The Cardima EP SELECT Switchbox is an accessory intended to provide selective connection of multi-electrode catheters for electrogram recording and pacing during diagnostic electrophysiology studies.

Device Description

The Cardima EP SELECT Switchbox is a passive switching unit used in conventional electrophysiology (EP) diagnostic procedures. It is designed to provide a convenient means by which the user can record or pace from multiple unipolar or bipolar intracardiac electrodes. The device is designed to be placed on a horizontal surface or at the patient's side. It is designed to accept up to eight electrodes using standard pin connectors typically found in the EP lab. Switching between record or pace modes is accomplished by a simple switch for each electrode.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Conformance to International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.	The results show that the switchbox meets conformance with the standard.

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

The document does not specify a distinct "test set" in the context of clinical or performance data using a sample of devices. The safety and effectiveness study was based on conformance to an engineering standard. Therefore, traditional sample size and data provenance for a test set (e.g., country of origin, retrospective/prospective) are not applicable in the way they would be for a clinical study involving patient data. The study primarily involved testing the device itself against engineering specifications.

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

This information is not applicable. The ground truth was established by conformance to an industrial safety standard (IEC-60601-1), which involves engineering testing and evaluation, not expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable as the "test set" refers to the device being evaluated against an engineering standard, not a clinical dataset requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a passive switching unit, not an AI or diagnostic tool that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone (algorithm only) performance study was not conducted for an AI component. The device is a hardware component with a specific electrical function, not an algorithm. The study was focused on the device's electrical safety and functionality.

7. Type of Ground Truth Used:

The ground truth used was conformance to established engineering and safety standards, specifically International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.

8. Sample Size for the Training Set:

This information is not applicable. The device is a hardware product, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This information is not applicable as there is no training set for a machine learning model. The safety and effectiveness were established through
"Declaration of Conformity" with a recognized consensus standard.

Summary

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OCT 29 1998

Summary of Safety and Effectiveness

Trade Name:

Cardima EP SELECT Switchbox

Owner:

Cardima, Inc. 47266 Benicia Street Fremont. CA 94538-7330 Contact: Jack P. Douglas, Ph.D. Establishment Registration Number: 9007594

Classification Name:

Electrode Recording Catheter (21 CFR 870.1220)

Device Classification:

Class II (21 CFR 870.1220) Panel: Circulatory System Devices Panel, DCRND

Intended Use and Product Description:

Sterilization, Packaging and Pyrogenicity:

The EP SELECT is individually packaged non-sterile in plastic wrap and cardboard box.

Substantial Equivalence:

The EP SELECT is a modified version of other conventional accessory switchboxes found in EP mapping systems. Establishment of equivalence was based on similarities of labeling, design, and functionality with the Webster CES-500 switching system.

Summarv of Safety and Effectiveness:

Safety and effectiveness were established through a "Declaration of Conformity", in part, with recognized consensus standards using International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety. The results show that the switchbox meets conformance with the standard and is thus safe and effective for use.

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Image /page/1/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" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1998

Dr. Jack Douglas Manager, Regulatory Affairs CARDIMA, Inc. 47266 Benicia Street Freemont, CA 94539-1372

Re: . K982835 Electrode Switchbox, Model 11-081002 Requlatory Class: II (two) Product Code: 74 DRF Dated: October 14, 1998 Received: October 15, 1998

Dear Dr. Douglas:

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 aqainst 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 Regulations, 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 Requlation (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 Failure to comply with the GMP regulation may result in assumptions. 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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Page 2 - Dr. Jack Douglas

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 requlations.

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 diaqnostic 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,

Thomas J. Callahon

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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5 1 0(k) Number (if known):

K 982835

Device Name:

Cardima EP SELECT Switchbox

Indications For Use:

The Cardima EP SELECT Switchbox is an accessory intended to provide selective connection of multi-electrode catheters for electrogram recording and pacing during diagnostic electrophysiology studies.

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NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vola Telle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K982835

Prescription Use
(Per 21 CFR 801. 109)

す

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).