(25 days)
No
The summary describes a standard electrophysiology catheter for sensing cardiac signals and fluid infusion, with no mention of AI or ML capabilities.
No
The device is described as a "diagnostic catheter" used for "electrophysiological diagnostic" purposes and "intracardiac electrogram sensing (IECG)," which are activities related to evaluation and sensing rather than treatment.
Yes
The device is described as an "electrophysiological diagnostic catheter" used for "intracardiac electrogram sensing (IECG)" to evaluate cardiac arrhythmias.
No
The device description clearly states it is a physical catheter with electrodes and a lumen, indicating it is a 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 for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This involves sensing electrical signals within the body, which is an in vivo (within a living organism) procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is described as an "electrophysiological diagnostic catheter" used for "intracardiac electrogram sensing (IECG)." This further confirms its use within the body to measure electrical activity.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) outside the body, which is a hallmark of IVD devices.
Therefore, the St Jude Medical (SJM) Electrophysiology Catheter is an in vivo diagnostic device, not an IVD.
N/A
Intended Use / Indications for Use
St Jude Medical (SJM) 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 Response™ Electrophysiology Catheter with Lumen is a sterile, single use, electrophysiological diagnostic catheter with multiple electrodes and a fixed distal curve for intracardiac electrogram sensing (IECG). The body is a continuous tube with a central lumen for fluid infusion through a 3-way valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac, endocardial, 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)
Bench testing was performed to verify the device modifications. Results of testing demonstrate that the modified design meets specifications as biocompatibility was confirmed in accordance with ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Response™ Electrophysiology Catheter with Lumen (K914278).
Reference Device(s)
Not Found
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
12
MAR 1 9 2012
510(k) Summary | |
---|---|
510(k) Number | |
Date Prepared: | February 21, 2012 |
Submitter Information: | |
Submitter | |
Name/Address: | St. Jude Medical - Atrial Fibrillation Division |
14901 DeVeau Place | |
Minnetonka, MN 55345 | |
Establishment Registration Number: 3005188751 | |
Contact Person: | Marlene Peterson |
Principal Regulatory Affairs Specialist | |
Phone (651) 756-3268 | |
Fax (952) 930-9481 | |
MPeterson07@sjm.com | |
Device Information: | |
Trade Name: | Response™ Electrophysiology Catheter with Lumen |
Common Name: | Electrode Recording Catheter |
Classification Name: | Electrode Recording Catheter |
Classification: | Class II, 21 CFR 870.1220, Product Code DRF. |
Predicate Device(s): | Response™ Electrophysiology Catheter with Lumen |
(K914278). | |
Device Description: | The Response™ Electrophysiology Catheter with Lumen is a |
sterile, single use, electrophysiological diagnostic catheter with | |
multiple electrodes and a fixed distal curve for intracardiac | |
electrogram sensing (IECG). The body is a continuous tube with a | |
central lumen for fluid infusion through a 3-way valve. | |
Intended Use: | |
(Indications for Use) | St Jude Medical (SJM) Electrophysiology Catheters can be used in |
evaluation of a variety of cardiac arrhythmias from endocardial and | |
intravascular sites. | |
Comparison to | |
Predicate Devices | The modified Response™ Electrophysiology Catheter with Lumen |
has the same intended use and fundamental scientific technology as | |
the predicate device. The technological characteristics of the | |
modified Response™ Electrophysiology Catheter with Lumen are | |
substantially equivalent to the predicate devices including | |
packaging, biocompatibility, sterilization, and labeling. Through | |
biocompatibility testing it was demonstrated that the resin | |
modification does not adversely affect the safety and effectiveness. | |
Summary on Non- | |
Clinical Testing | Bench testing was performed to verify the device modifications. |
Results of testing demonstrate that the modified design meets | |
specifications as biocompatibility was confirmed in accordance | |
with ISO 10993-1. | |
Statement of | |
Equivalence | The modified St. Jude Medical Response™ Electrophysiology |
Catheter with Lumen has the same indications for use and | |
technological characteristics as the predicate device. Based on this | |
and the data provided in this pre-market notification, St. Jude | |
Medical's modified Response™ Electrophysiology Catheter with | |
Lumen has been shown to be substantially equivalent to the | |
predicate. |
Response Electrophysiology Catheter
With Lumen
Special 510(k)
Confidential
St. Jude Medical
·
1
Note; K914278 was originally submitted under the Daig Corporation which was subsequently obtained by St. Jude Medical. The predicate to K914278 was K894500 for Electrophysiology Catheters
Response Electrophysiology Catheter With Lumen Special 510(k)
Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 9 2012
St. Jude Medical c/o Ms. Marlene Peterson Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345
Re: K120544
Trade/Device Name: St Jude Medical Response Electrophysiology Catheter with Lumen Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe. Regulatory Class: Class II (two) Product Code: DRF Dated: February 21, 2012 Received: February 23, 2012
Dear Ms. Peterson:
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 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 - Ms. Marlene Peterson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kmphe
Bram Ø. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
12 12 05 44 510(K) Number (if known):
Device Name: Response™ Electrophysiology Catheter with Lumen
Indications for Use:
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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(Division Si Division of C 510(k) Number