(175 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the device's intended use for intraoperative diagnosis based on corticospinal axonal conduction.
No
The device is intended for diagnosis of dysfunction, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used for the intraoperative diagnosis of active dysfunction."
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The name "Protektor Stimulator" suggests a hardware component for stimulation, but this is not explicitly stated or denied in the provided information.
Based on the provided information, the Protektor Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "intraoperative diagnosis of active dysfunction in corticospinal axonal conduction." This involves directly stimulating and monitoring a physiological response within the patient's body during surgery.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Protektor Stimulator does not involve the analysis of such specimens.
- Anatomical Site: The device interacts directly with the "corticospinal" system within the patient.
The device is used in vivo (within a living organism) to assess neurological function, not in vitro (in a lab setting using specimens).
N/A
Intended Use / Indications for Use
The Protektor Stimulator is intended to be used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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_________________________________________________________________________________________________________________________________________________________________