(112 days)
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Not Found
No
The summary describes a standard electrophysiology catheter and does not mention any AI or ML capabilities.
No.
The device is used for temporary studies, pacing, stimulation, sensing, and ECG recording, not for treating a disease or condition.
Yes
The device is used for electrophysiology studies, which involve sensing and recording electrical activity (ECG recording) to diagnose heart conditions.
No
The device description explicitly states "Electrophysiology Catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electrophysiology studies, intracardiac pacing, stimulation, sensing and ECG recording." These are procedures performed within the body (in vivo) to assess and interact with the heart's electrical activity.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The ProCath® Electrophysiology Catheter is a medical device used for diagnostic and therapeutic procedures performed directly on the patient's heart, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies, intracardiac pacing, stimulation, sensing and ECG recording only.
Product codes
DRF
Device Description
Electrophysiology Catheter (Steering Modification)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Intracardiac
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Mr. Joseph C. Griffin, III President ProCath Corporation Cooper Run Executive Park 575 Route 73 North, Bldg. D West Berlin, NJ 08091-9293
Re : K991001 Modification of ProCath Electrophysiology Catheter Requlatory Class: II (two) Product Code: DRF Dated: June 10, 1999 Received: June 18, 1999
Dear Mr. Griffin:
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, qood 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 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
1
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 regulation entitled, 2 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
2
510(k) Number (if known): K991001
Device Name: Electrophysiology Catheter (Steering Modification)
Indications for use:
ــــ ــــ ــــ ـــــ ــــــ ـــــ
— —
ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies, intracardiac pacing, stimulation, sensing and ECG recording only.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Or K. T. M.
ivision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi
Neurological Devices
510(k) Number K991001
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The -Counter Use - - -
(Optional Format 1-2-96)