(21 days)
Not Found
No
The description focuses on mechanical features and does not mention any AI/ML terms or functionalities.
Yes
The device is described as being used for the "treatment of vascular disorders" and for "excising or disrupting venous valves," which are therapeutic actions.
No
Explanation: The device is described as a "valvulotome" used for the "treatment of vascular disorders and more particularly for excising or disrupting venous valves." This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly describes a physical, mechanical device (valvulotome with centering hoops and blades) used for surgical intervention, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of vascular disorders by excising or disrupting venous valves. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a surgical tool (valvulotome) used for a physical intervention (lysis of vein valves).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, this device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
Product codes
MGZ
Device Description
The ELV and OTW-LV are self-centering and self-sizing valvulotome used for blind lysis of vein valves. Once the valves have been rendered ineffectual, it can then be utilized as an arterial conduit. Centering hoops keep the devices centered in the vein and prevent the valve-cutting blades from damaging the vein wall. The size of hoops and blades adjusts to the internal diameter of the vein as the valvulotome is being drawn through the vessel. The OTW-LV facilitates navigation of the vein with the assistance of a guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No additional testing was performed for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K132190
510(k) Summary
Submitter Information:
:
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue Burlington, MA 01803 |
| Contact Person: | Anna Kasseris Regulatory Affairs Specialist Phone: 781-425-1706 Fax: 781-425-5049 Email: akasseris@lemaitre.com |
| Date Prepared: | July 10, 2013 |
| Trade Name: | Expandable LeMaitre Valvulotome (ELV), Over-the-wire LeMaitre Valvulotome |
| Common Name: | Valvulotome |
| Classification Name: | External Vein Stripper |
| Class: | II (two) |
| Classification Panel: | Cardiovascular |
| Product Code: | MGZ |
| Establishment: | 63 Second Avenue Burlington, MA 01803 |
AUG 0 5 2013
1
| Device
Description: | The ELV and OTW-LV are self-centering and self-sizing valvulotome used
for blind lysis of vein valves. Once the valves have been rendered
ineffectual, it can then be utilized as an arterial conduit. Centering hoops
keep the devices centered in the vein and prevent the valve-cutting blades
from damaging the vein wall. The size of hoops and blades adjusts to the
internal diameter of the vein as the valvulotome is being drawn through the
vessel. The OTW-LV facilitates navigation of the vein with the assistance
of a guidewire. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed
Intended Use: | It is used for the treatment of vascular disorders and more particularly for
excising or disrupting venous valves. |
| Predicate
Devices: | K080178- Valvulotome by Koven, |
| Summary of
Technological
Characteristics: | The ELV and OTW-LV are self-centering and self-sizing valvulotome used
for blind lysis of vein valves. Upon deployment the centering hoops expand
to the walls of the vessel. As the device is retracted the hoops keep the
blade away from the vessel while allowing them to lyse the valves. The
OTW LV navigates the vein via a passage over a guidewire. |
| Summary of
Product Testing: | No additional testing was performed for this submission. |
| Biocompatibility: | The biocompatibility of the devices were tested in accordance to ISO 10993
guidelines. |
| Sterilization: | The device is validated for ethylene oxide (EtO) gas sterilization according
to ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices -
Validation and Routine Control of Ethylene Oxide Sterilization". |
| Functional/Safety
Testing: | No additional testing was performed for this submission. |
| Summary of Pre-
clinical Study: | No preclinical study was performed for this submission. |
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LeMaitre Vascular has demonstrated that the ELV and OTW LeMaitre Conclusion: Valvulotome, are substantially equivalent to the predicate device based on its intended use and fundamental scientific technology.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2013
LeMaitre Vascular, Inc. c/o Anna Kasseris Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803
Re: K132190
Trade/Device Name: Expandable Le Maitre Valvulotome and Over-the-wire LeMaitre Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: Valvulotome, External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: July 10, 2013 Received: July 15, 2013
Dear Ms. Kasseris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Anna Kasseris
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman -S
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K132190
Device Name: Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome
Indications for Use: It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
Prescription Use _____ and/or Over-The Counter Use____________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)