K Number
K120544
Device Name
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
Manufacturer
Date Cleared
2012-03-19

(25 days)

Product Code
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
St Jude Medical (SJM) Electrophysiology Catheters can be used in evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
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.
More Information

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 DevicesThe 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 TestingBench 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
EquivalenceThe 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)

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(Division Si Division of C 510(k) Number