(171 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is described as a "Dual Lumen Catheter" and is "For use during a two guidewire procedure." This indicates it's an accessory or tool for a medical procedure rather than a device that delivers therapy or treats a condition itself.
No
The device is described as a "Dual Lumen Catheter" for use during a "two guidewire procedure," indicating an interventional or procedural use rather than a diagnostic one. There is no mention of it being used to detect, identify, or monitor medical conditions or diseases.
No
The device description explicitly states "Dual Lumen Catheter," which is a physical medical device, not software.
Based on the information provided, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use "For use during a two guidewire procedure" describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: A "Dual Lumen Catheter" is a medical device used within the body, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
IVDs are specifically designed to perform tests on samples outside the body to provide information for diagnosis, monitoring, or screening. This device's description clearly indicates it's used within the body during a medical procedure.
N/A
Intended Use / Indications for Use
For use during a two guidewire procedure
Product codes
DQY
Device Description
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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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 1999
Ms. Karen Ú. Salinas Vice President, RA/CA/QA Endologix, Inc. 20 Fairbanks, Ste. 173 Irvine, CA 92618
K991601 Re : Trade Name: Dual Lumen Catheter Regulatory Class: II Product Code: DQY September 2, 1999 Dated: Received: September 7, 1999
Dear Ms. Salinas:
We have reviewed your Section 510(k) notification of intent to market we nave revironed above and we have determined the device is ene acreaally equivalent (for the indications for use stated in the substancially oquivalented predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Dewice 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 TTT (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 A substantially equivalent determination assumes compliance with 895. 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 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
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Page 2 - Ms. Karen U. Salinas
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.
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) 594-4586. Additionally, for questions on the promotion and advertisinq 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" (21CFR 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,
Atl. A. Ciarlowski.
for Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K991601 510(k) number (if known): _
Dual Lumen Catheter Device Name:
Indications for Use:
For use during a two guidewire procedure
(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 _________________________________________________________________________________________________________________________________________________________
Christopher M. Ahler for Sginistein
(Division Sign-Of Division of Cardiova 510(k) Num