Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.

Device Description

Same as the predicate Zynergy Zolution Electrophysiology catheter, the Zynergy Z.5000 Electrophysiology catheter is comprised of a radiopaque tubing reinforced with stainless steel braiding. The soft tip is fitted with electrodes in varying sizes and configurations. The back end of the catheter is comprised of an electrical connector.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable) seeking substantial equivalence to a predicate device. It focuses on demonstrating that changes in material do not raise new safety or effectiveness concerns.

Therefore, the information required to answer the prompt is not present in the provided text. The document states that "Extensive functional and performance testing, and biocompatibility testing were conducted to assess the safety and effectiveness... All results are satisfactory," but it does not provide specific acceptance criteria or detailed study results.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: This detailed information is not included in the summary.
Sample sizes used for the test set and the data provenance: No sample sizes for testing are mentioned, nor is any information about the origin of data (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the device is for physiological data acquisition, not image interpretation or diagnosis requiring expert ground truth. However, even for the device's operational performance, no expert involvement in defining 'ground truth' or evaluation is detailed.
Adjudication method for the test set: Not applicable as per point 3.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic image interpretation by humans, often with AI assistance. This device is an electrophysiology catheter.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware component.
The type of ground truth used: Not explicitly stated beyond "extensive functional and performance testing." For an electrophysiology catheter, ground truth would typically refer to physical measurements, electrical signal fidelity, and biocompatibility standards, not expert consensus or pathology in the diagnostic sense.
The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML or statistical modeling.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Summary

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K011847

JUL 1 3 2001

Attachment 10

510(k) Summary

June 1, 2001

Submission Applicant & Correspondent:

Name:	Zynergy CardioVascular, Inc.
Address:	298 Fernwood Ave.
	Edison, NJ 08837
Phone No.:	(732) 225-3800
Contact Person:	Ms. Jing Zhang

1. Name of Device:
  Trade/Proprietary/Model Name: Zynergy Z5000 Electrophysiology Catheter With

Common or Usual Name: Classification Names:

Z9000 Accessory Cable Electrophysiology Catheter Electrode Recording Catheter

1. Devices to Which New Device is Substantially Equivalent: Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is substantially equivalent to Zynergy Zolution Electrophysiology Catheter Model Z5000 and Cable Model Z9000 as described in 510(k) K991060, which is cleared by the FDA on April 6, 2000.
1. Device Description:

1. Intended Use of the Device:
  Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.
1. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
  The Zynergy Z5000 Electrophysiology Catheters have identical indicated use, use the same operating principle, have similar size ranges, incorporate the same basic catheter design and technological characteristics, and are packaged and sterilized using the same materials and processes (ETO sterile and pyrogen free) as the predicate Zynergy Zolution catheters.

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K011847 p.2/2

The major differences between the Z5000 catheter and the predicate device are in the catheter's main body tube material and electrode material. These changes do not raise any new issues of safety or effectiveness as demonstrated by the biocompatibility test results and comparable results from the design verification testing.

7. Tests and Conclusions:

Extensive functional and performance testing, and biocompatibility testing were conducted to assess the safety and effectiveness of the Zynergy Z5000 Electrophysiology Catheter. All results are satisfactory.

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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

Mr. Jing Zhang Manager, Regulatory Affairs Zynergy CardioVascular, Inc. 298 Fernwood Avenue Edison, NJ 08837-3839

Re: K011847

Trade Name: Zynergy Z5000 Electrophysiology Catheters with Z9000 Accessory Cables Regulation Number: 870.1200 Regulatory Class: II (Two) Product Code: DRF Dated: June 1, 2001 Received: June 13, 2001

Dear Mr. Zhang:

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 requirements, as set forth in the Quality System Regulation (OS) 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Mr. Jing Zhang

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and hype a ding 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 and 11 you done opening vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 3	Indications for Use Statement
510(k) Number(if known)
Device Name	Zynergy Z5000 Electrophysiology Catheter With Z9000Accessory Cable
Indications for Use	Identical to the indications of the predicate Zynergy Zolutioncatheters and cables cleared through 510(k) K991060,Zynergy Z5000 Electrophysiology Catheter With Z9000Accessory Cable is indicated for temporary use inelectrophysiology studies for intracardiac simulation and/orECG recording.

K011847

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(per 21 CFR 801.109)
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Over-The Counter Use
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Division of Cardiovascular & Respiratory Devices

510(k) Number	K011847
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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).