(87 days)
Not Found
No
The device description and performance summary focus on the mechanical aspects of a balloon catheter and its historical use, with no mention of AI or ML technologies.
Yes
The catheter is used to temporarily occlude blood vessels, irrigate with heparin or contrast media, and for the non-surgical removal of emboli and thrombi, all of which are direct medical interventions aimed at treating a condition.
No
The device is described as a catheter used for temporary occlusion, irrigation, and removal of emboli and thrombi. Its functions are therapeutic and interventional, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon, shaft, bands, manifold, extensions, hub, and stopcock, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description of this catheter clearly indicates it is used within the body for procedures like occluding blood vessels, irrigating, and removing emboli/thrombi. These are invasive procedures performed directly on the patient.
The intended use and device description are consistent with an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
This catherer is intended for:
- Temporarily occlude blood vessel.
- Irrigating facility for heparin or contrast media.
- USed for the non-surgical removal of emboli and thrombi,
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
-
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
2
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.
3
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
4
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. 】.
-
- Irrigating facility for heparin or contrast media.
-
- USed for the non-surgical removal of emboli and thrombi,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
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