(264 days)
No
The device description explicitly states, "This medical device has no software components." Additionally, there are no mentions of AI, DNN, or ML in the provided text.
Yes
The device is used to render venous valves incompetent during in situ bypass procedures, which is a therapeutic intervention aimed at restoring blood flow to the extremities in patients with peripheral vascular disease.
No
The device description explicitly states, "This device is not an in vitro diagnostic device," and its intended use is for disrupting venous valves during bypass procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states, "This medical device has no software components."
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "This device is not an in vitro diagnostic device."
- Intended Use: The intended use is to "render venous valves incompetent during in situ bypass procedures." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Mechanism of Action: The device works by physically disrupting venous valves using cutting heads. This is a mechanical action, not a diagnostic test that analyzes biological samples.
Therefore, the EZE SIT Valvulotome is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.
Product codes
MGZ
Device Description
The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Venous valves (for in situ bypass procedures, including distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Attending physician. Surgically invasive.
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)
N/A. This submission is intended to simply indicate a new manufacturer for a currently cleared device design that has not changed since its clearance (K930011). This submission includes 3 types of nonclinical data, including Sterilization, Shelf Life/Aging, and Biocompatibility.
Sterilization: The EZE SIT is Ethylene Oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6. Sterilization is validated with half-cycle using ISO 11135-1: 2014. Residuals measured at 48h after sterilization indicate that the device has a maximum of EtO of 0.6 mg, and a maximum of
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2019
LeMaitre Vascular, Inc. Xiang Zhang VP of Regulatory 63 Second Avenue Burlington, Massachusetts 01803
Re: K190267
Trade/Device Name: EZE SIT Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: September 26, 2019 Received: September 30, 2019
Dear Xiang 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carmen Gacchina Johnson, Ph.D. Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K190267
Device Name EZE SIT Valvulotome
Indications for Use (Describe)
The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a blue and white abstract shape on the left, followed by the words "LeMaitre" in a bold, teal font. Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter blue font. The logo is clean and professional, and it conveys a sense of trust and reliability.
SECTION 8: 510(k) Summary
| I. SUBMITTTER | LeMaitre Vascular, Inc.
63 Second Avenue
Burlington, MA 01803 |
|----------------------------|----------------------------------------------------------------------------------------------------------------|
| Establishment Registration | 1220948 |
| Phone: | 781-425-1685 |
| Fax: | 781-425-5049 |
| Contact Person: | Xiang Zhang
VP of Regulatory
Email: xzhang@lemaitre.com |
| Date Prepared | September 26, 2019 |
| I. DEVICE | |
| Device Name: | EZE-SIT Valvulotome |
| Trade Name: | EZE-SIT Valvulotome |
| Common Name: | External Vein Stripper |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21CFR §870.4885 |
| Class: | II (2) |
| Product Code: | MGZ |
| Prior Submissions: | No prior submissions have been made for the changes
detailed in this traditional 510(k). |
| II. PREDICATE DEVICE | Tru-Incise Valvulotome (K930011)
This predicate device has not been subject to a design-
related recall. |
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Image /page/4/Picture/0 description: The image is a logo for LeMaitre Vascular. The logo features a stylized blue wave-like design on the left, followed by the words "LeMaitre" in a bold, teal font. Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter blue font.
III. DEVICE DESCRIPTION:
The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.
IV. INDICATIONS FOR USE:
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a nonanatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.
Overall Description, Device Design: The EZE SIT Valvulotome comprises a catheter with a luer lock hub at the proximal end, a threaded connector at the distal end, and a lumen that extends throughout its entire length. The threaded connector allows attachment of 2mm, 3mm and 4mm diameter cutting heads, which also feature a central lumen. The design allows the physician to select the cutter head diameter best suited for a particular vein being prepared. The central lumen allows irrigation during the procedure. The cutting heads minimize vessel wall contact while effectively disrupting valve leaflet tissue. The design of the EZE SIT Valvulotome has not changed since the original clearance (K930011).
Materials: The materials of the EZE SIT Valvulotome are identical to those used for the Tru-Incise Valvulotome (K930011). All components are patient-
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Image /page/5/Picture/0 description: The image is a logo for LeMaitre Vascular. The logo features a stylized blue and white graphic on the left, resembling a wave or a stylized letter 'L'. To the right of the graphic is the company name, "LeMaitre," in a bold, teal font, with the registered trademark symbol next to it. Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter teal font.
contacting unless indicated otherwise. EZE SIT is
surgically invasive and intended for Packaging Materials (all non-patient contacting) | |
| EZE SIT Head Holder
Pouch | Tyvek/Polyethylene
Terephthalate (PET)/
Polyethylene (PE) |
| EZE SIT Device Pouch | Polyethylene (PE) |
| EZE SIT Tyvek Lid | Tyvek |
| EZE SIT Packaging Tray | Polyethylene
Terephthalate Glycol
(PETG) |
Chemical Composition: All of the components of the EZE SIT Valvulotome remain unchanged from the original device design cleared in K930011.
Energy Source: The EZE SIT Valvulotome is a device that transduces manual force provided by the user into the lysis of valve cusps, thus allowing retrograde blood flow in a vein. EZE SIT uses and provides no other source of energy of electromechanical, radiological or other origin. The aspect of energy source supplied to the medical device remains unchanged from the predicate device cleared in K930011.
Summary: All aspects of the medical device, including the design, materials, chemical composition and energy source of the subject device remain unchanged from the original predicate device cleared in K930011, and thus support substantial equivalence of the subject to the predicate device.
VI. PERFORMANCE DATA
N/A. This submission is intended to simply indicate a new manufacturer for a currently cleared device design that has not changed since its clearance (K930011). This submission includes 3 types of nonclinical data, including Sterilization, Shelf Life/Aging, and Biocompatibility.
Sterilization: The EZE SIT is Ethylene Oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6. Sterilization is validated with half-cycle using ISO 11135-1: 2014. Residuals measured at 48h after sterilization indicate that the device has a maximum of EtO of 0.6 mg, and a maximum of