Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Device Description

The Radia™ Steerable Diagnostic Catheter is a steerable atrial mapping EP catheter with up to 20 electrodes. The device consists of a polymer shaft with platinum electrodes and internal steering wires mounted on a rotary-style handle for deflection of the catheter tip.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Radia™ Steerable Diagnostic Catheter (K091370)

The information provided describes a 510(k) submission for the Radia™ Steerable Diagnostic Catheter, indicating it is a Class II device (21 CFR 870.1220). The submission primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific quantitative acceptance criteria through a standalone clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria or detailed performance metrics from a dedicated study are not explicitly stated. The submission relies on establishing substantial equivalence to predicate devices. The "performance" is generally described as meeting product specifications and intended uses, implied by the successful bench testing.

Acceptance Criteria	Reported Device Performance
Explicit Acceptance Criteria (quantitative values for sensitivity, specificity, accuracy, etc.)	Not explicitly stated in the provided document. The submission relies on substantial equivalence to predicate devices (Orbiter ST Diagnostic Electrode Catheter K992373, EP•XT Steerable Electrode Catheter K921872A).
Meeting product specifications and intended uses	Bench testing results demonstrate that the Radia™ Steerable Diagnostic Catheter design meets product specifications and intended uses.
Demonstration of substantial equivalence	The device has the same intended use and fundamental scientific technology as predicate devices. Technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent. Minor differences were addressed by performance testing showing no adverse effect on safety and effectiveness.

2. Sample Size and Data Provenance for Test Set

Sample Size Used for Test Set: Not explicitly stated. The document mentions "bench testing" but does not provide details on the number of units or conditions tested.
Data Provenance: The study described appears to be a non-clinical bench testing study conducted by the manufacturer, Bard Electrophysiology Division of C. R. Bard, Inc. (Lowell, MA, USA). The data is not related to patient cases or clinical data in the traditional sense of a "test set" for performance metrics like sensitivity/specificity.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: This information is not applicable/not provided in the context of this 510(k) summary. The ground truth for this type of submission is typically based on engineering specifications and direct physical measurements during bench testing, not expert interpretation of diagnostic output.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided. As the described study is bench testing, there would be no expert adjudication of results in the traditional sense. Test outcomes would be compared against engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The provided document does not mention an MRMC study. This device is a diagnostic catheter for intracardiac sensing, recording, stimulation, and temporary pacing, not a device that generates images or results requiring human reader interpretation in the way an AI algorithm might. Therefore, a comparative effectiveness study measuring human reader improvement with or without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study Done: No. This device is a physical medical instrument (catheter), not a software algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The "performance" is inherently linked to its physical characteristics and functionality.

7. Type of Ground Truth Used for Test Set

Type of Ground Truth: The ground truth for the "bench testing" would likely be based on engineering specifications, direct physical measurements, and industry standards for catheter performance. This would include parameters like steering mechanisms, electrode integrity, electrical performance (sensing/recording/pacing capabilities), biocompatibility, and sterilization effectiveness.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not provided. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and manufacturing process are informed by established engineering principles and prior device experience, but not through a data-driven training set.

9. How Ground Truth for the Training Set was Established

How Ground Truth for Training Set was Established: Not applicable/not provided. As there is no training set, there is no ground truth established for one. The design and development of the device would follow medical device development processes, including design inputs, verification, and validation against specified requirements.

Summary

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8. 510(k) Summary

K091370 510(k) SUMMARY

JUN - 5 2009

This 510(k) Summary is provided per the requirements of section 807.92(c).

510(k) Number:	TBD
Owner Name:	Bard Electrophysiology Division of C. R. Bard, Inc.
Address:	55 Technology DriveLowell, MA 01851
Contact Person:	Julie BroderickDirector, Regulatory AffairsTel: 978-323-2220Fax: 978-323-2222Email address: julie.broderick@crbard.com
Alternate Contact:	Ana RandallManager, Regulatory AffairsTel: 978-323-2348Fax: 978-323-2222Email address: ana.randall@crbard.com
Date Prepared:	May 1, 2009
Device Trade Name:	Radia™ Steerable Diagnostic Catheter
Device Common Name:	Diagnostic electrode catheter
Class:	Class II. 21 CFR 870.1220. Product Code DRE

Predicate Device(s):

Orbiter ST Diagnostic Electrode Catheter (K992373) .
EP•XT Steerable Electrode Catheter (previously known as Bard Steerable Catheter) . (K921872A)

Device Description:

Page 1 of 2

Special 510(k) Submission fo Bard Radia™ Steerable Diagnostic Catheter

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Indication for Use:

Comparison to Predicate Devices:

The Radia™ Steerable Diagnostic Catheter has the same intended use and fundamental scientific technology as the predicate devices. All technological characteristics of the Radia™ Steerable Diagnostic Catheter are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where minor technological and material differences exist between the proposed device and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed device.

Summary of Non-Clinical Testing:

Bench testing of the Radia™ Steerable Diagnostic Catheter was performed to support substantial equivalence. Results of testing demonstrate that the Radia™ Steerable Diagnostic Catheter design meets product specifications and intended uses.

Statement of Equivalence:

The Radia™ Steerable Diagnostic Catheter has the same indications for use and technological characteristics as the predicate devices. Based on this and the design and engineering data provided in the pre-market notification, Radia™ Steerable Diagnostic Catheter has been shown to be substantially equivalent.

Page 2 of 2

Special 510(k) Submiss Bard Radia™ Steerable Diagnostic Car

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2009

C.R. Bard, Inc. Bard Electrophysiology c/o Ms. Julie Broderick, RAC Director, Regulatory Affairs 55 Technology Drive Lowell, MA 01851

Re: K091370

Trade/Device Name: RadiaTM Steerable Diagnostic Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (Two) Product Code: DRF

Dated: May 7, 2009 Received: May 8, 2009

Dear Ms. Broderick:

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. Ilsting 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 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. Julie Broderick, RAC

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

smuch R. behmes

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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Statement of Indications for Use 91370 ndications for Use

510(k) Number (if known):

Device Name: Radia™ Steerable Diagnostic Catheter

Indications for Use:

Contraindications:

The catheter should not be used in conditions where manipulation of the catheter would be unsafe (e.g., intracardiac mural thrombus).

The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Victor H. Von Brzackermay

Division Slar-Off Division of Cardiovascular Devic

510(k) Number K091370

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).