(414 days)
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Disclaimer: The provided text is a 510(k) summary for a reprocessed medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than conducting new clinical trials for effectiveness in the way an AI/ML algorithm might. Therefore, many of the requested points related to AI/ML clinical studies (e.g., MRMC studies, ground truth establishment for training sets) are not directly applicable or explicitly stated in this type of document. I will address the points as best as possible given the information provided.
Device: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
The document demonstrates that the reprocessed device is substantially equivalent to the predicate device, St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K151622). The acceptance criteria are primarily defined by successful completion of various non-clinical performance, safety, and reprocessing validation tests, ensuring the reprocessed device maintains the same technological characteristics and performance as the original predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Summary from submission) |
|---|---|---|
| Functional Performance | - Simulated use and artificial soiling | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... simulated use and artificial soiling." |
| - Tensile testing | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... tensile testing." | |
| - Torsional strength | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... torsional strength." | |
| - Leakage current | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... leakage current." | |
| - Continuity | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... continuity." | |
| - Isolation resistance | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... isolation resistance." | |
| - Three-point bend corrosion resistance | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... three-point bend corrosion resistance." | |
| Cleaning | - Protein, total organic carbon, and endotoxins (residual limits) | "Cleaning: protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification." (Implies compliance with established limits). |
| - Visual inspection under magnification (absence of visible residues) | "Cleaning: ...visual inspection under magnification..." (Implies absence of visible residues was met). | |
| - Cleaning performance qualification | "Cleaning: ...cleaning performance qualification." (Implies successful qualification). | |
| Biocompatibility | - Cytotoxicity | "Biocompatibility: cytotoxicity..." (Implies satisfactory results). |
| - Sensitization | "Biocompatibility: ...sensitization..." (Implies satisfactory results). | |
| - Irritation | "Biocompatibility: ...irritation..." (Implies satisfactory results). | |
| - Acute systemic toxicity | "Biocompatibility: ...acute systemic toxicity..." (Implies satisfactory results). | |
| - Materials-mediated pyrogen complement activation | "Biocompatibility: ...materials-mediated pyrogen complement activation..." (Implies satisfactory results). | |
| - Hemolysis (direct and indirect) coagulation complement activation thrombosis | "Biocompatibility: ...hemolysis (direct and indirect) coagulation complement activation thrombosis." (Implies satisfactory results). | |
| Packaging & Sterilization | - Packaging and shelf life validation (maintaining sterility and device integrity) | "Packaging and shelf life validation;" (Implies successful validation of packaging integrity and established shelf life). |
| - Sterilization validation (Sterility Assurance Level) | "sterilization validation: bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing; bacteriostasis/fungistatis." (Implies successful validation to a specified SAL). | |
| - Bioburden testing | "sterilization validation: bioburden testing..." (Implies compliance with bioburden limits prior to sterilization). | |
| - Ethylene oxide and ethylene chlorohydrin residuals testing (to safe limits) | "sterilization validation: ...ethylene oxide and ethylene chlorohydrin residuals testing..." (Implies residuals are within safe limits). | |
| - Bacteriostasis/Fungistasis testing | "sterilization validation: bacteriostasis/fungistatis." (Implies satisfactory results to ensure sterilization effectiveness). | |
| Product Stability | - Product stability over time | "Product stability" (Implies studies were conducted to ensure device performance and integrity over its shelf life). |
| Reprocessing Limits | - Each catheter is reprocessed no more than two times. | "Each catheter is reprocessed no more than two times." (This is a condition of the reprocessing, rather than a test result, but implicitly the performance tests support that this limit is safe and effective). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test. It lists the types of tests performed. For reprocessed devices, the "test set" would typically involve multiple units of the reprocessed devices subjected to each of the listed functional, cleaning, biocompatibility, and sterilization tests.
- Sample Size: Not explicitly stated for each test. It would be an industry standard sample size for each specific test (e.g., a certain number of devices for tensile strength, a certain number for biocompatibility assays).
- Data Provenance: Retrospective (reprocessed existing devices from St. Jude Medical) and prospective (testing performed on these reprocessed devices). The "country of origin of the data" is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards and potentially testing done within the U.S. or by labs recognized by U.S. standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This point is not applicable here. This submission is for a reprocessed electrophysiology catheter, which is a hardware device, not an AI/ML diagnostic or image analysis algorithm. Therefore, there is no "ground truth" in the clinical AI sense (e.g., expert labels on images) to be established by experts for an AI test set. The "ground truth" for this device is based on physical and biological testing against established engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of an AI/ML algorithm's clinical performance. The "adjudication" for this type of device is the assessment of test results against predefined acceptance criteria (e.g., pass/fail for functional tests, within limits for chemical residuals, absence of adverse effects for biocompatibility).
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:
Not applicable. This is a reprocessed medical device, not an AI-assisted diagnostic tool. No MRMC study was performed as it is irrelevant to the substantial equivalence of a physical catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance relies on a combination of:
- Engineering Specifications: Performance parameters (e.g., tensile strength, electrical properties) are measured against established engineering standards and the specifications of the original predicate device.
- Biological/Chemical Standards: Residual limits for cleaning agents, sterility assurance levels, and biocompatibility endpoints are evaluated against recognized biological and chemical safety standards (e.g., ISO standards for biocompatibility).
- Predicate Device Performance: The original, new St. Jude Medical Livewire catheter establishes the benchmark for "ground truth" performance and safety, to which the reprocessed device must demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
May 31, 2023
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Mays Senior Regulatory Affairs Specialist 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K221067
Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: NLH Dated: May 4, 2023 Received: May 4, 2023
Dear Stephanie Mays:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (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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| Model | Description | Electrodes | Curve | Size | |
|---|---|---|---|---|---|
| No. | Qty. | Spacing | (cm)a | ||
| 401572 | Quadripolar | 4 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401575 | Decapolar | 10 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401580 | Hexapolar | 6 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401581 | Octapolar | 8 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401582 | Decapolar | 10 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401600 | Quadripolar | 4 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401603 | Quadripolar | 4 | 2-5-2 | M Curl | 6 Fr x 115 |
| 401606 | Quadripolar | 4 | 2-5-2 | L Sweep | 6 Fr x 115 |
| 401648 | Quadripolar | 4 | 5-5-5 | L Curl | 5 Fr x 115 |
| 401652 | Octapolar | 8 | 2-2-2 | M Sweep CRD-2 ™ | 5 Fr x 115 |
| 401653 | Hexapolar | 6 | 2-5-2 | M Sweep CRD-2™ | 5 Fr x 115 |
| 401654 | Hexapolar | 6 | 5 | M Sweep CRD-2 ™ | 5 Fr x 115 |
| 401655 | Decapolar | 10 | 5-5-5 | XL Curl | 5 Fr x 115 |
| 401780 | Quadripolar | 4 | 5-5-5 | M sweep | 5 Fr x 115 |
| 401904 | Duo-Decapolar | 20 | 2-10-2 | Super L Curl | 7 Fr x 95 |
| 401905 | Duo-Decapolar | 20 | 5-5-5 | Super L Curl | 7 Fr x 95 |
| 401908 | Duo-Decapolar | 20 | 2-2-2 | M Curl | 7 Fr x 115 |
| 401914 | Duo-Decapolar | 20 | 2-5-2 | Super L Curl | 7 Fr x 95 |
| 401915 | Decapolar | 10 | 2-5-2 | XL Curl | 6 Fr x 115 |
| 401917 | Octapolar | 8 | 2-2-2 | M Sweep | 6 Fr x 115 |
| 401918 | Duo-Decapolar BDB™ | 20 | 2-20-2-2-2-2-2-2-2-2-2-2-2-25-2-25-2-25-2 | Super L Curl | 7 Fr x 95 |
| 401923 | Decapolar | 10 | 2-2-2 | XL Curl | 6 Fr x 115 |
| 401926 | Decapolar CSL™ Bi-directional | 10 | 2-8-2 | XL Sweep CSL | 6 Fr x 115 |
| 401932 | Dual-Purpose Duo-Decapolar (20Electrodes) | 20 | 2-8-2-(60)-2-8-2 | Super L Curl | 7 Fr x 95 |
| 401933 | Quadripolar | 4 | 5-5-5 | M Sweep | 6 Fr x 115 |
| 401934 | Quadripolar | 4 | 5-5-5 | L Sweep | 6 Fr x 115 |
| 401935 | Decapolar | 10 | 2 | XL Sweep | 7 Fr x 115 |
| 401938 | Decapolar | 10 | 5-5-5 | M Sweep | 5 Fr x 115 |
The model numbers included in the scope of this submission are listed in the following table.
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Indications for Use
510(k) Number (if known) K221067
Device Name
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheters
Indications for Use (Describe)
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, with the word "MEDLINE" in white letters on a blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters, with the letters "Re" in green and the rest of the word in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.
221067 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)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 8, 2022 | |||
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed St. Jude MedicalLivewire Steerable Electrophysiology Catheters | ||
| Common or Usual Name | Diagnostic Electrophysiology Catheter, Reprocessed | |||
| Regulatory Name/Reference | Electrode recording catheter or electrode recordingprobe, 21 CFR § 870.1220 | |||
| Regulatory Class | 2 | |||
| Product Code | NLH | |||
| Panel | Cardiovascular | |||
| 510(k) Number | K151622 | |||
| Proprietary or Trade Name | St. Jude Medical MediGuide Enabled LivewireSteerable Electrophysiology Catheter, LivewireElectrophysiology Catheter, ResponseElectrophysiology Catheter with Lumen, ResponseElectrophysiology Catheter and SJM EpicardialCatheter System, Supreme ElectrophysiologyCatheter | |||
| Predicate Device | Common or Usual Name | Diagnostic Electrophysiology Catheter | ||
| Regulatory Name/Reference | Electrode recording catheter or electrode recordingprobe, 21 CFR § 870.1220 | |||
| Regulatory Class | 2 | |||
| Product Code | DRF | |||
| Panel | Cardiovascular | |||
| Manufacturer | St. Jude Medical14901 DeVeau Place, Minnetonka, MN 55345 | |||
| Device Description | The Medline ReNewal Reprocessed St. Jude Medical Livewire SteerableElectrophysiology Catheter is a flexible electrode catheter constructed of apolyurethane insulation/shaft and incorporates platinum electrodes. Theactive tip may be manipulated by a remote means located at the proximalend of the catheter. | |||
| Indications for use | The Medline ReNewal Reprocessed St. Jude Medical Livewire SteerableElectrophysiology Catheter can be used in the evaluation of a variety ofcardiac arrhythmias from endocardial and intravascular sites. |
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Image /page/5/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is a blue square with the word "MEDLINE" in white letters and a white star-like symbol. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below. The Renewal logo also has a trademark symbol.
| TechnologicalCharacteristics | The technological characteristics and the fundamental scientific technologyof the subject devices are equivalent to the predicate device. The proposeddevices are a reprocessed version of the predicate devices. K151622 St.Jude Medical Livewire Steerable Electrophysiology Catheter was used asthe primary predicate to support intended use, technological characteristics,and functional performance specifications. | |||
|---|---|---|---|---|
| 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; tensile testing; torsional strength; leakage current; continuity; isolation resistance; three-point bend corrosion resistance. | ||||
| Cleaning: | ||||
| protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification. | ||||
| Biocompatibility: | ||||
| cytotoxicity; sensitization; irritation; acute systemic toxicity; materials-mediated pyrogen complement activation; hemolysis (direct and indirect) coagulation complement activation thrombosis. | ||||
| Packaging and shelf life validation; sterilization validation: | ||||
| bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing | ||||
| bacteriostasis/fungistatis | ||||
| Product stability | ||||
| Summary Table: Predicate and Medline ReNewal Reprocessed St. Jude MedicalLivewire Reprocessed Electrophysiology Catheter device comparisonchart. | ||||
| Predicate | Proposed | Comparison |
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| DeviceCharacteristics | St. Jude Medical MediGuideEnabled Livewire SteerableElectrophysiology Catheter,Livewire Electrophysiology | Medline ReNewal St. JudeMedical Livewire SteerableElectrophysiology Catheter | As Stated |
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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with the word "MEDLINE" in white text and a white star symbol. To the right of the Medline logo is the word "Renewal" in green text, with the words "Full Circle Reprocessing" in blue text below it. The Renewal logo also has a trademark symbol.
| Catheter, ResponseElectrophysiology Catheterwith Lumen, ResponseElectrophysiology Catheterand SJM Epicardial CatheterSystem, SupremeElectrophysiology Catheter | |||
|---|---|---|---|
| 510(k) | K151622 | TBD | N/A |
| Model Numbers | 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 | As stated |
| Common Name | Diagnostic ElectrophysiologyCatheter | Diagnostic ElectrophysiologyCatheter, Reprocessed | As stated |
| Regulation No. | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| Regulatory Class | 2 | 2 | Same |
| Product Code | DRF | NLH | As stated |
| Indications forUse (IntendedUse) | The Livewire SteerableElectrophysiology Catheter canbe used in the evaluation of avariety of cardiac arrhythmiasfrom endocardial andintravascular sites. | The Medline ReNewalReprocessed St. Jude MedicalLivewire SteerableElectrophysiology Cathetercan be used in the evaluationof a variety of cardiacarrhythmias from endocardialand intravascular sites. | Same |
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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white star inside. The Renewal logo is on the right side of the image and is written in green and blue. Below the Renewal logo is the text "Full Circle Reprocessing".
Summary Table: Predicate and Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable EP Catheters device comparison chart (concluded).
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| DeviceCharacteristics | St. Jude Medical MediGuideEnabled Livewire SteerableElectrophysiology Catheter,Livewire ElectrophysiologyCatheter, ResponseElectrophysiology Catheterwith Lumen, ResponseElectrophysiology Catheterand SJM Epicardial CatheterSystem, SupremeElectrophysiology Catheter | Medline ReNewal St. JudeMedical Livewire SteerableElectrophysiology Catheter | As stated |
| TechnologicalCharacteristicsa | To operate, the LivewireSteerable ElectrophysiologyCatheters are connected to agenerator via a universalcable. | To operate, the MedlineReNewal ReprocessedLivewire SteerableElectrophysiology Cathetersare connected to a generatorvia a universal cable. | As stated |
| a Neither K151622 nor the current submission included the universal cable or generators as part of their respective submissions. Only catheter models were included in the project scope. | |||
| Reprocessing | Each catheter is reprocessed no more than two times. Medline ReNewal does not reprocess the catheters of other reprocessors. | ||
| Conclusion | The predicate and proposed devices in this application have the same indications for use and technological characteristics. Based on this and the non-clinical testing data presented in this 510(k) submission, the Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Catheter device models listed in this summary table are substantially equivalent to the predicate devices. |
§ 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).