(182 days)
Stimulation of peripheral nerves for diagnostic purposes.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Magstim Model 200-2 with Double 70mm Remote Coil, an evoked response electrical stimulator. This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.
However, the document does not contain any information regarding acceptance criteria, device performance metrics, or the details of a study that proves the device meets specific criteria.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with detailed acceptance criteria and performance metrics typically associated with new or high-risk device approvals.
Therefore, I cannot provide the requested information based on the given input. The document explicitly states the device is for "Stimulation of peripheral nerves for diagnostic purposes" and that it is substantially equivalent to a predicate device, but it doesn't offer the specific study details you've asked for.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 26 2006
Dr. Reza Jalinous Magstim Company US, LLC 304 Cambridge Road, Suite 502 Woburn, Massachusetts 01801
Re: K060847
Trade/Device Name: Magstim Model 200-2 with Double 70mm Remote Coil Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Codes: GWF, JXE Dated: August 26, 2006 Received: August 28, 2006
Dear Dr. Jalinous:
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
{1}------------------------------------------------
Page 2 – Dr. Reza Jalinous
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) I mo letter wotification. The FDA finding of substantial equivalence of your device to a premainer 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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Intribution 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 N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE
510(K) Number (if known):
Device Name: Magstim 2002
Indications for Use:
Stimulation of peripheral nerves for diagnostic purposes.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of General, «Res Jolari Editologi and Neurological Devic
11060847 510(k) Namber .
Prescription Use: (Per 21 CFR 801.109)
OR
Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).