HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

• K Number: K971504
• Device Name: HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
• Manufacturer: J-LLOYD MEDICAL, INC.
• Date Cleared: 1998-04-20 ( 360 days)
• Product Code: DRF
• Regulation Number: 870.1220
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K930069
• Predicate For: N/A

Intended Use

The Hexapolar Electrode Balloon 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 Description

The Hexapolar Electrode Balloon Flotation Catheter (HEBFC) is furnished in both five and seven French sizes. The device has an electrode mounted at the distal tip with a latex balloon proximal to the tip electrode. There are five electrodes mounted on the shaft proximal to the balloon. The shaft has bands every ten centimeters. At the manifold, the extension with a Stopcock is connected to the Air Lumen. The electrode wire are connected to wire extensions with pin connectors. These are coded with numbers for identification.

AI/ML Overview

The provided FDA 510(k) summary for the Hexapolar Electrode Balloon Flotation Catheter does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification (510(k)) seeking substantial equivalence to a predicate device. The information provided focuses on:

• Device Description: Comparing the new device (Hexapolar Electrode Balloon Flotation Catheter) to a previously approved predicate device (J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter).
• Technological Characteristics: Highlighting similarities in materials, design, and assembly, and the addition of four electrodes with expanded functions (electrophysiology studies and intracardiac ECG recording).
• Performance Data: Stating that mechanical strengths and electrical tests remain the same as with the Predicate Device.
• Safety Statement: Emphasizing inherent hazards of invasive procedures are identified, and that the basic design has been in use for a long time by many physicians.
• Intended Use/Indications for Use: Listing the specific applications for the device.
• FDA Clearance: The letter from the FDA confirming substantial equivalence.

Therefore, I cannot populate the requested table and answer the study-related questions based on the input text.

Here's why and what's missing:

• Acceptance Criteria & Performance: The document states that "The performance data such as mechanical strengths and electrical tests remain the same as with the Predicate Device." It does not provide what those specific performance data points or acceptance criteria are, nor does it present new test results for the Hexapolar device against those criteria. It implies that since the core technology is similar, the existing predicate device's performance data applies.
• Study Details: There is no mention of a specific study, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically required for novel devices or when significant changes warrant new performance testing. For a 510(k) based on substantial equivalence, especially for a device that is essentially an enhanced version of an existing product, extensive new performance studies are often not required if the changes are deemed minor and do not alter the fundamental safety and effectiveness.

Summary

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KG71504

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 text. The text is in bold, sans-serif font and is all capitalized.

ommerce Lane, Suite 6, 1. New Jersey 08009, U.S.A.

APR 20 1998

510 K SUMMARY (as required by 807.92 c)

Date: April 15, 1997

Telephone [phone]

Fax [phone]

Submitter: James L. Skaggs, Sr. 415 Commerce Lane, Suite 6 Berlin, New Jersey 08009 Phone: [phone] FAX:

Contact Person: Same as above.

Product: Hexapolar Electrode Balloon Flotation Catheter

I. Predicate Device:

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

II. Description of New Device:

The Hexapolar Electrode Balloon Flotation Catheter (HEBFC) is furnished in both five and seven French sizes.

The device has an electrode mounted at the distal tip with a latex balloon proximal to the tip electrode. There are five electrodes mounted on the shaft proximal to the balloon. The shaft has bands every ten centimeters. At the manifold, the extension with a Stopcock is connected to the Air Lumen. The electrode wire are connected to wire extensions with pin connectors. These ದಿನ ನಾಗಿ ಸ್ಥ are coded with numbers for identification. 2 2017 11:11

III. Intended Use of New Device:

The Hexapolar Electrode Balloon 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.

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

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

1. The Hexapolar Electrode Balloon 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 four electrodes to the Predicate Device which has two electrodes. The addition of the four electrodes increases the functions from just electrical stimulation to also include temporary use in electrophysiology studies and intracardiac ECG recording.

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 the only physical difference is the addition of materials (electrodes) presently used on the Predicate Device.

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 the J-LLoyd Medical. Inc. devices and the fact that the basic 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 when properly used by a trained physician.

James L. Shepard.

James L. Skaggs, Jr. General Manager

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three profiles facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 20 1330

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

K971504 Re: Hexapolar Electrode Balloon Flotation Catheter Requlatory 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 regulation 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.gov/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): K971504

Device Name: Hexapolar Electrode Balloon Floatation Catheter

Indications For Use:

The Hexapolar Electrode Balloon 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)

Obertk Tule

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_

Prescription Use X (Per 21 CFR 801.109)

OR

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).