The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

Disclaimer: This response is based solely on the provided text, which is a 510(k) summary, not a full submission. 510(k) summaries are intended to be concise and often reference more detailed information contained within the full submission (e.g., Appendices A, B, C, D, and E in this case). Therefore, some details you requested may not be explicitly present in this summary.

This 510(k) summary (K012520) for the Gyro-Tip Lariat Deflectable Loop Mapping Catheter describes a device intending to demonstrate substantial equivalence to predicate devices, rather than meeting specific performance criteria against a pre-defined standard in a de novo study. The acceptance criteria and "proof" primarily stem from demonstrating similarity in performance to legally marketed predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Non-Clinical Tests)
Safety and Effectiveness comparable to predicate devices.	"The comparison of the results indicates that the subject device is as safe, and as effective, as the named predicate devices.""The results of the non-clinical tests... indicates that the subject device... 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."
Similar torsional stiffness (under clockwise and counterclockwise torque).	"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."
Radiopacity under fluoroscopy for required visibility during cardiac electrophysiology mapping.	"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." (This is a feature description, implying it meets the need for visibility).
Steering mechanism and actuation resulting in a deflectable loop/halo-shaped configuration, safe and effective.	"The steering mechanism of the subject device is exactly similar to the steering mechanism of the primary predicate device... The halo-shaped configuration... and the process of assuming this final halo-shaped configuration... has shown to be safe and effective through a series of non-clinical testing."
Compliance with UL 544 Standard for Safety for accessory cables.	"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."
Non-clinical performance, as determined by FDA's "Electrode Recording Catheter preliminary Guidance," should compare favorably.	"These tests were performed according to FDA's 'Electrode Recoding Catheter preliminary Guidance'." The summary states the device performs "as well as" predicate devices with no significant differences.

2. Sample Size Used for the Test Set and Data Provenance

The provided text states that a "series of non-clinical testing" was performed, and the results are included in "Appendices A, B, and C" of the 510(k) submission. However, the specific sample size for each non-clinical test (e.g., number of catheters tested for torsional stiffness, radiopacity, or deflection) is not mentioned in this 510(k) summary.

The data provenance is non-clinical testing, meaning it was performed in a laboratory or simulated environment, not on human subjects. This implies the data is retrospective in the sense that the tests were completed before submission. The country of origin of the data is not explicitly stated but would typically be where the manufacturer (Cardiac Assist Devices, Inc., Cleveland, Ohio) conducted their R&D and testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable / not provided in this context. The study is a non-clinical, benchtop, or simulated environment comparison to predicate devices, not a study involving human data requiring expert ground truth assessment (like image interpretation by radiologists). The "ground truth" here is the measured performance of both the subject device and the predicate devices against engineering and performance specifications.

4. Adjudication Method for the Test Set

This information is not applicable / not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation or subjective assessments, where multiple experts provide opinions that need to be resolved. For non-clinical tests, results are typically objective measurements compared against specifications or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers (e.g., clinicians) evaluating cases with and without AI assistance to measure performance improvement. The current submission is for a physical medical device (catheter) and focuses on its physical and functional performance, not on an AI algorithm's interpretative capabilities.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical testing comprises objective measurements and specifications related to the device's physical properties and functionality. This would include:

Measurement of torsional stiffness.
Evaluation of radiopacity.
Assessment of deflection mechanism performance (loop formation, steerability, mechanical integrity).
Compliance with electrical safety standards (UL 544 for cables).

The "ground truth" is established by the methods and standards used to measure these properties for both the subject device and the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable / not provided. The device in question is a physical medical catheter, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable / not provided. As explained in point 8, there is no training set for a physical device. Ground truth for non-clinical testing is established through standard measurement techniques and engineering specifications.

Summary

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K012520

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 MappingCatheter
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

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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:

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.

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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

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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.

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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).

[10] Additional Information:

Available upon request

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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.

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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

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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.

Over-The-Counter Use_

(Optional Format 1-2-96)

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).