(28 days)
Not Found
No
The summary describes a mechanical device for cutting vein valves and mentions only standard biocompatibility and bench testing, with no indication of AI/ML components or data analysis methods.
Yes
The device is indicated for cutting saphenous vein valves during in-situ bypass, which is a therapeutic intervention.
No
The device is indicated for cutting saphenous vein valves, which is a therapeutic intervention, not a diagnostic one.
No
The device description and performance studies clearly indicate a physical catheter with mechanical components and biological interactions, not a software-only device.
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 saphenous vein valves during in-situ bypass." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire." This is a surgical instrument.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The information provided clearly indicates a surgical device used for a therapeutic purpose within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during In Situ bypass.
Product codes
MGZ
Device Description
The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous 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)
Biocompatibility testing was conducted in accordance with AAMI/ANSI/ ISO 10993-1: 2003 Biological Evaluation of Medical Devices- Part 1 Evaluation and Testing. The following biocompatibility tests were conducted with results that demonstrated that the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use:
- . ISO MEM Elution Assay
- Complement Activation C3a and SC5b-9 Assay .
- Platelet & Leukocyte Count .
- ASTM Hemolysis Assay ●
- Partial Thromboplastin Time ●
- ISO Intracutaneous Reactivity .
- Murine Local Lymph Node Assay .
- ISO Acute Systemic Injection Test in the Mouse t
The proposed OTW-ELV was tested through in-vitro bench-top testing as well as in-vitro cadaver testing. The following performance bench testing was completed for the OTW-ELV:
- Tensile testing of all bond joints .
- Dimensional verification against product design specifications t
- Guidewire compatibility .
- Trackability through in-vitro models (simulated use) .
- Trackability through cadaver models (simulated use) .
- Efficacy cutting of in-vitro vein valves (simulated use) .
- Efficacy cutting of cadaver vein valves (simulated use) t
- Hemostasis .
- . Fatigue testing
All test results demonstrated that the materials chosen, the manufacturing process, and the design utilized for OTW-Expandable LeMaitre Valvulotome met the established specifications necessary for consistent performance during its intended use as well as substantial equivalence to its predicate.
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 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
JUL 2 9 2011 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Section 5.0
A. Submitter Information
| Submitter's Name: | LeMaitre Vascular Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Telephone: | 781-221-2266 |
| Fax: | 781-425-5049 |
| Contact Person: | Andrew Hodgkinson, Vice President Clinical |
| Regulatory and Quality Affairs | |
| Date of Preparation: | July 28, 2011 |
B. Subject Device
Trade Name: Common/Usual Name: Classification Name:
OTW-Expandable LeMaitre Valvulotome Valvulotome Valvulotome (870.4885, Product Code MGZ)
C. Predicate Device Name:
Trade Name:
Expandable LeMaitre Valvulotome, (K980723)
D. Device Description:
The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.
E. Intended Use:
The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.
F. Summary of Technological Characteristics
The OTW ELV navigates the vein via passage over a guidewire. Upon deployment, the centering hoops expand to the walls of the vessel. As the device is retracted, the hoops keep the blades away from the vessel while allowing them to cut the valves as they are encountered.
G. Performance Data:
Biocompatibility testing was conducted in accordance with AAMI/ANSI/ ISO 10993-1: 2003 Biological Evaluation of Medical Devices- Part 1 Evaluation and Testing. The following biocompatibility tests were conducted with results that demonstrated that the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use:
- . ISO MEM Elution Assay
- Complement Activation C3a and SC5b-9 Assay .
- Platelet & Leukocyte Count .
1
- ASTM Hemolysis Assay ●
- Partial Thromboplastin Time ●
- ISO Intracutaneous Reactivity .
- Murine Local Lymph Node Assay .
- ISO Acute Systemic Injection Test in the Mouse t
The proposed OTW-ELV was tested through in-vitro bench-top testing as well as in-vitro cadaver testing. The following performance bench testing was completed for the OTW-ELV:
111 284
2.22
- Tensile testing of all bond joints .
- Dimensional verification against product design specifications t
- Guidewire compatibility .
- Trackability through in-vitro models (simulated use) .
- Trackability through cadaver models (simulated use) .
- Efficacy cutting of in-vitro vein valves (simulated use) .
- Efficacy cutting of cadaver vein valves (simulated use) t
- Hemostasis .
- . Fatigue testing
All test results demonstrated that the materials chosen, the manufacturing process, and the design utilized for OTW-Expandable LeMaitre Valvulotome met the established specifications necessary for consistent performance during its intended use as well as substantial equivalence to its predicate.
H. Conclusion:
LeMaitre Vascular has demonstrated that the OTW-Expandable LeMaitre Valvulotomc is substantially equivalent to the predicate device based on its indications for use and fundamental scientific technology.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 9 2011
LeMaitre Vasculature c/o Andrew Hodgkinson Vice President, Clinical, Regulatory, & Quality Affairs . 63 Second Avenue Burlington, MA 01803
Re: K111884
Trade/Device Name: OTW-Expandable LeMaitre Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: June 30, 2011 Received: July 1, 2011
Dear Mr. 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. However, we remind you 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.
3
Page 2 – Mr. Andrew Hodgkinson
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 of medical devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Zuckerman, M
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Over-The-Wire Expandable LeMaitre Valvulotome
Indications for Use:
The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during In Situ bypass.
Prescription 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)
LL
ovascular Devices
510(k) Number K111884