picture/0 description: The image shows the Medline ReNewal logo. The word "ReNewal" is in a combination of green and blue, with "Re" in green and "Newal" in blue. Below "ReNewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a stylized star.