(350 days)
Not Found
No
The document describes a standard electrophysiology catheter system for recording and stimulation, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is described as being used for "recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies," and for "monitoring and recording," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" states that the device is used for "recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies." The "Device Description" further clarifies that the catheters are used for "electrophysiology electrocardiograph recording and cardiac stimulation during diagnostic procedures." These phrases explicitly indicate a diagnostic purpose.
No
The device description explicitly mentions physical components like catheters, cables, and a box, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is used for "recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies." This involves placing catheters inside the body (intracardiac) to measure electrical activity and stimulate the heart.
- Anatomical Site: The specified anatomical sites (high right atrium, right ventricular apex, and HIS bundle) are all locations within the heart.
The device is used for in vivo (within the living body) diagnostic procedures, not in vitro testing of specimens.
N/A
Intended Use / Indications for Use
The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The PadTac Electrophysiology catheters are between 5 and 8 french (fr), 4, 10, 12 and 14 pole, fixed, monitoring and recording.
The multi-electrode electrophysiology catheters are used for electrophysiology electrocardiograph recording and cardiac stimulation during diagnostic procedures. The cables and box serve as an extension between the catheter and the pin block.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
high right atrium, right ventricular apex and HIS bundle
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)
The TZ Medical PadTac EP Catheter have been tested and are considered safe and effective per "Electrode Recording Catheter Preliminary Guidance", Mark Massi, Pacing and Electrophysiology Device Branch, Division of Cardiovascular, Respiratory and Neurological Devices, Office of Device Evaluation FDA,CDRH, 1995.
The TZ medical PadTac cables have been tested and are considered safe and effective per "Standard for Medical Equipment; Part 1: General Requirements, UL 2601 (IEC 60601-1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K02142
1/2
510(k) SUMMARY of Safety and Effectiveness
(Persuant to 21 CFR 807.92)
APR 1 8 2003
l. GENERAL
C.
| A. | Submitted By: | TZ Medical Inc.
7272 S.W. Durham Road #800
Portland, Oregon 97724 |
|----------------------------|----------------------|-------------------------------------------------------------------------------------------------|
| B. | Contact Person | Madalyn C. Duncan
Regulatory Specialist |
| C. | Proprietary Name: | PadTac Electrophysiology Recording Catheters
PadTac Junction Cable Connector
PadTac Cable |
| D. | Classification Name: | Electrode Recording Catheter |
| E. | Classification: | Class II, Cardiovascular DRF,
CFR 870.1220 |
| DEVICE INFORMATION SUMMARY | | |
| A. | Predicate Device | IBI 1100 Electrophysiology Catheter System
K961924 |
IBI 1000 Electrophysiology Catheter System K946333
- Device Description The PadTac Electrophysiology catheters are between 5 and 8 french (fr), 4, 10, 12 and 14 pole, fixed, monitoring and recording.
The multi-electrode electrophysiology catheters are used for electrophysiology electrocardiograph recording and cardiac stimulation during diagnostic procedures. The cables and box serve as an extension between the catheter and the pin block.
B. Device Intended Use
The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.
1
SUBSTANTIAL EQUIVQALENCE TESTING SUMMARY lll.
The TZ Medical PadTac EP Catheters have been tested and are considered safe and effective per "Electrode Recording Catheter Preliminary Guidance", Mark Massi, Pacing and Electrophysiology Device Branch, Division of Cardiovascular, Respiratory and Neurological Devices, Office of Device Evaluation FDA,CDRH, 1995.
The TZ medical PadTac cables have been tested and are considered safe and effective per "Standard for Medical Equipment; Part 1: General Requirements, UL 2601 (IEC 60601-1).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2003
TZ Medical Inc. c/o Ms. Madalyn C. Duncan RA/OA Specialist 7272 S.W. Durham Rd., #800 Portland, OR 97224
Re: K021421
Trade Name: PadTac Electrophysiology Recording Catheters, Junction Box Cable Connector, and Electrophysiology Connector Cables Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: January 17, 2003 Received: January 21, 2003
Dear Ms. Duncan:
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 either 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.
3
Page 2 - Ms. Madalyn Duncan
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 (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. 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Kala Gill
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) (((() 2 /4 2
PadTac Mapping and Recording EP Catheters: Device Name:
Indications for Use:
The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.
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)
Over-The-Counter Use
(Optional P
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K02142