(128 days)
The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.
The catheter consists of a stainless steel wire reinforced silicone tube that is end formed to create a rounded leading nose. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The distal end of the catheter has four side ports as well as central lumens that provide openings for irrigating fluid. The "DEVICE" is packaged in an ElO breathable tray for protection and then sealed in an EtO breathable pouch. It is E.O sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only and is used only By or On the Order of a Physician.
The provided text is a 510(k) summary for a medical device (Lucas Medical, Inc.'s LMI Irrigation Catheter) seeking clearance from the FDA in 1997. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical studies or performance criteria in the way a modern AI/ML device submission would.
Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. These elements are typically found in submissions for novel devices or those with more complex functional claims, especially those involving AI/ML.
Here's a breakdown of why each requested point cannot be answered from the provided text:
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A table of acceptance criteria and the reported device performance:
- Reason not available: This document is a 510(k) submission from 1997 for a medical catheter. The concept of "acceptance criteria" and "reported device performance" in the context of quantifiable metrics, as would be expected for an AI/ML device, is not applicable here. The goal of this submission is to demonstrate "substantial equivalence" to existing, legally marketed devices. Performance is generally assumed to be similar to the predicate based on design and material similarities, rather than statistical performance metrics.
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Sample sizes used for the test set and the data provenance:
- Reason not available: No test set or sample size data is mentioned. The submission relies on comparing the device's design, materials, and intended use to existing predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Reason not available: No "ground truth" establishment or expert review of a test set is discussed. This is not a study design where expert consensus or other forms of ground truth would be established for evaluating a device's diagnostic or predictive performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Reason not available: No adjudication method is mentioned as there is no test set or study requiring such a method.
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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:
- Reason not available: This device is an irrigation catheter, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study or any assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Reason not available: This is a physical medical device (catheter), not an algorithm. Standalone algorithm performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reason not available: No ground truth in the context of an evaluative study is mentioned or implied.
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The sample size for the training set:
- Reason not available: This is a physical device, not an AI/ML model. There is no concept of a "training set" for an irrigation catheter.
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How the ground truth for the training set was established:
- Reason not available: As there is no training set, there is no ground truth for it.
In summary, the provided documentation is for a 1997 medical device (catheter) 510(k) submission, which focuses on demonstrating substantial equivalence rather than presenting extensive performance study data typical of modern AI/ML device evaluations.
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510K SUMMARY
NOV 1 9 1997
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 intent to introduce the LMI Irrigation Catheter for commercial distribution. The common names for the device are silicone irrigation catheter.
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 catheter consists of a stainless steel wire reinforced silicone tube that is end formed to create a rounded leading nose. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The distal end of the catheter has four side ports as well as central lumens that provide openings for irrigating fluid. The "DEVICE" is packaged in an ElO breathable tray for protection and then sealed in an EtO breathable pouch. It is E.O sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only and is used only By or On the Order of a Physician.
CLASSIFICATION: The "DEVICE" is a Class II Medical device and has a classification number of 74DXE 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 intra-operative procedures requiring irrigation in blood vessels, namely arteries and veins.
Irrigation catheters are generally used in procedures to facilitate the use of irrigating PRINCIPLE OF OPERATION: media in either arterial or venous blood vessels, to flush the immediate area of a thrombectomy. The affected blood vessed is accessed surgically proximal to the desired region. The appropriately sized irrigating cathere for the blood vessel is selected. The catheter is inserted into the vessel and advanced distaily to the desired region. The irrigating media is then infused into the catheter via a syringe. Then pulled back toward the venous'arterial incision and removed. Additional irrigating media may be infused by utilizing the same technique.
SUBSTANTIAL EQUIVALENCE: The "DEVICE" is substantially equivalent to the Fogarty Irrigation Catheter and Intimax Irrigating Catheter currently in the materials of construction, methods of construction and the packaging and sterilization of the "DEVICE" are identical to the approved LMI Arterial Bi-Lumen Irrigation Embolectorny Catheter (510k -K955499). The Indicated Use of the Device is substantially equivalent to the Fogarty Irrigation Catheter manufactured by Baxter Healthcare and the Intimax Irrigation Catheter manufactured by Applied Vascular.
Please Address all correspondence and questions to:
Mr. Daniel R. Lucas, President Lucas Medical, Incorporated 1751 S. Douglass Road Anaheim CA 92806 Phone: 1-714-938-0233 1-714-938-0130 FAX:
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three distinct head shapes stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 9 1997
Mr. Daniel R. Lucas Lucas Medical, Inc. 1751 S. Douglass Road 92806 Anaheim, California
K972623 Re: LMI Irrigation Catheter Requlatory Class: II (two) Product Code: 74 DXE October 26, 1997 Dated: Received: October 30, 1997
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 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 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 EFR 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 requlatory 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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Page 2 - Mr. Daniel R. Lucas
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 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,
Sincerely yours,
Thomas J. Callahan
allahan, Ph.D. Thomas J. C Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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LUCAS MEDICAL, INC.
INDICATIONS FOR USE
The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.
T.A.R
(Division Sign-Off) Division of Cardiovascul and Neurological Device 510(k) Number
§ 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).