VESALIUS

K131696 · Telea Electronic Engineering Srl · GEI · Jan 31, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K131696
• Device Name: VESALIUS
• Applicant: Telea Electronic Engineering Srl
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Vesalius (models MCNplus and QUANTUM) is an electrosurgical device for soft tissue resection, ablation, coagulation, and hemostasis. Used in OR settings by surgeons across orthopedic, arthroscopic, neurosurgical, ENT, and spinal specialties. Device delivers electrical energy to tissue via accessories to achieve desired surgical effect. Provides surgeons with precise control over tissue interaction; facilitates hemostasis and tissue removal; improves surgical efficiency and patient outcomes by minimizing thermal damage compared to traditional electrosurgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to legally marketed predicate devices.

Technological Characteristics

Electrosurgical unit for cutting and coagulation. Energy source: electrical. Form factor: console with accessories. Intended for soft tissue management. Class II device (Product Codes GEI, HRX).

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during orthopedic, arthroscopic, neurosurgical, ENT, and spinal surgical procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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