(191 days)
The IBI Luma-Cath™ Steerable Electrophysiology Catheters are used for 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.
The Irvine Biomedical, Inc. Luma-Cath™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 6 and 8 French. The diameter of the electrodes is between 6 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch.
The provided text does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (like sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies).
The text is a summary of safety and effectiveness for a 510(k) submission, confirming the device's substantial equivalence to predicate devices and its compliance with general controls. It focuses on biocompatibility, performance tests (without detailing them or their outcomes), manufacturing quality, and regulatory approval.
Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided document.
The document indicates:
- Device: Luma-Cath™ Steerable Electrophysiology Catheter System
- Purpose: Electrophysiology recording and cardiac stimulation during diagnostic electrophysiologic studies.
- Safety and Effectiveness Claim: Based on biocompatibility, passed unnamed performance tests, manufacturing process following GMP, and substantial equivalence to predicate devices.
- Predicate Device: K961924 for accessory cables (though this is for the cables, not the catheter itself, which is stated to have patient contact materials "the same as the predicate devices").
- Regulatory Conclusion: Device is "substantially equivalent" to legally marketed predicate devices.
Without specific performance metrics and a study design, I cannot populate the requested table or answer the detailed questions about the study's execution.
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SUMMARY OF SAFETY AND EFFECTIVENESS
The Irvine Biomedical, Inc. Luma-Cath™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 6 and 8 French. The diameter of the electrodes is between 6 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch.
The electrophysiology catheters are commonly placed at the high right ventricular apex, and His bundle. The Luma-Cath™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.
The components of the Luma-Cath™ 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 Luma-Cath™ 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 Luma-Cath™ Steerable Electrophysiology Catheter on this submission to be safe and effective.
The accessory cables used to connect the Luma-Cath™ Steerable Electrophysiology Catheters to a recorder are conventional and are cleared in the 510(k) K961924, which comply with Section 12A of the Underwriters Laboratories UL 544 Standard for Safety.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other, with wavy lines below them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Mr. Roger Tu Vice President - QA/RA Irvine Biomedical, Inc. 2146-A Michelson Drive Irvine, CA 92612
Re: K991878 Luma-Cath™ Steerable EP Catheters Requlatory Class: II (two) Product Code: DRF Dated: September 10, 1999 September 14, 1999 Received:
Dear Mr. 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 A substantially equivalent determination assumes compliance to 895. 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 Druq 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.
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Page 2 - Mr. Roger Tu
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,
Celia M. Witten, Ph.D., M.D.
Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
IBI Luma-Cath™ Steerable EP Catheters Device Name: The IBI Luma-Cath™ Steerable Electrophysiology Catheters are Indications For Use: used for 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Dan Mitchell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use
§ 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).