Predicate Devices

Not Found

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a catheter and introducer system for electrophysiology studies, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.

Therapeutic

No
The device is intended for electrophysiology studies, which are diagnostic procedures, not therapeutic interventions.

Diagnostic

Yes
The device is described as being "intended for electrophysiology studies involving the epicardial surface of the heart" and specifically to "perform electrophysiology studies of the epicardial surface of the heart." Electrophysiology studies are diagnostic procedures used to understand the electrical activity of the heart.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components: a catheter, a guiding introducer, a dilator, a guidewire, and a steerable sheath.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "electrophysiology studies involving the epicardial surface of the heart." This describes a procedure performed directly on the patient's heart, not a test performed on a sample (like blood, urine, or tissue) outside the body.
Device Description: The device components (catheter, introducer, sheath) are designed for accessing and interacting with the epicardial surface of the heart in vivo.
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is procedural and diagnostic in the sense of measuring electrical activity in situ, not through in vitro analysis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.

Product codes

DRF, DYB

Device Description

The St. Jude Medical Epicardial Catheter System consists of the ResponseTM 6 French quadripolar electrophysiology catheter and the AgilisTM NxT 40 cm steerable guiding introducer (which includes a dilator, guidewire and steerable sheath). The Agilis NxT Steerable Introducer provides pericardial access for the Response catheter to perform electrophysiology studies of the epicardial surface of the heart.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

epicardial surface of the heart

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

KO81803

MAY 1 3 2009

Section 5 – 510(k) Summary

| Submitter: | St. Jude Medical - Atrial Fibrillation Division
14901 DeVeau Place
Minnetonka, MN 55345
Establishment Registration Number: 2182269 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joshua Clarin
Regulatory Affairs Specialist
Phone (651) 756-2855
Fax (952) 930-9481 |
| Date Prepared: | June 25, 2008 |
| Trade Name: | St. Jude Medical Epicardial Catheter System |
| Classification: | Class 11 - 21 CFR 870.1220
Electrode recording catheter or electrode recording probe
Class II - 21 CFR 870.1340
Catheter Introducer |
| Product Code: | DRF
DYB |
| Predicate Device(s): | The subject device is equivalent to the following St. Jude Medical
devices:
◦ ResponseTM Electrophysiology Catheter
◦ AgilisTM NxT Steerable Introducer |
| Device Description: | The St. Jude Medical Epicardial Catheter System consists of the
ResponseTM 6 French quadripolar electrophysiology catheter and the
AgilisTM NxT 40 cm steerable guiding introducer (which includes a
dilator, guidewire and steerable sheath). The Agilis NxT Steerable
Introducer provides pericardial access for the Response catheter to
perform electrophysiology studies of the epicardial surface of the heart. |
| Intended Use: | The St. Jude Medical Epicardial Catheter System is intended for
electrophysiology studies involving the epicardial surface of the heart. |
| Comparison to
Predicate Devices | The St. Jude Medical Epicardial Catheter System has a similar intended
use and the same fundamental scientific technology as the predicate
devices. All technological characteristics of the of the Epicardial Catheter
System are substantially equivalent to the predicate devices including
packaging, biocompatibility, sterilization, and labeling. Where
differences exist between the proposed devices and the predicate devices,
performance testing demonstrated that these differences do not adversely
affect the safety and effectiveness of the proposed devices. |
| Conclusion: | St. Jude Medical considers the Epicardial Catheter System to be
equivalent to the predicate devices listed above. This conclusion is based
upon the devices' similarities in design, technological characteristics,
principles of operation, materials, and indications for use. |

PreMarket Notification for the St. Jude Medical Epicardial Catheter System

Page 14 of 68

.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an abstract human figure or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

MAY 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Mr. Joshua Clarin Regulatory Affair Specialist One St. Jude Medical Drive St. Paul, MN 55117

Re: K081803

.

Trade/Device Name: Epicardial Catheter System Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: April 17, 2009 Received: April 20, 2009

Dear Mr. Clarin:

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.

2

Page 2 - Mr. Joshua Clarin

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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

		Indications for Use



510(k) Number (if known):	K081803


Device Name:	St Jude Medical Epicardial Catheter System

Indications for Use:

The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.









	AND/OR	Over-The-Counter
Prescription Use	X
(Part 21 CFR 801 Subpart D	(21 CFR 801 Subpart




(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)


	Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division/Sign-Off)
		Division of Cardiovascular Devices
	510(k) Number	K081803

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