(32 days)
Not Found
No
The description focuses on a mechanical coupling device for vessel anastomosis and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as a mechanical method for connecting vessels during microsurgical and vascular reconstructive procedures, which is a surgical tool rather than a device for treatment or therapy.
No
The device description states it is a "mechanical method for anastomosis, or connection, of small vessels." This indicates it is used for surgical connection rather than diagnosis.
No
The device description explicitly states it is a "mechanical method for anastomosis" and a "Microvascular Anastomotic Coupler," indicating it is a physical, mechanical device, not software.
Based on the provided information, the VesseLink device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- VesseLink's Function: The VesseLink is a mechanical device used during surgery to connect blood vessels (veins and arteries) within the body. It is a surgical tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for "anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures." This describes a surgical procedure, not a diagnostic test.
- Device Description: The description reinforces that it's a "mechanical method for anastomosis" of vessels.
Therefore, the VesseLink falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
Product codes
MVR
Device Description
The VesseLink Microvascular Anastomotic Coupler (VesseLink) is a mechanical method for anastomosis, or connection, of small vessels ranging in size from 0.8 mm to 4.3 mm in outer diameter. The VesseLink is intended for use in the end-to-end and end to side vessel anastomosis as well as arterial/venous vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and arteries
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
Bench testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for ViOptix. The logo consists of the text "ViOptix" in a simple, sans-serif font. To the right of the text, there is a stylized graphic that resembles a person with outstretched arms forming a "V" shape, with a circle representing the head. The graphic is bold and black, contrasting with the white background.
APR 1 7 2009
47224 Mission Falls Ct. Fremont, CA 94539 510-360-7523 info@vioptix.com
SUMMARY
Submitter's name: Address:
Phone: Fax number: Name of contact person: ViOptix, Inc. 47224 Mission Falls Ct. Fremont, CA 94539 510-360-7523 510-226-5864 Grace Holland Requiatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411
March 13, 2009 Date the summary was prepared:
Name of the device: Classification name: Product code
Device Class
VesseLink Microvascular Anastomotic Coupler System Microvascular Anastomotic Coupler MVR 878.4300
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| Reference # | Device Name | Applicant |
|---|---|---|
| K040163 | Microvascular Anastomotic Device | Synovis Micro Companies |
Description of the device:
The VesseLink Microvascular Anastomotic Coupler (VesseLink) is a mechanical method for anastomosis, or connection, of small vessels ranging in size from 0.8 mm to 4.3 mm in outer diameter. The VesseLink is intended for use in the end-to-end and end to side vessel anastomosis as well as arterial/venous
REGULATORY SPECIALISTS, INC.
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vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
Indications:
To be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
Summary of the technological characteristics of our device compared to the predicate device:
Technological Characteristics
proposed device has the same technological This characteristics as the predicate device.
Indications for Use
The Indications for Use for this proposed device had the same Indications for Use as the predicate device.
Performance Testing
Bench testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent.
CONCLUSION
Based on the design, technology, performance, functional testing, and intended use, the VesseLink is substantially equivalent to the devices currently marketed under the Federal Food. Drug and Cosmetic Act. The VesseLink raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of VesseLink.
REGULATORY SPECIALISTS, INC.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2009
ViOptix, Inc. % Regulatory Specialist, Inc. Ms. Grace Holland 3722 Avenue Sausalito Irvine, California 92606
Re: K090679
Trade/Device Name: Microvascular Anastomotic Coupler System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: MVR Dated: March 13, 2009 Received: March 16, 2009
Dear Ms. Holland:
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 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 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.
3
Page 2 - Ms. Grace Holland
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Moll
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
Indications for Use
く、
510(k) Number (if known): ____K090679
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ssakaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MXM
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K090679
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