(35 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, deep neural networks, or training/test sets for algorithms. The device description is also not available, but the intended use and anatomical site suggest a simple electrical stimulator.
No
Explanation: The device is intended for stimulation to locate and identify nerves during surgery, not for treating a condition or disease. This indicates a diagnostic or intraoperative monitoring function rather than a therapeutic one.
Yes
The device is described as stimulating nerves for "location and identification during surgery," which is a diagnostic function aimed at understanding the real-time anatomy and function for surgical planning and execution.
No
The device is described as "probes," which are physical instruments used for stimulation. This indicates a hardware component, not a software-only device.
Based on the provided information, the XLTEK Stimulator Probes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The XLTEK Stimulator Probes are described as being used to "stimulate cranial and peripheral motor nerves for location and identification during surgery." This is a direct interaction with the patient's body during a surgical procedure, not a test performed on a sample outside the body.
Therefore, the function and intended use of the XLTEK Stimulator Probes clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The probes are sterile and are for single patient use only.
Product codes
ETN
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
cranial and peripheral motor nerves, spinal nerve roots
Indicated Patient Age Range
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Intended User / Care Setting
surgery
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Excel-Tech Ltd c/o Nicole Landreville, Eng. RAC Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K062549 Trade/Device Name: XLTEK Stimulator Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: II Product Code: ETN Dated: August 28, 2006 Received: September 1, 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 for use stated in the entrebute) 75 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). and Coometre fore, market the device, subject to the general controls provisions of the Act. The r va mayy are so rovisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
OLT = 4 2006
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.
1
Page 2 - Nicole Landreville, Eng. RAC
This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to logally marketed predicate device results in a classification for your device and thus, permitts your cevice 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indications for Use
510(k) Number (if known):
Device Name: XLTEK Stimulator Probes
Indications for Use:
The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The probes are sterile and are for single patient use only.
Prescription Use X (Per 21 CFR 801.109) ાર
Over-The Counter Use __________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Vorent A. Bober
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number
(Optional Format 1-2-96)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |