(349 days)
Not Found
No
The summary describes a physical catheter for recording electrical signals and stimulation, with no mention of AI or ML for data analysis or processing.
No
The device is described as a mapping catheter used for recording signals and cardiac stimulation, and for mapping the atrial regions of the heart. It does not perform a therapeutic function but rather aids in diagnosis and understanding of heart activity.
Yes.
The device's intended use is "for recording intracardiac signals" and "to map the atrial regions of the heart," which are diagnostic activities.
No
The device description clearly describes a physical catheter with a polymer shaft, platinum electrodes, a handle, and a shaft actuator mechanism. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "recording intracardiac signals and for cardiac stimulation during electrophysiology studies" and "to map the atrial regions of the heart." This describes a device used within the body for diagnostic and therapeutic procedures, not a test performed outside the body on biological samples.
- Device Description: The description details a catheter with electrodes designed to be inserted into the heart. This is consistent with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Reflexion HD™ High-Density Mapping Catheter is an in-vivo medical device, not an in-vitro diagnostic.
N/A
Intended Use / Indications for Use
The Reflexion HD™ High-Density Mapping Catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion HD™ High-Density Mapping Catheter is to be used to map the atrial regions of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The St. Jude Medical (SJM) Reflexion HD™ High Density Mapping Catheter is a flexible, bi-directional, fixed radius loop catheter constructed of a polymer shaft that incorporates platinum electrodes.
The Reflexion HD™ High Density Mapping Catheter has a fixed loop and a proximal handle (the ComfortGrip™ handle) that contains: A shaft actuator mechanism for deflecting the distal portion of the shaft; and An electrical connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial regions 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing of the Reflexion HD™ High Density Mapping Catheter was performed to support substantial equivalence. Results of the testing demonstrates that the Reflexion HD™ High-Density Mapping Catheter design meets product specifications and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K080/79
p1/2
St. Jude Medical 510(k) Premarket Notification
Reflexion HD™ High-Density Mapping Catheter 510(k) Summary as required by 21 CFR 807.92(c)
JAN - 7 2009
510(k) Number: TBD
Date Prepared:
January 23, 2008
Submitter Information:
Submitter's Name/ Address:
Contact Person:
Alternate Contact Person:
St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126
Andrea Hudack Regulatory Affairs Specialist Tel: 952-351-1627 Fax: 952-930-9481 ahudack(@sjm.com
Glenn Jacques Manager, Regulatory Affairs Tel: 952-351-1356 Fax: 952-930-9481 gjacques@sjm.com
Device Information:
Trade Name:
Common Name:
Reflexion HD™ High-Density Mapping Catheter
Electrode recording catheter
Classification Name:
Class II, 21 CFR 870.1220, Product Code DRF
Electrode recording catheter or electrode recording probe
Class:
Predicate Device:
- Reflexion Spiral™ Variable Radius Catheter (K062251) 1.
- Reflexion Spiral™ Variable Radius Catheter (K072012) 2.
1
St. Jude Medical 510(k) Premarket Notification
Reflexion HD" High-Density Mapping Catheter 510(k) Summary as required by 21 CFR 807.92(c)
Device Description:
The St. Jude Medical (SJM) Reflexion HD™ High Density Mapping Catheter is a flexible, bi-directional, fixed radius loop catheter constructed of a polymer shaft that incorporates platinum electrodes.
The Reflexion HD™ High Density Mapping Catheter has a fixed loop and a proximal handle (the ComfortGrip™ handle) that contains: A shaft actuator mechanism for deflecting the distal portion of the shaft; and An electrical connector.
Indications for Use:
The Reflexion HD High-Density Mapping Catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion HD High-Density Mapping Catheter is to be used to map the atrial regions of the heart.
Comparison to Predicate Devices:
The Reflexion HD™ High-Density Mapping Catheter has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the of the Reflexion HD High-Density Mapping Catheter is equivalent to the predicate devices including packaging, substantially biocompatibility, sterilization, and labeling. Where dimensional and material differences exist between the proposed device and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed device.
Summary of Non-Clinical Testing:
Bench testing of the Reflexion HD" High Density Mapping Catheter was performed to support substantial equivalence. Results of the testing demonstrates that the Reflexion HD™ High-Density Mapping Catheter design meets product specifications and intended uses.
Statement of Equivalence:
The St. Jude Medical Reflexion HD" High-Density Mapping Catheter has the same indications for use and technological characteristics as the predicate devices. Based on this and the design and engineering data provided in the pre-market notification, SJM's Reflexion HD" High-Density Mapping Catheter has been shown to be substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2009
St. Jude Medical c/o Mr. Joshua Clarin Regulatory Affairs Specialist II 14901 De Veau Place Minnetonka, MN 55345
Re: K080179
Trade/Device Name: Reflexion™ HD High Density 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: November 12, 2008 Received: November 13, 2008
Dear Mr. Clarin:
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.
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
3
Page 2 – Mr. Joshua Clarin
Enclosure
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 Genter for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Dina R. Vohrer
~ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
St. Jude Medical 510(k) Premarket Notification
Reflexion HD™ High-Density Mapping Catheter Indications for Use
510(K) Number (if known): _ K080179
Device Name: Reflexion HD" High-Density Mapping Catheter
Indications for Use:
The Reflexion HDTM High-Density Mapping Catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion HD™ High-Density Mapping Catheter is to be used to map the atrial regions of the heart.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use OR (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)
R. Va. Aues
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K080179
Page 1 of 1
January, 2008