(120 days)
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
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 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 provided FDA 510(k) clearance letter (K250772) pertains to a reprocessed medical device, specifically the Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and functional performance testing.
Crucially, the provided text does not contain information about acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, as assumed by the structured request. The clearance is for a physical medical device (a reprocessed catheter), not a software or AI/ML algorithm. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information contained within this document.
The "Non-clinical Testing Summary" section describes the types of tests performed to demonstrate safety and effectiveness for a reprocessed physical device. These tests assess the physical and electrical properties of the catheter after reprocessing.
I will attempt to answer the applicable sections based on the information provided, and explicitly state when information is not available or not applicable due to the nature of the device.
Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria for K250772
As noted above, this 510(k) clearance is for a reprocessed physical medical device (a catheter), not an AI/ML-powered device. Therefore, the "acceptance criteria" and "study" described herein are related to the physical, functional, and safety performance of the reprocessed catheter compared to the original, new device, rather than a statistical evaluation of an AI algorithm's diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary (pages 6-8) describes the non-clinical testing performed to establish substantial equivalence. While explicit numerical acceptance criteria values are not provided in this public summary, the types of tests indicate the areas where the reprocessed device must perform equivalently to the predicate. The "reported device performance" is implied by the statement "found to be substantially equivalent to the predicate device based on the following tests."
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Functional Performance (overall) | Found to be substantially equivalent to the predicate device. |
| Visual Inspection | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Dimensional Measurement | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Electrical Safety | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Mechanical Characteristics | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Continuity | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Isolation | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Resistance | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Corrosion Resistance | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Cleaning Validation | Validated (implies meeting pre-defined criteria for residual contaminants). |
| Biocompatibility | Met acceptance criteria (implies no adverse biological reactions). |
| Packaging and Shelf Life Validation | Validated (implies maintaining sterility and integrity over time). |
| Sterilization Validation | Validated (implies achieving required Sterility Assurance Level). |
| Product Stability | Met acceptance criteria (implies maintaining performance over time). |
| Reprocessing Cycle Limit | Does not exceed validated reprocessing cycles (stated as 1). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of reprocessed catheters (the "test set") used for each functional and safety test. For medical devices, particularly reprocessed ones, sample sizes are typically determined by statistical rationale to demonstrate equivalence or meet performance specifications, but these details are not in the summary.
- Data Provenance: This relates to the testing of the reprocessed device itself. The data would be prospective, as it involves testing reprocessed devices manufactured by Medline ReNewal. The country of origin for the data would be where Medline ReNewal conducts its testing, likely the USA given the FDA clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This concept applies to diagnostic or AI/ML devices where a "ground truth" is established by human experts (e.g., radiologists interpreting images). For a reprocessed physical device, "ground truth" is established by objective engineering and safety standards (e.g., measuring dimensions against specifications, testing electrical resistance against a standard). The "experts" would be qualified engineers and technicians performing the tests.
4. Adjudication Method for the Test Set
- N/A. Adjudication (e.g., 2+1, 3+1 consensus) is used in studies with human readers interpreting data, often to resolve discrepancies in diagnoses or interpretations. This is not applicable to the direct physical and functional testing of a medical device like a catheter.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This type of study is relevant for AI/ML-assisted diagnostic tools, not for a reprocessed physical device like this catheter. The clearance is based on the catheter's physical and functional equivalence to new catheters, not on improving human diagnostic accuracy.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This refers to the performance of an AI/ML algorithm on its own. It is not applicable to a physical medical device.
7. The Type of Ground Truth Used
- For the physical and functional aspects of the reprocessed catheter, the "ground truth" is established by:
- Engineering Specifications: The design and performance specifications of the original (predicate) new device. The reprocessed device must meet these same specifications.
- Regulatory Standards: Relevant FDA and international standards for medical device safety and performance (e.g., electrical safety, biocompatibility, sterilization).
- Objective Measurements: Direct measurements (e.g., dimensions, electrical properties, mechanical strength) and analytical tests (e.g., for residual contaminants).
8. The Sample Size for the Training Set
- N/A. "Training set" refers to data used to train an AI/ML algorithm. This is not applicable to a physical reprocessed medical device. The "training" for this device is the validation of the reprocessing procedure itself.
9. How the Ground Truth for the Training Set Was Established
- N/A. Since there is no "training set" in the AI/ML sense, this question is not applicable. For a reprocessed device, the "ground truth" is inherent in the established manufacturing and safety standards that the reprocessing procedure must meet. The reprocessor (Medline ReNewal) developed and validated a controlled process (cleaning, inspection, testing, packaging, sterilization) to ensure that the reprocessed catheter performs equivalently to a new device.
FDA 510(k) Clearance Letter - K250772
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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K250772
Traditional 510(k) Notification
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Page 1 of 3
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 LeMayRegulatory Affairs Specialist, Quality/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • klemay@medline.com |
| 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 Corporation4100 Hamline Ave NorthSt 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
Traditional 510(k) Notification
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Page 2 of 3
| 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
Traditional 510(k) Notification
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Page 3 of 3
| 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. |
|---|
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
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.(b)
Classification. Class II (performance standards).