(175 days)
The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Not Found
This document is a 510(k) clearance letter from the FDA for the XLTEK Protektor Stimulator. It does not contain the acceptance criteria, reported device performance, or details of a study proving the device meets those criteria.
The letter explicitly states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device meets the safety and effectiveness profile of an existing device, rather than providing new performance data against specific acceptance criteria in this document.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present. The device is an electrical stimulator, not an AI algorithm for image reading.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document primarily covers the administrative details of the 510(k) clearance, including:
- The device name: XLTEK Protektor Stimulator
- The 510(k) number: K040358
- The date of clearance: August 6, 2004
- The product code: GWF (Evoked response electrical stimulator)
- The regulatory class: Class II
- Indications for Use: "The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."
To obtain the information you requested (acceptance criteria, study details, etc.), one would typically need to review the full 510(k) submission document or related clinical study reports, which are not included here. This letter is the final decision from the FDA, not the detailed submission itself.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Mr. Cameron Mahon Vice President Customer Satisfaction Excel Tech, Ltd. 2568 Bristol Circle Road Oakville, Ontario Canada L6H 5S1
Re: K040358
Trade/Device Name: XLTEK Protektor Stimulator Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: July 8, 2004 Received: July 12, 2004
Dear Mr. Mahon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prior to May 20, 1776, the enaoudance with the provisions of the Federal Food, Drug, devices mat have been rochise in assire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, market the Act include requirements for annual registration, listing of general Controls provisions of the rest 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 If your device is classified (800 a0070) inst Existing major regulations affecting your device can may be subject to sach address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3155aates over device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any it cacal statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CT N Fart 6077, moeing (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Cameron Mahon
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manteing of substantial equivalence of your device to a legally premarket notification. The PDA mainly of the Admin volume of this, 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 advice for your act 100 % on one of a more one one one of a cregulation entitled, and Contact the Office of Complanes at (SST) ->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> "Misbranding by relevelec to promance notified in the Act from the Division of Small other general information on your responsible in the man at its toll-free number (800) 638-2041 or Manufacturers, International and Octable Scheer http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ I of __ I
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K040358
XLTEK Protektor Stimulator Device Name:
Indications for Use:
The Protektor Stimulator is intended to be used for the intraoperative diagnosis The Protection Stimation in corticospinal axonal conduction brought about by of active dystunetion in occuressport.
mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Prescription Use X (Pcr 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)
Miriam C. Provost
(Division Sign-Off Division of General, Restorative, and Neurological Devices
(Optional Format 1-2-96)
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).