Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

K250772 · Surgical Instrument Service and Savings, Inc. · NLH · Jul 11, 2025 · Cardiovascular

Device Facts

• Record ID: K250772
• Device Name: Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Jul 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation or cardiac arrhythmias. The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.

Device Story

Device is a reprocessed, steerable, diagnostic electrode catheter used for temporary intracardiac sensing, recording, stimulation, and pacing. Input consists of electrical signals from the heart; device transforms these via a mechanical plunger mechanism that actuates a pull cable to steer the distal tip. Output is the diagnostic signal captured by electrodes for physician analysis. Used in clinical settings (e.g., EP lab) by physicians to evaluate cardiac arrhythmias. Reprocessing involves cleaning, inspection, functional testing, packaging, and sterilization. Benefit is the diagnostic evaluation of arrhythmias.

Clinical Evidence

Bench testing only. Evidence includes functional performance studies (visual inspection, dimensional measurement, electrical safety, mechanical characteristics, continuity, isolation, resistance, corrosion resistance), cleaning validation, biocompatibility, packaging/shelf-life validation, sterilization validation, and product stability.

Technological Characteristics

Radiopaque, flexible, insulated polymer shaft catheters with mechanical plunger mechanism and pull cable for distal tip steering. Electrodes for sensing/pacing. Reprocessed via validated cleaning, inspection, and sterilization cycles. Limited to one reprocessing cycle.

Indications for Use

Indicated for use to diagnose cardiac arrhythmia in adult patients, excluding pregnant and nursing patients.

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

• Boston Scientific EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters (K240366)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 11, 2025

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

Re: K250772
Trade/Device Name: Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Regulation Number: 21 CFR 870.1220
Regulation Name: Electrode recording catheter or electrode recording probe
Regulatory Class: Class II
Product Code: NLH
Dated: June 13, 2025
Received: June 13, 2025

Dear Kelsey LeMay:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250772 - Kelsey LeMay
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250772 - Kelsey LeMay
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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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K250772 - Kelsey LeMay
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The following devices are included in the scope of this 510(k) premarket notification:

| OEM Part No. | Description | Electrodes (Qty.) | Electrode Spacing (mm) | Curve Type | Size (F x cm) | Connector Type |
| --- | --- | --- | --- | --- | --- | --- |
| 201101 | Decapolar | 10 | 2-5-2 | Large 4.0 | 6 x 110 | SureLink |
| 201102 | Decapolar | 10 | 2-6-2 | Large 4.0 | 6 x 110 | SureLink |
| 201103 | Quadripolar | 4 | 2-5-2 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201104 | Quadripolar | 4 | 5 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201105 | Octapolar | 8 | 2-5-2 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201106 | Octapolar | 8 | 2 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201107 | Octapolar | 8 | 5 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201108 | Octapolar | 8 | 2-10-2 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201109 | Hexapolar | 6 | 10 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201110 | Quadripolar | 4 | 10 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201112 | Quadripolar | 4 | 2 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201113 | Hexapolar | 6 | 5 | Large 4.0 | 6 x 110 | Easy-Mate |
| 201115 | Quadripolar | 4 | 2-1-1 | Large 4.0 | 6 x 110 | Easy-Mate |
| 6DYNXT002 | Decapolar | 10 | 5 | Large 4.0 | 6 x 110 | SureLink |
| 6DYNXT004 | Decapolar | 10 | 2 | Large 4.0 | 6 x 110 | SureLink |
| 6DYNXT009 | Quadripolar | 4 | 2-5-2 | Large 4.0 | 6 x 110 | SureLink |
| 6DYNXT011 | Quadripolar | 4 | 5 | Large 4.0 | 6 x 110 | SureLink |

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250772 | |
| Device Name Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | |
| Indications for Use (Describe) Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia. | |
| 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." | |

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K250772

The Newal

Full Circle Reprocessing

Traditional 510(k) Notification

Medline ReNewal Reprocessed

Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

# 510(k) 250772 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)
1500 NE Hemlock Ave., Redmond, OR 97756 | |
| --- | --- | --- |
| Contact/Prepared by | Kelsey LeMay
Regulatory Affairs Specialist, Quality/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • [e-mail] | |
| Date Prepared | July 10, 2025 | |
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter |
| | Common or Usual Name | Catheter, recording, electrode, reprocessed |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording probe/21 CFR § 870.1220 |
| | Regulatory Class | 2 |
| | Product Code | NLH |
| | Panel | Cardiovascular |
| Predicate selection | Rationale | The predicate models in K240366 include the subject device models of this submission. |
| Predicate Device | 510(k) Number | K240366 |
| | Proprietary or Trade Name | Boston Scientific EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters |
| | Common or Usual Name | catheter, electrode recording, or probe, electrode recording |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording probe/21 CFR § 870.1220 |
| | Regulatory Class | 2 |
| | Product Code | DRF |
| | Panel | Cardiovascular |
| | 510(k) applicant | Boston Scientific Corporation
4100 Hamline Ave North
St Paul, MN 55112 |
| Device Description/Intended Use | The Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation or cardiac arrhythmias. The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients. | |
| Indications for Use | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia. | |

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K250772

The Newal

Full Circle Reprocessing

Traditional 510(k) Notification

Medline ReNewal Reprocessed

Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

| Technological Characteristics | The technological characteristics, materials, and the fundamental scientific technology of the subject device are equivalent to the predicate devices. The proposed devices are reprocessed versions of the predicate devices. Each device undergoes a validated process that includes cleaning, inspections and functional tests, packaging and sterilization. Devices are tracked to ensure they do not exceed the number of validated reprocessing cycles (1). Devices that have reached the maximum number of cycles or do not meet inspection criteria are rejected and disposed of appropriately. The predicate devices were used to support intended use, technological characteristics, and functional performance specifications. |
| --- | --- |
| Non-clinical Testing Summary | The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests: • Functional performance studies: • visual inspection; • dimensional measurement; • electrical safety; • mechanical characteristics; • continuity, isolation, resistance; and • corrosion resistance. • Cleaning validation • Biocompatibility • Packaging and shelf life validation • Sterilization validation • Product stability |

Summary Table: Predicates and Proposed Device Comparison Chart

| Device Characteristics | PREDICATE | PROPOSED | Comparison |
| --- | --- | --- | --- |
| | Boston Scientific EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | |
| 510(k) number | K240366 | K250772 | N/A |
| Model number | Not listed in K240366 Summary | 201101, 201102, 201103, 201104, 201105, 201106, 201107, 201108, 201109, 201110, 201112, 201113, 201115, 6DYNXT002, 6DYNXT004, 6DYNXT009, 6DYNXT011 | As stated |
| Classification Name | Catheter, Electrode Recording, Or Probe, Electrode Recording | Catheter, Recording, Electrode, Reprocessed | As stated |
| Regulation No. | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |

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K250772

The Newal

Full Circle Reprocessing

Traditional 510(k) Notification

Medline ReNewal Reprocessed

Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

| Regulatory Class | 2 | 2 | Same |
| --- | --- | --- | --- |
| Product Code | DRF | NLH | As stated |
| Technological Characteristics | The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip. | The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip. | Same |
| Indications for Use | EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia. | Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia. | Dynamic XT predicate and proposed indications for use are the same |
| Reprocessing | Each catheter is reprocessed no more than one time. Medline ReNewal does not reprocess the Dynamic XT Unidirectional Steerable Diagnostic 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 Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are substantially equivalent to the predicate device. | | |

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