Pacel Bipolar Pacing Catheters

K152784 · St Jude Medical · LDF · Oct 22, 2015 · Cardiovascular

Device Facts

• Record ID: K152784
• Device Name: Pacel Bipolar Pacing Catheters
• Applicant: St Jude Medical
• Product Code: LDF · Cardiovascular
• Decision Date: Oct 22, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording.

Device Story

Pacel Bipolar Pacing Catheter is a temporary pacing electrode; used for right ventricular pacing and ECG recording. Device features distal tip electrode and stainless steel connector ring; proximal end has two-pin electrical connector. Operated by clinicians under fluoroscopy guidance; transmits electrical signals between heart and external pacing/monitoring equipment. Benefits include temporary cardiac rhythm management. Device is a modification of existing predicate; manufacturing process change for catheter shaft; no changes to materials, packaging, sterilization, or specifications.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Design verification testing confirmed that catheters manufactured with the modified process met all product performance specifications.

Technological Characteristics

Bipolar pacing catheter; stainless steel electrical connector ring and tip electrode; two-pin proximal electrical connector. Designed for fluoroscopy-guided placement. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring temporary right ventricular intracardiac pacing and/or ECG recording.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Predicate Devices

• Pacel™ Bipolar Pacing Catheters (K875059)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 22, 2015

St. Jude Medical Parita Mehta Regulatory Affairs Specialist 14901 Deveau Place Minnetonka, Minnesota 55345

Re: K152784

Trade/Device Name: Pacel Bipolar Pacing Catheters Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: September 24, 2015 Received: September 25, 2015

Dear Parita Mehta:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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

Enclosure

{2}------------------------------------------------

### INDICATIONS FOR USE

510(k) Number (if known): _ Device Name: Pacel™ Bipolar Pacing Catheters

Indications for Use: The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use __ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

# Pacel™ Bipolar Pacing Catheter

Image /page/3/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left and the text "ST. JUDE MEDICAL" on the right. The grid is made up of nine smaller squares, with one of the squares rotated.

Premarket Notification 510(k)

| 510(k) Summary | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be Assigned |
| Submitter Information: | |
| Date Prepared: | September 24, 2015 |
| Submitter Name &<br>Address: | St. Jude Medical<br>14901 DeVeau Place<br>Minnetonka, MN 55345<br>Establishment Registration Number: 2182269 |
| Contact Person: | |
| | Parita Mehta |
| | Regulatory Affairs Specialist |
| | 5050 Nathan Lane N |
| | Plymouth MN 55426 |
| | Phone [phone] |
| | Fax [phone] |
| | [e-mail] |
| Device Information: | |
| Trade Name: | Pacel™ Bipolar Pacing Catheters |
| Common Name: | Electrode, Pacemaker, Temporary |
| Class | II |
| Classification Name: | 21CFR § 870.3680 – Cardiovascular permanent or temporary<br>pacemaker electrode |
| Predicate Device: | Pacel™ Bipolar Pacing Catheters (K875059) |
| Device Description: | The Pacel™ Bipolar Pacing Catheters are designed to establish<br>temporary right ventricular pacing with fluoroscopy guidance for<br>placement. Electrodes at the catheter tip enable ECG monitoring<br>and bipolar pacing. The distal end of the catheter includes a<br>stainless steel electrical connector ring and a tip electrode. The<br>proximal end of the catheter includes a two pin electrical connector.<br>The electrical signals can be transmitted to external equipment or<br>from external equipment to the heart. |
| Intended Use:<br>(Indications for Use) | The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended<br>for use in the intracardiac pacing and/or ECG recording. |
| Comparison to Predicate<br>Devices | The Pacel™ Bipolar Pacing Catheter that is the subject of this<br>application remains substantially equivalent to the predicate device.<br>There have been no changes to the device materials, packaging,<br>sterilization, final device specifications or labeling.<br>Biocompatibility and design verification (DV) testing demonstrate<br>that the catheter shaft manufacturing process change does not<br>adversely affect the device safety and effectiveness |
| Summary on Non-Clinical<br>Testing | Biocompatibility testing was performed in accordance with ISO<br>10993. The catheters with the modified surface morphology of the<br>proximal shaft demonstrated acceptable biocompatibility profile.<br>The catheters manufactured with the proposed new process met all<br>the product performance specifications. |
| Statement of Equivalence | The Pacel™ Bipolar Pacing Catheters that are subject of this<br>application have the same indications for use and technological<br>characteristics as the predicate device. Based on this and the data<br>provided in this pre-market notification, the subject device remains<br>substantially equivalent to the predicate device. |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid with one square tilted, followed by the text "ST. JUDE MEDICAL" in a serif font. The text is aligned to the right of the grid.

# Pacel™ Bipolar Pacing Catheter

Premarket Notification 510(k)