Supreme and Response Electrophysiology Catheters

K161272 · Surgical Instrument Service and Savings, Inc. · NLH · May 18, 2017 · Cardiovascular

Device Facts

• Record ID: K161272
• Device Name: Supreme and Response Electrophysiology Catheters
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: May 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Story

Reprocessed diagnostic electrophysiology catheters used for electrogram recording and cardiac stimulation. Catheters are placed at high right atrium, right ventricular apex, His bundle, and coronary sinus. Used by physicians in clinical electrophysiology studies to evaluate cardiac arrhythmias. Device inputs are electrical signals from cardiac tissue; outputs are recorded electrograms and stimulation delivery. Reprocessed a maximum of two times; marked and removed from service after cycle limit. Benefits include clinical utility of diagnostic mapping while reducing medical waste through reprocessing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: functional performance (simulated use, bond/torsional strength, leakage current, flex fatigue, electrode adherence, shaft flexibility, tip buckling, impedance, corrosion resistance), cleaning validation (protein, TOC, endotoxins), biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility), and sterilization/packaging validation.

Technological Characteristics

Diagnostic electrophysiology catheters with various fixed curves and electrode spacings. Materials and design identical to predicate. Reprocessed via validated cleaning and ethylene oxide sterilization. Functional characteristics include electrical continuity and mechanical integrity (tensile, torsional, flex fatigue).

Indications for Use

Indicated for the evaluation of cardiac arrhythmias from endocardial and intravascular sites in patients requiring electrophysiology studies.

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 Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (K002976)

Reference Devices

• Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheters (K151617)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are connected and form a single, flowing shape.

Public Health Service

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

May 18, 2017

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

Re: K161272

Trade/Device Name: Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 12, 2017 Received: May 16, 2017

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

M.A. Willemsen

for

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Table 1a: K161272 List of Models in Scope<br>Supreme EP Catheters | | | | |
|--------------------------------------------------------------------|------------|---------------------|---------------------|---------------|
| Manufacturer Model No. | Electrodes | Spacing | Curve | Size |
| 401430 | 4 | 5 | JSNa | 6 Fr x 120 cm |
| 401433 | 4 | 10 | CRDb | 5 Fr x 120 cm |
| 401434 | 4 | 10 | CRD | 6 Fr x 120 cm |
| 401435 | 4 | 10 | JSN | 5 Fr x 120 cm |
| 401436 | 4 | 10 | JSN | 6 Fr x 120 cm |
| 401438 | 4 | 10 | DAOc | 6 Fr x 120 cm |
| 401441 | 4 | 5 | CRD | 5 Fr x 120 cm |
| 401442 | 4 | 5 | CRD | 6 Fr x 120 cm |
| 401443 | 4 | 5 | JSN | 5 Fr x 120 cm |
| 401444 | 4 | 5 | DAO | 5 Fr x 120 cm |
| 401445 | 4 | 5 | DAO | 6 Fr x 120 cm |
| 401448 | 4 | 2-5-2 | CRD | 5 Fr x 120 cm |
| 401449 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm |
| 401450 | 4 | 2-5-2 | JSN | 5 Fr x 120 cm |
| 401451 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm |
| 401453 | 4 | 2-5-2 | DAO | 6 Fr x 120 cm |
| 401466 | 4 | 5 | DAO-1d | 5 Fr x 120 cm |
| 401468 | 4 | 2-5-2 | DAO-1 | 5 Fr x 120 cm |
| 401474 | 4 | 5 | CRD-1e | 6 Fr x 120 cm |
| 401475 | 4 | 5 | JSN-1f | 6 Fr x 120 cm |
| 401859 | 4 | 10 | CRD-2g | 5 Fr x 120 cm |
| 401860 | 4 | 5 | CRD-2 | 5 Fr x 120 cm |
| 401863 | 10 | 2-8-2 | CSLh | 5 Fr x 120 cm |
| 401864 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm |
| 401865 | 10 | 5-5-5 | CSL | 5 Fr x 120 cm |
| 401871 | 4 | 2 | CRD-1 | 5 Fr x 120 cm |
| 401872 | 6 | 2-2-2 | CRD-1 | 5 Fr x 120 cm |
| 401876 | 6 | 5-5-5-175-175 | CRD-1 | 6 Fr x 120 cm |
| 401877 | 6 | 5-5-5-175-175 | JSN | 6 Fr x 120 cm |
| 401878 | 6 | 5-5-5-175-175 | JSN | 5 Fr x 120 cm |
| 401950 | 4 | 5 | CRD | 6 Fr x 120 cm |
| 401951 | 4 | 5 | JSN | 6 Fr x 120 cm |
| 401952 | 4 | 10 | CRD | 6 Fr x 120 cm |
| 401956 | 2 | 10 | CRD | 6 Fr x 120 cm |
| 401957 | 2 | 10 | CRD | 5 Fr x 120 cm |
| 402004 | 4 | 5 | CRD-2 | 6 Fr x 120 cm |
| 402008 | 6 | 2-5-2 | CRD-2 | 5 Fr x 120 cm |
| 402009 | 6 | 5-5-5 | CRD-2 | 5 Fr x 120 cm |
| 402010 | 6 | 2-5-2 | CRD-2 | 6 Fr x 120 cm |
| 402011 | 6 | 5-5-5 | CRD-2 | 6 Fr x 120 cm |
| Table 1b: K161272 List of Models in Scope<br>Response EP Catheters | | | | |
| Manufacturer Model No. | Electrodes | Spacing | Curve Size | |
| 401150 | 6 | 2-1-1-10-1-1-1-1-1- | CRD 6 Fr x 120 cm | |
| 401154 | 4 | 5 | CRD 6 Fr x 120 cm | |
| 401155 | 4 | 5 | JSN 6 Fr x 120 cm | |
| 401156 | 4 | 5 | DAO-1 6 Fr x 120 cm | |
| 401158 | 4 | 10 | CRD 6 Fr x 120 cm | |
| 401206 | 4 | 10 | CRD 5 Fr x 120 cm | |
| 401207 | 4 | 10 | JSN 5 Fr x 120 cm | |
| 401210 | 4 | 10 | CRD 6 Fr x 120 cm | |
| 401211 | 4 | 10 | JSN 6 Fr x 120 cm | |
| 401212 | 4 | 10 | DAO 6 Fr x 120 cm | |
| 401222 | 4 | 5 | CRD 5 Fr x 120 cm | |
| 401223 | 4 | 5 | JSN 5 Fr x 120 cm | |
| 401226 | 4 | 5 | CRD 6 Fr x 120 cm | |
| 401227 | 4 | 5 | JSN 6 Fr x 120 cm | |
| 401228 | 4 | 5 | DAO 6 Fr x 120 cm | |
| 401260 | 4 | 2-5-2 | CRD 6 Fr x 120 cm | |
| 401261 | 4 | 2-5-2 | JSN 6 Fr x 120 cm | |
| 401271 | 6 | 2-5-2 | JSN 6 Fr x 120 cm | |
| 401275 | 6 | 2-2-2 | CRD 6 Fr x 120 cm | |
| 401276 | 6 | 2-2-2 | JSN 6 Fr x 120 cm | |
| 401278 | 6 | 2-2-2 | CRD 6 Fr x 120 cm | |
| 401282 | 6 | 5-5-5 | JSN 6 Fr x 120 cm | |
| 401305 | 10 | 2-5-2 | CRD 6 Fr x 120 cm | |
| 401306 | 10 | 2-5-2 | JSN 6 Fr x 65 cm | |
| 401308 | 10 | 2-5-2 | CRD 6 Fr x 120 cm | |
| 401309 | 10 | 2-5-2 | JSN 6 Fr x 120 cm | |
| 401310 | 10 | 2-5-2 | DAO 6 Fr x 120 cm | |
| 401311 | 10 | 2-2-2 | CRD 6 Fr x 120 cm | |
| 401312 | 10 | 2-2-2 | JSN 6 Fr x 120 cm | |
| 401317 | 2 | 10 | CRD 6 Fr x 120 cm | |
| 401318 | 2 | 10 | JSN 6 Fr x 120 cm | |
| 401353 | 10 | 2-8-2 | CSL 6 Fr x 120 cm | |
| 401356 | 4 | 5 | CRD-1 6 Fr x 120 cm | |
| 401357 | 4 | 5 | JSN-1 6 Fr x 120 cm | |
| 401360 | 6 | 2-5-2 | JSN 5 Fr x 120 cm | |
| 401381 | 10 | 2-8-2 | CSL 6 Fr x 120 cm | |
| 401386 | 6 | 5-5-5 | CSL 6 Fr x 120 cm | |
| 401392 | 10 | 2-2-2 | CSL 6 Fr x 120 cm | |
| 401399 | 10 | 5-5-5 | CSL 6 Fr x 120 cm | |
| 401400 | 10 | 5-5-5 | CSL 6 Fr x 120 cm | |
| 401425 | 6 | 5-5-5-150-5 | CRD 6 Fr x 120 cm | |

Table 1a: K161272 List of Models in Scope

(List of models continued on next page)

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Table 1b: K161272 List of Models in Scope

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### Indications for Use

510(k) Number (if known) K161272

#### Device Name

Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters

Indications for Use (Describe)

The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/Picture/0 description: The image contains the logos for Medline and Renewal. The Medline logo is on the left and features the company name in a stylized font with a blue star-like symbol. To the right of the Medline logo is a vertical line, followed by the Renewal logo. The Renewal logo has the word "Renewal" in a combination of green and blue, with the words "Full Circle Reprocessing" underneath in a smaller font.

# 510(k) Summary — K161272

| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon<br>Director, Quality Assurance and Regulatory Affairs<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] |
| Prepared by | Stephanie Boyle Mays<br>Regulatory Affairs Specialist<br>P: 541-516-4205<br>F: 541-923-3375<br>E: [e-mail] |
| Date Prepared | May 2, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Supreme and Response<br>Electrophysiology Catheters<br>Common Name: Diagnostic Electrophysiology Catheter, Reprocessed |
| Classification | Classification: Class II<br>Regulation Number: 21 CFR § 870.1220<br>Product Code: NLH |
| Predicate<br>Device | K002976 St. Jude Medical Response Electrophysiology Catheter, Supreme<br>Electrophysiology Catheter |
| Reference<br>Device | K151617 Medline ReNewal Reprocessed St. Jude Medical Livewire<br>Electrophysiology Catheters |
| Device<br>Description/<br>Intended Use | Medline ReNewal Reprocessed St. Jude Supreme and Response<br>Electrophysiology Catheters are commonly placed at the high right atrium,<br>right ventricular apex and His bundle, and in the coronary sinus, and are<br>used for electrogram recording and cardiac stimulation during diagnostic<br>electrophysiology studies.<br>The electrophysiology catheters are manufactured in various fixed curves<br>and electrode spacings for electrophysiological mapping for the evaluation<br>of a variety of cardiac arrhythmias from endocardial and intravascular<br>sites. 1 |
| Indications for<br>Use | The Medline ReNewal Reprocessed Supreme and Response<br>Electrophysiology Catheters can be used in the evaluation of a variety of<br>cardiac arrhythmias from endocardial and intravascular sites. |

l

Device Description and Intended Use were the same category in predicate K002976.

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Image /page/6/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue stylized image of a medical symbol. The Renewal logo is in green and blue, and the Full Circle Reprocessing logo is in a smaller font below the Renewal logo.

| Technological<br>Characteristics | The technological characteristics of the proposed devices and the<br>fundamental scientific technology of the subject device are identical to the<br>predicate device. The proposed devices are a reprocessed version of the<br>predicate devices. Only Medline ReNewal reprocesses the Medline<br>ReNewal Reprocessed St. Jude Supreme and Response Electrophysiology<br>Catheters. Catheters are reprocessed a maximum of two times. Catheters<br>are marked and taken out of service after the maximum number of cycles is<br>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: simulated use and artificial soiling; bond strength (tensile testing); torsional strength; leakage current; catheter/handle joint flexibility and continuity (flex fatigue); electrode adherence; 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; and hemocompatibility (hemolysis, thrombogenicity; & complement activation). Packaging and shelf life validation; sterilization validation: bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability | | | | |
| | Model | Electrodes | Spacing | Curve | Size |
| | 401430 | 4 | 5 | JSN | 6 Fr x 120 cm |
| | 401433 | 4 | 10 | CRD | 5 Fr x 120 cm |
| | 401434 | 4 | 10 | CRD | 6 Fr x 120 cm |
| Device Models<br>- Supreme | 401435 | 4 | 10 | JSN | 5 Fr x 120 cm |
| | 401436 | 4 | 10 | JSN | 6 Fr x 120 cm |
| | 401438 | 4 | 10 | DAO | 6 Fr x 120 cm |
| | 401441 | 4 | 5 | CRD | 5 Fr x 120 cm |
| | 401442 | 4 | 5 | CRD | 6 Fr x 120 cm |
| | 401443 | 4 | 5 | JSN | 5 Fr x 120 cm |
| Model | Electrodes | Spacing | Curve | Size | |
| 401444 | 4 | 5 | DAO | 5 Fr x 120 cm | |
| 401445 | 4 | 5 | DAO | 6 Fr x 120 cm | |
| 401448 | 4 | 2-5-2 | CRD | 5 Fr x 120 cm | |
| 401449 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401450 | 4 | 2-5-2 | JSN | 5 Fr x 120 cm | |
| 401451 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401453 | 4 | 2-5-2 | DAO | 6 Fr x 120 cm | |
| 401466 | 4 | 5 | DAO-1 | 5 Fr x 120 cm | |
| 401468 | 4 | 2-5-2 | DAO-1 | 5 Fr x 120 cm | |
| 401474 | 4 | 5 | CRD-1 | 6 Fr x 120 cm | |
| 401475 | 4 | 5 | JSN-1 | 6 Fr x 120 cm | |
| 401859 | 4 | 10 | CRD-2 | 5 Fr x 120 cm | |
| 401860 | 4 | 5 | CRD-2 | 5 Fr x 120 cm | |
| 401863 | 10 | 2-8-2 | CSL | 5 Fr x 120 cm | |
| 401864 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm | |
| 401865 | 10 | 5-5-5 | CSL | 5 Fr x 120 cm | |
| 401871 | 4 | 2 | CRD-1 | 5 Fr x 120 cm | |
| 401872 | 6 | 2-2-2 | CRD-1 | 5 Fr x 120 cm | |
| 401876 | 6 | 5-5-5-175-175 | CRD-1 | 6 Fr x 120 cm | |
| 401877 | 6 | 5-5-5-175-175 | JSN | 6 Fr x 120 cm | |
| 401878 | 6 | 5-5-5-175-175 | JSN | 5 Fr x 120 cm | |
| 401950 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401951 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401952 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401956 | 2 | 10 | CRD | 6 Fr x 120 cm | |
| 401957 | 2…