(26 days)
Response™ Electrophysiology Catheter
Not Found
No
The summary describes a standard electrophysiology catheter for recording and pacing, with no mention of AI or ML capabilities, image processing, or data analysis that would typically involve such technologies.
No
The device is used to evaluate cardiac arrhythmias and record electrograms, not to directly treat a condition. While it can pace the heart, its primary described use here is diagnostic (evaluation and sensing/recording).
Yes
The device is described as an "electrophysiology catheter" used to "sense and record bipolar intracardiac electrograms" which are then used in the "evaluation of a variety of cardiac arrhythmias." This process of sensing and recording biological signals to evaluate conditions is characteristic of a diagnostic device.
No
The device description explicitly states it is a catheter with electrodes and conductor wires, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "evaluation of a variety of cardiac arrhythmias." This involves using the catheter within the body to sense and record electrical signals from the heart.
- Device Description: The description confirms it's a catheter used to "pace the heart and sense and record bipolar intracardiac electrograms." This is an in vivo (within the living body) procedure.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The provided information does not mention any such use or analysis of specimens.
Therefore, the St. Jude Medical Evaluator™ Electrophysiology Catheter is an in vivo diagnostic and therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.
Product codes
74 DRF
Device Description
The Evaluator™ Electrophysiology Catheter is a fixed-curve, electrode recording catheter with ring electrodes that are electrically coupled to conductor wires to pace the heart and sense and record bipolar intracardiac electrograms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Response™ Electrophysiology Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
| | JUL - 3 2001 | 510(k) Summary
(As required by 21 CFR 807.92) |
|----|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. | Submitter Information | |
| | Submitter's Name: | St. Jude Medical, Daig Division |
| | Address: | 14901 DeVeau Place
Minnetonka, Minnesota 55345-2126 U.S.A. |
| | Telephone Number: | (952) 352-9716 |
| | Contact Person: | Angela Byland |
| | Date Submission Prepared: | June 6, 2001 |
| B. | Device Information | |
| | Common or Usual Name: | Evaluator™ Electrophysiology Catheter |
| | Classification Name: | Electrode Recording Catheter |
| | Predicate Device: | Response™ Electrophysiology Catheter
St. Jude Medical, Daig Division |
| | Device Description: | The Evaluator™ Electrophysiology Catheter is a fixed-
curve, electrode recording catheter with ring electrodes
that are electrically coupled to conductor wires to pace
the heart and sense and record bipolar intracardiac
electrograms. |
| | Intended Use: | The St. Jude Medical electrophysiology catheters can be
used in the evaluation of a variety of cardiac
arrhythmias. |
C. Comparison of Required Technological Characteristics
All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling.
Support of the Substantial Equivalence D.
St. Jude Medical, Daig Division considers the Evaluator™ Electrophysiology Catheters to be substantially equivalent to the predicate device, Response™ Electrophysiology Catheters.
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Image /page/1/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2001
Ms. Angela Byland Senior Regulatory Affairs Manager St. Jude Medical, Daig Division 14901 DeVeau Place Minnetonka, MN 55345
Re: K011766
Trade Name: Evaluator™ Electrophysiology Catheter Regulation Number: 870.1220 Regulatory Class: II (two) Product Code: 74 DRF Dated: June 6, 2001 Received: June 7, 2001
Dear Ms. Byland:
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 Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish
2
Page 2 - Ms. Angela Byland
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) 594-4646. 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,
Dak Telle
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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______________________________________________________________________________________________________________________________________________________________________________ Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
St. Jude Medical, Daig Division™ Electrophysiology Catheter (Evaluator™) Device Name:
Indications for Use:
The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | R011766 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | -------------------------------- | ---- | -------------------------------------------------- |
|---|