(168 days)
CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.
CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.
The provided text is a 510(k) premarket notification letter from the FDA for the Clavis EMG device. It establishes substantial equivalence but does not contain detailed information about acceptance criteria, study methodologies, or specific performance metrics. Therefore, I cannot extract the requested information from this document.
To answer your questions, I would need access to the actual 510(k) submission summary or the associated clinical trial data, which is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic A/S % Ms. Ann-Christine Provoost Regulatory Affairs Specialist 16-18 Tonsbakken DK- 2740 Skovlunde Denmark
8 2007 FEB
Re: K062478
Trade Name: Clavis EMG Device Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: Class II Product Codes: BXN, GWL Dated: January 15, 2007 Received: January 18, 2007
Dear Ms. Provoost:
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. 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
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Page 2 - Ms. Ann-Christine Provoost
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 If you desire specific acrioliance at (240) 276-0120. 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
2/8/07
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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· Indications for Use
Indications for Use
510(k) Number (if known): K062478
Device Name: CLAVIS
Indications for Use:
CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.
X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sinn-Off) (Division Broneral, Restorative, Divisionomical Devices
Page 1_of_1
510(k) Number
ា
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).