Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Device Description

Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.

AI/ML Overview

The document provided describes a 510(k) premarket notification for a medical device, specifically a "Disposable Subdermal Needle Electrode, Corkscrew." The purpose of this notification is to demonstrate substantial equivalence to an existing legally marketed predicate device. This type of submission relies on non-clinical testing to show that changes do not raise new questions of safety or effectiveness, rather than a clinical effectiveness study comparing the device to a gold standard.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of diagnostic accuracy, AI, and human reader performance, is not applicable to this submission. This document focuses on demonstrating that a modified version of an existing device is just as safe and effective as its predicate through various engineering and biocompatibility tests.

Here's a breakdown of why many of your questions cannot be answered from this document:

Acceptance Criteria & Device Performance (Table): While the document lists "tensile strength" and "impedance" as performance metrics with target values (which can be considered acceptance criteria in an engineering sense), these are not diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that would be relevant to an AI/diagnostic device study. The reported performance is that the device "passed the tests and meets the set requirements."

Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Impedance	<15 kΩ	Passed the tests / Meets requirements
Tensile strength needle to cable	>22N (Predicate) / >25N (New Device)	Passed the tests / Meets requirements
Tensile strength needle to hub	>25N (New Device)	Passed the tests / Meets requirements
Maximum retraction force protection cap vs hub	Max. 10N (New Device)	Passed the tests / Meets requirements
Torsion force Needle to hub	> 15.5 Ncm (New Device)	Passed the tests / Meets requirements
Biocompatibility	In accordance with ISO 10993 series	Evaluated to be biocompatible
Sterility Assurance Level	10^-6	Passed the tests / Meets requirements

Sample Size for Test Set & Data Provenance: Not applicable as this is not a diagnostic device study. The "test sets" here refer to batches of devices used for various engineering and biocompatibility tests.
Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth in this context would be engineering specifications and validated test methods, not expert consensus on diagnostic interpretations.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device.
Standalone Performance: Not applicable. This is not an AI algorithm. Its "performance" relates to its physical and electrical properties, not diagnostic accuracy.
Type of Ground Truth Used: The ground truth for the non-clinical tests is established by recognized international standards (e.g., ISO, ASTM, IEC) and internal test methods with defined specifications. For sterility, it's a Sterility Assurance Level of 10^-6. For biocompatibility, it's compliance with the ISO 10993 series.
Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.
How Ground Truth for Training Set was Established: Not applicable.

Summary of Non-Applicable Information and Reasons:

Information Request	Applicability	Reason
1. A table of acceptance criteria and the reported device performance (diagnostic metrics)	Not Applicable	The provided document is for a 510(k) submission of a physical medical device (needle electrode), focusing on demonstrating substantial equivalence through non-clinical engineering and biocompatibility testing. It addresses whether mechanical, electrical, and material properties meet specifications, not diagnostic accuracy or effectiveness in comparison to a gold standard. The table above reflects the engineering-focused criteria.
2. Sample size used for the test set and the data provenance	Not Applicable	The "test set" in this context refers to samples of the device used for various engineering and biocompatibility tests, not a dataset for evaluating diagnostic performance. The document doesn't specify sample sizes for these internal tests, nor is 'data provenance' (e.g., country of origin, retrospective/prospective) relevant to device manufacturing and testing.
3. Number of experts used to establish the ground truth for the test set and their qualifications	Not Applicable	Ground truth for this device is based on established engineering specifications, international standards (ISO, ASTM, IEC), and internal validated test methods, not expert clinical interpretation of images or patient data.
4. Adjudication method	Not Applicable	Adjudication methods (e.g., 2+1) are used for resolving discrepancies in expert interpretation of diagnostic data, which is not relevant to the non-clinical testing of a needle electrode.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size	Not Applicable	MRMC studies are used to assess the comparative diagnostic performance of readers, usually with and without AI assistance. This device is a physical electrode and does not involve AI or human interpretation of diagnostic results in that manner.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done	Not Applicable	Standalone performance refers to the diagnostic accuracy of an AI algorithm on its own. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)	Manufacturing/Engineering Specifications, Recognized Standards	The ground truth for this device's evaluation is based on meeting predefined specifications for its physical, electrical, material, and sterility properties as determined by engineering standards, internationally recognized testing methodologies (e.g., ISO, ASTM, IEC), and internal validation protocols.
8. The sample size for the training set	Not Applicable	This device does not utilize machine learning or AI algorithms; therefore, there is no "training set" in the computational sense.
9. How the ground truth for the training set was established	Not Applicable	As there is no training set for an AI algorithm, this question is not applicable.

The studies performed were non-clinical tests to ensure the device's physical, electrical, and biological safety and performance:

Performance Testing: Visual, dimensional, electrical (impedance), and mechanical (torsion, pull force) aspects were tested using internal methods.
Shelf Life (Accelerated Aging): Tested according to ASTM F1980-21, including mechanical, dimensional, electrical, visual, label assessment, and pouch integrity.
Transit Testing: Electrical and mechanical assessment, label assessment, and pouch integrity after transit simulation (ISTA 3A).
Electrical, Mechanical and Thermal Safety: Compliance with IEC 60601-1 (Ed. 3.2), specifically section 8.5.2.3.
Biocompatibility: Extensive testing (Chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization, pyrogenicity) performed by an external laboratory in accordance with the ISO 10993 series and related standards.
Sterilization: Validation leveraged from the predicate device (ISO 11135:2014) as the changes did not affect sterilization.
Pyrogenicity: LAL test performed after sterilization.
Usability: Applied the "User Interface of Unknown Provenance" (UOUP) principle according to IEC 62366-1, considering the user interface remained unchanged from the predicate.

In conclusion, the document successfully argues for substantial equivalence based on rigorous engineering, material, and safety testing, but it does not contain the type of diagnostic performance data or AI study details you requested.

Summary

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December 11, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Technomed Europe Sanne Habets Team Lead Regulatory Affairs Amerikalaan 71 Maastricht-Airport, 6199 AE Netherlands

Re: K241045

Trade/Device Name: Disposable Subdermal Needle Electrode, Corkscrew Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ, IKT Dated: November 14, 2024 Received: November 14, 2024

Dear Sanne Habets:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image contains the text "Patrick Antkowiak -S". To the left of the text is a faded blue logo that appears to be "FDA". The text is black and the background is white. The text is aligned to the left.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241045

Device Name

Disposable Subdermal Needle Electrode, Corkscrew

Indications for Use (Describe)

Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K240145 Traditional 510(k) Summary Technomed Europe's Disposable Subdermal Needle Electrode, Corkscrew

Prepared according to the requirements outlined in 21 CFR 807.92

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Technomed Europe Amerikalaan 71, 6199 AE, Maastricht-Airport The Netherlands Phone: Facsimile: Contact Person: E-mail:

+31 (0) 43 408 6868 N/A Sanne Habets, Team Lead Regulatory Affairs regulatory@technomed.nl

Date Prepared: December 10, 2024

Trade Name of Device

Disposable Subdermal Needle Electrode, Corkscrew

Common or Usual Name

Disposable Subdermal Corkscrew Needle Electrode

Classification

21 C.F.R. § 882.1350, Needle Electrode, Class II, product code GXZ and IKT

Predicate Devices

K130136 Disposable Monopolar Needle Electrode and Disposable Subdermal Needle Electrode, 21 C.F.R. § 882.1350, GXZ and IKT.

Device Description

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These devices are used by healthcare professionals specifically trained and certified in electrophysiology techniques, in healthcare facility/hospital environment. These professionals can use the devices on patients for use with recording / monitoring equipment for the recording of biopotential signals including electroencephalography (EEG). electromyography (EMG) and nerve potential signals.

The technological characteristics are described in further detail below.

Indications for Use

Technological Characteristics

The DSNE, Corkscrew's technological characteristics remain almost identical to that cleared within K130136.

The proposed modification to the DNSE, Corkscrew is to change the soldering connection between lead wire and needle to a crimped connection, which is qlued to the hub. Also, the internal shape of the hub has been optimized to fit the new connection. As demonstrated within this 510(k) premarket notification, this change does not raise new or different questions of safety and effectiveness, and is supported by non-clinical testing of the product.

The positioning, functioning and use of the product remains unchanged.

All other aspects of the device compared to the currently marketed version remain unchanged and are identical. For further information on substantial equivalence, see Table 1.

PredicateDisposableSubdermalNeedleElectrode,Corkscrew(covered byK130136)	New Disposable SubdermalNeedle Electrode,Corkscrew	Discussion ofpotentialdifferences
Device Name	Disposable Subdermal Needle Electrode,Corkscrew	Identical
510(k) number	K130136	K241045	NA
510(k) clearance date	19th of July,2013	Unknown yet	NA
Product code	GXZ and IKT	Identical
Intended use /	Needle Electrodes for Neurological purposes are	Identical

Table 1: Substantial Equivalence Summary

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Indications for use (assubmitted to FDA during510(k) submission; andas listed in the IFU)	intended for use with recording, monitoringequipment for the recording of biopotentialsignals including electroencephalograph (EEG),electromyograph (EMG) and nerve potentialsignals, and are intended forstimulation/recording with stimulation/recordingequipment for electromyograph (EMG) andnerve potential signals.
Regulation name	Needle Electrode	Identical
Regulation number	21 CFR 882.1350	Identical
Target population	All patients	All patients identifiedby the healthcareprofessional to benefitfrom the diagnosticprocedures as listed inthe indications for use.	Specified in moredetail.
Where used	Hospital	Identical
Human factors	Predicate and subject device are visuallyidentical, no change in user interface.Compatibility and connections	Identical
Connector	DIN 42802	Identical
Compatibility	This device is equipped with DIN 42802connectors and is compatible with anyintraoperative neuromonitoring equipment that isequipped with DIN 42802 connections.	Identical
	Dimensions
Hub diameter	10 mm	Identical
Hub length	13 mm	Identical
Needle shape	Spiral (Corkscrew)	Identical
Needle surface area	49 mm²	Identical
Needle length (Height ofneedle windings comingout of the hub)	2.5-4.0 mm	Identical
Needle diameter	0.6 mm	Identical
Tip geometry / angle(defining sharpness)	25° ± 5°(equalling range:20°-30°)	24°+2°-4° (equalling range:20°-26°)	The tip geometryrange of the subjectdevice falls withinthe range of thepredicate device,and therefore isequivalent.
Lead wire lengths	1.20-2.5 m	Identical
	Materials
Needle to lead wireconnection		Solder		Brass crimp bushing	Modification, asdescribed in currentsubmission. Non-clinical testing didnot raise new ordifferent questionsrelating to safety
Lead wire lengths	1.20-2.5 m			Identical
Materials
Needle to lead wire connection	Solder	Brass crimp bushing		Modification, as described in current submission. Non-clinical testing did not raise new or different questions relating to safety and effectiveness.
Hub to needle-lead wire	N/A	Glue (Loctite 454)		Modification, as

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connection			described in current submission. Non-clinical testing did not raise new or different questions relating to safety and effectiveness.
Needle	AISI 304		Identical
Hub	PVC		Identical
Lead wire	Multiple colours PVC insulated tin-plated copper strands		Identical
DIN 42802 connector	PVC over-moulded tin-plated brass		Identical
Protection cap	Polypropylene (PP)		Identical
Electrical insulation	Electrical insulation is present on all surfaces that are not intended to provide electrical contact with the patient.		Identical
	Electrical behaviour
Impedance	<15 kΩ		Identical
	Mechanical behaviour
Tensile strength needle to cable	>22N	>25N	Tightened specification.
Tensile strength needle to hub	Not specified	>25N	Added specification
Maximum retraction force protection cap versus hub (if applicable)	Not applicable	Max. 10N	Addition of protection cap and specification of force. This did not raise new or different questions relating to safety and effectiveness.
Torsion force Needle to hub	Not specified	> 15.5 Ncm	Added specification
	Other information
Lead wire type	Single / Twisted		Identical
Hub material colour	Blue		Identical
Single use	Yes		Identical
Provided to the user sterile	Yes		Identical
Sterilization method	Ethylene oxide		Identical
Sterility assurance level	10-6		Identical
Shelf life	3 years		Identical
Sterile barrier / container (transparent - film)	Biaxially oriented polyethylene film		Identical
Sterile barrier / container (paper)	Gas Paper		Identical
Pouch size	175x75 mm200x100 mm		Identical
Number of items per box	12 pairs or 24 single pieces		Identical
Anatomical site	To be applied to subdermal tissue		Identical
Energy used and/or delivered	No energy used, no energy delivered, only conduction of electrical signals		Identical
Biocompatible	Yes	Yes, tested in accordance with current ISO 10993 series	Non-clinical testing did not raise new or different questions relating to safety and effectiveness.

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Non-clinical Testing

Non-clinical testing was conducted to validate the performance and safety of the subject device, to ensure that the device performs as intended and meets the design specifications.

Mechanical, dimensional, electrical, and visual aspects of the device were tested according to internal test method.

Regarding accelerated aging, aging was performed according to ASTM F1980-21. Mechanical, dimensional, electrical, and visual assessment were performed according to internal test method. Label assessment was performed according to ISO 20417 (Ed. 1). Pouch integrity testing was performed according to ASTM F1929-15.

A transit simulation was performed according to ISTA 3A (2018 edition). Electrical and mechanical assessment of the products was done according to internal test methods.

Biocompatibility testing was performed by an external laboratory according to the ISO 10993 series. This included chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization and pyrogenicity testing.

Regarding Electrical, Mechanical and Thermal Safety testing, compliance with the applicable section of IEC 60601-1 (Ed. 3.2) was tested.

Sterilization validation (ISO 11135:2014 (Ed. 2))) was leveraged from the predicate device as the changes to the product do not affect the sterilization, nor result in the need for choosing a different worst-case product in sterilization. The reason is that device and packaging materials, device dimensions and device shape are substantially equivalent to the predicate.

Regarding usability (IEC 62366-1:2015 (Ed. 1.1)), the User Interface of Unknown Provenance principle was applied in accordance with Annex C of IEC 62366-1 as the User Interface has been commercialized prior to the release of the standard and no modifications to the User Interface or its parts have been made.

A summary of the non-clinical testing performed on the subject device, Disposable Subdermal Needle Electrodes, Corkscrew is provided in Table 2.

Table 2: Summary of Non-Clinical Testing

Test	Method	Results / Comment

Performance Testing(Visual, dimensional,electrical, and mechanicalaspects)	Internal test methods were applied.Visual checks: including fixation of protection cap to hub, visibility of bare wires, visual damage. Dimensional checks Electrical testing: including impedance measurements. Mechanical testing: including torsion and pull force measurements.	The product passed the tests and meetsthe set requirements.The testing did not raise new or differentquestions of safety and effectiveness.
Shelf life (Acceleratedaging)	Aging was performed according to ASTMF1980-21 Standard Guide for AcceleratedAging of Sterile Barrier Systems andMedical Devices.FDA recognition number: 14-575Mechanical, dimensional, electrical, andvisual assessment was performedaccording to internal test method.Label assessment method was based onISO 20417:2021 (Ed. 1) Medical devices –Information to be supplied by themanufacturer.FDA recognition number: 5-135Pouch integrity testing was performedaccording to ASTM F1929-15 StandardTest Method for Detecting Seal Leaks inPorous Medical Packaging by DyePenetration.FDA recognition number: 14-484	The product passed the 3-yearsaccelerated shelf-life validation andmeets the set requirements.The testing did not raise new or differentquestions of safety and effectiveness.
Transit testing	Electrical and mechanical assessmentwere performed according to internal testmethod.Label assessment method was based onISO 20417:2021 (Ed. 1) Medical devices –Information to be supplied by themanufacturer.FDA recognition number: 5-135Pouch integrity testing was performedaccording to ASTM F1929-15 StandardTest Method for Detecting Seal Leaks inPorous Medical Packaging by DyePenetration.FDA recognition number: 14-484Transit simulation was performedaccording to ISTA 3A (2018) Packaged-Products For Parcel Delivery SystemShipment 70 Kg (150 Lb) Or Less.FDA recognition number: 5-126	The product passed the tests and meetsthe set requirements.The testing did not raise new or differentquestions of safety and effectiveness.
	IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Ed. 3.2) - Medical electricalequipment - Part 1: General requirementsfor basic safety and essential performance;section 8.5.2.3.FDA recognition number: 19-49	The product meets the applicablerequirements of section 8.5.2.3.
Electrical, Mechanical andThermal Safety		The testing did not raise new or differentquestions of safety and effectiveness.
	A biological evaluation plan was written.Chemical characterization, cytotoxicity,intracutaneous reactivity, acute systemictoxicity, sensitization and pyrogenicity weretested in accordance with the below listedstandards by an independent laboratory.Based on the data, a biological riskassessment was written.ISO 10993-1:2018 (Ed. 5) -Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess.FDA recognition number: 2-258 ISO 10993-7:2008 (Ed. 2) -Biological evaluation of medicaldevices - Part 7: Ethylene oxidesterilization residuals.FDA recognition number: 2-275 ISO 10993-18:2020 (Ed. 2) -Biological evaluation of medicaldevices - Part 18: Chemicalcharacterization of medical devicematerials within a riskmanagement processFDA recognition number: 2-276 ISO 10993-5:2009 (Ed. 3) -Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicityFDA recognition number: 2-245 ISO 10993-10:2021 (Ed. 4) -Biological evaluation of medicaldevices - Part 10: Tests for skinsensitizationFDA recognition number: 2-296 ISO 10993-23:2021 (Ed. 1) -Biological evaluation of medicaldevices - Part 23: Tests forirritationFDA recognition number: 2-291 ISO 10993-11:2017 (Ed. 3) -Biological evaluation of medicaldevices -Part 11: Tests for systemic toxicityFDA recognition number: 2-255 ISO 10993-6:2016 (Ed. 3) -Biological evaluation of medicaldevices - Part 6: Tests for localeffects after implantation
Biocompatibility (includingChemical characterization,cytotoxicity, intracutaneousreactivity, acute systemictoxicity, sensitization andpyrogenicity)		The product is evaluated to bebiocompatible.The testing did not raise new or differentquestions of safety and effectiveness.

	FDA recognition number: 2-247
	• ISO 10993-3:2014 (Ed. 3) -
	Biological evaluation of medical
	devices - Part 3: Tests for
	genotoxicity, carcinogenicity, and
	reproductive toxicity
	FDA recognition number: 2-228
	ISO 11135:2014+AMD1:2018 (Ed. 2) –
	Sterilization of health-care products –
Sterilization	Ethylene oxide – Requirements for thedevelopment, validation, and routinecontrol of a sterilization process for medicaldevices.FDA recognition number: 14-529	The changes to the product do not haveany impact on the latest sterilizationvalidation.
	The sterilization revalidation as executed in2022 is still valid for the device that issubject of this submission as the predicatedevice was already part of the productportfolio that was validated in 2022; andthe changes to the product do not affectthe sterilization validation, nor result in theneed for choosing a different worst-caseproduct in sterilization revalidation. Thereason is that device and packagingmaterials, device dimensions and deviceshape are substantially equivalent to thepredicate.	The changes to the product did not raisenew or different questions of safety andeffectiveness regarding sterilization.
	Pyrogenicity	A LAL test of the product was performedafter sterilization by the sterilizationprovider.	The product conformed to therequirements of the test.
			The changes to the product did not raisenew or different questions of safety andeffectiveness.
		Usability	IEC 62366-1:2015+AMD1:2020 (Ed. 1.1) –Medical devices - Part 1: Application ofusability engineering to medical devices.FDA recognition number: 5-129	The UOUP assessment of the DSNE,Corkscrew determined the usability ofthe DSNE, Corkscrew to be acceptable.
			The user interface of unknown provenance(UOUP) principle was applied. The userinterface for both the predicate device andthe subject device are equivalent.	The changes to the product did not raisenew or different questions of safety andeffectiveness regarding usability.

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Clinical testing

There is no clinical testing required to support this submission.

Substantial Equivalence

The device and its predicate are equivalent in most aspects, such as product classification, connections, sizes, majority of the materials used, sterilization characteristics, packaging materials, and safety characteristics. The difference is the internal joining method of the needle to the lead wire. The predicate device utilizes a soldering connection, whereas the

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proposed subject device utilizes a brass crimped connection, which is glued to the hub. Also, the internal shape of the hub has been optimized to fit the new connection.

The change does not raise new or different questions of safety and effectiveness and is supported by non-clinical testing of the product.

Thus, in summary, the DSNE, Corkscrew as cleared under K130136 and as part of the current submission are considered equivalent and do not raise new or different questions of safety and effectiveness.

All other aspects of the device compared to the predicate device remain unchanged and are identical. For further information on substantial equivalence, see Table 1.

Conclusion

In summary, the intended use, and indications for use for the DNSE, Corkscrew and its predicate devices are identical.

Non-clinical testing performed on the DSNE, Corkscrew has demonstrated that the minor modifications to Disposable Subdermal Needle Electrode, Corkscrew do not raise new or different questions regarding safety and effectiveness.

Although the internal joining method of needle to lead wire and the internal shape of the hub change, the overall operating principles of the device remain the same.

Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the DNSE, Corkscrew.

A tabular comparison of device characteristics can be found in Table 1.

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).