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

The Orbiter ST extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.

Device Description

The Orbiter ST Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter ST catheter will be offered in 7F diameter with 2-20 electrodes with a variety of inter-electrode spacings and curve styles.

An accessory to the Orbiter ST Diagnostic Electrode Catheter, the Orbiter ST Extension Cable will be sold separately.

AI/ML Overview

The provided K992373 document is a 510(k) summary for the Orbiter ST Diagnostic Electrode Catheter and Orbiter ST Extension Cable. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the document primarily discusses performance testing against specified requirements rather than a clinical study comparing device performance against a gold standard or human readers.

Here's an analysis of the provided information, framed by your request, and identifying where the document does not contain the requested details:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document states that the Orbiter ST catheter underwent "performance testing" to demonstrate its safety and effectiveness, and that it met all testing acceptance criteria. However, the specific quantitative acceptance criteria for each test are not detailed in this summary document. The document refers to "Appendix 2" for detailed protocols and results, which is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria and detailed performance results are not present in the provided 510(k) summary. These would typically be found in the appendices (Appendix 2, for performance testing). The document only states that the device "meets the requirements of the specified performance testing" and "was found to meet all testing acceptance criteria and was therefore acceptable."

Test Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Biocompatibility	(Not specified in summary, but implies standard biocompatibility requirements for blood-contacting devices)	"successful biocompatibility testing demonstrates that the blood contacting materials used in the construction of the Orbiter ST catheter are nontoxic and biocompatible."
Performance Testing	(Not specified in summary, but derived from "required characteristics of electrode recording catheters" and "1995 Draft Guidance")	"in vitro bench testing conducted on the Orbiter ST catheter demonstrates that the device meets the requirements of the specified performance testing."
		"The performance of the Orbiter ST catheter was found to meet all testing acceptance criteria and was therefore acceptable."

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

Sample Size for Test Set: Not specified in the provided summary. The summary refers to "in vitro bench testing" and "performance testing" but does not give the number of devices or units tested.
Data Provenance: The testing was "in vitro bench testing," meaning it was conducted in a laboratory setting. The country of origin for the testing itself is not explicitly stated, but the submitter (C.R. Bard, Inc.) is based in Massachusetts, USA. The data is prospective, meaning the tests were performed specifically for this submission.

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

This information is not applicable to this type of submission or the reported testing. The "ground truth" for in vitro bench testing is typically based on established engineering principles, regulatory standards, and material science, rather than expert clinical consensus. For example, a test for tensile strength would compare the device's performance against a pre-defined strength requirement, not against an expert's opinion.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth establishment, which is not the nature of the reported in-vitro performance testing.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a medical device (electrode catheter) and its accessory, not for an AI or diagnostic imaging algorithm that requires human interpretation. Therefore, a study to assess the improvement of human readers with AI assistance is irrelevant and was not performed.

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 device is a physical electrode catheter and an extension cable, not a software algorithm.

7. The Type of Ground Truth Used

For the reported performance and biocompatibility testing, the "ground truth" was based on:

Established Scientific Methods and Standards: The document states that "Tests were chosen and developed based on the 1995 Draft Guidance and through previous experience with the Viking catheter 510(k)." This implies that the 'ground truth' for whether the device performed adequately was defined by these regulatory guidelines and historical performance benchmarks for similar devices.
Biocompatibility Standards: The biocompatibility testing results demonstrated that the materials are "nontoxic and biocompatible," which refers to compliance with recognized biological safety standards.
Engineering Specifications: Implicitly, the performance tests would have measured various physical and electrical properties against pre-defined engineering specifications and safety margins.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware medical device, not a machine learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

Summary

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K992373

Bard Electrophysiology Division C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851 (800) 282-1332 (978) 441-6202 Fax: (978) 323-2222 BardEP@CRBARD.COM http://www.BardEP.com

Image /page/0/Picture/19 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and modern appearance. The letters are closely spaced, creating a compact and unified visual element.

510(k) SUMMARY FOR THE ORBITER ST DIAGNOSTIC VI. ELECTRODE CATHETER AND ORBITER ST EXTENSION CABLE

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.

Submitter's Information A.

Name: Address:

Phone: Fax: Contact Person: C.R. Bard, Inc. 55 Technology Drive, Suite 1 Lowell, MA 01851 (978) 323-2216 (Direct Line) (978) 323-2222 Deborah L. Herrington Requlatory Affairs Manager July 14, 1999

Date of Preparation:

B. Device Name:
Trade Name:

Common/Usual Name: Classification Name:

Orbiter ST Diagnostic Electrode Catheter Electrode Recording Catheter Electrode Recording Catheter

C. Predicate Device Name(s):
Viking Diagnostic Electrode Catheter Bard EP•XT Electrode Catheter Bard Woven Electrode Catheter Cordis Webster Electrophysiology Catheter

Image /page/0/Picture/17 description: The image shows the logo for Bard Electrophysiology. The logo consists of a stylized heart shape enclosed in a square on the left, followed by the word "Bard" in a larger, bolder font. Below "Bard" is the word "electrophysiology" in a smaller, italicized font. The logo is in black and white.

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Device Description/Indications for Use: D.

Description

The Orbiter ST Diagnostic Electrode Catheter is a closed lumen, Typical of electrode recording catheters steerable device. currently sold, the Orbiter ST catheter will be offered in 7F diameter with 2-20 electrodes with a variety of inter-electrode spacings and curve styles.

Indications:

An accessory to the Orbiter ST Diagnostic Electrode Catheter, the Orbiter ST Extension Cable will be sold separately. The Orbiter ST catheter will be labeled that it is to be used with this cable (see Section V for proposed box and pouch labels). This cable will have the following indications (reference Information For Use in Section V):

Indications:

ட். Technological Characteristics/Performance Data Summary

The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (CDRH 510(k) Manual 92-4158) was utilized in conjunction with the technological characteristics and performance testing results to make a determination of substantial equivalence as follows:

1. Does New Device Have Same Indication Statements?

Yes. The indications for the Orbiter ST catheter are the same as those for the Viking catheter, they are diagnostic electrode catheters intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

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2. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?

No. Although the Orbiter ST catheter has similar technological characteristics to the Viking catheter as shown in Table IV-1 (Section IV), they are not identical. The Orbiter ST catheter utilizes some materials that are not used for the construction of the Viking catheter. Some of these materials are used in the construction of various other catheters, currently sold, with similar indications for use. The successful results of biocompatibility and performance testing demonstrate that the use of the different materials do not have an adverse impact upon the device (see summary in Section III and results in Appendix 1 for the biocompatibility testing; see summary in Section IV and results in Appendix 2 for the performance testing).

Could the New Characteristics Affect Safety or Effectiveness? 3.

Yes. Although the use of different materials could affect safety effectiveness. successful biocompatibility testing and demonstrates that the blood contacting materials used in the construction of the Orbiter ST catheter are nontoxic and biocompatible (see summary in Section III and results in Appendix1). Also, in vitro bench testing conducted on the Orbiter ST catheter demonstrates that the device meets the requirements of the specified performance testing (see summary in Section IV and results in Appendix 2 for the performance testing).

4. Do the New Characteristics Raise New Types of Safety or Effectiveness Questions?

No. The use of different materials do not raise new types of safety or effectiveness questions. This has been demonstrated through successful biocompatibility and testing and in vitro bench testing. (see summary in Section III and results in Appendix 1 for the biocompatibility testing; see summary in Section IV and results in Appendix 2 for the performance testing).

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5. Do Accepted Scientific Methods Exist for Assessing Effects of the New Characteristics?

Yes. The Orbiter ST catheter (or a device containing the same blood contacting materials) was tested for safety and performance based on the required characteristics of electrode recording catheters as discussed in Section IIID, Principles of Operation. Tests were chosen and developed based on the 1995 Draft Guidance and through previous experience with the Viking catheter 510(k). A summary of this testing is provided in Part C below. Results for this testing may be found in Appendix 2. A copy of the checklist to the 1995 Draft Guidance, with references to the appropriate locations where each element of the guidance is discussed, is included in Appendix 2.

In addition, as previously mentioned, the Orbiter ST catheter (or a device containing the same blood contacting materials) was subjected to biocompatibility testing (see summary in Section III and results in Appendix 1).

6. Are Performance Data Available to Assess Equivalence?

Yes. Performance data are available to demonstrate equivalence to the Viking catheter or other commercially available devices with similar indications for use (see summary in this Section IV and results in Appendix 2).

7. Do Performance Data Demonstrate Equivalence?

Yes. The performance of the Orbiter ST catheter was found to meet all testing acceptance criteria and was therefore acceptable. In addition, as mentioned previously, the Orbiter ST catheter (or a device containing the same blood contacting materials) passed all tests of biocompatibility.

A summary of the safety and performance testing may be found in Section IV. Detailed protocols and results may be found in Appendix 2.

See summary in Section III and results in Appendix 1 for the biocompatibility testing; see summary in Section IV and results in Appendix 2 for the performance testing.

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SUBSTANTIALLY EQUIVALENT DETERMINATION:

Based on the decision tree found in Section IV, Figure IV-1 and results of safety and performance testing, the Orbiter ST catheter is substantially equivalent to currently marketed devices.

510(k) Submission for the Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable Bard electrophysiology Division of C.R. Bard, Inc.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Deborah L. Herrington Requlatory Affairs Manager Bard Electrophysiology Division C.R. Bard. Inc. 55 Technology Drive Lowell, MA 01851

Re: K992373 Orbiter™ ST Steerable Electrode Catheter Regulatory Class: II (two) Product Code: DRF Dated: October 14, 1999 Received: October 29, 1999

Dear Ms. Herrington:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 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.

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Page 2 - Ms. Deborah Herrington

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 requlation (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, "Misbranding 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Whitten, Ph.D.

Witten, Ph.D., M.D. ia M. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D. INDICATIONS FOR USE

Orbiter ST Diagnostic Electrode Catheter Device Name:

Indications for Use:

Contraindications:

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.

Indications:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Va. La. Tille

on Sign-Off Division of Cardiovascular, Respiratory, and Neurological Device

Over-the-Counter Use _________

510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

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).