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.

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.

AI/ML Overview

The provided text describes the regulatory clearance of the FIRMap™ Catheter, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way envisioned by the posed questions (e.g., regarding performance metrics like accuracy, sensitivity, or specificity for a diagnostic device).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "Performance data" section only states that various tests (biocompatibility, dimensional, mechanical integrity, mate/de-mate, electrical safety, and GLP animal study) were performed to support substantial equivalence. It does not provide specific acceptance criteria or the results of these tests in a quantifiable manner relevant to clinical performance.

Therefore, I cannot populate most of the requested table or answer the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies from the provided text.

Here's what I can extract based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text for clinical or diagnostic performance benchmarks.	"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." (This is a general statement, not specific performance data.)

Explanation of Gaps: The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and safety testing (biocompatibility, mechanical, electrical). It does not detail specific acceptance criteria for diagnostic capability (e.g., accuracy in identifying arrhythmias) or present data from a study that quantifies the device's performance against such criteria.

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "GLP animal study" but gives no details about sample size, design, or data provenance. There is no mention of human clinical trial data for performance evaluation in this 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not provided. Since no specific clinical performance study is detailed, there's no mention of experts establishing ground truth for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided.
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 such study is mentioned. The device is a catheter for recording electrical potentials and delivering pacing stimuli, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. The FIRMap™ Catheter is a medical device (electrode recording catheter), not an algorithm or standalone AI system. Its performance would be evaluated in terms of its ability to accurately record electrical signals, not as an "algorithm only" system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided. As no specific performance study against a clinical ground truth is detailed, this information is absent. The "GLP animal study" would likely involve physiological measurements as ground truth, but specific details are missing.
The sample size for the training set
- Not applicable/Not provided. The FIRMap™ Catheter is a hardware device; it does not explicitly use a "training set" in the context of machine learning.
How the ground truth for the training set was established
- Not applicable/Not provided.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through comparison of technological characteristics and general safety/performance testing (biocompatibility, mechanical, electrical). It does not contain the detailed clinical performance study data, acceptance criteria, or ground truth methodologies that would be typical for evaluating a diagnostic algorithm's accuracy, sensitivity, or specificity.

Summary

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Appendix 1: 510(k) Summary per 21CFR §807.92

Submitter'sinformation	Topera, Inc.3668 S. Geyer Rd, Suite 365St. Louis, MO 63127Contact: Dennis PozzoPhone: 314-300-6580Fax: 702-920-8509OCT 3 1 2013
Device/classificationname	• 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
Devicedescription	The FIRMap™ Catheter is comprised of these major components,• Handle• Handle Strain Relief• Introducer Tool• Catheter Shaft• BasketThe FIRMap™ Catheter is a sterile, single use device used to detect andrecord intracardiac electrical potentials and to deliver externally generatedpacing stimuli. The distal, expandable basket assembly is, in essence, eightminiature octapolar catheters that are arranged into a three dimensional"basket" shape.. The basket assembly contains an array of 64 electrodesmounted onto eight support structures called splines.
Indications foruse	For use in cardiac electrophysiology procedures to assist in the diagnosis ofcomplex arrhythmias that may be difficult to identify using conventionalmapping systems alone (i.e., linear mapping catheters). The ToperaFIRMap™ Catheter may also be used for delivery of externally generatedpacing stimuli.
		Continued on next page

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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 DeviceConstellationCatheter
Splines expand	Yes	Yes
No. of Splines	8	8
No. of electrodes	64	32-64
Sterile	Yes	Yes
Method ofsterilization	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.

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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

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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

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Appendix 2: Indications for Use Statement

Statement The Indications for Use Statement:

510(k) Number: K_130827_______________________________________________________________________________________________________________________________________________________

Device Name: FIRMap™ Catheter

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'

Page __ of ___________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).