(13 days)
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Not Found
No
The summary describes a passive electrode device for recording biopotential signals and contains no mention of AI or ML.
No
The device is described as "intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals", which indicates a diagnostic or monitoring function, not a therapeutic one.
Yes
The device is described as being used for "recording of biopotential signals," including Electromyography (EMG) and Electroencephalography (EEG), which are diagnostic procedures used to assess physiological conditions.
No
The device description explicitly states "Sub-dermal Needle Electrodes," which are hardware components used for recording biopotential signals. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are for "recording of biopotential signals" such as EMG, EEG, and nerve potential signals. These are signals measured directly from the patient's body, not from samples taken from the body (like blood, urine, or tissue).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device does not perform such tests.
The device is an electrode used for physiological signal acquisition, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
XLTEK Clear Signal Sub-dermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and are for single patient use only.
Product codes
GXZ
Device Description
XLTEK Clear Signal Sub-dermal Needle Electrodes are sterile and are for single patient use only.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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): 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.
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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.
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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).
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§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
AUG 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nicole Landreville, Eng. RAC Director of Quality and Regulatory Excel Tech LTD 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K052111
Trade/Device Name: XLTEK Clear Signal Sub-dermal Needle Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: August 11, 2005 Received: August 12, 2005
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 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- Ms. Nicole Landreville, Eng. RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to oegil mainenes your alence of your device to a legally premaired 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 if you desire specific darrioliance at (240) 276-0115. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to your responsibilities under the Act from the Division of Small other general miornituren on Jour Corpumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buckland
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page loof l
Statement of Indications for Use
K052111 510(k) Number (if known):
XLTEK Clear Signal Sub-dermal Needle Device Name:
Indications for Use:
XLTEK Clear Signal Sub-dermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and are for single patient use only.
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)
K052111 barbara bucklus for Mulkerson
(Division Sign-Off)
Division of General. Restorative. and Neurological Devices
510(k) Number K052111
(Optional Format 1-2-96)