(373 days)
No
The summary describes a standard electrophysiology catheter and accessory cable for recording and pacing, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No
The device is described as a "primary diagnostic tool for intracardiac electrogram recording and pacing," indicating its function is for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" states it's for "electrophysiology studies for intracardiac stimulation and/or ECG recording," and the "Device Description" elaborates that it's "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 arrhythmia vulnerability of the cardiac chambers." These explicitly describe diagnostic purposes.
No
The device description clearly details physical components like catheters, cables, and electrodes, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
- Device function: The Zynergy Zolution Electrophysiology Catheter is used inside the body ("in vivo") for intracardiac stimulation and ECG recording. It directly interacts with the heart's electrical activity.
- Intended Use: The intended use clearly states "temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording." This is an in-vivo procedure.
- Device Description: The description further emphasizes its use for "intracardiac electrogram recording and pacing," which are also in-vivo functions.
The device is a medical device used for diagnostic purposes, but it is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Product codes
DRF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
- 6 2000
Image /page/0/Picture/1 description: The image shows the letters ZCV in a bold, sans-serif font. The letters are large and take up most of the frame. A horizontal line underlines the letters, adding a sense of completion to the design.
Zynergy CardioVascular, Inc. 298 Fernwood Avenue 08837-6803 Edison. NJ USA Tel: (732) 225-3800 Fax: (732) 225-4454
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 | ||
| Zynergy Zolution | |||
| Electrophysiology Catheters | Electro-Catheter Co. | ||
| Detector Series | |||
| Electrophysiology Catheters | Arrow International | ||
| Intracardiac Electrode | |||
| Catheter Products | |||
| Distal Tip Design | Soft, non-braided, | ||
| atraumatic tip | Soft, non-braided, | ||
| atraumatic tip | Soft, non-braided, | ||
| atraumatic tip | |||
| Tip Curve Styles | Coumand, Josephson, Damato, | ||
| Straight | Coumand, Josephson, Damato | Coumand, Josephson, Damato, Straight | |
| Tubing Materials | Polyamide TPE / | ||
| SS Wire Braid | Polyamide TPE / | ||
| 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 | |||
| 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 |
Tunarni Cardin/acoular Inc
7 unarau 7 alution Elastranhicinlany Cathato
510(k) Submission
II-2
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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
2
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 (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,
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
3
Page lof l
510(k) Number (if known): K991060
Device Name: Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set
Indications For 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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
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 _