(221 days)
Not Found
No
The summary describes a reprocessed electrophysiology catheter used for recording and stimulation, with no mention of AI or ML in its function or analysis.
No.
The device is used for diagnostic purposes (electrogram recording and cardiac stimulation during diagnostic electrophysiology studies to evaluate cardiac arrhythmias), not for treating or curing a condition.
Yes.
The device's description explicitly states it is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies."
No
The device description clearly indicates it is a physical catheter used for electrophysiology studies, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This involves direct interaction with the patient's body for diagnostic purposes related to the heart's electrical activity.
- Device Description: The description further clarifies its use for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." This is a procedure performed on a living patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not operate on such samples.
The device described is an invasive medical device used for electrophysiology studies, which are performed directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
NLH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac, endocardial, intravascular sites, high right atrium, right ventricular apex, His bundle, coronary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three overlapping heads suggesting a sense of community and interconnectedness.
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
1
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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Image /page/2/Picture/0 description: The image contains the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it.
Traditional 510(k) Notification Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter
4.0 Indications for Use
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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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Image /page/3/Picture/0 description: The image shows the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, followed by the Renewal logo in green and blue. Below the Renewal logo is the text "Full Circle Reprocessing".
510(k) Summary – K151617
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon
Director, QA/RA
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com | | |
| Date Prepared | June 19, 2015 | | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Livewire
Electrophysiology Catheter
Common Name: Diagnostic Electrophysiology Catheter, Reprocessed | | |
| Classification | Classification: Class II
Regulation Number: 870.1220
Product Code: NLH | | |
| Predicate
Device | K022380 St. Jude Medical Livewire Electrophysiology Catheter | | |
| Device
Description | 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. | | |
| Statement of
Intended Use | Medline ReNewal Reprocessed Electrophysiology catheters can be used in
the evaluation of a variety of cardiac arrhythmias from endocardial and
intravascular sites. | | |
| Technological
Characteristics | The Medline ReNewal Reprocessed Electrophysiology Catheters contain
various electrode spacing and a steerable design with a tip that can be
shaped into a user-desired curve. The technological characteristics of the
proposed devices are substantially equivalent to the predicate devices
listed in this submission. The proposed devices are a reprocessed version
of the predicate devices. Only Medline ReNewal reprocesses the Medline
ReNewal Reprocessed St. Jude Livewire Electrophysiology Catheters.
Catheters are reprocessed a maximum of two times. Catheters are marked
and taken out of service after the maximum number of cycles is reached. | | |
| Performance
Testing | 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: | ●
O
O
O
O | 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 predicate
devices, Medline ReNewal Reprocessed St. Jude Medical Livewire
Electrophysiology Catheters are substantially equivalent to the predicate
device. | | |
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Image /page/4/Picture/0 description: The image shows the Medline ReNewal logo. The word "ReNewal" is in a combination of green and blue, with "Re" in green and "Newal" in blue. Below "ReNewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a stylized star.