(71 days)
No
The summary describes standard electrophysiology catheters used for mapping cardiac arrhythmias and does not mention any AI or ML capabilities.
No
The device is used for evaluation and mapping of cardiac arrhythmias, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states the device "can be used in the evaluation of a variety of cardiac arrhythmias." Evaluation of medical conditions is a diagnostic activity. Additionally, the "Summary of Performance Studies" mentions "electrophysiology diagnostic catheters."
No
The device description explicitly states it is an electrophysiology catheter, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This describes a procedure performed within the body (in vivo) to assess the electrical activity of the heart.
- Device Description: The description of "electrophysiology catheters" used for "electrophysiological mapping" further confirms its use in an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used on specimens taken from the human body. This device is used directly within the body.
N/A
Intended Use / Indications for Use
SJM-Daig Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Product codes
DRF
Device Description
The electrophysiology catheters are manufactured in various fixed and deflectable curve profiles and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intraluminal sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac (endocardial and intravascular sites)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Electrophysiology Catheter DAIG Corporation
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
K022380
page 1 of 2
OCT 01 2002
510(k) Summary (as required by 21 CFR 807.92)
Submitter Information A.
| Submitter's Name: | St. Jude Medical, DAIG Division |
|---|---|
| Address: | 14900 Minnetonka Industrial Blvd |
| Minnetonka, Minnesota 55345-2126 U.S.A. | |
| Telephone Number: | (952) 933-4700 |
| Contact Person: | Jim M. Taufen |
| Date Submission Prepared: | 19-July-2002 |
B. Device Information
| Common or usual Name: | Diagnostic Electrophysiology Catheter |
|---|---|
| Classification Name: | Catheter, Electrode Recording |
| Predicate Device: | Electrophysiology Catheter |
| DAIG Corporation | |
| Device Description/Intended Use: | The electrophysiology catheters are manufactured in various |
| fixed and deflectable curve profiles and electrode spacings | |
| for electrophysiological mapping for the evaluation of a | |
| variety of cardiac arrhythmias from endocardial and | |
| intravacular sites. | |
| Indications for Use: | SJM-Daig Electrophysiology Catheters can be used in the |
| evaluation of a variety of cardiac arrhythmias from | |
| endocardial and intravascular sites. |
C. Comparison of Required Technological Characteristics
All technological characteristics of the SJM-Daig Livewire Electrophysiology Catheters are substantially equivalent to the predicate SJM-Daig Electrophysiology Catheter including product design, materials, packaging, and sterilization.
1
D. Performance Data
Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites.
E. Conclusion
In accordance with the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device,' issued January 10, 1997; the new labeling is being submitted to FDA as part of a new 510(k) Change Being Effected. SJM-Daig intends to continue to market the Livewire device with the amended labeling.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three distinct lines forming the body and wings. The bird is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 01 2002
St. Jude Medical c/o Mr. Jim M. Taufen Sr. Regulatory Affairs Specialist Daig Division 14901 DeVeau Place Minnetonka, MN 55345
Re: K022380
Trade Name: Livewire™ Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: July 19, 2002 Received: July 22, 2002
Dear Mr. Taufen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Jim M. Taufen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This Jetter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Kala Teth
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2380
Page
| 510(k) Number (if known): | K022380 |
|---|---|
| --------------------------- | --------- |
St. Jude Medical, Daig Division™ Electrophysiology Catheter (Livewire™) Device Name:
Indications for Use:
SJM-Daig electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
(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 K022380
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)