(29 days)
Not Found
No
The device description and performance studies focus on mechanical cutting and physical properties, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to cut venous valves to render them ineffectual, allowing the vein to be used as an arterial conduit. This is a direct intervention to treat a medical condition (venous insufficiency or to prepare a vein for bypass), thus acting as a therapeutic device.
No
Explanation: The device is described as an "antegrade cutting blade" designed for "cutting the venous valves" to allow the vein to be used as an arterial conduit. This indicates a therapeutic function (modifying anatomy) rather than a diagnostic one (identifying a disease or condition). The performance studies also focus on mechanical properties like sharpness and tensile strength, not diagnostic accuracy.
No
The device description clearly outlines physical components like a metal cutting blade, stainless steel wire, and a plastic handle, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut venous valves" within the body. This is a surgical procedure performed directly on a patient's anatomy.
- Device Description: The device is a physical instrument designed for cutting tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not interact with specimens in this way.
The device is clearly an invasive surgical instrument used for a therapeutic purpose (preparing a vein for use as an arterial conduit), not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The LeMills Valvulotomes are intended to cut venous valves.
Product codes (comma separated list FDA assigned to the subject device)
MGZ
Device Description
The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel 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)
Functional/Safety Testing: The verification activities conducted indicate that Antegrade LeMills Valvulotome device meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Summary of Product Testing: The following tests have been completed to evaluate the safety and performance of the Antegrade LeMills Valvulotome: Dimensional Comparison Sharpness Test (Effectiveness Test) Visual Inspection Joint Tensile Strength (Pull Test)
Summary of Pre-clinical Study: N/A
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an abstract representation of an eagle or a similar bird, with stylized feathers or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Lemaitre Vascular, Inc. % Anna Kasseris Regulatory Affairs Specialist 63 Second Avenue Burlington, Massachusetts 01803
Re: K142660
Trade/Device Name: Antegrade LeMills Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: September 15, 2014 Received: September 18, 2014
Dear Anna 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142660
Device Name Antegrade LeMills Valvulotome
Indications for Use (Describe) The LeMills Valvulotomes are intended to cut venous valves.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510k Summary
Submitter's Information
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Anna Kasseris |
| Regulatory Affairs Specialist | |
| Email: akasseris@lemaitre.com | |
| Date Prepared: | September 15, 2014 |
| Device Name: | Antegrade LeMills Valvulotome |
| Trade Name: | LeMills Valvulotome |
| Common Name: | External Vein Stripper |
| Classification Name: | Cardiovascular |
| Classification Panel: | 21CFR §870.4885 |
| Class: | II (2) |
| Product Code: | MGZ |
| Establishment | |
| Registration: | 1220948 |
| Establishment: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Predicate Device: | LeMills Valvulotome (Retrograde) K132047 |
| Reference Device: | Mills Valvulotome (Antegrade), Pre-amendment |
| Device Description: | The Antegrade LeMills Valvulotome consists of small |
| metal antegrade cutting blade with atraumatic distal edge. | |
| The blade is a part of a long stainless steel 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. | |
| Intended Use: | The LeMills Valvulotome is intended to cut venous valves. |
| Summary of Technological | |
| Characteristics: | The Antegrade LeMills Valvulotome maintains the same |
| technological characteristics as the predicate Retrograde | |
| LeMills Valvulotome. | |
| Functional/Safety Testing: | The verification activities conducted indicate that |
| Antegrade LeMills Valvulotome device meets the product | |
| performance requirements of the device specifications and | |
| does not raise any additional safety issues. | |
| Sterilization: | The device is ethylene oxide (EO) sterilized according to |
| ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical | |
| Devices - Validation and Routine Control of Ethylene | |
| Oxide Sterilization" | |
| Biocompatibility: | Biocompatibility of the device has been assessed according |
| to ISO 10993 guidelines for an externally communicating | |
| device with limited contact duration ( |