Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe

K152633 · Edwards Lifesciences, LLC · LDF · Oct 15, 2015 · Cardiovascular

Device Facts

• Record ID: K152633
• Device Name: Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
• Applicant: Edwards Lifesciences, LLC
• Product Code: LDF · Cardiovascular
• Decision Date: Oct 15, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chandler Transluminal V-Pacing Probe is indicated for temporary emergency ventricular pacing when used with a Swan-Ganz Paceport or A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraventricular ECG detection (during placement). The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary emergency atrial pacing or sequential A-V pacing when used with a Swan-Ganz A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraatrial ECG detection (during placement).

Device Story

2.4F bipolar pacing probes; Chandler (straight tip) for ventricular pacing; Flex-Tip ('J' tip) for atrial/sequential A-V pacing. Used with Swan-Ganz Paceport/A-V Paceport catheters; connected to external pulse generator. Inserted by trained clinicians in hospital/clinical settings with or without fluoroscopy. Probes incorporate stainless steel electrode pairs to depolarize cardiac tissue; enable intra-cardiac ECG detection during placement to assist positioning. Output is electrical stimulation to heart tissue; facilitates temporary cardiac pacing for patients in emergency settings.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 and functional performance testing conducted to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

2.4F diameter; 135 cm total length; 15 cm usable length. Stainless steel electrode pairs. Chandler model: straight distal tip. Flex-Tip model: 'J' distal tip. Passive pacing electrodes. No software or energy source integral to the probe (connects to external pulse generator).

Indications for Use

Indicated for temporary emergency ventricular, atrial, or sequential A-V pacing in patients requiring temporary cardiac pacing via Swan-Ganz Paceport or A-V Paceport catheters. Also indicated for intraventricular or intraatrial ECG detection during placement. For use by trained clinicians in hospital or clinical settings.

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

• Transluminal BiPolar Pacing Probe (K813521)

Submission Summary (Full Text)

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

Public Health Service

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

October 15, 2015

Edwards Lifesciences, LLC Deana Boushell Sr. Principal Project Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K152633

| Trade/Device Name: | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal<br>Bipolar Pacing Probe |
|--------------------|------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 870.3680 |
| Regulation Name: | Cardiovascular Permanent or Temporary Pacemaker Electrode |
| Regulatory Class: | Class II |
| Product Code: | LDF |
| Dated: | September 14, 2015 |
| Received: | September 15, 2015 |

Dear Deana Boushell:

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 device

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

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 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) K152633

Device Name Bipolar Transluminal Pacing Probes

#### Indications for Use (Describe)

The Chandler Transluminal V-Pacing Probe is indicated for temporary ventricular pacing when used with a Swan-Ganz Paceport or A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraventricular ECG detection (during placement).

The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary emergency atrial pacing or sequential A-V pacing when used with a Swan-Ganz A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraatrial ECG detection (during placement).

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# SECTION 5 - 510(k) SUMMARY

| | Chandler™ Transluminal V-Pacing Probe and |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flex-Tip™ Transluminal A-Pacing Probe | |
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Establishment<br>Registration<br>Number | 2015691 |
| Address | One Edwards Way<br>Irvine, CA 92614<br>Phone: [phone] |
| Contact Person | Deana M. Boushell RAC<br>Senior Principal Project Manager, Regulatory Affairs<br>Direct Line: 949-250-4472<br>email: [e-mail]<br>FAX: [phone] |
| Date Prepared | September 14, 2015 |
| Trade Names | Chandler Transluminal V-Pacing Probe<br>Flex-Tip Transluminal A-Pacing Probe |
| Common Name | Pacing Probe |
| Classification<br>Name | Electrode, Pacemaker, Temporary<br>21 CFR 870.3680(a), Product Code LDF |
| Regulation<br>Class/Product<br>Code | Class II<br>LDF |
| Predicate Device(s) | K813521 Transluminal™ BiPolar Pacing Probe (cleared March 15, 1982) |
| Device Description | The Chandler Transluminal V-Pacing Probe and the Flex-Tip<br>Transluminal A-Pacing Probe are 2.4F probes indicated for temporary<br>emergency pacing of either the ventricle or atrium. |
| Models | Chandler Transluminal V-Pacing Probe Model: D98100<br>Flex-Tip Transluminal A-Pacing Probe Model: D98500 |
| Device Characteristics | |
| Indications for<br>Use/Intended Use | The Chandler Transluminal V-Pacing Probe is indicated for temporary<br>emergency ventricular pacing when used with a Swan-Ganz Paceport or<br>A-V Paceport catheter, and can be inserted with or without the aid of<br>fluoroscopy. The probe can also be used for intraventricular ECG<br>detection (during placement).<br><br>The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary<br>emergency atrial pacing or sequential A-V pacing when used with a<br>Swan-Ganz A-V Paceport catheter, and can be inserted with or without<br>the aid of fluoroscopy. The probe can also be used for intraatrial ECG<br>detection (during placement). |
| Environment of<br>Use | The system is intended for use by a trained clinician in a hospital or<br>other appropriate clinical setting. |
| Device Description | The Chandler Transluminal V-Pacing probe is a 2.4F pacing probe with<br>a straight distal electrode tip for emergency temporary ventricular pacing<br>when connected to an external pulse generator.<br><br>The Flex-Tip Transluminal A-Pacing probe is a 2.4F pacing probe with a<br>'J' tip distal electrode for emergency temporary atrial or A-V sequential<br>pacing when connected to an external pulse generator. |
| Key Performance<br>Specifications/<br>Characteristics of<br>the Device | The Chandler Transluminal V-Pacing probe and the Flex-Tip<br>Transluminal A-Pacing probe have a total usable length of 135 cm and a<br>usable length of 15 cm in either the ventricle or atrium. The devices<br>incorporate an electrode pair that is comprised of stainless steel with<br>adequate surface area to depolarize the cardiac tissue. |
| Comparative<br>Analysis | Material biocompatibility testing in compliance with applicable ISO 10993<br>requirements, and performance testing was conducted to compare the<br>subject devices to the predicate device. The results of the testing<br>indicate that the fundamental scientific technology of the proposed<br>devices remain unchanged from the legally marketed predicate device.<br>The proposed change to the Chandler Transluminal V-Pacing probe and<br>the Flex-Tip Transluminal A-Pacing probe has been shown to be safe,<br>effective, and substantially equivalent to the predicate device (K813521<br>Transluminal BiPolar Pacing Probe) for its intended use. |
| Functional/ Safety<br>Testing | The Chandler Transluminal V-Pacing probe and the Flex-Tip<br>Transluminal A-Pacing probe have successfully passed functional-<br>performance testing and biocompatibility testing, in accordance with<br>applicable consensus standards. |
| Conclusion | The Chandler Transluminal V-Pacing Probe and the Flex-Tip<br>Transluminal A-Pacing Probe have been shown to be substantially<br>equivalent to the predicate Transluminal BiPolar Pacing Probe and safe<br>and effective for their intended use. |

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