The Radii Diagnostic Electrophysiology Catheter is intended to be used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

Device Description

The Radii Diagnostic Electrophysiology Catheter is a 7 F steerable, deflectable, quadrapolar catheter. It has a 4 mm tip electrode and three 1 mm ring electrodes in the flexible distal tip and a handle at the proximal end. The catheter is available in several curve sizes, two shaft stiffnesses, and two electrode spacings. The four electrodes at the distal end of the catheter include one 4 mm electrode at the distal tip, and three 1 mm ring electrodes placed at specified distances proximal to the tip electrode. One interelectrode spacing configuration is 2 mm, 5 mm, and 2 mm (2,5,2) and the other interelectrode spacing configuration is 2 mm, 2 mm, and 2 mm (2,2,2). Each of the electrodes is attached to a conductor that extends from the electrode to a specific pin in the connector in the handle. The shaft has two lumens, one for the electrode wires and the other for the pull-wire. To facilitate the transmission of rotational force, the shaft includes braiding sandwiched between layers of tubing. At the proximal end of the handle (i.e., farthest from the shaft), there is a connector for connecting the device to an external stimulator and electrophysiologic recorder. The knob utilized to deflect the tip is on the distal end of the handle (i.e., nearest to the shaft). This knob is connected to the tip by the pull-wire. Pulling the knob toward the connector causes the tip to deflect, with the extent of deflection controlled by the extent of movement of the knob. Pushing the knob toward the shaft causes the tip to straighten. Rotating the handle to the right rotates the catheter tip counterclockwise or clockwise, respectively (as viewed from the handle). The Radii Catheter connects to an electrophysiologic recorder using an EGM Cable designed specifically for the connector configuration on the recorder. Each cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the recorder. Within the insulated cable bundle, each conductor is insulated. A separate cable is utilized for connecting the Radii Catheter to an external stimulator. Like the EGM Cables, this cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the stimulator. Each conductor within the insulated cable bundle is insulated. Because many pacing stimulators do not contain protected-pin attachments (these are designed into the Cardiac Pathways cable), a Pin Adaptor is provided with the cable to allow for a variety of connection situations.

AI/ML Overview

The provided text describes a medical device, the Radii Diagnostic Electrophysiology Catheter, and its 510(k) summary for premarket notification. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through:

Device Description: Detailing the physical characteristics, materials, and functionality.
Intended Use/Indications: Clearly stating the purpose of the device.
Performance Data (Engineering Bench Testing): Summarizing that the device underwent electrical, mechanical, and biocompatibility testing and "met the specifications." This is typical for demonstrating safety and basic functionality in a 510(k) for such a device, rather than a clinical performance study with detailed statistical results.

Therefore, many of the requested elements (sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not found in this document because the type of study described is a series of engineering and bench tests, not a clinical trial or performance evaluation employing those methodologies.

Here's a breakdown of what can be extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Electrical Specifications (e.g., continuity, short circuits, DC/AC impedance, capacitance, dielectric strength, current leakage)	"The device met the specifications."	Specific quantitative values for "specifications" are not provided.
Mechanical Specifications (e.g., joint strengths, ability to withstand multiple deflections)	"The device met the specifications."	Specific quantitative values for "specifications" are not provided.
Biocompatibility	"Biocompatibility testing was performed to verify that the devices did not elicit toxicological responses."	Indicates compliance with biocompatibility standards, but specific test results or thresholds are not detailed.

Study Details (Based on available information)

Sample size used for the test set and the data provenance: Not explicitly detailed. The "test set" refers to physical units of the device and cables used for engineering bench testing, not a clinical data set. Data provenance is not applicable in the context of bench testing of physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineering tests is based on predefined technical specifications and measurements, not expert clinical consensus.
Adjudication method for the test set: Not applicable. Engineering tests rely on objective pass/fail criteria against specifications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was NOT done. This type of study is relevant for diagnostic imaging or interpretation where human readers' performance is evaluated. The Radii Catheter is a diagnostic device for recording signals and delivering pacing, not for interpretation of complex clinical data by humans that would require an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Radii Catheter is a physical medical device, not an algorithm, so standalone algorithm performance is not a concept that applies.
The type of ground truth used: For the electrical and mechanical tests, the ground truth was the predetermined engineering specifications and standards set for the device's components and overall function. For biocompatibility, it was compliance with biocompatibility standards to ensure no toxicological responses.
The sample size for the training set: Not applicable. This refers to the training of an algorithm, which is not relevant to this device.
How the ground truth for the training set was established: Not applicable.

Summary from the provided text:
The 510(k) summary focuses on demonstrating that the Radii Diagnostic Electrophysiology Catheter (and its associated cables) is substantially equivalent to existing legally marketed predicate devices. This is achieved by showing that it has the same intended use, similar technological characteristics, and that its performance (through electrical, mechanical, and biocompatibility bench testing) "met the specifications." The document confirms that the FDA reviewed this data and found the device substantially equivalent. The information provided is consistent with the requirements for a Class II medical device seeking 510(k) clearance, which primarily involves demonstrating safety and effectiveness through substantial equivalence, often relying heavily on non-clinical performance data (bench testing) rather than extensive clinical efficacy trials typically seen for novel, higher-risk devices or software.

Summary

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CARDIAC PATHWAYS CORPORATION Premarket Notification

510(k) SUMMARY

Indications

Radii Diagnostic Electrophysiolog

Catheter

Device Description

Image /page/0/Figure/7 description: The image shows a diagram of a medical instrument, possibly an endoscope or catheter, with a handle and a long, flexible tube. The tube is bent at a 90-degree angle, and a measurement of "120 cm" is indicated near the bend, suggesting the length of the curved section. The instrument appears to be designed for insertion into the body, with the flexible tube allowing it to navigate through internal passages.

Figure 1: Radii Catheter

The four electrodes at the distal end of the catheter include one 4 mm electrode at the distal tip, and three 1 mm ring electrodes placed at specified distances proximal to the tip electrode. One interelectrode spacing configuration is 2 mm, 5 mm, and 2 mm (2,5,2) and the other interelectrode spacing configuration is 2 mm, 2 mm, and 2 mm (2,2,2). Each of the electrodes is attached to a conductor that extends from the electrode to a specific pin in the connector in the handle.

Image /page/0/Figure/10 description: The image shows a diagram of a cylindrical object with several labeled dimensions. There are three shaded regions along the cylinder, each separated by a distance. The dimensions provided are 1mm, 2mm, 4mm, and 5mm.

Figure 2: Distal Tip: 2,5,2 interelectrode spacing configuration

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The shaft has two lumens, one for the electrode wires and the other for the pull-wire. To facilitate the transmission of rotational force, the shaft includes braiding sandwiched between layers of tubing.

At the proximal end of the handle (i.e., farthest from the shaft), there is a connector for connecting the device to an external stimulator and electrophysiologic recorder. The knob utilized to deflect the tip is on the distal end of the handle (i.e., nearest to the shaft). This knob is connected to the tip by the pull-wire.

Pulling the knob toward the connector causes the tip to deflect, with the extent of deflection controlled by the extent of movement of the knob. Pushing the knob toward the shaft causes the tip to straighten. Rotating the handle to the right rotates the catheter tip counterclockwise or clockwise, respectively (as viewed from the handle).

Figure 3 depicts the movement of the catheter tip in three-dimensional space.

Image /page/1/Figure/6 description: This image shows a 3D coordinate system with the X, Y, and Z axes labeled. A curve is shown in the Z direction, labeled as a catheter tip, and it is noted that it goes from 0 to 270 degrees. The rotation is shown in the Y direction, and it is noted that it goes from 0 to 360 degrees.

Figure 3: Radii Tip Movement in Three Dimensional Space

Cables

The Radii Catheter connects to an electrophysiologic recorder using an EGM Cable designed specifically for the connector configuration on the recorder. Each cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the recorder. Within the insulated cable bundle, each conductor is insulated.

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Image /page/2/Figure/2 description: The image shows three different cable models with their specifications. The first cable is the Model 2001 EGM Cable, which is 96 inches long with a tolerance of plus or minus 4 inches and has a 6-pin plug on each end. The second cable is the Model 2028 EGM Cable, which is 36 inches long with a tolerance of plus or minus 4 inches and also has a 6-pin plug on each end. The third cable has a 6-pin plug on one end and a DIN 42802 protected socket on the other end, with a length of 96 inches plus or minus 4 inches to the start of the socket, then 5 inches plus or minus 1 inch to the start of the pins, and finally 1.52 inches to the end of the pins.

Image /page/2/Figure/3 description: The image shows the text "Model 2002 EGM Cable". The text is written in a simple, sans-serif font and is horizontally aligned. The text appears to be a label or identifier for a product, possibly a cable.

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Image /page/3/Figure/2 description: The image shows a technical drawing of a cable assembly. The cable has a 6-pin plug on one end and four DIN 42802 protected sockets on the other end. The cable is 36 inches long, plus or minus 4 inches. The length from the split to the sockets is 5 inches, plus or minus 1 inch, and the length of the socket is 1.52 inches.

Model 2029 EGM Cable

Figure 4: EGM Cables

A separate cable is utilized for connecting the Radii Catheter to an external stimulator. Like the EGM Cables, this cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the stimulator. Each conductor within the insulated cable bundle is insulated. Because many pacing stimulators do not contain protected-pin attachments (these are designed into the Cardiac Pathways cable), a Pin Adaptor is provided with the cable to allow for a variety of connection situations. This pin adaptor is also pictured below.

Pacing Stimulator Cable

Image /page/3/Figure/7 description: The image shows a diagram of a cable with connectors on both ends. On the left side, there are two protected pin connectors. The cable has a total length of 12 1/2 feet and on the right side, there is a quick disconnect circular connector.

Image /page/3/Figure/8 description: The image shows the text "Model 2039 Pacing Stimulator Cable". The text is in a sans-serif font and is black. The background is white. The text is centered in the image.

Pin Adaptor (approximately 1 1/8 inch long)

Image /page/3/Figure/10 description: The image is a technical drawing of a cylindrical object. The object appears to be composed of several sections with varying diameters. Dashed lines within the drawing indicate internal features or hidden edges of the object.

Figure 5: Pacing Stimulator Cable

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Predicate Devices

The Radii Diagnostic Electrophysiology Catheter is substantially equivalent to the Polaris–Dx™ Steerable Diagnostic Catheter and the EPT–Dx™ manufactured by EP Technologies, and Diagnostic/Ablation Large & Grooved Dome Delectable Catheters manufactured by Webster Laboratories.

Performance Data

The Radii Diagnostic Electrophysiology Catheter, the EGM Cables, and the Pacing Stimulator Cable were subjected to a battery of electrical and mechanical tests to verify that the devices met the specifications. Electrical testing included, but was not limited to. assessment for continuity and short circuits, DC impedance, AC impedance, capacitance, and dielectric strength and current leakage. The device met the specifications. Mechanical testing included, but was not limited to, assessment of joint strengths and the ability to withstand multiple deflections. The device met the specifications. Biocompatibility testing was performed to verify that the devices did not elicit toxicological responses.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1998

Ms. Erin Dignan Manager, Regulatory Affairs Cardiac Pathways Corporation 995 Benecia Avenue Sunnyvale, CA 94086

Re: K983653 Radii Diagnostic Electrophysiology Catheter Requlatory Class: II (two) Product Code: DRF Dated: October 16, 1998 Received: October 19, 1998

Dear Ms. Dignan:

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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, 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

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obligation you might have under sections 531 through 542 of the Act 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 regulation (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, 2Misbranding 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 -

510(k) Number: K983653

Device Name: Cardiac Pathways Corp., Radii Diagnostic Electrophysiologic Catheter

Indications For Use:

The Radii Diagnostic Electrophysiologic Catheter is intended to be used to record . intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

N. Oadly Willin

iovascular. Respiratory.

510(k) Number K983653

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).