(32 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a connector, with no mention of data processing, algorithms, or learning capabilities.
No.
The device description states it is a "non-patient contact device that is intended to be used in conjunction with the FIRMapTM catheter. The MAC acts as an interface between the catheter and electrophysiology recording system." It facilitates the use of a therapeutic device (the catheter) but is not directly therapeutic itself.
No
The device is described as an "interface between the catheter and electrophysiology recording system." Its function is to connect cables, not to collect or process diagnostic information itself. The performance studies also focus on electrical and mechanical integrity rather than diagnostic accuracy.
No
The device description explicitly states it is a "re-usable, non-sterile, non-patient contact device" that acts as an interface between a catheter and an electrophysiology recording system. It also mentions hardware testing like "Continuity and Hi Pot" and "Mate De-Mate Cycle," indicating it is a physical hardware component.
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" and acts as an interface between a catheter and an electrophysiology recording system. This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: It's described as a "re-usable, non-sterile, non-patient contact device" that connects a catheter to an EP system. This aligns with a device used during a medical procedure, not a diagnostic test performed in a lab.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The Topera FIRMap(TM) Mapping Adapter Connector (MAC) is indicated for use with Topera's FIRMap(TM) Catheters in cardiac electrophysiology procedures. Refer to the individual Instructions for Use of the associated FIRMap Catheter. It is important to carefully review the specific indications included with the associated catheters prior to use.
Product codes
MTD
Device Description
The FIRMap(TM) MAC is a re-usable, non-sterile, non-patient contact device that is intended to be used in conjunction with the FIRMap(TM) catheter. The MAC acts as an interface between the catheter and electrophysiology recording system by connecting the extension cable to the EP system fan out cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
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
The MAC has undergone the following battery of tests:
- Electromagnetic Compatibility
- Continuity and Hi Pot
- Mate De-Mate Cycle
- Mate De-Mate Force
Based upon the test data, it has been demonstrated that the MAC is safe and effective for its intended use.
Key Metrics
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/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2014
Topera, Inc. % Dennis Pozzo Senior Regulatory Affairs Master Specialist 3668 S. Geyer Road, Suite 365 St. Louis, Missouri 63127
Re: K142182
Trade/Device Name: FIRMap Mapping Adapter Connector (MAC) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: August 8, 2014 Received: August 11, 2014
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 device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 2: Indications for Use Statement
The following page contains FDA Form 3881 regarding the Indications for Use for the FIRMap™ MAC.
3
| 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)
Device Name
FIRMap Mapping Adapter Connector (MAC)
Indications for Use (Describe)
The Topera FIRMap™ Mapping Adapter Connector (MAC) is indicated for use with Topera's FIRMap™ Catheters in cardiac electrophysiology procedures. Refer to the individual Instructions for Use of the associated FIRMap Catheter. It is important to carefully review the specific indications included with the associated catheters prior to use.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
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Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Topera, Inc.
3668 S. Geyer Rd, Ste 365
St. Louis, MO 63127
Contact: Dennis Pozzo
Phone: 314-300-6580 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | Device Name: FIRMapTM Mapping Adapter Cable (MAC) Classification/Common name: Catheter, Intracardiac, High Density Array The marketed device(s) to which substantial equivalence is claimed:
FIRMap Catheter 510(k) – K130827, cleared 10/31/2013 |
| Device
description | The FIRMapTM MAC is a re-usable, non-sterile, non-patient contact device
that is intended to be used in conjunction with the FIRMapTM catheter. The
MAC acts as an interface between the catheter and electrophysiology
recording system by connecting the extension cable to the EP system fan out
cable. |
| Indications for
use | The Topera FIRMapTM MAC is indicated for use with Topera's FIRMapTM
Catheters in cardiac electrophysiology procedures. Refer to the individual
Instructions for Use of the associated FIRMap Catheter. It is important to
carefully review the specific indications included with the associated catheters
prior to use. |
| Comparison of
key
characteristics | The FIRMapTM MAC and FIRMapTM Catheter Cables have numerous
similarities, both in their intended use and mode of operation. Both are re-usable connectors. Both are intended to act as an interface between the catheter and
electrophysiology recording system. Both assemblies deliver electrical signals from the heart to an external
diagnostic system. Both assemblies are capable of delivering externally generated pacing
stimuli. |
| Performance
data | The MAC has undergone the following battery of tests: |
| | • Electromagnetic Compatibility |
| | • Continuity and Hi Pot |
| | • Mate De-Mate Cycle |
| | • Mate De-Mate Force |
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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
Based upon the test data, it has been demonstrated that the MAC is safe and effective for its intended use.