(30 days)
Not Found
No
The description focuses on the physical construction and mechanical functionality of the catheter for recording and stimulation, with no mention of AI or ML for data analysis, interpretation, or control.
No.
The device is used for recording and mapping, not for treating a disease or condition.
Yes
The device "can be used for recording intracardiac signals" and "to map the atrial regions of the heart," which are diagnostic activities.
No
The device description explicitly details a physical catheter with a polymer shaft, platinum electrodes, and a handle with mechanical actuators, indicating it 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 device used to test samples outside the body (which is the definition of an IVD).
- 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.) or performing tests on these samples outside of the body.
Therefore, the Reflexion Spiral catheter is an in-vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.
Product codes
DRF
Device Description
The St. Jude Medical Reflexion Spiral™ Bi-directional Variable Radius Mapping Catheter (Reflexion Spiral™ Decapolar EP Catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.
The Reflexion Spiral™ Decapolar EP Catheter has a loop and a proximal handle (the ComfortGrip™ handle) that contains: 1) A shaft actuator mechanism for varying the distal portion of the shaft; 2) A loop actuator mechanism for varying the loop diameter from approximately 20mm to approximately 15mm; and 3) 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 Spiral™ Variable Radius Catheter was performed to support substantial equivalence. Results of the testing demonstrates that the Reflexion Spiral™ Variable Radius Catheter design meets product specifications and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary
As required by 21 CFR 807.92(c)
AUG 2 2 2007
510(k) Number:
Date Prepared:
July 20, 2007
Submitter Information:
Submitter's Name/ Address:
St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126
Contact Person:
Laura Moen-Ftacek Regulatory Affairs Specialist Tel: 952-351-1453 Fax: 952-930-9481 Imoen-ftacek a sim.com
Device Information:
| Trade Name: | Reflexion Spiral™ Variable Radius Catheter |
|---|---|
| Common Name: | Electrode recording catheter |
| Classification Name: | Electrode recording catheter or electrode recording probe |
| Class: | Class II, 21 CFR 870.1220, Product Code DRF |
Predicate Device:
- Reflexion Spiral™ Variable Radius Catheter (K062251)
Device Description:
The St. Jude Medical Reflexion Spiral™ Bi-directional Variable Radius Mapping Catheter (Reflexion Spiral™ Decapolar EP Catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.
The Reflexion Spiral™ Decapolar EP Catheter has a loop and a proximal handle (the ComfortGrip™ handle) that contains: 1) A shaft actuator mechanism for varying the distal portion of the shaft; 2) A loop actuator mechanism for varying the loop diameter from approximately 20mm to approximately 15mm; and 3) An electrical connector.
1
Indications for Use:
The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.
Comparison to Predicate Devices:
The Reflexion Spiral™ Variable Radius Catheter has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the of the Reflexion Spiral™ Variable Radius Catheter are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling. Where dimensional and material differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness
Summary of Non-Clinical Testing:
Bench testing of the Reflexion Spiral™ Variable Radius Catheter was performed to support substantial equivalence. Results of the testing demonstrates that the Reflexion Spiral™ Variable Radius Catheter design meets product specifications and intended uses.
Statement of Equivalence:
The St. Jude Medical Reflexion Spiral™ Variable Radius Catheter has the same indications for use and technological characteristics as the predicate device. Based on this and the design and engineering data provided in the pre-market notification, SJM's Reflexion Spiral™ Variable Radius Catheter has been shown to be substantially equivalent.
2
Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2007
St. Jude Medical c/o Ms. Laura Moen-Ftacek Regulatory Affairs Specialist 14901 Deveau Place Minnetonka, MN 55345
Re: K072012
Trade/Device Name: Reflexion Spiral Variable Radius Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Moen-Ftacek:
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
3
Page 2 - Ms. Laura Moen-Ftacek
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. lochner
) 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
510(K) Number (if known): _K072012
Device Name: Reflexion Spiral™ Variable Radius Catheter
Indications for Use:
The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. be. lines
(Division Sign-Off) (Division Sign-Olf)
Division of C = diovascular Devices
K072012 510px) with the
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