(73 days)
Not Found
Not Found
No
The summary describes a standard electrophysiology catheter for recording and stimulation, with no mention of AI, ML, or any computational analysis of the recorded data.
No.
The device is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies, which are diagnostic procedures, not therapeutic ones.
Yes
Explanation: The "Intended Use / Indications for Use" states that the catheters are used for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies." The term "diagnostic" directly indicates that the device is used for diagnosis.
No
The device description explicitly details a physical catheter and connecting cable, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies." This involves placing the catheter inside the body to interact directly with the heart's electrical activity.
- Lack of Specimen Analysis: There is no mention of analyzing samples taken from the body. The device is used in vivo (within the living body).
Therefore, based on the provided information, the ORTHOGONAL TM Electrophysiology Catheters are not IVDs. They are invasive medical devices used for diagnostic procedures within the body.
N/A
Intended Use / Indications for Use
The ORTHOGONAL TM Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and His bundle.
Product codes
DRF
Device Description
The Irvine Biomedical, Inc. ORTHOGONAL™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
high right atrium, right ventricular apex, and His bundle
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
The Irvine Biomedical, Inc. ORTHOGONAL™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and His bundle. The ORTHOGONAL™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.
The components of the ORTHOGONAL™ Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been approved by the FDA. The sterilized, finished ORTHOGONAL™ Steerable Electrophysiology Catheter has passed the performance tests. Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process. Therefore, we believe the ORTHOGONAL™ Steerable Electrophysiology Catheter on this submission to be safe and effective.
the ORTHOGONAL™ The accessory cables used to connect Steerable Electrophysiology Catheters to a recorder are conventional and comply with Section 12A of the Underwriters Laboratories UL 544 Standard for Safety.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 1999
Roger Tu, Ph.D. Vice President Quality Assurance and Regulatory Affairs Irvine Biomedical, Inc. 2146A Michelson Drive Irvine, CA 92612
Re: K990958/S1 ORTHOGONAL™ EP Catheters Requlatory Class: II Product Code: DRF Dated: May 4, 1999 Received: May 6, 1999
Dear Dr. Tu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and
2
Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K990958
| Device Name: | ORTHOGONAL TM EP Catheters |
|---|---|
| Indications For Use: | The ORTHOGONAL TM Electrophysiology Catheters are used for |
| electrogram recording and cardiac stimulation during diagnostic | |
| electrophysiologic studies. The electrophysiology catheters are | |
| commonly placed at the high right atrium, right ventricular apex, | |
| and His bundle. |
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Valkell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1990958 510(k) Number __
Prescription Use (Per 21 CFR 801.109)
Or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________