(32 days)
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.
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.
This document describes the regulatory submission for the FIRMap Mapping Adapter Connector (MAC), a reusable, non-sterile device intended to interface Topera's FIRMap™ Catheters with electrophysiology recording systems.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
| Continuity and High Potential (Hi Pot) | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
| Mate/Demate Cycle | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
| Mate/Demate Force | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
Note: The document states the MAC underwent these tests and, based on the test data, "it has been demonstrated that the MAC is safe and effective for its intended use." This implies that the device met the acceptance criteria for each of these tests, even though specific pass/fail values or detailed results are not provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the performance tests (Electromagnetic Compatibility, Continuity and Hi Pot, Mate Demate Cycle, Mate Demate Force).
The data provenance is not specified. It is likely internal testing performed by Topera, Inc. as part of their device development and regulatory submission process. There is no indication of country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The FIRMap MAC is a hardware connector, and its performance tests (EMC, continuity, mechanical durability) are typically evaluated against engineering standards and specifications, not against "ground truth" established by clinical experts in the same way a diagnostic algorithm would be.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the type of engineering performance testing conducted for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for evaluating results against human interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The device is a hardware connector and not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. The device is a passive hardware component, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as expert consensus, pathology, or outcomes data is not directly applicable to the engineering performance tests (EMC, continuity, mechanical) conducted for this device. The "ground truth" for these tests would be the established engineering specifications and regulatory standards that the device must meet to function safely and effectively. For example, for "Continuity and Hi Pot," the ground truth would be a pass/fail according to a predefined electrical resistance or dielectric strength threshold.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The FIRMap MAC is a hardware device developed through engineering design and testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, there is no "training set" for this hardware device.
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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
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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.
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| 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'sinformation | Topera, Inc.3668 S. Geyer Rd, Ste 365St. Louis, MO 63127Contact: Dennis PozzoPhone: 314-300-6580 |
|---|---|
| Device/classificationname | 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 |
| Devicedescription | The FIRMapTM MAC is a re-usable, non-sterile, non-patient contact devicethat is intended to be used in conjunction with the FIRMapTM catheter. TheMAC acts as an interface between the catheter and electrophysiologyrecording system by connecting the extension cable to the EP system fan outcable. |
| Indications foruse | The Topera FIRMapTM MAC is indicated for use with Topera's FIRMapTMCatheters in cardiac electrophysiology procedures. Refer to the individualInstructions for Use of the associated FIRMap Catheter. It is important tocarefully review the specific indications included with the associated cathetersprior to use. |
| Comparison ofkeycharacteristics | The FIRMapTM MAC and FIRMapTM Catheter Cables have numeroussimilarities, 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 andelectrophysiology recording system. Both assemblies deliver electrical signals from the heart to an externaldiagnostic system. Both assemblies are capable of delivering externally generated pacingstimuli. |
| Performancedata | 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.
§ 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).