(350 days)
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.
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.
The provided text outlines the 510(k) summary for the TZ Medical PadTac Electrophysiology Recording Catheters, Junction Box Cable Connector, and Electrophysiology Connector Cables. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, a complete answer as requested is not possible from the provided text. However, I can extract what is available regarding the "acceptance criteria" and "study" as presented:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria or specific performance metrics in terms of accuracy, sensitivity, specificity, or other numerical results for the device's function. Instead, it references adherence to existing guidance documents and standards for safety and effectiveness.
| Acceptance Criteria (Reference Standard/Guidance) | Reported Device Performance |
|---|---|
| "Electrode Recording Catheter Preliminary Guidance," 1995 (for PadTac EP Catheters) | Considered safe and effective per this guidance. |
| "Standard for Medical Equipment; Part 1: General Requirements, UL 2601 (IEC 60601-1)" (for PadTac Cables) | Considered safe and effective per this standard. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a test set of data. The assessment appears to be based on engineering tests and adherence to recognized standards for substantial equivalence, not on performance data from patient cases. Therefore, information on sample size and data provenance is not available.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The document does not describe a study involving expert-established ground truth for performance evaluation.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through adherence to existing guidelines and standards, not through comparative clinical performance against human readers.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical medical catheter and associated cables, not an algorithm, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used:
Not applicable. The document does not describe a study that uses ground truth data from patients (e.g., pathology, outcomes data, or expert consensus) to evaluate performance. The "ground truth" implicitly refers to the established safety and effectiveness parameters outlined in the referenced preliminary guidance and standards.
8. Sample Size for the Training Set:
Not applicable. The document does not describe a machine learning algorithm or a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. The document does not describe a machine learning algorithm or a training set.
Summary of the "Study" (as described in the 510(k) summary):
The "study" referenced in the 510(k) summary is not a clinical performance study with human or simulated data. Instead, it refers to the testing and evaluation conducted to demonstrate that the PadTac EP Catheters and cables meet the safety and effectiveness requirements outlined in existing FDA guidance and international standards.
- For the PadTac Electrophysiology Catheters: The device was tested and determined to be safe and effective per the "Electrode Recording Catheter Preliminary Guidance" from 1995. This guidance likely outlines specific engineering and performance tests (e.g., electrical parameters, biocompatibility, mechanical integrity) that the device must pass to be considered equivalent to existing devices.
- For the PadTac Cables: The cables were tested and determined to be safe and effective per "Standard for Medical Equipment; Part 1: General Requirements, UL 2601 (IEC 60601-1)." This refers to electrical safety and general requirements for medical equipment.
In essence, the "study" is an engineering and regulatory compliance assessment, not a clinical trial or a performance study involving patient data or human readers. The acceptance criteria are implicitly the requirements set forth in the referenced guidance and standards, and the "reported performance" is the conclusion that the device meets those criteria and is therefore considered safe and effective and substantially equivalent to predicate devices.
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K02142
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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 #800Portland, Oregon 97724 |
|---|---|---|
| B. | Contact Person | Madalyn C. DuncanRegulatory Specialist |
| C. | Proprietary Name: | PadTac Electrophysiology Recording CathetersPadTac Junction Cable ConnectorPadTac 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 SystemK961924 |
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.
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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).
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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.
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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
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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
§ 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).