EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. by J-LLOYD MEDICAL, INC.

This balloon catheter is furnished in three, four, five, six, seven, eight and nine French sizes. The device has an balloon mounted at the distal tip. The shaft has bands every ten centimeters. The proximal end has a manifold and one extension with a hub and a second extension with a stopcock.

AI/ML Overview

The provided text is a 510(k) summary for the Embolectomy Irrigation - Occlusion Balloon Catheter (EIOBC). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or medical imaging device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this submission.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:

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

The submission does not present a table of specific acceptance criteria or reported device performance in the typical sense of a clinical or technical effectiveness study with quantifiable metrics. Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is assessed by comparison to the predicate device.

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (vs. Predicate)
Intended Use Equivalence	The new device shares the same intended uses as the predicate device: temporary vessel occlusion, injection of contrast media and other fluids, and removal of thrombi and emboli.
Technological Characteristics Equivalence	The new device is "basically the same" as the predicate, using the "same materials, the same basic design and the same methods of assembly." The only difference is the addition of a lumen, which increases function.
Performance Data Equivalence	"The performance data such as mechanical strengths and balloon tests remain the same as with the Predicate Device." (This implies the new device meets the same or similar established internal specifications as the predicate for these aspects). Note: Specific numerical values for these tests are not provided in this summary.
Biological, Chemical, and Sterilization Equivalence	"The Biological, Chemical, and Sterilization specifications remain the same as the Predicate Device."
Safety Equivalence	The device presents an "acceptable level of safety" when properly used by a trained physician, based on engineering testing and the long-standing use of the basic design of the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not describe a "test set" in the context of an AI or diagnostic device study. The comparison is based on the design, materials, and intended use to a predicate device already on the market. The "engineering testing" mentioned for safety and performance (mechanical strengths, balloon tests) would have been conducted internally by the manufacturer, likely on a sample of devices, but the size of this sample is not specified, nor is the data provenance in terms of country or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" establishment in the context of expert consensus, as this is not a diagnostic device or an AI performance study. The assessment is based on comparison to an existing device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) summary.

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 is not an AI-assisted device, and no MRMC study was performed.

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

Not applicable. This is a physical medical device (catheter), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The validation for this device is based on demonstrating substantial equivalence to a predicate device, which includes equivalence in design, materials, manufacturing, intended use, and performance claims derived from engineering testing (rather than clinical ground truth via expert consensus, pathology, or outcomes data).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable. There is no training set mentioned in this 510(k) summary.

Summary

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K974335

FEB 1 3 1998

510 K SUMMARY (as required by 807.92 c)

Date: November 15, 1997

Submitter: James L. Skaggs, Sr. 415 Commerce Lane, Suite 6 Berlin, New Jersey 08009 Phone: 609-753-8339 FAX: 609-753-8340

Contact Person: Same as above.

Product: Embolectomy Irrigation - Ocelusion Balloon Catheter (EIOBC)

I. Predicate Device:

The J-LLoyd Medical, Inc. Embolectorny Catheter has been approved by FDA 510K #K935405 and K920871/B. The function of this device is to provide for non-surgical removal of emboli and thrombi.

II. Description of New Device:

This balloon catheter is furnished in three, four, five, six, seven, eight and nine French sizes.

The device has an balloon mounted at the distal tip. The shaft has bands every ten centimeters. The proximal end has a manifold and one extension with a hub and a second extension with a stopcock.

III. Intended Use of New Device:

This catheter is designed for use as follows:

Temporary use in vessel occlusion.
Injection of contrast media and other fluids.
The removal of thrombi and emboli.

IV. Technological Characteristics of New Device and Predicate Device (510K #K935405 and K920871/B).

The Embolectorny Irrigation - Occlusion Balloon Catheter and the Predicate Catheter are basically the same, using the same materials, the same basic design and the same methods of assembly.

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The difference is the addition of a lumen to the Predicate Device which has one lumen. The addition of the lumens increases the functions of the catheters.
The performance data such as mechanical strengths and balloon tests remain the same as with the Predicate Device.
The Biological, Chemical. and Sterilization specifications remain the same as the Predicate Device, in that the only physical difference is the addition of a lumen presently used on the Predicate Device.

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 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. Skaggs, Jr.
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 consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

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

K974335 Re: Embolectomy, Irrigation - Occlusion Balloon Catheter by J-LLoyd Medical, Inc. Regulatory Class: II Product Code: DXE November 15, 1997 Dated: Received: November 18, 1997

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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts_800_to_895 ... A ........................................................................................................................ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.

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Page 2 - James L. Skaggs, Sr.

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) 594-4595. 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" (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.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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74335

Page ೧೯

SIO(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Narne: __Embolectomy_Irrigation_occlusion_Balloon_Catheter

Indications For Use:

This catherer is intended for:

Temporarily occlude blood vessel. 】.
1. Irrigating facility for heparin or contrast media.
1. USed for the non-surgical removal of emboli and thrombi,

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974335

Prescription Use
(Per 21 CFR 801.109)
OR
Over-Tuc-Counter Use

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).