(200 days)
Not Found
No
The summary describes a standard electrophysiology catheter for measuring electrical activity and does not mention any AI or ML components or functionalities.
No
The device is used for measurement of electrical activity and not for treatment.
Yes
The device is used for "measurement of electrical activity in the heart," which is a diagnostic function.
No
The device description explicitly states it is a "multiple-electrode electrophysiology recording catheter and its connecting cable," which are hardware components.
Based on the provided information, the Luma-Cath™ Fixed Curve Electrophysiology Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "measurement of electrical activity in the heart." This is a direct measurement of physiological activity within the body (in vivo).
- Device Description: The description details a catheter designed to be inserted into the body to interact with the heart.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a person's health. The Luma-Cath does not perform this function.
Therefore, the Luma-Cath is an in vivo diagnostic device, specifically an electrophysiology catheter used for diagnostic purposes within the heart.
N/A
Intended Use / Indications for Use
The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.
Product codes
DRF
Device Description
The Irvine Biomedical, Inc. Luma-Cath™ Fixed Curve Electriophysiology 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 electrodes is between 5 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch for insertion of a guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
Special 510(k): Luma-Cath™Fixed Curve EP Catheters/K991025
OCT 1 5 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
1991025/53
The Irvine Biomedical, Inc. Luma-Cath™ Fixed Curve Electriophysiology 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 electrodes is between 5 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch for insertion of a guidewire.
The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and His bundle. The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.
The components of the Luma-Cath™ Fixed Curve Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. The sterilized, finished Luma-Cath™ Fixed Curve 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 Luma-Cath™ Fixed Curve Electrophysiology Catheter on this submission to be safe and effective.
The accessory cables used to connect the Luma-Cath™ Fixed Curve Electrophysiology Catheters to a recorder are conventional and are cleared in the 510(k) K946333. which 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 stylized eagle with three stripes representing human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Roger Tu, Ph.D. Vice President Irvine Biomedical, Inc. 2146A Michelson Drive Irvine, CA 92612
Re: K991025 Luma-Cath™ Fixed Curve EP Catheters Requlatory Class: II (two) Product Code: DRF September 9, 1999 Dated: September 16, 1999 Received:
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 aqainst 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 Regulation (QS) for Medical Devices: General requlation (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 requlation 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
Page 2 - Roger Tu, Ph.D.
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 regulation 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 yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K991025
Device Name:
Luma-Cath™ Fixed Curve EP Catheters
Indications For Use:
The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Day Ve Tich
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Division of Cardiovascular, Respiratory
510(k) Number_________________________________________________________________________________________________________________________
Prescription Use V (Per 21 CFR 801.109)
Or
Over-The-Counter Use