Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

K221067 · Surgical Instrument Service and Savings, Inc. · NLH · May 31, 2023 · Cardiovascular

Device Facts

• Record ID: K221067
• Device Name: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: May 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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

Device Story

Flexible electrode catheter; polyurethane shaft; platinum electrodes; remote tip manipulation via proximal handle. Used in clinical electrophysiology labs by physicians for cardiac arrhythmia evaluation. Device connects to external generator via universal cable to record intracardiac signals. Reprocessed version of original St. Jude Medical Livewire catheters; limited to maximum two reprocessing cycles. Benefits include clinical utility of diagnostic catheter while reducing medical waste through reprocessing.

Clinical Evidence

No clinical data. Bench testing only. Functional studies included simulated use, artificial soiling, tensile/torsional strength, electrical continuity, isolation resistance, and bend/corrosion resistance. Cleaning validation included protein, TOC, and endotoxin testing. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, and thrombosis. Sterilization and shelf-life validation performed.

Technological Characteristics

Polyurethane insulation/shaft; platinum electrodes. Remote tip manipulation mechanism. Connects to external generator via universal cable. Sterilized via ethylene oxide. Reprocessed device; maximum two reprocessing cycles.

Indications for Use

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

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 MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (K151622)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

May 31, 2023

Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Mays Senior Regulatory Affairs Specialist 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K221067

Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable 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: May 4, 2023 Received: May 4, 2023

Dear Stephanie Mays:

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.

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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 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 [phone] or 301-796-7100).

Sincerely.

# Aneesh S. Deoras -S

Aneesh Deoras 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

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| Model | Description | Electrodes | | Curve | Size |
|--------|---------------------------------------------------|------------|-------------------------------------------------------|---------------------|------------|
| No. | | Qty. | Spacing | | (cm)a |
| 401572 | Quadripolar | 4 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401575 | Decapolar | 10 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401580 | Hexapolar | 6 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401581 | Octapolar | 8 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401582 | Decapolar | 10 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401600 | Quadripolar | 4 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401603 | Quadripolar | 4 | 2-5-2 | M Curl | 6 Fr x 115 |
| 401606 | Quadripolar | 4 | 2-5-2 | L Sweep | 6 Fr x 115 |
| 401648 | Quadripolar | 4 | 5-5-5 | L Curl | 5 Fr x 115 |
| 401652 | Octapolar | 8 | 2-2-2 | M Sweep CRD-<br>2 ™ | 5 Fr x 115 |
| 401653 | Hexapolar | 6 | 2-5-2 | M Sweep CRD-<br>2™ | 5 Fr x 115 |
| 401654 | Hexapolar | 6 | 5 | M Sweep CRD-<br>2 ™ | 5 Fr x 115 |
| 401655 | Decapolar | 10 | 5-5-5 | XL Curl | 5 Fr x 115 |
| 401780 | Quadripolar | 4 | 5-5-5 | M sweep | 5 Fr x 115 |
| 401904 | Duo-Decapolar | 20 | 2-10-2 | Super L Curl | 7 Fr x 95 |
| 401905 | Duo-Decapolar | 20 | 5-5-5 | Super L Curl | 7 Fr x 95 |
| 401908 | Duo-Decapolar | 20 | 2-2-2 | M Curl | 7 Fr x 115 |
| 401914 | Duo-Decapolar | 20 | 2-5-2 | Super L Curl | 7 Fr x 95 |
| 401915 | Decapolar | 10 | 2-5-2 | XL Curl | 6 Fr x 115 |
| 401917 | Octapolar | 8 | 2-2-2 | M Sweep | 6 Fr x 115 |
| 401918 | Duo-Decapolar BDB™ | 20 | 2-20-2-2-2-<br>2-2-2-2-2-2-<br>2-2-25-2-25-<br>2-25-2 | Super L Curl | 7 Fr x 95 |
| 401923 | Decapolar | 10 | 2-2-2 | XL Curl | 6 Fr x 115 |
| 401926 | Decapolar CSL™ Bi-<br>directional | 10 | 2-8-2 | XL Sweep CSL | 6 Fr x 115 |
| 401932 | Dual-Purpose Duo-<br>Decapolar (20<br>Electrodes) | 20 | 2-8-2-(60)-2-<br>8-2 | Super L Curl | 7 Fr x 95 |
| 401933 | Quadripolar | 4 | 5-5-5 | M Sweep | 6 Fr x 115 |
| 401934 | Quadripolar | 4 | 5-5-5 | L Sweep | 6 Fr x 115 |
| 401935 | Decapolar | 10 | 2 | XL Sweep | 7 Fr x 115 |
| 401938 | Decapolar | 10 | 5-5-5 | M Sweep | 5 Fr x 115 |

The model numbers included in the scope of this submission are listed in the following table.

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### Indications for Use

510(k) Number (if known) K221067

Device Name

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheters

Indications for Use (Describe)

The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, with the word "MEDLINE" in white letters on a blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters, with the letters "Re" in green and the rest of the word in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.

## 221067 510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

| Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)<br>1500 NE Hemlock Ave., Redmond, OR 97756 | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact/Prepared by | Stephanie Boyle Mays<br>Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs<br>P: 541-516-4205 • F: 541-923-3375 • [e-mail] | | | |
| Date Prepared | April 8, 2022 | | | |
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed St. Jude Medical<br>Livewire Steerable Electrophysiology Catheters | | |
| | Common or Usual Name | Diagnostic Electrophysiology Catheter, Reprocessed | | |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording<br>probe, 21 CFR § 870.1220 | | |
| | Regulatory Class | 2 | | |
| | Product Code | NLH | | |
| | Panel | Cardiovascular | | |
| | 510(k) Number | K151622 | | |
| | Proprietary or Trade Name | St. Jude Medical MediGuide Enabled Livewire<br>Steerable Electrophysiology Catheter, Livewire<br>Electrophysiology Catheter, Response<br>Electrophysiology Catheter with Lumen, Response<br>Electrophysiology Catheter and SJM Epicardial<br>Catheter System, Supreme Electrophysiology<br>Catheter | | |
| Predicate Device | Common or Usual Name | Diagnostic Electrophysiology Catheter | | |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording<br>probe, 21 CFR § 870.1220 | | |
| | Regulatory Class | 2 | | |
| | Product Code | DRF | | |
| | Panel | Cardiovascular | | |
| | Manufacturer | St. Jude Medical<br>14901 DeVeau Place, Minnetonka, MN 55345 | | |
| Device Description | The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable<br>Electrophysiology Catheter is a flexible electrode catheter constructed of a<br>polyurethane insulation/shaft and incorporates platinum electrodes. The<br>active tip may be manipulated by a remote means located at the proximal<br>end of the catheter. | | | |
| Indications for use | The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable<br>Electrophysiology Catheter can be used in the evaluation of a variety of<br>cardiac arrhythmias from endocardial and intravascular sites. | | | |

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Image /page/5/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is a blue square with the word "MEDLINE" in white letters and a white star-like symbol. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below. The Renewal logo also has a trademark symbol.

| Technological<br>Characteristics | The technological characteristics and the fundamental scientific technology<br>of the subject devices are equivalent to the predicate device. The proposed<br>devices are a reprocessed version of the predicate devices. K151622 St.<br>Jude Medical Livewire Steerable Electrophysiology Catheter was used as<br>the primary predicate to support intended use, technological characteristics,<br>and functional performance specifications. | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Non-clinical<br>Testing<br>Summary | 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: | | | |
| | | Functional performance studies: | | |
| | | simulated use and artificial soiling; tensile testing; torsional strength; leakage current; continuity; isolation resistance; three-point bend corrosion resistance. | | |
| | | Cleaning: | | |
| | | protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification. | | |
| | | Biocompatibility: | | |
| | | cytotoxicity; sensitization; irritation; acute systemic toxicity; materials-mediated pyrogen complement activation; hemolysis (direct and indirect) coagulation complement activation thrombosis. | | |
| | | Packaging and shelf life validation; sterilization validation: | | |
| | | bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing | | |
| | | bacteriostasis/fungistatis | | |
| | | Product stability | | |
| Summary Table: Predicate and Medline ReNewal Reprocessed St. Jude Medical<br>Livewire Reprocessed Electrophysiology Catheter device comparison<br>chart. | | | | |
| Predicate | Proposed | Comparison | | |

| | Predicate | Proposed | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------|
| Device<br>Characteristics | St. Jude Medical MediGuide<br>Enabled Livewire Steerable<br>Electrophysiology Catheter,<br>Livewire Electrophysiology | Medline ReNewal St. Jude<br>Medical Livewire Steerable<br>Electrophysiology Catheter | As Stated |

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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with the word "MEDLINE" in white text and a white star symbol. To the right of the Medline logo is the word "Renewal" in green text, with the words "Full Circle Reprocessing" in blue text below it. The Renewal logo also has a trademark symbol.

| | Catheter, Response<br>Electrophysiology Catheter<br>with Lumen, Response<br>Electrophysiology Catheter<br>and SJM Epicardial Catheter<br>System, Supreme<br>Electrophysiology Catheter | | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) | K151622 | TBD | N/A |
| Model Numbers | Not listed in K151622<br>Summary | 401572, 401575, 401580,<br>401581, 401582, 401600,<br>401603, 401606, 401648,<br>401652, 401653, 401654<br>401655, 401780, 401904,<br>401905, 401908, 401914,<br>401915, 401917, 401918,<br>401923, 401926, 401932,<br>401933, 401934, 401935,<br>401938, 401939, 401940,<br>401941, 401949, 401990,<br>401991, 402022, 402032 | As stated |
| Common Name | Diagnostic Electrophysiology<br>Catheter | Diagnostic Electrophysiology<br>Catheter, Reprocessed | As stated |
| Regulation No. | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| Regulatory Class | 2 | 2 | Same |
| Product Code | DRF | NLH | As stated |
| Indications for<br>Use (Intended<br>Use) | The Livewire Steerable<br>Electrophysiology Catheter can<br>be used in the evaluation of a<br>variety of cardiac arrhythmias<br>from endocardial and<br>intravascular sites. | The Medline ReNewal<br>Reprocessed St. Jude Medical<br>Livewire Steerable<br>Electrophysiology Catheter<br>can be used in the evaluation<br>of a variety of cardiac<br>arrhythmias from endocardial<br>and intravascular sites. | Same |

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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white star inside. The Renewal logo is on the right side of the image and is written in green and blue. Below the Renewal logo is the text "Full Circle Reprocessing".

#### Summary Table: Predicate and Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable EP Catheters device comparison chart (concluded).

| | Predicate | Proposed | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device<br>Characteristic<br>s | St. Jude Medical MediGuide<br>Enabled Livewire Steerable<br>Electrophysiology Catheter,<br>Livewire Electrophysiology<br>Catheter, Response<br>Electrophysiology Catheter<br>with Lumen, Response<br>Electrophysiology Catheter<br>and SJM Epicardial Catheter<br>System, Supreme<br>Electrophysiology Catheter | Medline ReNewal St. Jude<br>Medical Livewire Steerable<br>Electrophysiology Catheter | As stated |
| Technological<br>Characteristicsa | To operate, the Livewire<br>Steerable Electrophysiology<br>Catheters are connected to a<br>generator via a universal<br>cable. | To operate, the Medline<br>ReNewal Reprocessed<br>Livewire Steerable<br>Electrophysiology Catheters<br>are connected to a generator<br>via a universal cable. | As stated |
| a Neither K151622 nor the current submission included the universal cable or generators as part of their respective submissions. Only catheter models were included in the project scope. | | | |
| Reprocessing | Each catheter is reprocessed no more than two times. Medline ReNewal does not reprocess the catheters of other reprocessors. | | |
| Conclusion | The predicate and proposed devices in this application have the same indications for use and technological characteristics. Based on this and the non-clinical testing data presented in this 510(k) submission, the Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Catheter device models listed in this summary table are substantially equivalent to the predicate devices. | | |