(219 days)
Not Found
No
The summary describes a physical catheter device for electrical signal detection and pacing, with no mention of AI or ML in its function or analysis.
Yes
The device is used to assist in the diagnosis of complex arrhythmias and can also be used for the delivery of externally generated pacing stimuli, which are therapeutic interventions.
Yes
The device is described as assisting in the "diagnosis of complex arrhythmias" by detecting and recording intracardiac electrical potentials, which directly supports a diagnostic function.
No
The device description explicitly details physical hardware components like a handle, catheter shaft, basket, and electrodes, indicating it is a physical medical device, not software-only.
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" and for "delivery of externally generated pacing stimuli." This describes a device used within the body to interact with and measure electrical activity, not a device used to test samples outside the body.
- Device Description: The description details a catheter with electrodes designed to be inserted into the heart to record electrical potentials and deliver pacing stimuli. This is consistent with an invasive medical device used for diagnosis and treatment, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (outside the living organism).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates directly within the body.
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 Topera FIRMap™ Catheter may also be used for delivery of externally generated pacing stimuli.
Product codes
MTD
Device Description
The FIRMap™ Catheter is comprised of these major components,
• Handle
• Handle Strain Relief
• Introducer Tool
• Catheter Shaft
• Basket
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 distal, expandable basket assembly is, in essence, eight miniature octapolar catheters that are arranged into a three dimensional "basket" shape.. The basket assembly contains an array of 64 electrodes mounted onto eight support structures called splines.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Various testing has been performed (biocompatibility, dimensional, mechanical integrity, mate/de-mate, electrical safety and GLP animal study) to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to verify its conformance to the requirements for its intended use. Therefore, it has been demonstrated that the FIRMap™ Catheter is 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
Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Topera, Inc.
3668 S. Geyer Rd, Suite 365
St. Louis, MO 63127
Contact: Dennis Pozzo
Phone: 314-300-6580
Fax: 702-920-8509
OCT 3 1 2013 | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Device/
classification
name | • Device Name: FIRMap™ Catheter
• Product Code: MTD
• Classification Number: 870.1220
• Classification/Common name: Electrode recording catheter or electrode recording probe
• The marketed device(s) to which substantial equivalence is claimed:
Constellation 510(k) - K021232, cleared 05/16/2002 | |
| Device
description | The FIRMap™ Catheter is comprised of these major components,
• Handle
• Handle Strain Relief
• Introducer Tool
• Catheter Shaft
• Basket
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 distal, expandable basket assembly is, in essence, eight
miniature octapolar catheters that are arranged into a three dimensional
"basket" shape.. The basket assembly contains an array of 64 electrodes
mounted onto eight support structures called splines. | |
| 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 Topera
FIRMap™ Catheter may also be used for delivery of externally generated
pacing stimuli. | |
| | | Continued on next page |
.
1
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics
The table below lists the technological characteristics for both the new and predicate device.
| Characteristic | Proposed FIRMap™™ Catheter | Predicate Device
Constellation
Catheter |
|----------------------------|----------------------------|-----------------------------------------------|
| Splines expand | Yes | Yes |
| No. of Splines | 8 | 8 |
| No. of electrodes | 64 | 32-64 |
| Sterile | Yes | Yes |
| Method of
sterilization | EO gas | EO gas |
| Single use | Yes | Yes |
| Radiopaque markers | Yes | Yes |
| Radiopaque material | platinum-iridium alloy | platinum-iridium alloy |
Performance data
Various testing has been performed (biocompatibility, dimensional, mechanical integrity, mate/de-mate, electrical safety and GLP animal study) to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to verify its conformance to the requirements for its intended use. Therefore, it has been demonstrated that the FIRMap™ Catheter is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 31, 2013
Topera, Inc. C/O Melissa Walker 3668 S. Geyer Road, Ste 365 Saint Louis, MO 63127 US
Re: K130827
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: September 13, 2013 Received: September 30, 2013
Dear Melissa Walker:
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. Iisting 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
3
Page 2- Melissa Walker
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Owen=P.Earis -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix 2: Indications for Use Statement
Statement The Indications for Use Statement:
510(k) Number: K_130827_______________________________________________________________________________________________________________________________________________________
Device Name: FIRMap™ Catheter
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 Topera FIRMap™ Catheter may also be used for delivery of externally generated pacing stimuli.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
u
Digitally signed by
Owen P. Faris -5
Date: 2013.10.31
15:41:21
-04:00'
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