ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000

K991060 · Zcv ,Inc. · DRF · Apr 6, 2000 · Cardiovascular

Device Facts

• Record ID: K991060
• Device Name: ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
• Applicant: Zcv ,Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

Device Story

The Zynergy Zolution Electrophysiology Catheter is a diagnostic tool used by physicians during electrophysiology studies. It functions as an electrode recording and pacing catheter, capturing intracardiac electrical signals and delivering stimulation to the heart. The device consists of a catheter (5Fr or 6Fr) with 2-20 platinum electrodes and a reusable Zyp-Lok accessory cable. The catheter is inserted into the cardiac chambers to map conduction pathways and assess arrhythmia vulnerability. The physician observes the recorded electrograms to determine conduction times and identify aberrant pathways. The device is supplied sterile for single-use in a clinical setting. It provides diagnostic information that assists the physician in clinical decision-making regarding cardiac rhythm management.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including tensile, engagement, electrical impedance, and torque transmission performance testing, and biocompatibility testing (cytotoxicity, hemolysis, pyrogenicity, sensitization, etc.) conducted in accordance with ISO 10993 and FDA guidelines.

Technological Characteristics

Materials: Polyamide, TPE, stainless steel wire braid, platinum electrodes. Design: Soft, non-braided, atraumatic distal tip. Dimensions: 5Fr/6Fr, 110cm length, 1-10mm electrode spacing. Connectivity: Positive locking multi-pin connector with reusable extension cable. Sterilization: Ethylene oxide (ETO).

Indications for Use

Indicated for patients undergoing electrophysiology studies requiring intracardiac stimulation and/or ECG recording for the determination of conduction times, identification of aberrant conduction pathways, and assessment of cardiac chamber arrhythmia vulnerability.

Regulatory Classification

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.

Predicate Devices

• Elecath Defector Series (K933450)
• Arrow Intracardiac Electrode Catheter Products (K953651)

Submission Summary (Full Text)

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- 6 2000

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Zynergy CardioVascular, Inc. 298 Fernwood Avenue 08837-6803 Edison. NJ USA Tel: [phone] Fax: [phone]

Safety & Effectiveness Zynergy Zolution Electrophysiology Catheter with Zyp Lok Accessory Cable Summary: 74 DRF Catheter. Electrode Recording, CFR 870.1220 Classification Name: Electrode Recording Catheter Common / Usual Name: Priscilla Whitehead Cox, Regulatory Affairs Manager Contact: Monday, March 29, 1999 Prepared:

The Zynergy Zolution Electrophysiology Catheter is intended as a primary diagnostic tool for intracardiac electrogram recording and pacing, for the determination of conduction times from one location to another, to identify aberrant conduction pathways and to assess arryhthmia vulnerability of the cardiac chambers.

Initial sizes to be marketed are 5Fr and 6Fr which include lengths of 1-5mm, electrode spacing of 1mm -1cm and varying in the number of electrodes per catheter of 2 - 20. Various curve styles are available in order to meet anatomical constraints and/or physician preference. The Zynergy Zolution, Zyp-Lok Accessory Cable is a reusable, medical grade cable in lengths of 18", 36" and 72" and 4, 10 & 20 conductor configurations.

Zynergy Zolution Electrophysiology Catheter and Zyp-Lok Accessory Cable in single use pouches. Zynergy Zolution Electrophysiology Catheter and Zyp-Lok Accessory Cable are supplied sterile in single use pouches. The packaged product is ETO sterilised with a sterility assurance level of 10°. Ethylene oxide residuals and bacterial endotoxin levels are monitored for compliance with ISO/FDA guidelines.

Performance testing including tensile, engagement, electrical impedence and torque transmission was successfully completed.

Biocompatibility testing, including cytotoxic injection, intracutaneous injection, hemolysis, complement activation, unactivated partial thromboplastin time assay, Lee White Clotting Time, pyrogenicity, intravenous toxicity, sensilisation has been successfully completed per ISO10993 and FDA guidelines.

Zynergy Zolution Electrophysiology Catheter is similar in design, composition and function to the Elecath Defector Series 510(k)# K933450, manufactured by Electro-Catheter Corporation and the Arrow Intracardiac Electrode Catheter Products, 510(k)# K953651 manufactured by Arrow International.

| COMPARATIVE FEATURES | | | |
|------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------|
| Characteristics | ZCV, Inc<br>Zynergy Zolution<br>Electrophysiology Catheters | Electro-Catheter Co.<br>Detector Series<br>Electrophysiology Catheters | Arrow International<br>Intracardiac Electrode<br>Catheter Products |
| Distal Tip Design | Soft, non-braided,<br>atraumatic tip | Soft, non-braided,<br>atraumatic tip | Soft, non-braided,<br>atraumatic tip |
| Tip Curve Styles | Coumand, Josephson, Damato,<br>Straight | Coumand, Josephson, Damato | Coumand, Josephson, Damato, Straight |
| Tubing Materials | Polyamide TPE /<br>SS Wire Braid | Polyamide TPE /<br>SS Wire Braid | Polyurethane |
| Electrode Materials | Platinum | Platinum | Gold/Platinum |
| French Size | 3/5/6 | 5/6 | 2/5/6 |
| Electrode Spacing | 1-10mm | 1-10mm | 1-10mm |
| Connector Type | Positive Locking Multi-Pin | Positive Locking Multi-Pin | Positive Locking Multi-Pin |
| Tip Electrode length | 2-5mm | 2-5mm | Not specified |
| Electrode Number | 2-20 | 2-10 | 2/4/6/10 |
| Proximal Electrode<br>Length | 1-5mm | 1-5mm | Not specified |
| Useable Length | 110cm | 110cm | 110cm |
| Extension Cable | 18"/3'/6' | 3'/6' | 18"/3'/6' |
| Packaging | Blister/Poly/Tyvek | Blister/Poly/Tyvek | Blister/Poly/Tyvek |
| Sterilisation Method | ETO | ETO | ETO |

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510(k) Submission

II-2

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 6 2000

Ms. Priscilla Whitehead Cox Zynergy CardioVascular, Inc. 298 Fernwood Ave. Edison, NJ 08837

Re: K991060 Zynergy Zolution Electrophysiology Catheter Model Z5000 and Cable Model Z9000 Regulatory Class: II (two) Product Code: DRF Dated: January 21, 2000 Received: January 24, 2000

Dear Ms. Cox:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice reguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act

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Page 2 - Ms. Pricilla Whitehead Cox

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

pax maynehen

James E. Dillard III Director

Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991060

## Device Name: Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set

Indications For Use:

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Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Reggantiche Counter Use____________________________________________________________________________________________________________________________ Prescription Use_ V and Neurological Devices (Per 21 CFR 801.109) (Optional Format 1-2-96) 510(k) Number _