(141 days)
The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.
Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are fixed electrode catheters constructed of a polyurethane insulation/shaft and incorporate platinum electrodes. Each device is marked and tracked and will be taken out of service once the maximum number of cycles has been reached.
The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters, specifically the Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter and Supreme Electrophysiology Catheter.
However, the document does not contain the detailed information necessary to complete the requested table and answer questions 2 through 9 regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for a medical device that uses an algorithm or AI.
The document is a regulatory submission for reprocessed physical medical devices (catheters), not a study of an algorithmic or AI-based diagnostic/detection device. The "Non-clinical Testing Summary" section discusses functional performance, mechanical characteristics, corrosion resistance, cleaning, biocompatibility, packaging, shelf-life, and sterilization validation, which are typical for reprocessed physical medical devices.
Therefore, I cannot extract the requested information as the context of the document does not align with the type of study and acceptance criteria you are asking about (i.e., for an AI/algorithm-based device).
To summarize, the relevant information you requested is not present in the provided text because the document is about reprocessed physical medical devices, not an AI or algorithm-driven device.
{0}------------------------------------------------
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 includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
September 14, 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: K241156
Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme 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: August 19, 2024 Received: August 19, 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.
{1}------------------------------------------------
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
{2}------------------------------------------------
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
{3}------------------------------------------------
The item numbers included in the scope of this submission are as follows:
| OEMPart No. | Description | Electrodes(Qty.) | ElectrodeSpacing(mm) | Curve | Size(diameter/length) | |
|---|---|---|---|---|---|---|
| Response Catheter Models | ||||||
| 401150 | Decapolar | 10 | 2-10-2 | CRD™ | 6 Fr, 120 cm | |
| 401206 | Quadripolar | 4 | 10 | CRD™ | 5 Fr, 120 cm | |
| 401207 | Quadripolar | 4 | 10 | JSN™ | 5 Fr, 120 cm | |
| 401210 | Quadripolar | 4 | 10 | CRD™ | 6 Fr, 120 cm | |
| 401211 | Quadripolar | 4 | 10 | JSN™ | 6 Fr, 120 cm | |
| 401212 | Quadripolar | 4 | 10 | DAO ™ | 6 Fr, 120 cm | |
| 401222 | Quadripolar | 4 | 5 | CRD™ | 5 Fr, 120 cm | |
| 401223 | Quadripolar | 4 | 5 | JSN™ | 5 Fr, 120 cm | |
| 401226 | Quadripolar | 4 | 5 | CRD™ | 6 Fr, 120 cm | |
| 401227 | Quadripolar | 4 | 5 | JSN™ | 6 Fr, 120 cm | |
| 401228 | Quadripolar | 4 | 5 | DAO™ | 6 Fr, 120 cm | |
| 401260 | Quadripolar | 4 | 2-5-2 | CRD™ | 6 Fr, 120 cm | |
| 401261 | Quadripolar | 4 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401271 | Hexapolar | 6 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401305 | Decapolar | 10 | 2-5-2 | CRD™ | 6 Fr, 120 cm | |
| 401306 | Decapolar | 10 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401309 | Decapolar | 10 | 2-5-2 | JSN™ | 6 Fr, 65 cm | |
| 401310 | Decapolar | 10 | 2-5-2 | DAO™ | 6 Fr, 65 cm | |
| 401311 | Decapolar | 10 | 2-2-2 | CRD™ | 6 Fr, 120 cm | |
| 401312 | Decapolar | 10 | 2-2-2 | JSN™ | 6 Fr, 120 cm | |
| 401317 | Bipolar | 2 | 10 | CRD™ | 6 Fr, 120 cm | |
| 401353 | Decapolar | 10 | 2-8-2 | CSL™ | 6 Fr, 65 cm | |
| 401357 | Quadripolar | 4 | 5 | JSN-1 ™ | 6 Fr, 120 cm | |
| 401381 | Decapolar | 10 | 2-8-2 | CSL ™ | 6 Fr, 120 cm | |
| 401392 | Decapolar | 10 | 2-2-2 | CSL ™ | 6 Fr, 120 cm | |
| 401399 | Decapolar | 10 | 5-5-5 | CSL™ | 6 Fr, 120 cm | |
| 401400 | Decapolar | 10 | 5-5-5 | CSL ™ | 6 Fr, 65 cm | |
| 401425 | Hexapolar | 6 | 5-5-5-150-5 | CRD™ | 6 Fr, 120 cm | |
| OEMPart No. | Description | Electrodes(Qty.) | ElectrodeSpacing (mm) | Curve | Size (diameter,length) | |
| Supreme Catheter Models | ||||||
| 401430 | Quadripolar | 4 | 5 | JSN™ | 6 Fr, 120 cm | |
| 401433 | Quadripolar | 4 | 10 | CRD™ | 5 Fr, 120 cm | |
| 401434 | Quadripolar | 4 | 10 | CRD™ | 6 Fr, 120 cm | |
| 401435 | Quadripolar | 4 | 10 | JSN™ | 5 Fr, 120 cm | |
| 401436 | Quadripolar | 4 | 10 | JSN™ | 6 Fr, 120 cm | |
| 401438 | Quadripolar | 4 | 10 | DAO™ | 6 Fr, 120 cm | |
| 401441 | Quadripolar | 4 | 5 | CRD™ | 5 Fr, 120 cm | |
| 401442 | Quadripolar | 4 | 5 | CRD™ | 6 Fr, 120 cm | |
| 401443 | Quadripolar | 4 | 5 | JSN™ | 5 Fr, 120 cm | |
| 401444 | Quadripolar | 4 | 5 | DAO™ | 5 Fr, 120 cm | |
| 401445 | Quadripolar | 4 | 5 | DAO™ | 6 Fr, 120 cm | |
| 401448 | Quadripolar | 4 | 2-5-2 | CRD™ | 5 Fr, 120 cm | |
| 401449 | Quadripolar | 4 | 2-5-2 | CRD™ | 6 Fr, 120 cm | |
| 401450 | Quadripolar | 4 | 2-5-2 | JSN™ | 5 Fr, 120 cm | |
| 401451 | Quadripolar | 4 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401453 | Quadripolar | 4 | 2-5-2 | DAO™ | 6 Fr, 120 cm | |
| 401466 | Quadripolar | 4 | 5 | DAO-1™ | 5 Fr, 120 cm | |
| 401468 | Quadripolar | 4 | 2-5-2 | DAO-1™ | 5 Fr, 120 cm | |
| 401474 | Quadripolar | 4 | 5 | CRD-1™ | 6 Fr, 120 cm | |
| 401475 | Quadripolar | 4 | 5 | JSN-1™ | 6 Fr, 120 cm | |
| 401859 | Quadripolar | 4 | 10 | CRD-2™ | 5 Fr, 120 cm | |
| 401860 | Quadripolar | 4 | 5 | CRD-2™ | 5 Fr, 120 cm | |
| 401863 | Decapolar | 10 | 2-8-2 | CSL™ | 5 Fr, 120 cm | |
| 401864 | Decapolar | 10 | 2-8-2 | CSL™ | 5 Fr, 65 cm | |
| 401865 | Decapolar | 10 | 5-5-5 | CSL™ | 5 Fr, 120 cm | |
| 401876 | Hexapolar | 6 | 5-5-5-175-175 | CRD-1™ | 6 Fr, 120 cm | |
| 401877 | Hexapolar | 6 | 5-5-5-175-175 | JSN™ | 6 Fr, 120 cm | |
| 401878 | Hexapolar | 6 | 5-5-5-175-175 | JSN™ | 5 Fr, 120 cm | |
| 401890 | Quadripolar | 4 | 5-5-5 | JSN™ | 4 Fr, 120 cm | |
| 401891 | Quadripolar | 4 | 5-5-5 | CRD™ | 4 Fr, 120 cm | |
| 401892 | Quadripolar | 4 | 5-5-5 | DAO™ | 4 Fr, 120 cm | |
| 401893 | Decapolar | 10 | 2-8-2 | CSL™ | 4 Fr, 65 cm | |
| OEMPart No. | Description | Electrodes(Qty.) | ElectrodeSpacing (mm) | Curve | Size (diameter,length) | |
| Supreme Catheter Models (concluded) | ||||||
| 401966 | Hexapolar | 6 | 5-5-5 | CRD-2™ | 4 Fr, 120 cm | |
| 401967 | Hexapolar | 6 | 2-2-2 | CRD-2™ | 4 Fr, 120 cm | |
| 401979 | Decapolar | 10 | 2-5-2 | CSL™ | 4 Fr, 65 cm | |
| 401994 | Quadripolar | 4 | 2-5-2 | JSN™ | 4 Fr, 120 cm | |
| 401996 | Quadripolar | 4 | 2-5-2 | CRD™ | 4 Fr, 120 cm | |
| 402004 | Quadripolar | 4 | 5 | CRD-2™ | 6 Fr, 120 cm | |
| 402008 | Hexapolar | 6 | 2-5-2 | CRD-2™ | 5 Fr, 120 cm | |
| 402009 | Hexapolar | 6 | 5-5-5 | CRD-2™ | 5 Fr, 120 cm | |
| 402010 | Hexapolar | 6 | 2-5-2 | CRD-2™ | 6 Fr, 120 cm | |
| 402011 | Hexapolar | 6 | 5-5-5 | CRD-2™ | 6 Fr, 120 cm | |
| 402012 | Quadripolar | 4 | 5-5-5 | CRD-2™ | 4 Fr, 120 cm |
{4}------------------------------------------------
{5}------------------------------------------------
{6}------------------------------------------------
Indications for Use
510(k) Number (if known) K241156
Device Name
Medine ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter
Indications for Use (Describe)
The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.
| 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 PRAStaff@fda.hhs.gov
"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."
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with a white star inside. To the right of the Medline logo is the word "Renewal" in green and blue lettering. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font.
Traditional 510(k) Notification Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
510(k) 241156
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 | Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • smays@medline.com | |||
| Date Prepared | April 25, 2024 | |||
| Device NameandClassification | Proprietary/TradeName: | Medline ReNewal Reprocessed St. Jude Medical ResponseElectrophysiology Catheter, Supreme Electrophysiology Catheter | ||
| Common or UsualName | Catheter, recording, electrode, reprocessed | |||
| RegulatoryName/Reference | Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220 | |||
| Regulatory Class | 2 | |||
| Product Code | NLH | |||
| Panel | Cardiovascular | |||
| Predicateselection rationale | The predicate models in K151622 include the subjectdevice models of this submission. | |||
| 510(k) Number | K151622 | |||
| Proprietary orTrade Name | St. Jude Medical MediGuide Enabled LivewireSteerable Electrophysiology Catheter, LivewireElectrophysiology Catheter, ResponseElectrophysiology Catheter with Lumen, ResponseElectrophysiology Catheter and SJM EpicardialCatheter System, Supreme ElectrophysiologyCatheter | |||
| PredicateDevice | Common or UsualName | Catheter, recording, or probe electrode recording | ||
| RegulatoryName/Reference | Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220 | |||
| Regulatory Class | 2 | |||
| Product Code | DRF | |||
| Panel | Cardiovascular | |||
| 510(k) applicant | St. Jude Medical,14901 DeVeau Place, Minnetonka, MN 55345 | |||
| ReferenceDevice | Reference devicerationale | Reference and proposed devices share originalequipment manufacturer, predicate device, similarmaterials, indications for use, intended use, andprocesses. | ||
| 510(k) Number | K221067 |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with a white cross inside. To the right of the Medline logo is the word "Renewal" in large, bold, green letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.
Traditional 510(k) Notification
Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
| Proprietary orTrade Name | Medline ReNewal Reprocessed St. Jude MedicalLivewire Steerable Electrophysiology Catheter | |
|---|---|---|
| Common or UsualName | Catheter, recording, or probe electrode recording | |
| RegulatoryName/Reference | Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220 | |
| Referencedeviceconcluded | Regulatory Class | 2 |
| Product Code | NLH | |
| Panel | Cardiovascular | |
| 510(k) applicant | Surgical Instrument Service and Savings (dbaMedline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756 | |
| DeviceDescription/Intended Use | Medline ReNewal Reprocessed St. Jude Medical Supreme and ResponseElectrophysiology Catheters are commonly placed at the high right atrium,right ventricular apex and His bundle, and in the coronary sinus, and areused for electrogram recording and cardiac stimulation during diagnosticelectrophysiology studies. The Medline ReNewal Reprocessed St. JudeMedical Supreme and Response Electrophysiology Catheters are fixedelectrode catheters constructed of a polyurethane insulation/shaft andincorporate platinum electrodes.Each device is marked and tracked and will be taken out" of service oncethe maximum number of cycles has been reached. | |
| Indications forUse | The Medline ReNewal Reprocessed St. Jude Medical ResponseElectrophysiology Catheters and Supreme Electrophysiology Catheters canbe used in the evaluation of a variety of cardiac arrhythmia fromendocardial and intravascular sites. | |
| TechnologicalCharacteristics | The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the predicate andreference devices. The proposed devices are reprocessed versions of theSupreme and Response predicate devices. K151622 was used as theprimary predicate to support intended use, technological characteristics,and functional performance specifications. K221067 was used as areference device to further demonstrate substantial equivalency. | |
| Non-clinicalTestingSummary | The functional characteristics of the subject device have been evaluatedand found to be substantially equivalent to the predicate device based onthe following tests:● Functional performance studies:● 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: |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image contains the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and consists of a blue square with a white star inside. The words "ReNewal" are in large green and blue letters, and the words "Full Circle Reprocessing" are in smaller blue letters below the word Renewal.
Traditional 510(k) Notification
Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
- sensitization; ●
- irritation;
- acute systemic toxicity; ●
- materials-mediated pyrogen;
- complement activation; ●
- thrombosis; and .
- hemocompatibility .
- Packaging and shelf life validation .
- Sterilization validation: ●
- bioburden; ●
- ethylene oxide/ ethylene chlorohydrin residuals; ●
- bacteriostasis/fungistasis; and
- . endotoxin
- Product stability
Summary Table: Predicate, Reference and Proposed Device Comparison Chart
| PREDICATESt. Jude MedicalMediGuide EnabledLivewire SteerableElectrophysiologyCatheter, LivewireElectrophysiologyCatheter, ResponseElectrophysiologyCatheter with Lumen,ResponseElectrophysiologyCatheter and SJMEpicardial CatheterSystem, SupremeElectrophysiologyCatheter | REFERENCEMedline ReNewalReprocessed St. JudeMedical LivewireSteerableElectrophysiologyCatheter | PROPOSEDMedline ReNewalReprocessed St. JudeMedical Supreme andResponseElectrophysiologyCatheters | Comparison |
|---|---|---|---|
| 510(k) number | |||
| K151622 | K221067 | K241156 | N/A |
| Model number | |||
| Not listed in K151622Summary | 401572, 401575, 401580,401581, 401582, 401600,401603, 401606, 401648,401652, 401653, 401654401655, 401780, 401904,401905, 401908, 401914,401915, 401917, 401918,401923, 401926, 401932,401933, 401934, 401935,401938, 401939, 401940,401941, 401949, 401990,401991, 402022, 402032 | 401150, 401206, 401207,401210, 401211, 401212,401222, 401223, 401226,401227, 401228, 401260,401261, 401271, 401305,401306, 401309, 401310,401311, 401312, 401317,401353, 401357, 401381,401392, 401399, 401400,401425, 401430, 401433,401434, 401435, 401436,401438, 401441, 401442,401445, 401443, 401444 | Same |
| 401448, 401449, 401450,401451, 401453, 401466,401468, 401474, 401475,401859, 401860, 401863,401864, 401865, 401876,401877, 401878, 401890,401891, 401892, 401893,401966, 401967, 401979,401994, 401996, 402004,402008, 402009, 402010,402011, 402012 | |||
| Classification Name | |||
| Catheter, electroderecording, or probeelectrode recording | Catheter, recording,electrode recording,reprocessed | Catheter, recording,electrode recording,reprocessed | As stated |
| Regulation No. | |||
| 21 CFR § 870.1220 | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| Regulatory Class | |||
| 2 | 2 | 2 | Same |
| Product Code | |||
| DRF | NLH | NLH | As stated |
| Indications for Use | |||
| St. Jude MedicalElectrophysiologyCatheters can be used inthe evaluation of a varietyof cardiac arrhythmiasfrom endocardial andintravascular sites. | Medline ReNewalReprocessed LivewireElectrophysiologyCatheters can be used inthe evaluation of a varietyof cardiac arrhythmiasfrom endocardial andintravascular sites. | Medline ReNewalReprocessed St. JudeMedical ResponseElectrophysiologyCatheters and SupremeElectrophysiologyCatheters can be used inthe evaluation of a varietyof cardiac arrhythmiafrom endocardial andintravascular sites. | Same |
| Technological Characteristics | |||
| The SJMElectrophysiologySupreme and ResponseCatheters contain variousfixed curves andelectrode spacings. | The Medline ReNewalReprocessed St. JudeMedical LivewireElectrophysiologyCatheters contain variouselectrode spacings and asteerable design with a tipthat can be shaped into auser-desired curve | The Medline ReNewalReprocessed St. JudeMedical Supreme andResponseElectrophysiologyCatheters contain variousfixed curves andelectrode spacings. | As stated |
| Reprocessing | |||
| Each subject catheter is reprocessed no more than one time. Medline ReNewal does not | |||
| reprocess the Supreme and Response Electrophysiology Catheters of other reprocessors. | |||
| Conclusion | |||
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The word "Renewal" is in a larger font, with "Re" in green and "newal" in navy blue. Below that is the phrase "Full Circle Reprocessing" in a smaller navy blue font. To the left of the text is the Medline logo, which is a navy blue square with a white cross and the word "MEDLINE" in white.
Traditional 510(k) Notification Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and is a blue square with a white star and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in large green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller blue letters.
Traditional 510(k) Notification Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
The predicate, reference 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 Supreme and Response Electrophysiology Catheters within the scope of this submission 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).