(190 days)
The LeMaitre Irrigation Catheters are used to irrigate arteries after thrombo-embolectomy, veins after thrombectomy, and the biliary tree after intraductal stone removal.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the LeMaitre Irrigation Catheter. It states the device's substantial equivalence to a legally marketed predicate device for its indicated uses. However, this type of regulatory document does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on a test set (sample size, data provenance).
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely a regulatory approval based on the comparison to a predicate device, not a performance study report. To obtain the kind of information you are looking for, one would typically need access to the technical documentation submitted to the FDA, such as preclinical or clinical study reports, which are not usually made public in this format.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2000
Mr. Trent G. Kamke Vascutech, Inc. 164 Middlesex Turnpike Burlington, MA 01803
Re: K992933 LeMaitre Irrigation Catheter Requlatory Class: II (two) Product Code: 74 DXE Dated: January 13, 2000 Received: January 18, 2000
Dear Mr. Kamke:
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 requlation (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 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. Trent G. Kamke
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,
Chistopher for
Celia M. Witten, Ph.D., 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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STATEMENT OF INDICATIONS FOR USE
| Device Name | LeMaitre Irrigation Catheter |
|---|---|
| Indications for Use | The LeMaitre Irrigation Catheters are used to irrigate arteries after thrombo-embolectomy, veins after thrombectomy, and the biliary tree after intraductal stone removal. |
ChistylMuth fa Witten
(Division Sign-Off)
Division of Cardiovascular, Respiratory.
Division of Cardiovascular, Respiratory.
and Neurological Devices of Occasion Organization 3 99 293 S10(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).