(164 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the mechanical and electrical functions of the catheter for mapping and pacing, not on algorithmic analysis of data.
No
The device is primarily used for diagnosis of complex arrhythmias and delivery of pacing stimuli, not for treating a disease or condition. While electrical stimulation can be therapeutic, in this context, it's for 'delivery of externally generated pacing stimuli,' likely for diagnostic purposes or temporary cardiac support rather than long-term treatment. The intended use focuses on aiding diagnosis.
Yes
The "Intended Use / Indications for Use" states that the device is "For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias."
No
The device description explicitly states it is a "catheter" and describes its physical delivery and expansion within the heart chamber, indicating it is a hardware 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 complex arrhythmias." This involves direct interaction with the patient's heart to record electrical signals and potentially deliver pacing stimuli.
- Device Description: The description details a catheter that is delivered to the heart chamber and expands to contact the heart wall. This is a medical device used in vivo (within the living body).
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not process or analyze biological specimens in vitro.
The device is clearly a medical device used for diagnostic and potentially therapeutic purposes within the patient's body during a medical procedure.
N/A
Intended Use / Indications for Use
For use in cardiac electrophysiology procedures to assist in the diagnosis of complex 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 catheter is used in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). 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 (cardiac)
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)
Performance Bench Testing data: The modification only impacts the basket subassembly of the catheter; the scope of testing was limited to confirming the mechanical integrity of the basket subassembly and its functionality.
Test Descriptions and Conclusions:
- Basket Radial force: PASS (Variable - 95/95 Confidence/Reliability)
- Basket Lateral Spline Stiffness: PASS (Variable - 95/95 Confidence/Reliability)
- Introduction/Withdrawal Cycling: PASS (Attribute - 95/95 Confidence/reliability per Weibull analysis)
- FIRMap Catheter Testing in Pancake Atrium: PASS (Attribute - 95/95 Confidence/reliability)
In-Vivo Testing: Evaluated the modification of the basket assembly during simulated use. No clinically significant differences in use or functionality were noted between the proposed and predicate catheters.
Conclusion: Performance testing has demonstrated that the modified FIRMap Catheter provides reasonable assurance of conformance to predicate device requirements.
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2016
Abbott Electrophysiology Dennis Pozzo Sr. Regulatory Affairs Specialist 3368 S. Geyer Road, Suite 365 St. Louis, MO 63127
Re: K153093
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: March 4, 2016 Received: March 7, 2016
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 (QS) 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,
Mitchell Stein
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) K153093
Device Name
FIRMap Catheter
Indications for Use (Describe)
For use in cardiac electrophysiology procedures to assist in the diagnosis of complex 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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Appendix 1: 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 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:
K130827, cleared October. 31, 2013 |
| Device
description | The catheter is used in cardiac electrophysiology procedures to assist in the
diagnosis of complex arrhythmias that may be difficult to identify using
conventional mapping systems alone (i.e., linear mapping catheters). 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
complex 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 | Both the proposed and predicate FIRMap catheters contain a distal basket
assembly. Arranged into a three dimensional shape that expands, Contain 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 splines are fixed at an equal distance labeled A through H in a
clockwise direction viewed from the catheter/basket's distal tip. The array orientation is displayed by use of radiopaque markers. Continued on next page |
4
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
The proposed device incorporates a design change to the distal spline which is Design change intended to improve performance and manufacturability compared with the predicate device.
| Device Characteristic
(Technological Comparison) | Predicate FIRMap
Catheter (K130827) | Proposed FIRMap
Catheter |
|-----------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use | Intracardiac
electrophysiological
mapping and pacing. | Intracardiac
electrophysiological
mapping and pacing. |
| Splines | | |
| No. of splines | 8 (expanding) | 8 (expanding) |
| Spline Material | Nitinol | Nitinol |
| Spline Tube Material | Pebax | Pebax |
| Spline radiopaque material | platinum-iridium alloy | platinum-iridium alloy |
| Distal spline connecting tip
(tip dome and cap) | 316 Stainless steel | 316 Stainless steel |
| Distal Catheter Tubing | Polyester Shrink Tubing | Polyester Shrink Tubing |
| Distal Spline Tubing | Polyester Shrink Tubing | NA |
| Method for limiting spline
movement | EDM "bowtie" feature | Extend Pebax tubing |
| Electrodes | | |
| No. of electrodes | 64 | 64 |
| Electrode material | Gold plated copper | Gold plated copper |
| Electrode configuration | Unipolar or bipolar | Unipolar or bipolar |
| Dimensions | | |
| Basket diameter/ Electrode
spacing | 40mm/ 6.8mm
50mm/ 9.0mm
60mm/ 11.2mm
70mm/13.5mm | 40mm/ 6.8mm
50mm/ 9.0mm
60mm/ 11.2mm
70mm/13.5mm |
| Device Characteristic
(Technological Comparison) | Predicate FIRMap
Catheter (K130827) | Proposed FIRMap
Catheter |
| Catheter shaft diameter | 2.8mm | 2.8mm |
| Working length | 128cm +/-1cm | 128cm +/-1cm |
| Recommended guide catheter | ID = 8.5 Fr. | ID = 8.5 Fr. |
| Electrical Rating | | |
| Electrical rating - Typical | +/- 27V, 25mA | +/- 27V, 25mA |
| Dielectric strength | 500V DC | 500V DC |
| Sterilization | | |
| Method of sterilization | EO gas | EO gas |
| Single use | Yes | Yes |
Continued on next page
5
Appendix 1:510(k) Summary per 21CFR §807.92, Continued
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
Performance Bench Testing data The modification only impacts the basket subassembly of the catheter; the scope of testing was limited to confirming the mechanical integrity of the basket subassembly and its functionality.
| Test Description | Acceptance Criteria | Conclusion |
|---|---|---|
| Basket Radial force | Variable - 95/95 | |
| Confidence/Reliability | PASS | |
| Basket Lateral Spline | ||
| Stiffness | Variable - 95/95 | |
| Confidence/Reliability | PASS | |
| Introduction/ Withdrawal | ||
| Cycling | Attribute - 95/95 | |
| Confidence/reliability | ||
| per Weibull analysis | PASS | |
| FIRMap Catheter Testing in | ||
| Pancake Atrium | Attribute - 95/95 | |
| Confidence/reliability | PASS |
Continued on next page
6
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Performance | In-Vivo Testing |
|---|---|
| data, continued | Evaluated the modification of the basket assembly during simulated use. No |
| clinically significant differences in use or functionality were noted between | |
| the proposed and predicate catheters. |
Conclusion
Performance testing has demonstrated that the modified FIRMap Catheter provides reasonable assurance of conformance to predicate device requirements. Therefore, it is substantially equivalent to the predicate device, safe and effective for its intended use.