(60 days)
Not Found
No
The summary describes a catheter for recording electrical potentials and delivering pacing stimuli. There is no mention of AI, ML, or any computational analysis of the recorded data beyond what would be expected from a conventional mapping system. The performance studies focus on mechanical properties, not algorithmic performance.
No.
The device's intended use is to assist in the diagnosis of arrhythmias and to deliver pacing stimuli, both of which are diagnostic and procedural assistance functions, not therapeutic treatments themselves.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to assist in the diagnosis of arrhythmias".
No
The device description explicitly states it is a "sterile, single use device" and a "catheter" used to "detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli." This indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias." This involves directly interacting with the patient's heart to record electrical signals and deliver pacing stimuli.
- Device Description: The device is a catheter that is inserted into the heart chamber to detect and record intracardiac electrical potentials and deliver pacing stimuli. This is an invasive procedure performed in vivo (within the living body).
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed in vitro (outside the living body).
This device is clearly designed for in vivo use within the patient's body, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.
Product codes
MTD
Device Description
The FIRMap Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart chamber/intracardiac
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 following is a list of the tests conducted: Radial Strength, Lateral Strength, Insertion/Withdrawal cycling, Torque and Pancake Atrium. No animal or clinical testing was conducted. The testing has demonstrated that the FIRMap catheter provides reasonable assurance that the proposed device conforms to the appropriate requirements for its intended use. Therefore, it is substantially equivalent to the predicate device, safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Abbott Electrophysiology Dennis Pozzo Senior Regulatory Affairs Specialist 3668 S. Geyer Road Suite 365 St. Louis, Missouri 63127
Re: K163709
Trade/Device Name: FIRMap Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: January 17, 2017 Received: January 18, 2017
Dear Dennis Pozzo:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
Mude Yellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
FIRMap Catheter
Indications for Use (Describe)
For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.
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)
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Section 5: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Abbott Electrophysiology
3668 S. Geyer Road, Suite 365, St. Louis, MO 63127
Contact: Dennis Pozzo
Phone 314-300-6580 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | • Device Trade Name: FIRMap Catheter
• Classification/Common name: Electrode recording catheter or electrode
recording probe
• Product Code/Classification No.: MTD/21 CFR 870.1220
• The marketed device(s) to which substantial equivalence is claimed:
FIRMap Catheter. K153093, cleared April 7, 2016 |
| Device
description | The FIRMap Catheter is a sterile, single use device used to detect and record
intracardiac electrical potentials and to deliver externally generated pacing
stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may
also be used for delivery of externally generated pacing stimuli.
The FIRMap catheter is delivered to the heart chamber via an intravascular
sheath. After the catheter is positioned the sheath is withdrawn enough to
allow the basket to expand and the electrodes to contact the heart wall. |
| Indications for
use | For use in cardiac electrophysiology procedures to assist in the diagnosis of
arrhythmias that may be difficult to identify using conventional mapping
systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also
be used for delivery of externally generated pacing stimuli. |
| Technological
characteristics | The distal, expandable basket assembly is arranged into a three dimensional
"basket" shape. The basket assembly contains an array of 64 electrodes
mounted onto eight support structures called splines. Each spline has 8
electrodes spaced at an equal distance along the length of the spline.
The eight splines are fixed at an equal distance labeled A through H in a
clockwise direction if viewed from the catheter/basket's distal tip. The array
orientation is displayed by use of radiopaque markers. To distinguish splines
under fluoroscopy, Spline A has a larger radiopaque marker next to electrode
8, Spline B has a larger marker next to electrode 7, Spline C has an additional
marker next to electrode 6, and so onwards in progression to Spline G. |
Continued on next page
4
Section 5: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | Predicate RhythmView
Workstation | Proposed RhythmView
Workstation |
|---------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Device Characteristic | Predicate FIRMap
Catheter (K153093) | Proposed FIRMap
Catheter |
| Intended Use | Intracardiac
electrophysiological
mapping and pacing. | Intracardiac
electrophysiological
mapping and pacing. |
| Splines expand | Yes | Yes |
| No. of Splines | 8 | 8 |
| No. of electrodes | 64 | 64 |
| Sterile | Yes | Yes |
| Method of sterilization | EO gas | EO gas |
| Single use | Yes | Yes |
| Radiopaque markers | Yes | Yes |
| Spline radiopaque material | platinum-iridium alloy | platinum-iridium alloy |
| Basket diameter/ Electrode
spacing | 50mm/ 9.0mm
60mm/ 11.2mm
70mm/13.5mm | 50mm/ 9.0mm
60mm/ 11.2mm
70mm/13.5mm |
| Basket Tip | Two Piece - Tip Dome
and Cap | Single Piece |
| Basket Tip Material | Stainless Steel | Stainless Steel |
Applicable standards
- ISO 14971: 2012, Medical Devices - Application of risk management to medical devices
- ISO 10555-1: 2012 Intravascular catheters Sterile and single-use ● catheters - Part 1: General requirements
Since there are no electrical updates, the EMC and Electrical Safety reports referenced in K153093 still apply.
- IEC 60601-1, 3rd Edition, Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Continued on next page
5
Section 5: 510(k) Summary per 21CFR §807.92, Continued
| Performance
data | The following is a list of the tests conducted: Radial Strength, Lateral
Strength, Insertion/Withdrawal cycling, Torque and Pancake Atrium.
P q'animal or clinical testing was conducted. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The testing has demonstrated that the FIRMap catheter provides
reasonable assurance that the proposed device conforms to the
appropriate requirements for its intended use. Therefore, it is
substantially equivalent to the predicate device, safe and effective for
its intended use. |