GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM

K024071 · Guidant Corporation, Cardiac Surgery · NHW · Feb 14, 2003 · Cardiovascular

Device Facts

• Record ID: K024071
• Device Name: GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
• Applicant: Guidant Corporation, Cardiac Surgery
• Product Code: NHW · Cardiovascular
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

Device Story

System comprises three temporary epicardial heart wires (unipolar, bipolar, tripolar), an External Defibrillator Interface Module (EDIM) attenuator box, and a cardioversion extension cable. Used in post-operative cardiac surgery patients. Wires sutured to heart; connected via cable to EDIM. EDIM attenuates energy from external low-energy defibrillator by 97% (50-360J to 1.3-11.5J). Enables atrial/ventricular pacing, ECG sensing, and synchronized atrial cardioversion. Operated by clinical staff in surgical/post-operative settings. Benefits patient by providing temporary cardiac rhythm management and low-energy internal cardioversion capability.

Clinical Evidence

Bench testing only. Testing confirmed compatibility with biphasic defibrillators and verified that all performance requirements were met.

Technological Characteristics

System includes epicardial heart wires, an attenuator box (EDIM), and extension cables. Energy source is an external, user-supplied low-energy defibrillator. EDIM provides 97% energy attenuation. No software or electronic processing components described.

Indications for Use

Indicated for post-operative cardiac surgery patients requiring temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

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

• Syncrus System (K020701)

Submission Summary (Full Text)

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FEB 1 4 2003 Syncrus System -

Special 510(k)

# SECTION 12: 510(k) SUMMARY

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## A. Name, Address, Phone and Fax number of Applicant

Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Tel: [phone] Fax: [phone]

B. Contact Person Debbie Cogan Requlatory Affairs Associate

### C. Date Prepared

December 6, 2002

### D. Device Name

Trade Name: Syncrus Internal Cardioversion System Classification Name: ELECTRODE, PACING AND CARDIOVERSION, TEMPORARY, EPICARDIAL Product Classification Code: NHW Device Classification: Class 2 Establishment Registration: 2953148

### E. Device Description

The Syncrus System consists of three components:

- Three temporary heart wires sutured onto the heart during open-heart . surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium).

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- An attenuator box (External Defibrillator Interface Module EDIM). The EDIM . attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules).
- A cardioversion extension cable, which connects the defibrillation heart wires . to the EDIM.

The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions:

- Atrial pacing and electrocardiogram sensing .
- Ventricular pacing and electrocardiogram sensing .
- Atrial defibrillation using low energy, synchronized cardioversion. .

#### F. Intended Use

The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

### G. Substantial Equivalence

Guidant proposes that the Syncrus System is substantially equivalent to the Syncrus System (K020701). The subject device is substantially equivalent to the predicate device with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety feature.

### H. Device Testing Results and Conclusions

Guidant Cardiac Surgery performed bench testing to confirm that the Syncrus System may be used with a biphasic defibrillator. All bench testing results met specified requirements.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Guidant Corporation c/o Ms. Debbie Cogan Regulatory Affairs Associate Guidant Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Re: K024071

Trade Name: Guidant Syncrus™ Internal Cardioversion System Regulation Number: 21 CFR 870.3680 Regulation Name: Electrode, Pacing and Cardioversion, Temporary, Epicardial Regulatory Class: Class II (two) Product Code: NHW Dated: January 10, 2003 Received: January 15, 2003

Dear Ms. Cogan:

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 cither class II (Special Controls) or class III (PMA), it may be subject to such 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.

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#### Page 2 -- Ms. Debbie Cogan

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

VeeertM

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

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K Ω2 4671

Guidant Syncrus™ Internal Cardioversion System Device Name:

Indications For Use:The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v

OR (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

Quilu Barrn for BDZ

510(k) Number