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 Orbiter PV Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter PV catheter will be offered in 7.5F diameter (7F shaft with a 5F tip) with 1-24 electrodes with a variety of inter-electrode spacings. The distal curve is capable of forming a 360-degree loop.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Orbiter PV Diagnostic Electrode Catheter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics typically seen for novel medical devices or AI-driven systems.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not explicitly present in the provided document, as it pertains to a regulatory clearance based on substantial equivalence to predicate devices, not a standalone performance study as would be required for a novel device or an AI/ML algorithm.

However, I can infer some aspects based on the nature of the submission:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. There are no specific quantitative performance metrics listed for the Orbiter PV itself in this summary that would typically be seen for AI/ML performance.
Reported Device Performance: The document states that the Orbiter PV Diagnostic Electrode Catheter is "typical of electrode recording catheters currently sold" and will be offered with similar specifications (7.5F diameter, 1-24 electrodes, variety of inter-electrode spacings, 360-degree loop capability). This implies that its performance is expected to be comparable to these existing devices.

Since the submission is for substantial equivalence to predicate devices, a table like the one requested, with specific quantitative performance metrics and acceptance criteria, is not included in the provided text. The "performance data summary" section refers to technological characteristics and references predicate devices.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided: This information is typically for de novo studies evaluating a device's performance against specific endpoints. For a 510(k) based on substantial equivalence, a formal "test set" with a specified sample size for clinical validation is generally not required unless new clinical questions arise. The regulatory review focuses on whether the new device is as safe and effective as the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided: As no specific "test set" for performance evaluation is detailed, there's no mention of experts establishing a ground truth.

4. Adjudication method for the test set:

Not applicable/Not provided: Without a test set and experts, there is no adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No: This device is an electrode catheter used for intracardiac sensing, recording, stimulation, and pacing. It is not an AI-assisted diagnostic imaging device, so an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable: The device is a physical catheter, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The type of ground truth used:

Not applicable/Not provided: As discussed, no formal performance study requiring ground truth establishment is detailed in this 510(k) summary. The ground truth for regulatory clearance in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable/Not provided: This device is not an AI/ML algorithm, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable/Not provided: As above, this is not an AI/ML device.

Summary

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OCT 2 3 2003

BARD

K030627

p / / 2

510(k) SUMMARY FOR THE ORBITER PV VI. DIAGNOSTIC ELECTRODE CATHETER

C.R. Bard, Inc.

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:

Date of Preparation:

Device Name: B.

Trade Name:

Common/Usual Name: Classification Name:

55 Technology Drive, Suite 1 Lowell, MA 01851 (978) 323-2216 (Direct Line) (978) 323-2222 Deborah L. Herrington Requlatory Affairs Manager February 26, 2003

Orbiter PV Diagnostic Electrode Catheter Electrode Recording Catheter Electrode Recording Catheter

Predicate Device Name(s): C.

Orbiter ST Diagnostic Electrode Catheter Viking Diagnostic Electrode Catheter Bard Woven Electrode Catheter

Image /page/0/Picture/16 description: The image shows the logo for Bard Electrophysiology. The logo consists of a square with a stylized heart shape inside it. To the right of the square, the word "Bard" is written in a bold, sans-serif font. Below "Bard", the word "electrophysiology" is written in a smaller, italicized, sans-serif font.

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D. Device Description/Indications for Use:

Description

Indications:

Technological Characteristics/Performance Data Summary ய்

1992372 The predicate device for this 510(k) Premarket Notification is the currently marketed Bard Orbiter ST Diagnostic Electrode catheter. Where appropriate, other Bard devices are referenced as supplemental predicate devices including the Viking catheter (K971265/FDA concurrence October 23, 1997) and the Woven catheter (Preamendment device).

Refer to Appendix 4 for the Instructions for Use for the predicate device and the supplemental predicate devices.

Appendix 5 contains the information demonstrating Preamendment Status for the Bard Woven Electrode Catheter.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2003

Bard Electrophysiology c/o Ms. Deborah L. Herrington Manager, Regulatory Affairs C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851

Re: K030627

Trade Name: Orbiter PV Diagnostic Electrode Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: September 18, 2003 Received: September 22, 2003

Dear Ms. Herrington:

We have reviewed your Section 510(k) premarket notification of intent to market the device refe:enced 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 - Ms. Deborah L. Herrington

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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dng Hemku for
B. Zaleski, MD

Bram D. Zuckerman, M.I Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D. INDICATIONS FOR USE

Diagnostic Electrode Catheter

Device Name: Orbiter PV Diagnostic Electrode Catheter Device Name. - Orbiter FV Blagnoons ff.com in both the 14-pole and 24-pole design.

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

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 interatial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

The retrograde transaortic approach is contraindicated due to the risk of entrapping the tip in the left ventricle.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dno Xumler

10(k) Number

Prescription Use
(Per 21 CFR 801.109)
✓

Over-the-Counter Use _

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).