The ProRhythm™, Inc. ProMap Coaxial Mapping Catheter is an intracardiac electrophysiology recording catheter. The ProMap is designed to be used to record cardiac electrograms for the evaluation of cardiac arrhythmias from endocardial and intravascular sites during invasive cardiac electrophysiology procedures. The ProRhythm ProMap is to be used with the ProMap Connection Cable.

The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from endocardial and intravascular sites. The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.

Device Description

ProRhythm's ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment. The device has 6 electrodes mounted at the distal end. A passive mechanism at the distal end conforms into the shape of a ring ranging from 15 to 25 mm in diameter. The electrodes are spaced either evenly. The handle at the proximal end of the device allows the device to be manipulated into position within the left atrium. A connector at the proximal end of the device enables connection to the ProMap Connection Cable.

The ProMap Coaxial Mapping Catheter is designed to be inserted through a delivery sheath catheter and into the left atrium to record electro grams. The distal end extends past the delivery sheath catheter and forms into a circular ring that is optimized for use in the pulmonary veins. Electrodes mounted at the distal end and spaced uniformly along the circular ring allow recording of pulmonary vein potentials in the left atrium.

The ProMap Coaxial Mapping Catheter can be withdrawn and reinserted (without excessive friction) while the delivery sheath catheter can be deflected. This enables the electro physiologist to perform other functions through the sheaths lumen, such as contrast injections to obtain venograms.

AI/ML Overview

The provided text focuses on the 510(k) summary for the ProRhythm, Inc. ProMap Coaxial Mapping Catheter. It describes the device, its intended use, contraindications, and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study designed to prove the device meets those criteria in the way one might expect for an AI/ML powered device.

Medical devices, especially those under a 510(k) pathway, often demonstrate safety and effectiveness through pre-clinical testing, sometimes in-vivo, to show that the device performs as intended and is substantially equivalent to a legally marketed predicate device. The text alludes to this but does not provide specific performance metrics or detailed study designs.

Here's an attempt to answer your questions based solely on the provided text, with acknowledgement of missing information where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative or tabular format, nor does it provide specific performance metrics for the ProMap Coaxial Mapping Catheter in terms of sensitivity, specificity, accuracy, or other quantifiable measures.

Instead, the "Performance Data" section makes a general statement:

Acceptance Criteria (Implied)	Reported Device Performance
Functioned as intended	In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected.
Met all pass criteria	In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected.

This implies that the device successfully performed its function of recording cardiac electrograms and conforming to a circular shape, consistent with its design and intended use, during pre-clinical in-vivo testing. The "pass criteria" are not specified.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Pre-clinical in-vivo testing further provided validation that the device performed as intended."

Sample Size for the Test Set: Not specified. The phrase "in-vivo testing" suggests animal or human subjects, but the number is not provided.
Data Provenance: "Pre-clinical in-vivo testing." This typically implies studies conducted in animal models or possibly cadavers, or early human feasibility studies, but the specific country of origin or whether it was retrospective or prospective is not mentioned. Given it's "pre-clinical," it's prospective by nature of being a designed test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the text. Given the nature of a mapping catheter, the "ground truth" would likely be the actual electrical activity recorded by the catheter itself, validated against established electrophysiology principles and potentially compared with other diagnostic tools or expert interpretation of the readings. However, no specific number of experts or their qualifications for establishing ground truth are mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the text. There is no mention of how potential discrepancies or interpretations of the "in-vivo testing" results were adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a physical mapping catheter, not an AI/ML algorithm or software that assists human readers in interpreting data. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone comparison for an algorithm was not done. This device is a physical catheter for electrophysiological recording, not an algorithm. Its performance is inherent in its ability to physically map and record electrical signals.

7. The Type of Ground Truth Used

The type of "ground truth" would be the actual physiological electrical signals measured by the catheter during the "pre-clinical in-vivo testing." The statement "The ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment" implies that the physical recordings themselves, validated by the electrophysiology equipment and expert interpretation (though experts are not specified), serve as the ground truth for its function.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI/ML device requiring a training set.

Summary of missing information and reasons:

The provided document is a 510(k) summary for a physical medical device (mapping catheter), not an AI/ML-powered software. Therefore, many of your questions, particularly those related to AI/ML specific methodologies like sample sizes for test/training sets of AI, expert adjudication, MRMC studies, or specific performance metrics like sensitivity/specificity, are not addressed because they are not typically part of the regulatory submission for this type of device. The focus for such devices is often on pre-clinical testing to demonstrate mechanical integrity, biocompatibility, and intended functional performance compared to predicate devices.

Summary

{0}------------------------------------------------

K061678

JAN 12

10(k) SUMMARY ProRhythm, Inc's ProMap Coaxial Mapping Catheter

This 510(k) summary is provided as part of the Premarket Notification for ProRhythm, Inc's ProMap Coaxial Mapping Catheter

Submitter: ProRhythm, Inc 105 Comac St. Ronkonkoma, New York 11779 Phone: +1-631-981-3907 ext. 127 Facsimile: +1-631-981-4068
Contact Person: John J. Talarico

June 12, 2005 Date Prepared:

Name of Device: ProMap Coaxial Mapping Catheter

Common or Usual Name: Mapping Catheter

Classification Name: Electrode Recording Catheter 21 CFR 870.1220

Predicate Devices:

Biosense Webster Lasso Deflectable Circular Mapping Catheter Cardima, Inc Pathfinder Catheter

Intended Use / Indications for Use

Intended Use

THE Florythim ProMap is to be used with the ProMap Connect.

Indications for Use

{1}------------------------------------------------

cb167j

Contraindications

This device is contraindicated for use as an ablation catheter.
- This device is contraindicated for use in the ventricles. The retrograde approach is contraindicated because of the risk of entrapping the catheter in the left or valvular apparatus.
  - This device is contraindicated for use in patients with:
left atrial thrombus .
prosthetic heart valves .

Electrophysiology studies are contraindicated when the patient's underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death as in the following examples.

. trial thrombus
. Recent history of stroke or transient ischemic attack
Unstable angina .
Myocardial Infarctions within the last two weeks. ●
Patients who do not tolerate anticoagulation . therapy.
Previous systemic embolization from the left . side of the heart
Technological Characteristics

Performance Data

The ProMap Coaxial Mapping Catheter is tested according to the specifications documented in Design Verification Testing Reports. Pre-clinical in-vivo testing further

Current systemic infection .
Recent pulmonary emboli .
Known or suspected left atrial myxoma

{2}------------------------------------------------

provided validation that the device performed as intended. In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected.

Substantial Equivalence

The ProMap Coaxial Mapping Catheter is as safe and effective as the Biosense Webster circular Lasso™ and the Cardima Pathfinder™ catheter. The ProMap Coaxial Mapping Catheter has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the ProMap Coaxial Mapping Catheter and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ProMap Coaxial Mapping Catheter is as safe and effective as the Biosense Webster circular Lasso™ and the Cardima Pathfinder™ catheter. Thus, the ProMap Coaxial Mapping Catheter is substantially equivalent to the predicate devices in construction, materials, and intended use

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ProRhythm, Inc. c/o Mr. John J. Talarico VP QA, Regulatory and Clinical Affairs 105 Comac Street Ronkonkoma, NY 11779

JAN 1 2 2007

Re: K061678

Trade Name: ProMap Coaxial Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: DRF Dated: January 8, 2007 Received: January 9, 2007

Dear Mr. Talarico:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{4}------------------------------------------------

Page 2 - Mr. Mr. Talarico

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

стандарт

Bram D/Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K061678

Device Name: ProMap Coaxial Mapping Catheter

The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from Indications For Use: endocardial and intravascular sites.

The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.

Contraindications

This device is contraindicated for use as an ablation catheter.
This device is contraindicated for use in the ventricles. The retrograde approach is contraindicated because of the risk of entrapping the catheter in the left or valvular apparatus.

This device is contraindicated for use in patients with:
. left atrial thrombus
. prosthetic heart valves

. trial thrombus

Unstable angina
Myocardial Infarctions within the last two weeks. .
. Patients who do not tolerate anticoagulation therapy,
Previous systemic embolization from the left side of the . heart

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C.A.M.P.

510(k) Number K061678

Page 1 of 1

attack . Current systemic infection
Recent history of stroke or transient ischemic
. Recent pulmonary emboli
Known or suspected left atrial myxoma

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).