(248 days)
Not Found
No
The summary describes a physical mapping catheter and its performance in bench, animal, and clinical studies. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is indicated for electrophysiological mapping (recording or stimulating only), which is a diagnostic function, not a therapeutic one.
Yes
The device description explicitly states, "The Rhythmia Catheter is an 8.5 French (2.8mm)... non-linear (basket shaped) diagnostic catheter." The intended use also involves "electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart," which is a diagnostic activity.
No
The device description clearly details a physical catheter with electrodes, a handle, and a shaft, indicating it is a hardware device, not software-only.
Based on the provided information, the Rhythmia Mapping Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart." This involves interacting directly with the patient's body to record electrical signals from the heart.
- Device Description: The description details a catheter designed for insertion into the vasculature and maneuvered within the heart. This is an invasive procedure performed in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The Rhythmia Mapping Catheter is a medical device used in vivo for diagnostic purposes related to the heart's electrical activity, but it does not analyze samples in vitro.
N/A
Intended Use / Indications for Use
The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Product codes
DRF
Device Description
The Rhythmia Catheter is an 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic 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 Rhythmia 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. The catheter can be connected to commercially available EP diagnostic systems such as recording systems or 3D mapping systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
In vitro testing was performed on the Rhythmia Mapping Catheter to assure reliable design and performance in accordance with ISO 10555-1:2004. The bench tests performed by the company included Physical Dimensions, Essential Catheter Features, Array Stiffness, Handle Control Forces, Compatibility with Sheaths, Array Shape Reproducibility, Radiopacity, Flushing Flow Rate, Labeling Content, Surface Inspection, Leak and Fluid.Ingress Resistance, Corrosion Resistance, Joint Strengths, Catheter Tip Flexibility, Catheter Torsion Resistance, Catheter Kink Resistance, Simulated Use Bench Test, Particulate Evaluation, Spling and Strength, Array Shape Resilience, Pigtail Performance, Labeling Durability, Handle Marking Content and Durability, Connector Mate Life, Connector Latch Holding Force, Catheter Electrical Performance, Catheter Memory Function, Compatibility with Third-Party Recording Systems, Catheter Defibrillation Survival, and Electrical Cross-Talk. The test results demonstrate that the Rhythmia Mapping Catheter meets the requirements in the applicable standards and specifications, and is substantially equivalent to the legally marketed predicate device.
Design validation of the catheter was performed in a GLP animal study designed to determine the catheter's ability to safely access, maneuver, stimulate and record electrical signals in the cardiac chambers as intended. The GLP study met the predefined endpoints in terms of safety and performance.
A clinical evaluation was performed outside the US using the Rhythmia Mapping Catheter. Twenty-nine (29) subjects were enrolled in 3 sites. There were no adverse events related to the Rhythmia Mapping Catheter, and the catheter performed as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the text "K122461 Page 1 of 3" at the top. Below the text is a logo for Rhythm Medical. The logo consists of a circular pattern of black dots and the word "RHYTHMIA" in a stylized font, with the word "medical" underneath.
510(k) Summary 1
APR 1 8 2013
1.1 General Information
Date Compiled April 15, 2013
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 Rhythmia Mapping Catheter
Model Number RM-C00101: Rhythmia Mapping Catheter
Submitter Rhythmia Medical, Inc. 111 South Bedford Street, Suite 205 Burlington, MA 01803
- Contact Leon Amariglio Co-CEO Rhythmia Medical, Inc. 111 S Bedford St. Suite 205 Burlington, MA 01803 Phone: 617-591-9191 Fax: 617-449-9513 Email: leon@rhythmia.com
1.2 Intended Use
The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
1.3 Predicate Device
Desai VectorCath™ Mapping Catheter
Manufactured by CathEffects
1.4 Engineering Part Number
The Rhythmia Mapping Catheter Model ID RM-C00101 is being referred to in most engineering documents as part number RM400-012.
1
Image /page/1/Picture/0 description: The image shows the logo for Rhythmia Medical. The logo is black and white and features a stylized honeycomb pattern above the text "RHYTHMIA medical". Above the logo is the text "K122461 Page 2 of 3".
1.5 Device Description
The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. The Rhythmia Catheter is an 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic 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 Rhythmia 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. The catheter can be connected to commercially available EP diagnostic systems such as recording systems or 3D mapping systems.
1.6 Testing
In vitro testing was performed on the Rhythmia Mapping Catheter to assure reliable design and performance in accordance with ISO 10555-1:2004. The bench tests performed by the company included Physical Dimensions, Essential Catheter Features, Array Stiffness, Handle Control Forces, Compatibility with Sheaths, Array Shape Reproducibility, Radiopacity, Flushing Flow Rate, Labeling Content, Surface Inspection, Leak and Fluid.Ingress Resistance, Corrosion Resistance, Joint Strengths, Catheter Tip Flexibility, Catheter Torsion Resistance, Catheter Kink Resistance, Simulated Use Bench Test, Particulate Evaluation, Spling and Strength, Array Shape Resilience, Pigtail Performance, Labeling Durability, Handle Marking Content and Durability, Connector Mate Life, Connector Latch Holding Force, Catheter Electrical Performance, Catheter Memory Function, Compatibility with Third-Party Recording Systems, Catheter Defibrillation Survival, and Electrical Cross-Talk. The test results demonstrate that the Rhythmia Mapping Catheter meets the requirements in the applicable standards and specifications, and is substantially equivalent to the legally marketed predicate device.
1.7 In vivo testing
Design validation of the catheter was performed in a GLP animal study designed to determine the catheter's ability to safely access, maneuver, stimulate and record electrical signals in the cardiac chambers as intended. The GLP study met the predefined endpoints in terms of safety and performance.
2
Image /page/2/Picture/0 description: The image shows the text 'K122461 Page 3 of 3' at the top. Below the text is a logo for 'RHYTHMIA medical'. The logo includes a cluster of small, filled circles arranged in a honeycomb pattern, with two unfilled circles on the periphery. The text 'RHYTHMIA' is in a larger, bold font, and the word 'medical' is in a smaller font below it.
1.8 Clinical experience
A clinical evaluation was performed outside the US using the Rhythmia Mapping Catheter. Twentynine (29) subjects were enrolled in 3 sites. There were no adverse events related to the Rhythmia Mapping Catheter, and the catheter performed as intended.
1.9 Summary of Substantial Equivalence
Rhythmia Medical believes the Rhythmia Mapping Catheter is substantially equivalent to the predicate product and is as safe, as effective, and performs as well as or better than the predicate device. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2013
- Rhythmia Medical, Inc. c/o Mr. Leon Amariglio Co-CEO 111 South Bedford Street, Suite 205 Burlington, MA 01803
Re: K122461
Trade/Device Name: Rhythmia Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Catheter, Electrode Recording, or Probe, Electrode Recording Regulatory Class: Class II (two) Product Code: DRF Dated: April 4, 2013 Received: April 5, 2013
Dear Mr. 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.
4
Page 2 - Mr. Leon Amariglio
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-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" (21CFR 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. Faris -S
for
Bram D. Zuckerman, MD Division Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the text "K122461 Page 1 of 1" at the top. Below the text is a logo for "RHYTHMIA medical". The logo includes a cluster of black and white circles in the upper left corner. The text "RHYTHMIA medical" is in a sans-serif font.
Indications for Use Statement . 4
510(k) Number This application (if known):
Device Name: Rhythmia Mapping Catheter
Indications for The Rhythmia Mapping Catheter is indicated for electrophysiological mapping Use: (recording or stimulating only) of the cardiac structures of the heart.
Prescription Use ___________________________________________________________________________________________________________________________________________________________
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)
Owen P. Faris -S
2013.04.18
12:34:06 -04'00'