ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.

K973639 · J-Lloyd Medical, Inc. · DRF · Apr 20, 1998 · Cardiovascular

Device Facts

• Record ID: K973639
• Device Name: ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
• Applicant: J-Lloyd Medical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Electrode Semi-Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following: 1. Temporary use in electrophysiology studies; 2. Intra-cardiac ECG; and 3. Electrical stimulation.

Device Story

Electrode Semi-Flotation Catheter; invasive diagnostic device for electrophysiology studies, intracardiac ECG recording, and electrical stimulation. Features distal tip electrode and 1-5 proximal shaft electrodes; shaft includes 10cm depth markings; wire extensions with numbered pin connectors. Used by physicians in clinical settings; provides intracardiac electrical signals for diagnostic interpretation. Benefits include temporary cardiac access for electrophysiological assessment. Device design excludes latex balloon found in predicate; utilizes same materials and assembly methods as predicate.

Clinical Evidence

No clinical data. Substantial equivalence based on engineering testing, mechanical strength, and electrical performance comparisons to the predicate device.

Technological Characteristics

Catheter available in 5, 6, and 7 French sizes. Features distal tip electrode and 1-5 proximal electrodes. Includes 10cm shaft markings. Connectivity via numbered pin connectors. Materials, assembly, and sterilization specifications identical to predicate K930069. Non-powered, passive diagnostic device.

Indications for Use

Indicated for patients requiring temporary electrophysiology studies, intracardiac ECG recording, or electrical stimulation. Intended for use by trained physicians in clinical settings.

Regulatory Classification

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.

Predicate Devices

• J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter (K930069)

Submission Summary (Full Text)

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K973639

Image /page/0/Picture/1 description: The image shows the logo for J-LLOYD MEDICAL INC. The logo features a stylized sunburst graphic to the left of the company name. The text is in a bold, sans-serif font.

mmerce Lane, Suite 6, New Jersey 08009, U.S.A. Telephone [phone] Fax [phone]

August 15, 1997

APR 20 1998

510 K SUMMARY (as required by 807.92 c)

Submitter: James L. Skaggs, Sr. 415 Commerce Lane, Suite 7 West Berlin, New Jersey 08091 Phone: [phone] FAX: [phone]

Contact Person: Same as above.

Product: Electrode Semi-Flotation Catheter.

I. Predicate Device:

The J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter has been approved by FDA 510 (K) #K930069. The function of this device is to provide emergency, temporary pacing, and intracardiac ECG recording.

II. Description of New Device:

The Electrode Semi-Flotation Catheter is furnished in five, six and seven French sizes.

The device has an electrode mounted at the distal tip. There are one to five electrodes mounted on the shaft proximal to the tip. The shaft has bands every ten centimeters. The electrode wires are connected to wire extensions with pin connectors. These are coded with numbers for identification.

III. Intended Use of New Device:

The Electrode Semi-Flotation Catheter is designed for use as follows:

1. Temporary use in electrophysiology studies.

2. Intracardiac ECG recording.

3. Electrical Stimulation.

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## LOYD MEDICAL INC.

415 Commerce Lane. Suite 6. Berlin, New Jersey 08009, U.S.A. Telephone [phone] Fax [phone]

IV. Technological Characteristics of New Device and Predicate Device (510K #K930069)

1. The Electrode Semi-Flotation Catheter and the Predicate Catheter are basically the same, using the same materials, the same basic design and the same methods of assembly.

2. The difference is the addition of electrodes to the Predicate Device which has two electrodes. The addition of the electrodes increases the functions from electrical stimulation, and intracardiac ECG recording, but will also include electrophysiology studies.

3. The performance data such as mechanical strengths and electrical tests remain the same as with the Predicate Device.

4. The Biological, Chemical and Sterilization specifications remain the same as the Predicate Device, in that only physical difference is the addition of materials (electrodes) presently used on the Predicate Device, and the elimination of the latex balloon.

V. Safety Statement:

1. As with any invasive procedure, there are certain inherent hazards, however, these hazards have been identified in the instruction sheet under the titles of Precautions and Warnings. It is important that the physicians be aware of the basic principles involved prior to using these devices in their varied application.

2. Based on engineering testing, the J-LLoyd Medical, Inc. devices and the fact that the asic design has been in use since before May 28, 1976, by thousands of physicians, in hundreds of hospitals world wide, it is our judgement that this device presents an acceptable level of safety then properly used by a trained physician.

James L. Skaggs, Sr.
General Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 20 1998

Mr. James L. Skaggs, Sr. General Manager J-Lloyd Medical, Inc. 415 Commerce Lane, Suite 6 Berlin, New Jersey 08009

K973639 Re: Electrode Semi-Flotation Catheter Regulatory Class: II (two) Product Code: 74 DRF February 5, 1998 Dated: Received: February 6, 1998

Dear Mr. Skaggs:

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 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 Druq 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 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

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 (if known): K973639

Electrode Semi-Floatation Catheter Device Name:

## Indications For Use:

The Electrode Semi-Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following:

- 1. Temporary use in electrophysiology studies;
- 2. Intra-cardiac ECG; and
- 3. Electrical stimulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Venta Tille

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 1 136

Prescription Use X (Per 21 CFR 801.109)

. .

OR

Over-The-Counter Use