(353 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The intended use describes a mechanical action (cutting vein valves).
Yes
The device is used to cut saphenous vein valves during a bypass procedure, indicating a direct therapeutic intervention on the body to restore function or treat a condition.
No
Explanation: The device "cuts saphenous vein valves" which indicates a therapeutic or surgical function, not a diagnostic one.
No
The intended use describes a physical procedure involving cutting, which strongly suggests a hardware component is involved. The lack of a device description prevents definitive confirmation, but the action described is not typically performed by software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Cuts saphenous vein valves during in situ bypass procedure in lower extremities." This describes a surgical procedure performed directly on a patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The device described is a surgical instrument used in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
Cuts saphenous vein valves during in situ bypass procedure in lower extremities.
Product codes
74 MGZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
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
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(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 consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Mr. Trent Kamke Director, Operations Vascutech, Inc. 164 Middlesex Turnpike Burlington, MA 01803
Re: K980723 2.0MM Expandable Lemaitre Valvulotome Requlatory Class: II (Two) Product Code: 74 MGZ Dated: January 15, 1999 Received: January 19, 1999
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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further requlatory action. 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.
1
Page 2 - Mr. Trent Kamke
This letter will allow you to begin marketing your device as Info iceee will as on Joan Joan maket notification. The FDA finding af substantial equivalence of your device to a legally marketed or babbeantlication 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 Graghobere devices), promoty, 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" (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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) NUMBER (IF KNOWN) : K980723
DEVICE NAME: 2.0mm Expandable LeMaitre Valvulotome
INDICATIONS FOR USE:
Cuts saphenous vein valves during in situ bypass procedure in lower extremities.
(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)
Bete L. Cooper C
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular. Respira Neurological Devices 510(k) Number _