The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Device Description

The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

AI/ML Overview

The provided document is a 510(k) summary for the IntellaMap Orion High Resolution Mapping Catheter. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing of a handle design modification. This type of regulatory submission does not typically include the detailed clinical study information requested in your prompt (e.g., acceptance criteria for diagnostic performance, human reader studies, ground truth establishment, sample sizes for training/test sets for AI devices).

This device is an "Electrode Recording Catheter," which is a medical instrument used for electrophysiological mapping of cardiac structures. It captures electrograms and can stimulate cardiac tissue. It is not an AI-powered diagnostic device in the sense of analyzing images or data to provide a diagnosis or improve human reader performance. Therefore, many of your requested points relate to AI/diagnostic device performance studies, which are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding the non-clinical performance described in the document.

Here's the information that can be extracted relevant to the performance criteria and study from the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Handle Design Performance	Met the product performance requirements of the predicate device.

Note: The document states "The verification testing confirmed that the new handle design met the product performance requirements of the predicate device." It does not specify the numerical or qualitative requirements themselves, only that they were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench top testing," which implies laboratory-based tests rather than data from human subjects.

3. 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)

This information is not applicable/provided. The testing described is benchtop testing for a handle modification, not a diagnostic or AI performance study requiring expert ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically for clinical studies involving interpretation, not for benchtop engineering verification.

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

This information is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a physical catheter for electrophysiological mapping.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is not an algorithm-only device. It's a medical instrument used by clinicians.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided. For benchtop testing of a handle, ground truth would relate to engineering specifications and measurements, which are not detailed here.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used for machine learning or AI model development, which is not relevant to this device's description.

9. How the ground truth for the training set was established

This information is not applicable/provided. As above, "ground truth for training set" is for AI models, not a physical medical device like this catheter.

Summary of what is clear from the document:

Device Type: IntellaMap Orion High Resolution Mapping Catheter (a physical medical instrument).
Purpose: Electrophysiological mapping (recording or stimulating) of cardiac structures.
Regulatory Submission Reason: Modification to the handle design of an already cleared device.
Performance Study Type: Non-clinical benchtop testing.
Key Finding: The new handle design met the product performance requirements of the predicate device.
Conclusion: The modified device is considered substantially equivalent to its predicate.

The document does not describe the specific performance metrics or acceptance criteria for the electrophysiological mapping overall, nor does it delve into the clinical accuracy of the mapping capability, as the focus of this particular 510(k) was on a modification to a previously cleared device's handle.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2015

Rhythmia Medical, Inc Frank Jurczak Manager, Regulatory Affairs 111 South Bedford St Suite 205 Burlington, Massachusetts 01803

Re: K143481

Trade/Device Name: IntellaMap Orion High Resolution Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: December 5, 2014 Received: December 9, 2014

Dear Frank Jurczak,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 yours,

Melissa A. Torres -S

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

Enclosure

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Indications for Use Statement

510(k) Number (if known):	K143481
Device Name:	IntellaMap Orion™ High Resolution Mapping Catheter
Indications for Use:	The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Prescription Use __X

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(Per 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)

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510(k) Summary of Safety and Effectiveness

Rhythmia Medical, Inc.

IntellaMap Orion™ High Resolution Mapping Catheter

General Information

Date Compiled December 5, 2014
Classification Class II, 21 CFR § 870.1220, Electrode Recording Catheter or Electrode Recording Probe, Product Code DRF (Catheter, Electrode Recording, or Probe, Electrode Recording)

Trade Name IntellaMap Orion™ High Resolution Mapping Catheter

Submitter Rhythmia Medical, Inc. 111 South Bedford Street, Suite 205 Burlington, MA 01803
Contact Frank Jurczak Sr. Manager, Regulatory Affairs Rhythmia Medical, Inc. 111 S Bedford St. Suite 205 Burlington, MA 01803 Phone: 617-803-9341 Fax: 617-218-3850 Email: Frank.Jurczak@bsci.com

Indications for Use

The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Predicate Device

Rhythmia Mapping Catheter, K122461, Manufactured by Rhythmia Medical, Inc.

Product Description

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Image /page/4/Picture/0 description: The image contains the logo for "Rhythmia medical". The logo features a cluster of blue hexagons on the left side, transitioning from dark blue to lighter shades, creating a gradient effect. To the right of the hexagons, the word "RHYTHMIA" is written in a bold, dark blue font. Below "RHYTHMIA", the word "medical" is written in a smaller, light blue font.

supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only.

The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

Determination of Substantial Equivalence

Rhythmia Medical believes the proposed modification to the IntellaMap Orion™ High Resolution Mapping Catheter does not impact the device's substantial equivalence to the previously cleared version of this device and is as safe, as effective, and performs as well as the predicate device. The indications for use, intended use, product function, design and materials used, are either identical or substantially equivalent to previously cleared IntellaMap Orion™ High Resolution Mapping Catheter (formerly Rhythmia Mapping Catheter) predicate device.

Conclusion

The proposed IntellaMap Orion™ High Resolution Mapping Catheter is equivalent in indications for use, intended use, product function, design and materials to the predicate device, the IntellaMap Orion™ High Resolution Mapping Catheter (formerly Rhythmia Mapping Catheter cleared in K122461).

Because of the similarities of indications for use, intended use, product function, design and materials, and verification testing, Rhythmia Medical, Inc. believes the IntellaMap Orion™ High Resolution Mapping Catheter to be substantially equivalent to the predicate device, the IntellaMap Orion™ High Resolution Mapping Catheter (formerly Rhythmia Mapping Catheter cleared in K122461).

Summary of Non-Clinical Performance Data

Non Clinical performance of the modified IntellaMap Orion™ High Resolution Mapping Catheter has been fully evaluated based upon bench top testing referenced within this submission. The verification testing confirmed that the new handle design met the product performance requirements of the predicate device. Based on this result, the modified device can be considered substantially equivalent to the predicate.

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).