(235 days)
The Vesalius, models Vesalius MCNplus and QUANTUM and accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopaedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
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I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a medical device called "Vesalius". It outlines the regulatory approval of the device for certain surgical procedures but does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or specific study methodologies such as MRMC studies or standalone algorithm performance.
Therefore, I cannot generate the table or answer the specific questions about the device's acceptance criteria and the study proving it meets them based on the given input.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 31, 2014
Telea Electronic Engineering Srl % Ms. Marisa Testa Thema S.r.l Via Saragat 5 Imola, Bologna, 40026 ITALY
Re: K131696
Trade/Device Name: Vesalius Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Product Code: GEI, HRX Dated: December 17, 2013 Received: December 19, 2013
Dear Ms. Testa:
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
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Page 2 - Ms. Marisa Testa
and and state schap and to a n
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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131696
Device Name:
Vesalius, models Vesalius MCNplus and QUANTUM
Indications for Use:
The Vesalius, models Vesalius MCNplus and QUANTUM and accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopaedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Long H. Che for BSA (Division Sign-off)
Division of Surgical Devices 510 (k) Number: K131696
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.