(270 days)
Not Found
No
The summary describes a physical electrode device for recording biopotential signals and mentions only mechanical and biocompatibility testing, with no indication of software processing or AI/ML algorithms.
No
The device is used for recording and monitoring biopotential signals (diagnostic), not for treating a condition (therapeutic).
Yes
The device is described as being intended for "stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals," which are used for diagnostic purposes in electromyography.
No
The device description clearly states it is a physical needle electrode consisting of an insulated core wire inside a stainless steel cannula, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals." This involves interacting directly with the patient's body to measure electrical activity.
- Device Description: The device is described as an "electrical bipolar recording device for use in electromyography," consisting of a needle electrode designed for insertion.
- Lack of IVD Characteristics: An IVD is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological or pathological state. This device does not perform such analysis on specimens.
The Dantec™ DCN Disposable Concentric Needle Electrode is a device used for in vivo (within the body) measurement of electrical signals.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IKT
Device Description
The Dantec™ DCN Disposable Concentric Needle Electrodes are designed as an electrical bipolar recording device for use in electromyography. The Dantec™ DCN Disposable Concentric Needle Electrode consists of an insulated core wire located inside a stainless steel cannula. The hub has a raised bevel indicator, allowing the user to always know the direction of the recording surface. A coaxial hub allows easy connection between needle and the electrode cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and clinical use under the supervision of a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
• Hub/Cover tensile testing
• Needle/Hub tensile testing
• Penetration testing – to measure sliding force
• Tip geometry-grind measurements (Pencil Point & Main Bevel)
• Impedance testing –needle electrodes should have low impedance
Summary of Performance Testing-Biocompatibility
Tests conducted:
- 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 Transfusion and Infusion Assemblies and Similar Medical Devices). The LAL Inhibition and Enhancement testing using the Turbidimetric method was used.
- Intracutaneous (Intradermal) Reactivity Test in the Rabbit
- Local Lymph Node Assay in the Mouse - Polar and Non-Polar Extracts
Key Results:
- The endotoxin levels of three tested lots were below 20 EU/device.
- The extract of the test item for cytotoxicity was considered to be non-cytotoxic to L929 cells under the conditions of this test.
- Polar and non-polar extracts of the test item meet the requirements of ISO 10993-10:2010 for intracutaneous reactivity.
- 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.
Performance Testing-Bench Testing:
- Hub/Cover tensile testing (Mean (kgf): 3.9, Specification: >1.2kgf)
- Needle/Hub tensile testing (Mean (lbf): 22.7, Specification: >6 lbf)
- Penetration testing – to measure sliding force (Not detailed further than successful completion)
- Tip geometry-grind measurements (Pencil Point & Main Bevel) (Pencil Point Height (mm): 0.354 (LSL = 0.345, USL = 0.377), Facet Angle (degrees): 44.9 (LSL = 40.0, USL = 46.0))
- Impedance testing (All samples pass, Specification:
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
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).(b)
Classification. Class II (performance standards).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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. 353 091 630050 fax.
Section 5: 510(k) Summary
| Manufacturer's Name: | Natus Manufacturing Limited
IDA Business Park
Gort, County Galway
Ireland |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Michael Galvin
Manager, Quality and Regulatory Affairs
Natus Manufacturing Limited
IDA Business Park
Gort, County Galway
Ireland |
| Telephone Number: | +353-(0)91-647451 |
| Fax Number: | +353-(0)91-630050 |
| 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
Electrodes |
| Device Description: | The Dantec™ DCN Disposable Concentric Needle
Electrodes are designed as an electrical bipolar recording
device for use in electromyography.
The Dantec™ DCN Disposable Concentric Needle Electrode
consists of an insulated core wire located inside a stainless
steel cannula. The hub has a raised bevel indicator, allowing
the user to always know the direction of the recording
surface.
A coaxial hub allows easy connection between needle and
the electrode cable. |
| 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. |
| Technological
Comparison: | Dantec™ DCN Disposable Concentric Needle Electrodes
employ the same technological characteristics as the
predicate device. |
| Nonclinical Tests: | Mechanical testing:
• Hub/Cover tensile testing
• Needle/Hub tensile testing
• Penetration testing – to measure sliding force
• Tip geometry-grind measurements (Pencil Point &
Main Bevel)
• Impedance testing –needle electrodes should have
low impedance |
| Substantial | |
4
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
5
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
(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
(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)
25mm 0.30 (30g)
25mm 0.46 (26g)
37mm 0.46 (26g)
50mm 0.46 (26g)
75mm 0.64 (23g) | Length Diameter (mm)
25mm 0.30 (30g)
25mm 0.46 (26g)
37mm 0.46 (26g)
50mm 0.46 (26g)
75mm 0.64 (23g) | Same |
| Internal Insulating
polymer coating
between the core and
lumen | Polyesterimide/Araldite | Polyesterimide | The Dantec™ DCN Disposable
Concentric Needle Electrodes and
the predicate device Teca™ Elite
Disposable Concentric Needles use
the same insulating polymer
Polyesterimide. The only slight
difference is that the Dantec™ DCN
uses this in conjunction with Araldite. |
| Tip geometry | Trocar Point | Trocar Point | Same |
| Recording area | Fine gauge = 0.02 mm2
Medium gauge = 0.07mm2 | Fine gauge = 0.03 mm2
Medium gauge = 0.07mm2 | The Dantec™ DCN Disposable
Concentric Needle Electrodes fine
gauge needle has a slightly smaller
recording area compared to the
predicate device Teca™ Elite
Disposable Concentric Needles.
However, there is no significant
difference in performance as it meets
the functional criteria of the predicate. |
| Manufacturer | Natus Manufacturing Limited | Natus Neurology Incorporated
(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
(cable) is a 59 inch (1.5m) cable with
an orientation free needle hub. The
proximal end has a 5-pin 240° DIN
connector which plugs into most EMG
instruments. | The shielded reusable needle holder
(cable) is a 59 inch (1.5m) cable with an
orientation free needle hub. The
proximal end has a 5-pin 240° DIN
connector which plugs into most EMG
instruments. | Same |
| Wiring Method | Detachable Lead Wire | Detachable Lead Wire | Same |
| Provided to the user
sterile | Yes | Yes | Same |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterility Assurance
Level (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Commercially
available, medical
grade, packaging | Heat sealed blister pack. | Heat sealed blister pack. | Same |
| Material | Pouch: Tyvek/EVA
Protective Tube: Polyethylene | Pouch: Tyvek/EVA
Protective Tube: Polyethylene | Same |
| Packaging | Needles shall be individually pouched
and packaged 25 needle pouches per
box. 20 cartons per shipper box.
Min 1 and Max 54 shipper boxes per
pallet. 6 Shipper boxes on each level, 3
by 2, can be stacked 9 levels high for
the sterilization cycle. | Needles shall be individually pouched
and packaged 25 needle pouches per
box. 20 cartons per shipper box.
Min 1 and Max 54 shipper boxes per
pallet. 6 Shipper boxes on each level, 3
by 2, can be stacked 9 levels high for
the sterilization cycle. | Same |
| Shelf life | Three years | Three years | Same |
| Single-Use | Yes | Yes | Same |
8
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
9
Natus Manufacturing Limited Traditional 510(k) Dantec™ DCN Disposable Concentric Needle Electrodes
| Manufacturer | Natus Manufacturing Limited | Natus Neurology Incorporated
(formerly Carefusion) | Discussion of Differences | | | | | | | | | | | | | | | | | | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|---------------------------|
| Trade Name | DantecTM DCN | TecaTM Elite | | | | | | | | | | | | | | | | | | | |
| 510(k) number | New Device | K112034 | | | | | | | | | | | | | | | | | | | |
| Product Code | IKT | IKT | | | | | | | | | | | | | | | | | | | |
| Grind Measurements
(Pencil Point & Main
Bevel) | Characteristic Specification Mean Pencil Point
Height (mm) LSL = 0.345
USL = 0.377 0.354 Facet Angle
(degrees) LSL = 40.0
USL = 46.0 44.9 | | | | | | | | | | Characteristic Specification Mean Pencil Point
Height (mm) LSL = 0.345
USL = 0.377 0.362 Facet Angle
(degrees) LSL = 40.0
USL = 46.0 44.9 | | | | | | | | | | No significant difference |
| Needle/Hub Tensile | Specification: >6 lbf
Results:
Mean (lbf)
22.7 | Specification: >6 lbf
Results:
Mean (lbf)
19.7 | No significant difference.
Results for the DantectTM DCN
shows that it meets and exceeds
results for the predicate, TecaTM
Elite. | | | | | | | | | | | | | | | | | | |
| Hub/Cover tensile | Specification: >1.2kgf
Results:
Mean (kgf)
3.9 | Specification: >1.2kgf
Results:
Mean (kgf)
3.9 | Same | | | | | | | | | | | | | | | | | | |
| Impedance | Specification: 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.
11
Image /page/11/Picture/0 description: The image shows the word "natus" in a sans-serif font. The word is teal in color. There is a registered trademark symbol to the right of the "s".
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.
12
| No | Component | Type of contact | Material | ||
|---|---|---|---|---|---|
| Name | Skin | Blood | Tissue | ||
| 1 | Cannula | Y | Y | Y | Stainless Steel |
| 2 | Cannula | ||||
| Coating | Y | Y | Y | Silicone | |
| 3 | Colour | ||||
| Cover | Y | N | N | Acrylonitrile-Butadiene- | |
| Styrene (ABS) | |||||
| 4 | Hub | N/A | N/A | N/A | Brass, copper/nickel |
| plating | |||||
| 5 | Core | ||||
| Material | Y | Y | Y | Tungsten | |
| 6 | Insulator | Y | Y | Y | Polyesterimide/ Araldite |
| 7 | Protective | ||||
| 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.
13
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.