Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

K143433 · Natus Manufacturing Limited · IKT · Aug 28, 2015 · Physical Medicine

Device Facts

• Record ID: K143433
• Device Name: Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
• Applicant: Natus Manufacturing Limited
• Product Code: IKT · Physical Medicine
• Decision Date: Aug 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Indications for Use

Dantec™ DCN Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

Device Story

Dantec DCN Disposable Concentric Needle Electrodes are invasive, single-use bipolar recording devices used in electromyography (EMG). The device consists of an insulated tungsten core wire housed within a stainless steel cannula, featuring a raised bevel indicator on the hub for orientation. It connects to external EMG recording/stimulation equipment via a coaxial hub and shielded cable. Used in hospital and clinical settings under physician supervision, the needle is inserted into tissue to record biopotential signals. The device facilitates diagnostic nerve and muscle potential monitoring. Benefits include reliable signal acquisition for clinical decision-making in neurological assessments. The device is provided sterile via gamma irradiation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including mechanical testing (tensile strength, penetration/sliding force, tip geometry/grind measurements), impedance testing, and biocompatibility testing (cytotoxicity, sensitization, and irritation per ISO 10993 standards).

Technological Characteristics

Materials: Tungsten core, stainless steel cannula, silicone lubricant, ABS hub, polyesterimide/Araldite insulator. Dimensions: 25mm-75mm lengths; 23G-30G diameters. Sensing: Bipolar concentric needle. Connectivity: Coaxial hub to 5-pin 240° DIN connector. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 10993 (biocompatibility), ISO 2859-1 (sampling), ASTM F1980 (accelerated aging).

Indications for Use

Indicated for use with recording, monitoring, and stimulation/recording equipment for the stimulation/recording of biopotential signals, including electromyograph (EMG) and nerve potential signals, in patients requiring diagnostic electromyography.

Regulatory Classification

Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Predicate Devices

• Teca™ Elite Disposable Concentric Needle Electrodes (K112034)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign related to public health services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 28, 2015

Natus Manufacturing Limited Michael Galvin Manager, Quality and Regulatory Affairs IDA Business Park Gort, County Galway Ireland

> Re: K143433 Trade Name: Dantec"14 DCN Disposable Concentric Needle Electrodes Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: July 23, 2015 Received: July 27, 2015

Dear Mr. Galvin:

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. 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 27f 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carlos L. Pena -5D/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143433

Device Name

DantecTM DCN Disposable Concentric Needle Electrodes

Indications for Use (Describe)

DantecTM DCN Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMC) and nerve potential signals.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

# natus.

Natus Manufacturing Limited, IDA Business Park Gort, Co. Galway 353 091 630043 tel. [phone] fax.

# Section 5: 510(k) Summary

| Manufacturer's Name: | Natus Manufacturing Limited<br>IDA Business Park<br>Gort, County Galway<br>Ireland |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Michael Galvin<br>Manager, Quality and Regulatory Affairs<br>Natus Manufacturing Limited<br>IDA Business Park<br>Gort, County Galway<br>Ireland |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Summary Date: | 23 July 2015 |
| Trade Names: | Dantec™ DCN Disposable Concentric Needle Electrodes |
| Common or Usual Name: | Electrode, Needle, Diagnostic Electromyograph |
| Classification Name : | Diagnostic Electromyograph Needle Electrode |
| Device Class: | Class II |
| Product Code: | IKT |
| Classification Regulation: | 21 CFR 890.1385 |
| Classification Panel: | Neurology |
| Predicate Device: | K112034 Teca™ Elite Disposable Concentric Needle<br>Electrodes |
| Device Description: | The Dantec™ DCN Disposable Concentric Needle<br>Electrodes are designed as an electrical bipolar recording<br>device for use in electromyography.<br>The Dantec™ DCN Disposable Concentric Needle Electrode<br>consists of an insulated core wire located inside a stainless<br>steel cannula. The hub has a raised bevel indicator, allowing<br>the user to always know the direction of the recording<br>surface.<br>A coaxial hub allows easy connection between needle and<br>the electrode cable. |
| Intended Use: | Dantec™ DCN Disposable Concentric Needle Electrodes<br>are intended for use with recording, monitoring and<br>stimulation/recording equipment for the stimulation/recording<br>of biopotential signals including electromyograph (EMG) and<br>nerve potential signals. |
| Technological<br>Comparison: | Dantec™ DCN Disposable Concentric Needle Electrodes<br>employ the same technological characteristics as the<br>predicate device. |
| Nonclinical Tests: | Mechanical testing:<br>• Hub/Cover tensile testing<br>• Needle/Hub tensile testing<br>• Penetration testing – to measure sliding force<br>• Tip geometry-grind measurements (Pencil Point &<br>Main Bevel)<br>• Impedance testing –needle electrodes should have<br>low impedance |
| Substantial | |

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### Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

Equivalence:

The Natus Manufacturing Limited Dantec™ DCN Disposable Concentric Needle Electrodes are equivalent to the device

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### Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

cleared under K112034 as is presented below in Table 5A Substantial Equivalence Comparison Table.

lt has been shown in this 510(k) submission that the differences between the Dantec™ DCN and the predicate device Teca™ Elite do not raise any questions regarding its safety and effectiveness. The Dantec™ DCN device is substantially equivalent to the predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices. The Dantec™ DCN, as designed and manufactured is determined to be substantially equivalent to the referenced predicate devices.

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Image /page/6/Picture/0 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are rounded. There is a small registered trademark symbol to the right of the "s".

### Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

# Table 5A: Substantial Equivalence Comparison Table

| Manufacturer | Natus Manufacturing Limited | Natus Neurology Incorporated<br>(formerly Carefusion) | Discussion of Differences |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Trade Name | Dantec™ DCN | Teca™ Elite | |
| 510(k) number | New Device | K112034 | |
| Product Code | IKT | IKT | |
| Regulation number | 21.CFR.890.1385 | 21.CFR.890.1385 | Same |
| Regulation Name | Diagnostic electromyograph needle electrode | Diagnostic electromyograph needle electrode | Same |
| Intended Use | Dantec™ DCN Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals. | Teca™ Elite Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals. | Same |
| Environment of Use | Hospital and clinical use under the supervision of a physician. | Hospital and clinical use under the supervision of a physician. | Same |
| Duration of use | Less than 24 hours | Less than 24 hours | Same |
| Core Material | Tungsten | Tungsten | Same |
| Low Friction Lubricant | Silicone | Silicone | Same |
| Cannula | Stainless Steel | Stainless Steel | Same |

23 July 2015

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Image /page/7/Picture/0 description: The image shows the word "natus." in a teal sans-serif font. The letters are bold and evenly spaced. There is a registered trademark symbol to the right of the "s".

### Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

| Manufacturer | Natus Manufacturing Limited | Natus Neurology Incorporated<br>(formerly Carefusion) | Discussion of Differences |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dantec™ DCN | Teca™ Elite | |
| 510(k) number | New Device | K112034 | |
| Product Code | IKT | IKT | |
| Sizes | Length Diameter (mm)<br>25mm 0.30 (30g)<br>25mm 0.46 (26g)<br>37mm 0.46 (26g)<br>50mm 0.46 (26g)<br>75mm 0.64 (23g) | Length Diameter (mm)<br>25mm 0.30 (30g)<br>25mm 0.46 (26g)<br>37mm 0.46 (26g)<br>50mm 0.46 (26g)<br>75mm 0.64 (23g) | Same |
| Internal Insulating<br>polymer coating<br>between the core and<br>lumen | Polyesterimide/Araldite | Polyesterimide | The Dantec™ DCN Disposable<br>Concentric Needle Electrodes and<br>the predicate device Teca™ Elite<br>Disposable Concentric Needles use<br>the same insulating polymer<br>Polyesterimide. The only slight<br>difference is that the Dantec™ DCN<br>uses this in conjunction with Araldite. |
| Tip geometry | Trocar Point | Trocar Point | Same |
| Recording area | Fine gauge = 0.02 mm2<br>Medium gauge = 0.07mm2 | Fine gauge = 0.03 mm2<br>Medium gauge = 0.07mm2 | The Dantec™ DCN Disposable<br>Concentric Needle Electrodes fine<br>gauge needle has a slightly smaller<br>recording area compared to the<br>predicate device Teca™ Elite<br>Disposable Concentric Needles.<br>However, there is no significant<br>difference in performance as it meets<br>the functional criteria of the predicate. |
| Manufacturer | Natus Manufacturing Limited | Natus Neurology Incorporated<br>(formerly Carefusion) | Discussion of Differences |
| Trade Name | DantecTM DCN | TecaTM Elite | |
| 510(k) number | New Device | K112034 | |
| Product Code | IKT | IKT | |
| Connector Type | The shielded reusable needle holder<br>(cable) is a 59 inch (1.5m) cable with<br>an orientation free needle hub. The<br>proximal end has a 5-pin 240° DIN<br>connector which plugs into most EMG<br>instruments. | The shielded reusable needle holder<br>(cable) is a 59 inch (1.5m) cable with an<br>orientation free needle hub. The<br>proximal end has a 5-pin 240° DIN<br>connector which plugs into most EMG<br>instruments. | Same |
| Wiring Method | Detachable Lead Wire | Detachable Lead Wire | Same |
| Provided to the user<br>sterile | Yes | Yes | Same |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterility Assurance<br>Level (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Commercially<br>available, medical<br>grade, packaging | Heat sealed blister pack. | Heat sealed blister pack. | Same |
| Material | Pouch: Tyvek/EVA<br>Protective Tube: Polyethylene | Pouch: Tyvek/EVA<br>Protective Tube: Polyethylene | Same |
| Packaging | Needles shall be individually pouched<br>and packaged 25 needle pouches per<br>box. 20 cartons per shipper box.<br>Min 1 and Max 54 shipper boxes per<br>pallet. 6 Shipper boxes on each level, 3<br>by 2, can be stacked 9 levels high for<br>the sterilization cycle. | Needles shall be individually pouched<br>and packaged 25 needle pouches per<br>box. 20 cartons per shipper box.<br>Min 1 and Max 54 shipper boxes per<br>pallet. 6 Shipper boxes on each level, 3<br>by 2, can be stacked 9 levels high for<br>the sterilization cycle. | Same |
| Shelf life | Three years | Three years | Same |
| Single-Use | Yes | Yes | Same |

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Image /page/8/Picture/0 description: The image shows the word "natus." in a teal sans-serif font. The letters are bold and evenly spaced. There is a registered trademark symbol to the right of the "s".

### Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

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### Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

| Manufacturer | Natus Manufacturing Limited | Natus Neurology Incorporated<br>(formerly Carefusion) | Discussion of Differences | | | | | | | | | | | | | | | | | | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|---------------------------|
| Trade Name | DantecTM DCN | TecaTM Elite | | | | | | | | | | | | | | | | | | | |
| 510(k) number | New Device | K112034 | | | | | | | | | | | | | | | | | | | |
| Product Code | IKT | IKT | | | | | | | | | | | | | | | | | | | |
| Grind Measurements<br>(Pencil Point & Main<br>Bevel) | Characteristic Specification Mean Pencil Point<br>Height (mm) LSL = 0.345<br>USL = 0.377 0.354 Facet Angle<br>(degrees) LSL = 40.0<br>USL = 46.0 44.9 | | | | | | | | | | Characteristic Specification Mean Pencil Point<br>Height (mm) LSL = 0.345<br>USL = 0.377 0.362 Facet Angle<br>(degrees) LSL = 40.0<br>USL = 46.0 44.9 | | | | | | | | | | No significant difference |
| Needle/Hub Tensile | Specification: >6 lbf<br>Results:<br>Mean (lbf)<br>22.7 | Specification: >6 lbf<br>Results:<br>Mean (lbf)<br>19.7 | No significant difference.<br>Results for the DantectTM DCN<br>shows that it meets and exceeds<br>results for the predicate, TecaTM<br>Elite. | | | | | | | | | | | | | | | | | | |
| Hub/Cover tensile | Specification: >1.2kgf<br>Results:<br>Mean (kgf)<br>3.9 | Specification: >1.2kgf<br>Results:<br>Mean (kgf)<br>3.9 | Same | | | | | | | | | | | | | | | | | | |
| Impedance | Specification: <200 K Ohms ( $KΩ$ )<br>Results:<br>All samples pass<br>Attribute data - 100% Pass | Specification: <200 K Ohms ( $KΩ$ )<br>Results:<br>All samples pass<br>Attribute data - 100% Pass | Same | | | | | | | | | | | | | | | | | | |

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### Natus Manufacturing Limited Traditional 510(k) Dantec ™ DCN Disposable Concentric Needle Electrodes

# Summary of Performance Testing-Biocompatibility

Dantec™ DCN Disposable Concentric Needle Electrodes are Invasive Electrodes, classified per ISO 10993-1:2009 as external communicating devices in limited (≤ 24 hours) contact with tissue. Annex A defines that the following evaluation tests need to be considered cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation sensitivity (ISO 10993-10).

The materials used in the Dantec™ DCN Disposable Concentric Needle Electrodes are outlined in Table 5B on the following page.

The Biocompatibility Evaluation testing summarized below was conducted on the Dantec "" DCN Disposable Concentric Needle Electrodes to demonstrate compliance of these materials to the following standards:

- USP (87) Biological Reactivity Tests, In Vitro -- elution test. 2014 ●
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- . ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

Dantec DCN Disposable Concentric Needle Electrodes were tested to conform to USP Endotoxin Reference Standard (USP chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices). The LAL Inhibition and Enhancement testing using the Turbidimetric method was used. The testing demonstrated that the endotoxin levels of three tested lots were below 20 EU/device.

# International Standard BS EN ISO 10993-5: (2009) Biological Evaluation of Medical Devices- Part 5: Tests for in vitro Cytotoxicity

The mean cytotoxicity grade for the extract of the negative control was 0. The extract of the positive control showed evidence of cytotoxicity and had a cytotoxic titre of N/4. The extract of the test item was considered to be non-cytotoxic to L929 cells under the conditions of this test.

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Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

## Intracutaneous (Intradermal) Reactivity Test in the Rabbit

The study was performed to assess the irritancy potential of polar and non-polar extracts of the test item following intradermal injection in the New Zealand White rabbit. Polar and non-polar extracts of the test item meet the requirements of ISO 10993-10:2010

# Local Lymph Node Assay in the Mouse - Polar and Non-Polar Extracts

The results of the tests demonstrated that:

The Polar extract of the test item was considered to be a non-sensitizer under the conditions of the test.

The non-polar extract of the test item was considered to be a non-sensitizer under the conditions of the test.

The polar positive control and non-polar positive control each gave a Stimulation Index of greater than 3.

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| No | Component | Type of contact | | | Material |
|----|--------------------|-----------------|-------|--------|-------------------------------------------|
| | Name | Skin | Blood | Tissue | |
| 1 | Cannula | Y | Y | Y | Stainless Steel |
| 2 | Cannula<br>Coating | Y | Y | Y | Silicone |
| 3 | Colour<br>Cover | Y | N | N | Acrylonitrile-Butadiene-<br>Styrene (ABS) |
| 4 | Hub | N/A | N/A | N/A | Brass, copper/nickel<br>plating |
| 5 | Core<br>Material | Y | Y | Y | Tungsten |
| 6 | Insulator | Y | Y | Y | Polyesterimide/ Araldite |
| 7 | Protective<br>Tube | Y | N | N | Polyethylene |
| 8 | Pouch | Y | N | N | Tyvek |
| 9 | Cartons | Y | N | N | Cardboard |

Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes

# Performance Testing-Bench Testing

Performance Testing was performed on device characteristics of the Dantec™ DCN Disposable Concentric Needle Electrodes. This performance mechanical testing consisted of

- Hub/Cover tensile testing
- Needle/Hub tensile testing ●
- Penetration testing - to measure sliding force
- Tip geometry-grind measurements (Pencil Point & Main Bevel) ●
- Impedance testing -completed to demonstrate that Dantec™ DCN Disposable ● Concentric Needle Electrodes have low impedance

# Conclusion

All performance testing and bench testing conducted as outlined above demonstrate that the device met the performance and design specifications.

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Natus Manufacturing Limited Traditional 510(k) Dantec ™ DCN Disposable Concentric Needle Electrodes

Verification results indicated that Dantec ™ DCN Disposable Concentric Needle Electrodes comply with their predetermined specification and with the applicable Standards detailed below:

- . 21 CFR 820.75 Quality System Requlation - Process Validation
- ISO 2859-1:1999 Sampling Procedures For Inspection By Attributes Part 1: ● Sampling Schemes Indexed By Acceptance Quality Limit (AQL) For Lot-By-Lot Inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
- ISO 10993-1:2009 Biological Evaluation of medical devices Part 1: Evaluation ● and testing
- ISO 10993-5:2009 Biological Evaluation of medical devices Part : Tests for in vitro cytotoxicity
- ASTM F 1980 07-2011 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices

Verification activities were conducted to establish the performance and safety characteristics of the Dantec™ DCN Disposable Concentric Needle Electrodes. The results of these activities demonstrate that the Dantec™ DCN Disposable Concentric Needle Electrodes are safe and effective when use in accordance with the intended use, labelling and Instructions for Use.

Therefore, the Dantec™ DCN Disposable Concentric Needle Electrodes are considered substantially equivalent to the predicate device Teca™ Elite Disposable Concentric Needle Electrodes.