(26 days)
The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.
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.
The provided text is a 510(k) Pre-Market Notification for the Evaluator™ Electrophysiology Catheter. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in the way a de novo or PMA submission might.
Therefore, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding test sets, expert involvement, or training data typically associated with performance studies.
Instead, the core of this submission is the comparison of technological characteristics to a legally marketed predicate device.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance:
- No explicit acceptance criteria or reported device performance are provided in the document. The submission relies on demonstrating substantial equivalence to a predicate device.
- The document states: "All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling." This is the primary claim, but no quantitative or qualitative performance metrics are given.
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an electrophysiology catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an electrophysiology catheter, not an algorithm.
7. The type of ground truth used:
- Not applicable. No ground truth from a performance study is mentioned. The "ground truth" in a 510(k) for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This submission does not describe a training set for a performance algorithm.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment is described.
Summary of the 510(k) Submission Approach:
The St. Jude Medical, Daig Division's submission for the Evaluator™ Electrophysiology Catheter (K011766) is based on demonstrating substantial equivalence to their own predicate device, the Response™ Electrophysiology Catheter. This means they are asserting that the new device has the same intended use and similar technological characteristics to a legally marketed device, and therefore does not raise new questions of safety or effectiveness.
The document explicitly states:
- Predicate Device: Response™ Electrophysiology Catheter (St. Jude Medical, Daig Division)
- Basis for Equivalence: "All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling."
The FDA's response confirms that they have "determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the "proof" in this context, rather than a detailed performance study with specific acceptance criteria.
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| 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 PlaceMinnetonka, 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 CatheterSt. Jude Medical, Daig Division | |
| Device Description: | The Evaluator™ Electrophysiology Catheter is a fixed-curve, electrode recording catheter with ring electrodesthat are electrically coupled to conductor wires to pacethe heart and sense and record bipolar intracardiacelectrograms. | |
| Intended Use: | The St. Jude Medical electrophysiology catheters can beused in the evaluation of a variety of cardiacarrhythmias. |
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
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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) | |
|---|---|---|---|
| ------------------------------------------ | -------------------------------- | ---- | -------------------------------------------------- |
§ 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).