(171 days)
For use during a two guidewire procedure
Dual Lumen Catheter
I am sorry, but the provided text does not contain acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Dual Lumen Catheter," indicating that the device is substantially equivalent to a predicate device and can be marketed.
It references the general controls provisions of the Act, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. However, it does not detail specific performance-based acceptance criteria for the device itself or any study data that would demonstrate compliance with such criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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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
§ 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).