Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

K241224 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NLH · Nov 15, 2024 · Cardiovascular

Device Facts

• Record ID: K241224
• Device Name: Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
• Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
• Product Code: NLH · Cardiovascular
• Decision Date: Nov 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Story

Diagnostic bi-directional 7F deflectable mapping EP catheter; used for mapping electrical activity within coronary sinus. Features braided bi-directional tip section with two 180° opposed single plane curves (DF or FJ); tip deflection controlled via rocker lever; high torque shaft allows plane rotation for accurate positioning. Auto ID models include EEPROM for storing unique catheter identification. Used by clinicians in electrophysiology procedures; interfaces with Carto EP Navigation Systems via interface cable. Reprocessed device; limited to maximum number of cycles; intended to provide functional equivalent to original OEM device.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing: functional performance (simulated use, artificial soiling, mechanical characteristics), cleaning qualification (protein/TOC, visual inspection), biocompatibility (cytotoxicity, irritation, acute systemic toxicity, materials-mediated pyrogen, complement activation, hemolysis, coagulation), packaging/shelf-life validation, and sterilization validation (bioburden, EO/ECH residuals, bacteriostasis/fungistasis, endotoxin, product stability).

Technological Characteristics

7F bi-directional deflectable mapping catheter; 10 electrodes with 2-8-2 mm spacing; 115 cm length. Features rocker lever for tip deflection and high-torque shaft. Auto ID models contain EEPROM for identification storage. Interfaces with Carto EP Navigation Systems. Sterilized via ethylene oxide. Reprocessed according to validated cleaning and sterilization protocols.

Indications for Use

Indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, specifically within 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

• Biosense Webster Webster CS Catheter With EZ Steer Technology, Webster CS Catheter With EZ Steer Technology and Auto ID (K101345)
• PENTARAY NAV ECO High Density Mapping Catheter, DECANAV Mapping Catheter, Webster CS Catheter with Auto ID, Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology with Auto ID (K231312)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

## November 15, 2024

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

Re: K241224

Trade/Device Name: Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: October 17, 2024 Received: October 17, 2024

Dear Stephanie Boyle 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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) 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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| OEM Model No. | Description | Electrodes | | Curve | Size |
|---------------|-------------------------------------------------------------|------------|---------|-------------------|----------|
| | | Qty. | Spacing | | (cm) |
| BD710DF282CT | 7F Webster CS AID 2-8-2<br>DF curve with Auto ID,<br>115 cm | 10 | 2-8-2 | DF<br>(64/76 mm) | 7F x 115 |
| BD710DF282RTS | 7F Webster CS 2-8-2 DF<br>curve, 115 cm | 10 | 2-8-2 | DF<br>(64/76 mm) | 7F x 115 |
| BD710FJ282CT | 7F Webster CS AID 2-8-2<br>FJ curve with Auto ID,<br>115 cm | 10 | 2-8-2 | FJ<br>(76/102 mm) | 7F x 115 |
| BD710FJ282RTS | 7F Webster CS 2-8-2 FJ<br>curve, 115 cm | 10 | 2-8-2 | FJ<br>(76/102 mm) | 7F x 115 |

The following devices are included in the scope of this 510(k) premarket notification:

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## Indications for Use

510(k) Number (if known) K241224

#### Device Name

Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID

#### Indications for Use (Describe)

The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

| 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/5/Picture/0 description: The image shows the logo for "ReNewal Full Circle Reprocessing". The word "Re" is in green, and the word "Newal" is in blue. To the left of the word "ReNewal" is the Medline logo, which is a blue square with a white star and the word "MEDLINE" in white letters.

Traditional 510(k) Notification Medline ReNewal Reprocessed Biosense Webster Webster CS ÉP Catheters

## 510(k) 241224 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 Inc. (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 | May 1, 2024 | |
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Biosense Webster<br>Webster CS Catheter with EZ Steer Technology and<br>Medline ReNewal Reprocessed Biosense Webster<br>Webster CS Catheter with EZ Steer Technology and<br>Auto ID |
| | Common or Usual Name | Catheter, recording, electrode, reprocessed |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording<br>probe/21 CFR § 870.1220 |
| | Regulatory Class | 2 |
| | Product Code | NLH |
| | Panel | Cardiovascular |
| | Predicate selection rationale | The models in this submission are the same as in the<br>predicate only that have been reprocessed |
| | 510(k) Number | K101345 |
| Predicate Device 1 | Proprietary or Trade Name | Biosense Webster Webster CS Catheter With EZ<br>Steer Technology, Webster CS Catheter With EZ<br>Steer Technology and Auto ID |
| | Common or Usual Name | Catheter, recording, or probe electrode recording |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording<br>probe/21 CFR § 870.1220 |
| | Regulatory Class | 2 |
| | Product Code | DRF |
| | Panel | Cardiovascular |
| | 510(k) applicant | Biosense Webster,<br>333 Diamond Canyon Rd. Diamond Bar, CA 91765 |
| Predicate Device 2 | 510(k) Number | K231312 |
| | Proprietary or Trade Name | PENTARAY NAV ECO High Density Mapping<br>Catheter, DECANAV Mapping Catheter, Webster CS<br>Catheter with Auto ID, Webster CS Catheter with EZ<br>Steer Technology, Webster CS Catheter with EZ<br>Steer Technology with Auto ID |
| | Common or Usual Name | Catheter, recording, or probe electrode recording |
| | Regulatory<br>Name/Reference | Electrode recording catheter or electrode recording<br>probe/21 CFR § 870.1220 |
| | Regulatory Class | 2 |
| Predicate 2<br>(concluded) | Product Code | MTD, DRF |
| | Panel | Cardiovascular |
| | 510(k) applicant | Biosense Webster,<br>333 Diamond Canyon Rd. Diamond Bar, CA 91765 |
| Device<br>Description/<br>Intended Use | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter<br>with EZ Steer Technology and Medline ReNewal Reprocessed Biosense<br>Webster Webster CS Catheter with EZ Steer Technology and Auto ID. The<br>reprocessed catheters are diagnostic bi-directional 7F deflectable mapping<br>electrophysiology EP catheters. The devices have the ability to map<br>electrical activity within the Coronary Sinus (CS) through electrodes along<br>the catheters' pre-shaped tip. The catheters have a braided bi-directional tip<br>section that provides the user with two 180° opposed single plane curves<br>(available curves are DF and FJ). The tip is deflected with a Rocker Lever,<br>and the high torque shaft permits the tip's plane to rotate to ease accurate<br>positioning of the catheter tip at the desired site. The Medline ReNewal<br>Reprocessed Biosense Webster Webster CS Catheter with EZ Steer<br>Technology and Auto ID are equipped with an Electronically Erasable<br>Programmable Read Only Memory (EEPROM) that is used to store unique<br>catheter identification information. | |
| Indications for<br>Use | The Medline ReNewal Reprocessed Biosense Webster Webster CS<br>Catheter is indicated for electrophysiological mapping of cardiac structures,<br>i.e., stimulation and recording only. The catheter is designed for use in the<br>coronary sinus. | |
| Technological<br>Characteristics | The technological characteristics, materials, and the fundamental scientific<br>technology of the subject device is equivalent to the primary predicate<br>devices. The proposed devices are reprocessed versions of the Webster<br>CS predicate devices. K101345 was used as the predicate to support<br>intended use, technological characteristics, and functional performance<br>specifications. Each device is marked, tracked and taken out of service<br>once the maximum number of cycles has been reached. | |
| Non-clinical<br>Testing<br>Summary | Functional performance studies:<br>simulated use and artificial soiling; Mechanical characteristics continuity, isolation, resistance; corrosion resistance. Cleaning: protein, total organic carbon visual inspection under magnification; and cleaning qualification. Biocompatibility: cytotoxicity; | The functional characteristics of the subject device have been evaluated<br>and found to be substantially equivalent to the predicate device based on |

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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 a white cross inside. The word "MEDLINE" is written in white letters inside the blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in black letters.

Traditional 510(k) Notification Medline ReNewal Reprocessed Biosense Webster Webster CS ÉP Catheters

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Image /page/7/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with a white star and the word "MEDLINE" in white letters. The Renewal logo is on the right and consists of the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it. There is a trademark symbol next to the word Renewal.

Traditional 510(k) Notification

Medline ReNewal Reprocessed Biosense Webster Webster CS EP Catheters

- irritation; ●
- acute systemic toxicity; ●
- materials-mediated pyrogen; ●
- complement activation;
- hemolysis; and
- coagulation; .
- Packaging and shelf life validation ●
- Sterilization validation: ●
- bioburden;
- ethylene oxide/ ethylene chlorohydrin residuals; ●
- bacteriostasis/fungistasis; and
- . endotoxin
- Product stability

.

Table 1: Comparison of Predicates and Subject devices.

| PREDICATE 1 | PREDICATE 2 | PROPOSED | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Biosense Webster<br>Webster CS Catheter<br>With EZ Steer<br>Technology, Webster<br>CS Catheter With EZ<br>Steer Technology and<br>Auto ID | Webster CS Catheter<br>with EZ Steer<br>Technology, Webster<br>CS Catheter with EZ<br>Steer Technology and<br>Auto ID | Medline ReNewal<br>Reprocessed Medline<br>ReNewal Reprocessed<br>Biosense Webster<br>Webster CS Catheter<br>with EZ Steer<br>Technology and<br>Medline ReNewal<br>Reprocessed Biosense<br>Webster Webster CS<br>Catheter with EZ Steer<br>Technology and Auto ID | Comparison |
| 510(k) number | | | |
| K101345 | K231312 | K241224 | N/A |
| Model numbers | | | |
| Bi-directional catheters:<br>BD710DF282RTS and<br>BD710FJ282RTS<br>Bi-directional catheters<br>with Auto ID:<br>BD710DF282CT and<br>BD710FJ282CTa | Bi-directional catheters:<br>D-1263-04-S & D-1263-<br>05-S<br>Bi-directional catheters<br>with Auto ID: D-1263-06-<br>S & D1263-07-S | Bi-directional catheters:<br>BD710DF282RTS and<br>BD710FJ282RTS<br>Bi-directional catheters<br>with Auto ID:<br>BD710DF282CT and<br>BD710FJ282CT | Same -<br>Proposed and<br>Predicate 1 |
| Classification Name | | | |
| Catheter, electrode<br>recording, or electrode<br>recording probe | Catheter, Intracardiac<br>Mapping, High-Density<br>Array | Catheter, recording,<br>electrode recording,<br>reprocessed | Same -<br>Proposed and<br>Predicate 1 |
| Regulation No. | | | |
| 21 CFR § 870.1220 | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| Regulatory Class | | | |
| 2 | 2 | 2 | Same |
| Product Code | | | |
| PREDICATE 1 | PREDICATE 2 | PROPOSED | |
| Biosense Webster<br>Webster CS Catheter<br>With EZ Steer<br>Technology, Webster<br>CS Catheter With EZ<br>Steer Technology and<br>Auto ID | Webster CS Catheter<br>with EZ Steer<br>Technology, Webster<br>CS Catheter with EZ<br>Steer Technology and<br>Auto ID | Medline ReNewal<br>Reprocessed Medline<br>ReNewal Reprocessed<br>Biosense Webster<br>Webster CS Catheter<br>with EZ Steer<br>Technology and<br>Medline ReNewal<br>Reprocessed Biosense<br>Webster Webster CS<br>Catheter with EZ Steer<br>Technology and Auto ID | Comparison |
| DRF | MTD, DRF | NLH | As stated |
| | Technological Characteristics | |…