(218 days)
Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Arthro Kinetics Vesalius MR Generator. The document is a 510(k) premarket notification letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance, but it does not detail any technical performance criteria or study results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2007
Arthro Kinetics. Inc. % Mr. James Hobbs President 8 Faneuil Hall, 3rd Floor Boston, Massachusetts 02109
Re: K070874
Trade/Device Name: Arthro Kinetics Vesalius MR Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX Dated: October 15, 2007 Received: October 17, 2007
Dear Mr. Hobbs:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Mr. James Hobbs
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
Indications for Use
| 510(k) Number: | K070874 |
|---|---|
| Device Name: | Arthro Kinetics Vesalius MR Generator |
| Indications for Use: | Intended for resection, ablation, and coagulation of soft tissue andhemostasis of blood vessels in surgical procedures such as but notlimited to orthopedic, arthroscopic, and spinal procedures. |
Prescription Use X (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
IF NEEDED)
(Division Sign-Of
Concurrence of CDRH Office of Device Evaluation (ODE)
Division of Gener
and Neurological L......
510(k) Number 1070874
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§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.