(30 days)
Not Found
Not Found
No
The summary describes a physical electrophysiology catheter system for recording and stimulation, with no mention of AI or ML in the device description, intended use, or any other section.
No.
The device is described as performing electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies, which is for diagnosis rather than treatment.
Yes
The device is used for "Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies," explicitly stating its role in diagnostic procedures.
No
The device description explicitly states it is a "multiple electrophysiology recording catheter and its connecting cable," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies." This describes a procedure performed within the body (in vivo) to record electrical signals and stimulate the heart.
- Device Description: The device is a catheter system designed to be placed inside the body.
- Anatomical Site: The specified anatomical sites (high right atrium, right ventricular apex, and the HIS bundle) are all locations within the heart.
IVD devices are designed to be used on specimens taken from the human body (such as blood, urine, tissue) to provide information about a person's health. This device operates directly within the body.
N/A
Intended Use / Indications for Use
Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
Product codes
DRF
Device Description
The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple 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 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
JUL 25 1998
SUMMARY OF SAFETY AND EFFECTIVENESS (K982232)
The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple 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 apex, and HIS bundle. The IBI-1100" ventricular Bi-directional Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.
The components of the IBI-1100" Bi-directional 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 a Electrophysiology Catherer has passed the blocompatibility and performance thet. Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process. Therefore, we believe the 191-1100 Bidirectional Steerable Electrophysiology Catheter on this submission to be safe and effective.
The accessory cables used to connect the IBI-1100" Bi-directional 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 1998
Roger Tu, Ph.D. Vice President - QA/RA Irvine Biomedical, Inc. 2146A Michelson Drive Irvine, CA 92612
K982232 Re: IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System Regulatory Class: II (two) Product Code: DRF Dated: June 23, 1998 Received: June 25, 1998
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
2
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 requlation (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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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07/16/1998 11:03 7148513062 LEI PAGE 04
Page 1 of 1
510(k) NUMBER (IF KNOWN): K982232
DEVICE NAME: IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System
INDICATIONS FOR USE:
Electrogram recording and cardiac stimulation during diagnostic
electrophysiologic studies. The catheters are commonly placed in
the high right atrium, right ventricular apex, and the HIS bundle.