(233 days)
Not Found
No
The document describes a physical mapping catheter and its performance characteristics, with no mention of AI or ML in its function or data processing.
No
The device is described as a "diagnostic catheter for electrophysiological mapping of cardiac structures" and is indicated for "multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure," which are diagnostic rather than therapeutic functions.
Yes
The "Device Description" explicitly states, "The Gyro-Tip Lariat Deflectable Loop Mapping Catheter... has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures." The "Intended Use / Indications for Use" also describes its purpose for "electrophysiological mapping, recording, and or temporary stimulation of cardiac structure," which are diagnostic activities.
No
The device description clearly details a physical catheter with electrodes and a braided outer tube, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure." This describes a procedure performed within the body (in vivo) to assess electrical activity of the heart.
- Device Description: The description details a catheter designed for "electrophysiological mapping of cardiac structures." This further reinforces its use within the body.
- Anatomical Site: The specified anatomical site is "Cardiac structures," which are internal to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body, such as blood, urine, or tissue samples. IVDs are specifically designed for testing these types of samples to diagnose conditions.
Therefore, the Gyro Tip Lariat Deflectable Loop Mapping Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Gyro-Tip lariat Deflectable Loop Mapping Catheter is indicated for multi electrode electrophysiological mapping, recording and/or temporary stimulation, of cardiac structures along circumferential paths.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Gyro-Tip Lariat Deflectable Loop Mapping Catheter of Cardiac Assist Devices, Inc. has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures. The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices. The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures. The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures
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 subject device, (The Gyro-Tip Lariat Deflectable Loop Mapping Catheter) has gone under a series of non-clinical testing in order to determine its performance characteristics as they relate to its safety and effectiveness. These tests were performed according to FDA's "Electrode Recoding Catheter preliminary Guidance". The results of these non-clinical tests were compared to results of the same tests on predicate devices. The comparison of the results indicates that the subject device is as safe, and as effective, as the named predicate devices.
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
p. 1/5
510(k) Submission
Gyro Tip Lariat Deflectable Loop Mapping Catheter
Cleveland, Ohio 44106 Phone: (216) 791-2234 (216) 791-2234 Fax:
MAR 2 7 2002
510(k) Summary
[1] Submitter's Information:
Cardiac Assist Devices, Inc. 11000 Cedar Avenue, Suit 451 Cleveland, Ohio 44106 Phone: (216) 791-2234 (216) 791-2234 Fax: E-mail: cardiacassist@aol.com
Contact Person: Rassoll Rashidi, President
Date Summary Prepared: 7-1-2001
- [2] _Device Names:
| Proprietary Device Name: | Gyro-Tip Lariat Deflectable Loop Mapping
Catheter |
|--------------------------|------------------------------------------------------|
| Classification name: | Diagnostic Electrophysiology catheter |
| Common Device Name: | Electrode Recording Probe |
Class II [3] Device Classification:
[4] Predicate Devices:
- Gyro Tip EP Catheter, Delta Series. K955847 1
- Cordis Webster A20 Diagnostic Deflectable Tip Catheter, K953768 1
- Cordis Webster T20 Diagnostic Deflectable Tip Catheter, K953663 해
1
1
5100k) Suhmission Gyro Tip Lariat Deflectable Loop Mapping Cathe
012520
une, Suite 44 leveland, Ohio 44106 Phone: (216) 791-2234 (216) 791-2234
510(k) Summary (continue)
[5] Device Description:
The Gyro-Tip Lariat Deflectable Loop Mapping Catheter of Cardiac Assist Devices, Inc. has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures. The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices. The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures. The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety.
A schematic view of the Gyro-Tip Lariat Deflectable Loop Mapping Catheter is shown in Figure 1.
[6] Indication for Use:
Gyro-Tip lariat Deflectable Loop Mapping Catheter is indicated for multi electrode electrophysiological mapping, recording and/or temporary stimulation, of cardiac structures along circumferential paths.
2
Cardiac Assist Devices, Inc. 11000 Cedar Avenue, Suite 451 Cleveland, Ohio 44106 (216) 791-2234 Phone: (216) 791-2234 Fax:
Kol2520 R315
510(k) Summary
Image /page/2/Figure/4 description: This image shows a catheter handle with a multi-pole end connector. The distal portion of the catheter is shown before and after actuation of the manual actuator. The catheter has a pre-formed bent shape.
Figure 1 Schematic View of the Gyro Tip Lariat Deflectable Loop Mapping Catheter
3
KO12520
veland, Ohio 44106
Phone: (216) 791-2234 (216) 791-2234 Fax:
510(k) Summary (continue)
[7] Technological Characteristics of the Subject Device:
The Gyro-Tip Lariat Deflectable Loop Mapping Catheter is technologically similar to the primary named predicate device, namely the Gyro Tip EP catheter of Cardiac Assist Devices, Inc. that is cleared for marketing under K955847. The subject device has more platinum electrodes (up to 20 electrodes) at its distal portion compared to the primary predicate device that has 4 electrodes. This total number of electrodes is however the same as the number of electrodes of the secondary predicate devices that are cleared for marketing under K953768 (Cordis Webster A20 Diagnostic Deflectable Tip Catheter) and K953663 (Cordis Webster T20 Diagnostic Deflectable Tip Catheter). Each of these secondary predicate devices has 20 electrodes at its distal portion.
The distal portion of the subject device has a pre-formed bend at its distal portion. This pre-formed bend causes formation of a deflectable loop at the catheter's distal portion in response to the actuation of the steering mechanism located in the catheter handle of the subject device. The steering mechanism of the subject device is exactly similar to the steering mechanism of the primary predicate device, namely the Gyro Tip EP Catheter of Cardiac Assist Devices, Inc. The actuating wires that transmit the actuation forces from the steering mechanism of the catheter handle to the distal portion of the subject device are stainless steel wires having generally circular crosssection with a diameter in the order of 0.012". These actuating wires are the same as the actuating wires of the primary predicated device (cleared under K955847). The distal portion of the actuating wires of the subject device has rectangular crosssection, having the same effective cross-sectional area as that of the circular crosssection portion. This better determines the plane of loop formation at the distal portion of the subject device. The geometric plane, in which the distal loop of the subject device is formed, upon the manual actuation of the steering mechanism, is generally perpendicular to the elongated shaft of the catheter. Therefore the subject device can assume a "halo-shaped" configuration at its distal portion, similar to the "halo-shaped" configuration of the distal portion of the secondary predicate device, namely Cordis Webster T20 Diagnostic Deflectable Tip Catheter that is cleared under K953663.
A
4
Cleveland, Ohio 44106 Phone: (216) 791-2234 Fax:
510(k) Summary (continue)
171 Technological Characteristics of the Subiect Device (continued):
The halo-shaped configuration of the distal portion of the subject device, and the process of assuming this final halo-shaped configuration, in response to the manual actuation of its steering mechanism, has shown to be safe and effective through a series of non-clinical testing. The descriptions and results of these tests are included in Appendices A , B, and C of this 510K, with a brief discussion presented next.
[8] Brief Discussion of the Non-Clinical Tests:
The subject device, (The Gyro-Tip Lariat Deflectable Loop Mapping Catheter) has gone under a series of non-clinical testing in order to determine its performance characteristics as they relate to its safety and effectiveness. These tests were performed according to FDA's "Electrode Recoding Catheter preliminary Guidance". The results of these non-clinical tests were compared to results of the same tests on predicate devices. The comparison of the results indicates that the subject device is as safe, and as effective, as the named predicate devices.
191 Conclusion Drawn From Non-Clinical and Clinical Tests:
The results of the non-clinical tests. presented in Appendices A. B. C. D, and E of this 510(k) indicates that the subject device (The Gyro-Tip Lariat Deflectable Loop Mapping Catheter) performs as well as the named predicate devices, and any minute differences in the test results are not significant to influence the safety and effectiveness of the subject device. Therefore, Cardiac Assist Devices, Inc. presents the Gvro-Tip Lariat Deflectable Loop Mapping Catheter વડ substantially equivalent to the named predicate devices in this 510(k).
5
[10] Additional Information:
Available upon request
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Mr. Rassoll Rashidi President Cardiac Assist Devices, Inc. 11000 Cedar Avenue, Suite 451 Cleveland, OH 44106-3052
Re: K012520
Trade Name: Gyro-Tip Lariat Deflectable Loop Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: December 20, 2001 Received: December 27, 2001
Dear Mr. Rashidi:
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.
6
Page 2 - Mr. Rassoll Rashidi
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Dealla Tellh
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known): K012520
Device Name: Gyro Tip Lariat Deflectable Loop Mapping Catheter
Indications For Use:
The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
of Cardiovascular & Respiratory Devices 510(k) Number
Image /page/7/Picture/8 description: The image shows the words "Prescription Use" with a check mark above the word "Use". Below that, the text "(Per 21 CFR 801.109)" is shown. The check mark indicates that the prescription use is confirmed. The text below indicates that the prescription use is in accordance with the Code of Federal Regulations.
OR
Over-The-Counter Use_
(Optional Format 1-2-96)