XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 by EXCEL TECH. LTD.

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.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding the XLTEK Clear Signal Sub-dermal Needle, focusing on acceptance criteria and study information.

It's important to note that this document is a 510(k) clearance letter from the FDA. While it confirms the device's substantial equivalence to a predicate device, it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary. The provided text primarily focuses on the regulatory aspects of the clearance.

Therefore, many of the requested details about specific acceptance criteria and the studies proving them are not available in the provided document. The 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trial data for every new device. This means that the "proof" often points to the predicate device's established safety and effectiveness.

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in this document. The document focuses on regulatory clearance based on substantial equivalence. This type of detail would typically be in the 510(k) summary or a specific testing report.	Not explicitly stated in this document. Device performance is implicitly deemed acceptable by the FDA's clearance, suggesting it performs comparably to its predicate for stated indications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in this document.
Data Provenance: Not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not specified in this document.
Qualifications of Experts: Not specified in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in this document.

5. 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

Not applicable. This device is an electrode for recording biopotential signals (EMG, EEG, Nerve potential signals), not an AI-assisted diagnostic tool. Therefore, a MRMC study concerning human readers with/without AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (sub-dermal needle electrode), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of an algorithm's ground truth. For a physical device like this, "ground truth" would relate to its physical properties, biocompatibility, electrical performance, sterility, and mechanical integrity, which are typically assessed through bench testing and, if necessary, animal or human studies to demonstrate safety and effectiveness. The specifics of these tests are not in this clearance letter.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm that requires a "training set" and corresponding ground truth.

Summary regarding the XLTEK Clear Signal Sub-dermal Needle 510(k) Clearance:

The provided document is an FDA 510(k) clearance letter. This type of clearance indicates that the device (XLTEK Clear Signal Sub-dermal Needle) has been found substantially equivalent to a legally marketed predicate device. This means the FDA believes it is as safe and effective as the predicate device for its stated indications for use: "recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals."

The letter itself does not provide the detailed scientific or clinical study reports, specific acceptance criteria, or performance data that would be found in the 510(k) summary or the underlying submission. The "proof" of meeting acceptance criteria for a 510(k) device often relies on:

Demonstration of substantial equivalence to a predicate device.
Bench testing (electrical performance, mechanical strength, biocompatibility).
Sterilization validation.
Biocompatibility testing.
Performance data from the predicate device.

To obtain the specific study details for this device, one would typically need to review the 510(k) summary document filed by the manufacturer, which is usually publicly available through the FDA's 510(k) database.

Summary

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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.

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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

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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:

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)

Regulation Number and Section

§ 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).