(89 days)
Medtronic CardioRhythm Marinr EP catheter
Not Found
No
The description focuses on the physical characteristics and function of a diagnostic catheter for recording electrical signals. There is no mention of AI or ML processing of these signals or any other data.
No
The device is described as a diagnostic tool for recording electrical activity and stimulating the heart to assess arrhythmia prognosis and guide therapy selection, not for directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Medtronic CardioRhythm StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures." Additionally, the "Device Description" mentions that the data from the EP study conducted with this device is "used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions," which are all diagnostic goals.
No
The device is a physical catheter with electrodes and a manipulator handle, clearly indicating it is a hardware device, not software-only.
Based on the provided information, the Medtronic CardioRhythm StableMapr Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The StableMapr Catheter is an in vivo device. It is inserted directly into the patient's body (the heart and its vasculature) to record electrical activity and stimulate the heart. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "diagnostic electrophysiologic procedures" and "recording intracardiac electrograms and temporary pacing associated with electrophysiology studies." This is a direct interaction with the patient's internal systems, not the analysis of external samples.
Therefore, the StableMapr Catheter falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic CardioRhythm StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Product codes
DRF
Device Description
The StableMapr Series of EP Diagnostic Catheters are used to record electrical activity from within the heart and its vasculature and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
The StableMapr Catheters are closed-lumen diagnostic electrophysiology catheters with a variable number of platinum allov recording/stimulating electrodes fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The StableMapr Catheters include addition mapping electrodes and a preformed distal tip section, as well as other minor modifications for improved manufacturability. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrode to the electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curvature of the catheter tip. All models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart and its vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
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Summary of Performance Studies
The non-clinical testing were conducted in accordance with applicable FDA guidance. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Marinr catheters. These tests support the substantial equivalence of the StableMapr catheters with the predicate device.
Key Metrics
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Predicate Device(s)
Medtronic CardioRhythm Marinr EP catheter
Reference Device(s)
Invine Biomedical Steerable Atrial Mapping Inquire H, Cordis Webster Halo XP Tricuspid Mapping Catheters
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).
0
Medironic &
SECTION 6. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Device Name
StableMapr Steerable Intracardiac Electrode Catheters
Device Description
The StableMapr Series of EP Diagnostic Catheters are used to record electrical activity from within the heart and its vasculature and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
The StableMapr Catheters are closed-lumen diagnostic electrophysiology catheters with a variable number of platinum allov recording/stimulating electrodes fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The StableMapr Catheters include addition mapping electrodes and a preformed distal tip section, as well as other minor modifications for improved manufacturability. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrode to the electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curvature of the catheter tip. All models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
Intended Use
The Medtronic CardioRhythm StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Substantial Equivalence
The StableMapr series of EP catheters is substantially equivalent to the Medtronic CardioRhythm Marinr EP catheter, as well as the Invine Biomedical Steerable Atrial Mapping Inquire H and Cordis Webster Halo XP Tricuspid Mapping Catheters.
1
Medtronic @
Catheter Testing Results and Conclusion
The StableMapr catheter is constructed of similar materials to those found in the Medtronic CardioRhythm Marinr Catheter. The patient contacting materials utilized in the fabrication of the StableMapr are identical to those used in the Marinr catheter. Therefore, all biocompatibility testing was fulfilled via the predicate Marinr Catheter device.
The non-clinical testing were conducted in accordance with applicable FDA guidance. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Marinr catheters. These tests support the substantial equivalence of the StableMapr catheters with the predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human silhouettes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
AUG - 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristen Honl Senior Product Requlation Manager Medtronic CardioRhythm 1312 Crossman Avenue Sunnyvale, CA 94089-1113
Re : K981642 StableMapr Steerable Intracardiac Electrode Catheter Regulatory Class: II (two) Product Code: DRF Dated: May 6, 1998 Received: May 8, 1998
Dear Ms. Honl:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: StableMapr Steerable Intracardiac Electrode Catheters
- The Medtronic CardioRhythm StableMapr catheter is Indications For Use: intended for use in diagnostic electrophysiology procedures. These catheters are designed for recording intracardiac pacing associated with electrograms and temporary electrophysiology studies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
y Oalk Jell
15- Offl
a: Devices
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)