(126 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical cutting and physical properties, with no mention of AI, ML, or related concepts.
Yes
The device is intended to cut venous valves, which is a therapeutic intervention to enable the vein to be used as an arterial conduit.
No
Explanation: The device is intended to cut venous valves to enable the vein to be used as an arterial conduit, indicating a therapeutic or surgical purpose rather than diagnosing a condition.
No
The device description clearly states it consists of physical components like a metal blade, wire, and plastic handle, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- LeMills Valvulotome Function: The LeMills Valvulotome is a surgical instrument designed to physically cut venous valves inside the body. It is used directly on the patient's anatomy during a procedure.
The description clearly indicates a surgical tool used for a physical intervention within the body, not a device used for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The LeMills Valvulotome is intended to cut venous valves.
Product codes (comma separated list FDA assigned to the subject device)
MGZ
Device Description
The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous anatomy
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 safety and performance of LeMills Valvulotome compared with the predicate device:
- 0 Dimensional comparison
- . Sharpness Test (Effectiveness Test)
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.
Mills Valvulotome, Pre-amendment device.
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
K132047
NOV 0 5 2013
510 (k) Summary
Submitter's information:
| LeMaitre Vascular, Inc. | |
|---|---|
| 63 Second Avenue | |
| Burlington, MA USA 01803 | |
| 781-425-1727 | |
| 781-425-5049 | |
Contact Person: Bryan Cowell, MSc., RAC
| Date of preparation: | July 1, 2013 |
|---|---|
| Device Name: | LeMills Valvulotome |
| Trade Name. | LeMills Valvulotome |
| Common/ Classification | |
| Name: | External Vein Striper |
| Classification Panel: | |
| Class: | 21CFR §870.4885 |
| II (2) |
Product Code: MGZ
Establishment Registration: 1220948
Establishment: LeMaitre Vascular, Inc., 63 Second Avenue, Burlington, MA USA 01803
Owner/Operator: 1220948
Proposed Device Description:
The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
Proposed Intended Use:
The LeMills Valvulotome is intended to cut venous valves.
1
Predicate Device:
Device Name: Mills Valvulotome, Pre-amendment device.
Substantial Equivalence:
Fundamental Scientific Technological Characteristics:
The LeMills Valvulotome maintains the same fundamental Scientific Technology as the Mills Valvulotome and is used to cut venous valves.
Functional/ Safety testing:
The verification activities conducted indicate that LeMills Valvulotome device meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Sterilization:
The device is validated for ethylene oxide (EO) sterilization according to ANSVAAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization"
Biocompatibility:
Materials used in this device were subjected to Biocompatibility assessment according to ISO 10993 guidelines for an externally communicating device with limited contact duration ( Trade/Device Name: LeMills Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: October 24, 2013 Received: October 28, 2013
Dear Andrew Hodgkinson:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Andrew Hodgkinson
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known)
K132047/5001
Device Name LeMills Valvulotome
Indications The LeMills Valvulotome is intended to cut venous valves. for Use
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)
ﺮ
OR
Over-The-Counter Use_