The Rhythmia Mapping System and accessories are indicated for catheter based atrial and ventricular mapping. The mapping system allows real-time visualization of intra-cardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intra-cardiac electrograms, may also be recorded and displayed on the system's display screen.

Device Description

The Rhythmia Mapping System and accessories are designed for electroanatomical mapping and is able to simultaneously acquire data from multiple electrodes. The Rhythmia Mapping System tracks catheters inside the heart in order to visualize their location and construct geometric shells. The Rhythmia Mapping System is also capable of using intra-cardiac location and electrical information to display electroanatomical maps - electrical activity information on the constructed geometry. Such electrical information can be visualized in 3D in color. The Rhythmia Mapping System can display various types of electroanatomical maps including geometrical shell only, activation maps, voltage maps and fractionation maps.

AI/ML Overview

{
  "acceptance_criteria_and_performance_table": {
    "title": "Device Performance",
    "headers": [
      "Test/Study Type",
      "Acceptance Criteria (Implicit)",
      "Reported Device Performance"
    ],
    "rows": [
      [
        "In vitro testing (Software V&V, Hardware V&V)",
        "Meets requirements in applicable standards and specifications; substantially equivalent to predicate device",
        "Test results demonstrate that the Rhythmia Mapping System meets the requirements in the applicable standards and specifications, and is substantially equivalent to the legally marketed predicate device."
      ],
      [
        "In vivo testing (GLP animal study)",
        "Ability to record/display intracardiac electrograms, share signals, route stimulator signals, create geometrical shells, create activation maps, create voltage maps, accurately track Rhythmia Mapping Catheter, accurately track third-party catheters; no safety issues.",
        "The Rhythmia Mapping System worked as intended and there were no safety issues identified."
      ],
      [
        "Clinical experience (Outside US)",
        "System performs as intended; no adverse events related to the Rhythmia Mapping System",
        "There were no adverse events related to the Rhythmia Mapping System, and the System performed as intended."
      ]
    ]
  },
  "sample_size_test_set_and_data_provenance": {
    "in_vivo_animal_study": "The in vivo study was performed in a GLP animal study using a swine model. The exact number of animals is not specified in this document.",
    "clinical_experience_study": "33 subjects were included in the studies. The study was performed outside the US, suggesting international data provenance. The study description implies it was prospective for the purpose of validating the device's performance in a clinical setting."
  },
  "number_of_experts_ground_truth_test_set": "Not specified. The document does not mention the use of experts to establish ground truth for the test sets. The 'ground truth' for the animal and clinical studies would instead be determined by the observed system performance and absence of adverse events.",
  "qualifications_of_experts": "Not applicable as the number of experts is not specified.",
  "adjudication_method": "Not applicable. The document does not describe any expert adjudication process for ground truth establishment.",
  "multireader_multicase_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies described focus on the device's standalone performance and safety rather than comparing human reader performance with and without AI assistance.",
  "standalone_performance_study": "Yes, standalone performance was demonstrated through the 'In vitro testing' and 'In vivo testing' sections. The 'In vitro testing' evaluated the system's compliance with standards and specifications, and the 'In vivo testing' in a swine model assessed its ability to perform its core functions (recording, displaying, mapping, tracking) as intended, without direct human-in-the-loop performance measurement. The clinical experience section also confirms the system performed as intended in humans.",
  "type_of_ground_truth_used": {
    "in_vitro_testing": "Compliance with applicable standards and specifications.",
    "in_vivo_animal_study": "Observed system functionality (e.g., ability to record/display electrograms, create maps, track catheters) and absence of safety issues.",
    "clinical_experience_study": "Observed system functionality ('performed as intended') and absence of adverse events."
  },
  "sample_size_training_set": "The document does not detail a separate training set or its sample size. The studies described are for validation and clinical experience, not for training a machine learning model, as this device (Rhythmia Mapping System) is described as an 'electroanatomical mapping' system, not an AI/ML-driven diagnostic algorithm in the context of this summary.",
  "how_ground_truth_training_set_established": "Not applicable. A separate training set and its ground truth establishment are not discussed for this device."
}

Summary

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K130750

5 510(k) Summary

General Information
· DateCompiled	March 15, 2013	JUL 2 2 2013
Classification	Class II, 21 CFR § 870.1425, Programmable Diagnostic Computer, ProductCode DQK
Trade Name	Rhythmia Mapping System
ModelNumber	The Rhythmia Mapping System is comprised of several components, see form3514 Section F for complete details. The model numbers of the maincomponents include: M004RH1000 0 through M004RH4400 0.
Submitter	Rhythmia Medical, Inc.111 South Bedford Street, Suite 205Burlington, MA 01803
Contact	Leon AmariglioRhythmia Medical, Inc.111 S Bedford St.Suite 205Burlington, MA 01803Phone: 617-591-9191Fax: 617-449-9513

Indications for Use

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

Predicate Device

CARTO 3 EP Navigation System (K072202)

Manufactured by Biosense Webster, Inc.

EnSite System Model EE3000 (K070902)

Manufactured by St. Jude Medical

Device Description

Testing

In vitro testing was performed on the Rhythmia Mapping System to assure reliable design and performance. The bench tests performed by the company included software verification and validation and hardware verification and validation. The test results demonstrate that the Rhythmia Mapping System meets the requirements in the applicable standards and specifications, and is substantially equivalent to the legally marketed predicate device.

In vivo testing

Design validation of the system was performed in a GLP animal study. The Rhythmia Mapping System was used in a swine model to determine the system's ability to record and display intracardiac electrograms, share intracardiac and ECG signal with recording system, route stimulator signal, create geometrical shells, create activation maps, create voltage maps, accurately track the position of the Rhythmia Mapping Catheter, and accurately track the position of third party catheters. The Rhythmia Mapping System worked as intended and there were no safety issues identified.

Clinical experience

A clinical evaluation was performed outside the US using the Rhythmia Mapping System. Thirty-three (33) subjects were included in the studies using the Rhythmia Mapping System. There were no adverse events related to the Rhythmia Mapping System, and the System performed as intended.

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

Summary of Substantial Equivalence

Rhythmia Medical believes the Rhythmia Mapping System and accessories are substantially equivalent to the predicate products. The indications for use, intended use, product function, design and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

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

Image /page/3/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 22, 2013

Rhythmia Medical, Inc. C/O Mr. Leon Amariglio 111 South Bedford St Suite 205 Burlington, MA 01803 US

Re: K130750

Trade/Device Name: Rhythmia mapping system Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 7, 2013 Received: June 10, 2013

Dear Mr. Leon Amariglio:

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

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

Page 2 - Leon Amariglio

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 (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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -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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K130750

4 Indications for Use Statement

510(k) Number (if known): This application Device Name: Rhythmia Mapping System Indications for Use: The Rhythmia Mapping System and accessories are indicated for catheter based atrial and ventricular mapping. The mapping system allows real-time visualization of intra-cardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intra-cardiac electrograms, may also be recorded and displayed on the system's display screen.

Prescription Use X (Per 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2013.07.22
14:19:01 -04'00'

DC000-148 Rev. 01

Page 30 of 85

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).