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

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.

AI/ML Overview

The provided text describes a 510(k) submission for the J-LLoyd Medical, Inc. Electrode Semi-Flotation Catheter. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with specific acceptance criteria as might be seen for novel technologies.

Therefore, many of the typical acceptance criteria and study details for a new device are not explicitly present in the provided documentation. The "study" here is essentially a comparison to the predicate device and the existing knowledge about such devices.

Here's an analysis based on the provided text, addressing your points where possible:

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

The submission does not define specific, quantifiable acceptance criteria in the format of a typical clinical trial (e.g., sensitivity, specificity thresholds). Instead, the primary "acceptance criterion" is substantial equivalence to the predicate device, the J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter (K930069), regarding materials, basic design, assembly methods, and performance data.

Acceptance Criterion (Implied)	Reported Device Performance (Claimed)
Material Equivalence	"The Electrode Semi-Flotation Catheter and the Predicate Catheter are basically the same, using the same materials..."
Basic Design Equivalence	"...the same basic design..."
Assembly Method Equivalence	"...the same methods of assembly."
Performance Data Equivalence (Mechanical, Electrical)	"The performance data such as mechanical strengths and electrical tests remain the same as with the Predicate Device."
Biological, Chemical, Sterilization Equivalence	"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." This implies that existing data/knowledge from the predicate device (which has already been approved) is considered applicable to the new device due to the equivalence of these specifications and the minor physical changes.
Safety	"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." This is a qualitative claim based on historical use and engineering testing, not a specific quantifiable safety metric from a new study.
Intended Use	The new device's intended uses (Temporary use in electrophysiology studies; Intracardiac ECG recording; Electrical Stimulation) are presented as an increase in function compared to the predicate's electrical stimulation and intracardiac ECG recording, but the predicate itself provides the basis for these functionalities. The document states that the addition of electrodes "increases the functions from electrical stimulation, and intracardiac ECG recording, but will also include electrophysiology studies." This indicates the device supports these new uses.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described for the new device itself. The evidence relies on:

Engineering testing on the device (not quantified in terms of sample size).
The established performance and safety of the predicate device.
The long history of similar basic designs in use since before May 28, 1976.

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

Not applicable. This was a 510(k) submission based on substantial equivalence, not a study requiring expert readers to establish ground truth for a new diagnostic or prognostic device's performance. The "judgement" of safety is provided by the submitter (James L. Skaggs, Sr., General Manager), referencing widespread physician use over a long period.

4. Adjudication method for the test set

Not applicable, as there was no test set requiring multi-expert adjudication.

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

Not applicable. This device is an electrode catheter, not an AI-powered diagnostic tool.

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

Not applicable. This device is an electrode catheter.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic performance studies is not relevant here. The "truth" in this context is the demonstrated safety and performance of the predicate device and the manufacturing/design equivalence of the new device to that predicate. This relies on:

Engineering Test Data: Mentioned for mechanical strengths and electrical tests, and for safety, though specifics are not provided.
Historical Data/Clinical Experience: The widespread use of the basic design by "thousands of physicians, in hundreds of hospitals world wide" since before May 28, 1976, forms the basis for the safety judgment.
Predicate Device Approval (K930069): The predicate device's prior FDA approval provides the basis for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

Summary

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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 609-753-8339 Fax 609-753-8340

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: 609-753-8339 FAX: 609-753-8340

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:

Temporary use in electrophysiology studies.
Intracardiac ECG recording.
Electrical Stimulation.

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LOYD MEDICAL INC.

415 Commerce Lane. Suite 6. Berlin, New Jersey 08009, U.S.A. Telephone 609-753-8339 Fax 609-753-8340

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

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

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.
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 (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 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 (800) 638-2041 or (301) 443-6597 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;
1. Intra-cardiac ECG; and
1. 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)

. .

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).