(92 days)
Not Found
No
The device description focuses on mechanical features and material properties (hydrophilic coatings). There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies are also focused on mechanical and physical properties.
Yes
The device is used for the "treatment of vascular disorders" by "excising or disrupting venous valves," which are therapeutic actions.
No
Explanation: The device description and intended use clearly state that this device is used for the "treatment of vascular disorders" by "cutting vein valves," not for diagnosing them.
No
The device description clearly describes a physical, mechanical device (valvulotome) used for cutting vein valves. The modifications mentioned are related to physical coatings and sheaths, not software. The performance studies listed are also focused on physical properties and performance in a cadaver study.
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 intervention performed in vivo (within the body).
- Device Description: The description details a surgical tool designed to be inserted into a vein to physically cut valves. This is a medical device used for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples to gain information about a patient's health status. This device is used inside the body for a therapeutic purpose.
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 (comma separated list FDA assigned to the subject device)
MGZ
Device Description
The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been completed to evaluate the performance of the Subject Device:
- Dimensional Verification .
- Fatigue Testing ●
- Flushability .
- . Force to insert and remove device
- Force to open and close device .
- Tortuous Sheathing ●
- Cadaver Study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510 (k) Summary
K140042
APR 1 1 9612
Submitter's information:
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA USA 01803 | |
| Phone: | 781-425-1729 |
| Contact Person: | Xiang (Vic) Zhang |
| Date of preparation: | January 6, 2014 |
| Device Name: | 1.5mm HYDRO Expandable LeMaitre Valvulotome |
| Trade Name: | HYDRO Expandable LeMaitre Valvulotome |
| Common/ Classification Name: | Valvulotome, External Vein Stripper |
| Classification Panel: | 21CFR §870.4885 |
| Class: | II (2) |
| Product Code: | MGZ |
| Classification Panel: | Cardiovascular |
Establishment Registration: 1220948
Establishment: LeMaitre Vascular, Inc., 63 Second Avenue, Burlington, MA USA 01803
Proposed Subject Device Description:
The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.
Proposed Intended Use (Subject Device):
1
It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.
Predicate Intended Use:
It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.
Predicate Devices:
| 510(k): | K132190 (Change to indication) |
|---|---|
| Device Name: | Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome |
| SE Date: | 8/5/2013 |
| Regulation Number: | 21CFR §870.4885 |
| Device Class Name: | Valvulotome, External Vein Stripper |
| Device Class: | II |
| Product Code: | MGZ |
| 510(k): | K980732 |
| Device Name: | Expandable LeMaitre Valvulotome |
| SE Date: | 2/12/1999 |
| Regulation Number: | 21CFR §870.4885 |
Device Class Name: Valvulotome, External Vein Stripper Device Class: II
Product Code: MGZ
Substantial Equivalence:
Fundamental Scientific Technological Characteristics:
The 1.5mm HYDRO Expandable LeMaitre Valvulotome maintains the same intended use and fundamental scientific technology as the predicate device(s) and is substantially equivalent to the predicate device(s).
Functional/ Safety testing:
The verification activities conducted on the subject device indicate that 1.5mm HYDRO Expandable LeMaitre Valvulotome meets the product performance specifications and the modifications do not raise any additional safety issues.
Sterilization:
The device is validated for ethylene oxide (EO) sterilization according to ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization". The Sterilization process remains unchanged.
Biocompatibility:
2
All blood contact portions of the device were subjected to Biocompatibility testing according to ISO 10993 guidelines for an externally communicating device with limited contact duration ( Trade/Device Name: 1.5mm Hydro Expandable Lemaitre Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: Valvulotome Regulatory Class: Class II Product Code: MGZ Dated: March 11, 2014 Received: March 12, 2014
Dear Mr. Zhang,
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 either 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
4
Page 2 - Xiang Zhang
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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,
Kenneth J. Cavanaugh -S
2014.04.10 15:12:05 -04'00'
for Bram D. Zuckerman, M.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) | K140042 |
|---|---|
| Device Name | 1.5mm HYDRO Expandable LeMaitre Valvulotome |
| Indications | |
| for Use | It is used for the treatment of vascular disorders, and more particularly for |
| excising or disrupting venous valves. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801. 109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Image /page/5/Picture/7 description: The image shows the name "Kenneth J. Cavanaugh - S" in a bold, sans-serif font. The text is black against a white background. There is some noise around the letters "J" and "Cavanaugh".