(275 days)
Not Found
Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a physical catheter for temporary blood flow bypass.
Yes
The device is described as providing temporary carotid artery bypass for cerebral circulation during a carotid endarterectomy procedure, which is a medical intervention to treat a disease or condition.
No
This device is a surgical tool designed to provide temporary blood flow bypass during a carotid endarterectomy procedure, not to diagnose a condition.
No
The device description clearly details a physical catheter made of silicone and stainless steel, with lumens, balloons, and connectors. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide temporary blood flow during a surgical procedure (carotid endarterectomy). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical catheter designed to be inserted into a blood vessel. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and related to blood flow management during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LMI Carotid Endarterectomy Shunt Catheter is intended for use during a carotid endarterectomy procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation.
Product codes
MJN
Device Description
The LMI Carotid Endarterectorny Shunt Catheter consists of a multi-lumen, straight or tapered silicone tube with or without stainless steel wire reinforcement with one or more silicone balloons formed at either or both ends. Additional silicone tubes are attached at the approximate center and at approximately 90 degrees of the main tube for communicaton with the main central lumen as well as the smaller lumen used to inflate the balloons that are located on either or both ends. The proximal ends of the balloon inflation tubes are fitted with a female luer connector and may on some models incorporate a strain relief that is bonded to the silicone shaft. The proximal communicating tube is also fitted with a female luer connector and models incorporate a strain relief that is bonded to the silicone shaft. Stopcocks are attached to the female her connecting tubes. The ends of the main nulti-lumen tube are end formed to create a soft leading edge. The main multi-lumen tube may also be tapered in certain models to enchance blood tlow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid artery
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
JUL 30 1999
KG83802
LMI CAROTID ENDARTERECTOMY SHUNT 510K NOTIFICATION LUCAS MEDICAL , INC. 1751 S. DOUGLASS ROAD, ANAHEIM CA 92806
510K APPLICATION PAGE 1 OF 25
510K SUMMARY
PURPOSE: Pursuant to the Federal Food, Drug, and Cosmetic Act, as amended May 28, 1976, Section 510(k), please consider the attached document as Lucas Medical, Inc.'s notification of introduce the LM1 Carotid Endarterectorny Shunt Catheter for commercial distribution. The common names for the device are silicone carotid shunt catheter, carotid catheter and carotid shunt.
MANUFACTURING & STERILIZATION SITES: The manufacturing and packaging facility is: Lucas Medical Inc., 1751 S. Douglass Road, Anaheim CA 92806. The establishment registration number is: 2029386. Sterilization will be performed by Griffith MicroScience (Establishment Registration Number: 2011171) 4900 S. Gilford, Los Angeles CA 90058.
DESCRIPTION: The LMI Carotid Endarterectory Shunt Catheter consists of a multi-lumen, straight or tapered silicone tube with or without stainless steel wire reinforcement with one or more silicone balloons formed at either or both ends. Additional silicone tubes are attached at the approximate center and at approximately 90 degrees of the main tube for communicaton with the main central lumen as well as the smaller lumen used to inflate the balloons that are located on either or both ends. The proximal ends of the balloon inflation tubes are fitted with a female luer connector and may on some models incorporate a strain relief that is bonded to the silicone shaft. The proximal communicating tube is also fitted with a female luer connector and models incorporate a strain relief that is bonded to the silicone shaft. Stopcocks are attached to the female her connecting tubes. The ends of the main nulti-lumen tube are end formed to create a soft leading edge. The main multi-lumen tube may also be tapered in certain models to enchance blood tlow.
CLASSIFICATION: The "DEVICE" is a Class II Medical device and has a classification number of 74GBK and is reviewed by the Cardiovascular Review Panel.
LABELING & INTENDED USE : Labeling including the Instructions for Use are included in this submission. The device is intended for use during a carotid endarterectory procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation. The device is designed as a temporary indwelling cather and is not intended for permanent placement.
PRINCIPLE OF OPERATION: Carolid Endarterectory Shunt Catheters are generally used in procedures for maintaining blood flow to the cerebral area during temporary occlusion of the carotid artery. The affected blood vessel is accessed surgically and the appropriately sized carotid shunt for the blood vessel is selected. The shunt is inserted first into the common carotid artery. The large balloon is inflated with saline until the blood flow has been obstructed. The central silicone tubing is clamped to permit back-flow into the through the stopcock and into the syringe. The smaller balloon is the then inserted into the interval carotid artery and flow is established. The balloon is then inflated with saline with sutficient volume to occlude arterial flow around the shunt and to prevent balloon slippage.
SUBSTANTIAL EQUIVALENCE: The "DEVICE" is substantially equivalent to the VASCUSHUNT CAROTID SILICONE CATHETER made by Research Medical, Inc., the PRUIT-INAHARA CAROTID SHUNT made by Ideas for Medicine, and the SUNDT INTERNAL AND EXTERNAL CAROTID SHUNTS made by Hever-Schulte NeuroCare, The materials of construction, methods of construction and sterilization of the "DEVICE" are identical to the approved LMI Embolectorny catheter 510(k) 954760. The Indicated Use of the Device is substantially equivalent to the Vascushunt Carotid Silicone Catheter, the Pruit-Inahara Carotid Shunt, and the Sundt Internal and External Carotid Shunt Catheters.
Please Address all correspondence and questions to:
Mr. Daniel R. Lucas, President Lucas Medical, Inc. 1751 S. Douglass Road
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and head. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Daniel R. Lucas Lucas Medical, Inc. 1751 S. Douglass Road Anaheim, CA 92806
Re: K983802 Carotid Endarterectomy Shunt Catheter Regulatory Class: II (two) Product Code: MJN Dated: May 14, 1999 Received: June 10, 1999
Dear Mr. Lucas:
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 legally marketed predicate 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 regulations 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. 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.
2
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 requlation (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 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/dsma/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
3
510(k) Number (if known):_K 983802
Device Name: LMI (ARONO ENOARTERITITITUTION Y SHUNT (APPOTER
Indications For Use:
INDICATIONS FOR USE
The LMI Carotid Endarterectomy Shunt Catheter is intended for use during a carotid endarterectomy procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use ______ |
(Optional Format 1-2-96)
Chito M. Ahor for Callahan
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | ____________________ |
|---|---|
| --------------- | ---------------------- |