(99 days)
The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.
The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the XLTEK NeuroPath device. This type of document primarily confirms that a new medical device is "substantially equivalent" to an already legally marketed predicate device.
Crucially, a 510(k) clearance letter itself does NOT typically contain detailed information about specific acceptance criteria or the comprehensive results of performance studies that prove a device meets those criteria.
Instead, the manufacturer (Excel-Tech Ltd. in this case) would have submitted detailed performance data, acceptance criteria, and study protocols to the FDA as part of their 510(k) submission. The FDA reviews this information to make their substantial equivalence determination.
Therefore, based solely on the provided text, I cannot provide the requested information. The text confirms the device name, K-number, regulation number, regulatory class, and its intended use, but it does not delve into the specifics of performance studies or acceptance criteria.
To answer your questions, one would need access to the actual 510(k) submission (traditional or special, which contain more detailed information), which is often publicly available through the FDA's Dockets Management Staff or a Freedom of Information Act (FOIA) request, though summaries are typically available on the FDA's 510(k) database.
In summary, the provided document is an FDA clearance letter, not the study report itself.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB 7
Nicole Landreville, Eng.RAC Director of Quality and Regulatory Excel- Tech Ltd. 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K053058
Trade/Device Name: XLTEK NeuroPath Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXE Dated: January 27, 2006 Received: January 30, 2006
Dear Ms. Landreville:
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
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Page 2- Nicole Landreville, Eng.RAC
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely, yours,
Barbara Buchner
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): K053058
Device Name: XLTEK NeuroPath
Indications for Use:
The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.
The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbora Buchnerova Mkal
Division of General, Restorative, and Neurological Devices
510(k) Number K05 3058
(Optional Format 1-2-96)
§ 882.1550 Nerve conduction velocity measurement device.
(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).