(221 days)
The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Medline ReNewal Reprocessed St. Jude Livewire 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 Livewire Electrophysiology Catheter (K151617) underwent performance testing to demonstrate substantial equivalence to its predicate device, the St. Jude Medical Livewire Electrophysiology Catheter (K022380).
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a list of functional performance studies, cleaning validation, biocompatibility testing, packaging/sterilization validation, and product stability tests performed. However, it does not explicitly define specific numerical acceptance criteria for each test nor provides detailed quantitative results (e.g., "bond strength was X N, meeting the criteria of >Y N"). Instead, it states that the functional characteristics were "evaluated and found to be substantially equivalent to the predicate device."
Here’s a summary of the tests performed, which implicitly form the basis for acceptance:
| Acceptance Criteria (Implicitly: Performance comparable to predicate) | Reported Device Performance (Implicitly: Met comparable performance) |
|---|---|
| Functional Performance Studies: | |
| Bond strength (tensile testing) | Tested and found comparable |
| Torsional strength | Tested and found comparable |
| Leakage current | Tested and found comparable |
| Steerable deflection and continuity | Tested and found comparable |
| Catheter/handle joint flexibility and continuity (flex fatigue) | Tested and found comparable |
| Electrode adherence | Tested and found comparable |
| Applied force deflection (tip flexibility) | Tested and found comparable |
| Shaft flexibility | Tested and found comparable |
| Tip buckling | Tested and found comparable |
| Direct current resistance | Tested and found comparable |
| Impedance at 5 kHz | Tested and found comparable |
| Corrosion resistance | Tested and found comparable |
| Cleaning: | |
| Protein, total organic carbon, and endotoxins | Tested and cleaning performance qualified |
| Visual inspection under magnification | Tested and cleaning performance qualified |
| Cleaning performance qualification | Performed and qualified |
| Biocompatibility: | |
| Cytotoxicity | Tested and found acceptable |
| Sensitization | Tested and found acceptable |
| Irritation | Tested and found acceptable |
| Acute systemic toxicity | Tested and found acceptable |
| Pyrogenicity | Tested and found acceptable |
| Hemocompatibility (hemolysis, thrombogenicity, complement activation) | Tested and found acceptable |
| Packaging and sterilization validation: | |
| Bioburden testing | Tested |
| Ethylene oxide and ethylene chlorohydrin residuals testing | Tested |
| Product stability | Tested and found acceptable |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable and not provided in the context of this 510(k) summary, as it describes a reprocessed medical device's physical and functional performance, not an AI/algorithmic medical device requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided for the reasons stated in point 3. The testing involves laboratory and benchtop evaluations of device properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed, as it is not relevant for the type of device (reprocessed catheter) described. This type of study is typically used for diagnostic imaging or AI devices that interact with human readers/clinicians.
6. Standalone (Algorithm Only) Performance:
Standalone performance (algorithm only) was not performed, as it is not relevant for this reprocessed physical medical device. This concept applies to AI/software as a medical device.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance evaluation is based on established engineering and biological standards relevant to medical devices, as well as comparison to the performance characteristics of the original, new device (predicate device). For instance, for bond strength, the "ground truth" would be the required mechanical integrity, and for cleaning, it would be the absence of specified contaminants below acceptable thresholds.
8. Sample Size for the Training Set:
This information is not applicable and not provided. The listed tests are for verifying the performance of the reprocessed device itself, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the reasons stated in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Medline ReNewal Brandi Panteleon Director, Quality Assurance/Regulatory Affairs Medline ReNewal 2747 SW 6th St Redmond. Oregon 97756
Re: K151617
Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Livewire 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: December 17, 2015 Received: December 18, 2015
Dear Brandi Panteleon:
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. 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Arthell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Notification Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter
4.0 Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. | |
|---|---|---|
| 510(k) Number (if known) | K151617 | |
| TBD |
Device Name
Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter
Indications for Use (Describe)
The Medline ReNewal Reprocessed St. Jude Medical Livewire 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) > 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." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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510(k) Summary – K151617
| Submitter/Owner | Medline ReNewal2747 SW 6th St.Redmond, OR 97756 | ||
|---|---|---|---|
| Contact Names | Brandi PanteleonDirector, QA/RAP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com | ||
| Date Prepared | June 19, 2015 | ||
| Device Names | Proprietary Name: Medline ReNewal Reprocessed LivewireElectrophysiology CatheterCommon Name: Diagnostic Electrophysiology Catheter, Reprocessed | ||
| Classification | Classification: Class IIRegulation Number: 870.1220Product Code: NLH | ||
| PredicateDevice | K022380 St. Jude Medical Livewire Electrophysiology Catheter | ||
| DeviceDescription | Medline ReNewal Reprocessed St. Jude Livewire ElectrophysiologyCatheters are commonly placed at the high right atrium, right ventricularapex and His bundle, and in the coronary sinus, and are used forelectrogram recording and cardiac stimulation during diagnosticelectrophysiology studies. | ||
| Statement ofIntended Use | Medline ReNewal Reprocessed Electrophysiology catheters can be used inthe evaluation of a variety of cardiac arrhythmias from endocardial andintravascular sites. | ||
| TechnologicalCharacteristics | The Medline ReNewal Reprocessed Electrophysiology Catheters containvarious electrode spacing and a steerable design with a tip that can beshaped into a user-desired curve. The technological characteristics of theproposed devices are substantially equivalent to the predicate deviceslisted in this submission. The proposed devices are a reprocessed versionof the predicate devices. Only Medline ReNewal reprocesses the MedlineReNewal Reprocessed St. Jude Livewire Electrophysiology Catheters.Catheters are reprocessed a maximum of two times. Catheters are markedand taken out of service after the maximum number of cycles is reached. | ||
| PerformanceTesting | 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: | ●OOOO | simulated use and artificial soiling;bond strength (tensile testing);torsional strength;leakage current;steerable deflection and continuity; |
| ○ | catheter/handle joint flexibility and continuity (flex fatigue); | ||
| ○ | electrode adherence; | ||
| ○ | applied force deflection (tip flexibility); | ||
| ○ | shaft flexibility; | ||
| ○ | tip buckling; | ||
| ○ | direct current resistance; | ||
| ○ | impedance at 5 kHz; and | ||
| ○ | corrosion resistance. | ||
| ● | Cleaning: | ||
| ○ | protein, total organic carbon, and endotoxins; | ||
| ○ | visual inspection under magnification; and | ||
| ○ | cleaning performance qualification. | ||
| ● | Biocompatibility: | ||
| ○ | cytotoxicity; | ||
| ○ | sensitization; | ||
| ○ | irritation; | ||
| ○ | acute systemic toxicity; | ||
| ○ | pyrogenicity; | ||
| ○ | hemocompatibility (hemolysis, thrombogenicity; and | ||
| complement activation). | |||
| ● | Packaging and shelf life validation; sterilization validation: | ||
| ○ | bioburden testing; and | ||
| ○ | ethylene oxide and ethylene chlorohydrin residuals testing. | ||
| ● | Product stability | ||
| Based on comparisons of the indications for use, intended use, | |||
| Conclusion | technological characteristics, and performance data to the predicatedevices, Medline ReNewal Reprocessed St. Jude Medical LivewireElectrophysiology Catheters are substantially equivalent to the predicatedevice. |
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§ 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).