(270 days)
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.
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.
Acceptance Criteria and Device Performance Study for Dantec™ DCN Disposable Concentric Needle Electrodes
This document describes the acceptance criteria and the study proving that the Dantec™ DCN Disposable Concentric Needle Electrodes meet these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dantec™ DCN Disposable Concentric Needle Electrodes are primarily demonstrated through equivalence to the predicate device (K112034 Teca™ Elite Disposable Concentric Needle Electrodes) and successful completion of various performance tests.
| Acceptance Criterion | Predicate Device Specification (K112034 Teca™ Elite) | Dantec™ DCN Performance | Discussion of Equivalence/Compliance |
|---|---|---|---|
| Material | |||
| Core Material | Tungsten | Tungsten | Same |
| Low Friction Lubricant | Silicone | Silicone | Same |
| Cannula | Stainless Steel | Stainless Steel | Same |
| Internal Insulating Polymer Coating (Core to Lumen) | Polyesterimide | Polyesterimide/Araldite | Dantec™ DCN uses Polyesterimide with Araldite, still considered equivalent. |
| Physical Dimensions | |||
| Length Diameter (mm) | 25mm 0.30 (30g), 25mm 0.46 (26g), 37mm 0.46 (26g), 50mm 0.46 (26g), 75mm 0.64 (23g) | 25mm 0.30 (30g), 25mm 0.46 (26g), 37mm 0.46 (26g), 50mm 0.46 (26g), 75mm 0.64 (23g) | Same |
| Tip geometry | Trocar Point | Trocar Point | Same |
| Recording Area | Fine gauge = 0.03 mm², Medium gauge = 0.07mm² | Fine gauge = 0.02 mm², Medium gauge = 0.07mm² | Fine gauge is slightly smaller but meets functional criteria, demonstrating no significant difference. |
| Mechanical Properties | |||
| Hub/Cover Tensile | Specification: >1.2 kgf, Mean: 3.9 kgf | Specification: >1.2 kgf, Mean: 3.9 kgf | Same |
| Needle/Hub Tensile | Specification: >6 lbf, Mean: 19.7 lbf | Specification: >6 lbf, Mean: 22.7 lbf | Exceeds predicate results, demonstrating no significant difference. |
| Penetration Testing | (Implicit: Demonstrates acceptable sliding force) | (Result not explicitly quantified in table, but stated as performed) | Stated that testing was performed, implying satisfactory results to deem equivalence. |
| Electrical Properties | |||
| Impedance | Specification: <200 K Ohms ($KΩ$), 100% Pass | Specification: <200 K Ohms ($KΩ$), 100% Pass | Same |
| Tip Geometry - Grind Measurements | |||
| Pencil Point Height (mm) | LSL = 0.345, USL = 0.377, Mean: 0.362 | LSL = 0.345, USL = 0.377, Mean: 0.354 | No significant difference |
| Facet Angle (degrees) | LSL = 40.0, USL = 46.0, Mean: 44.9 | LSL = 40.0, USL = 46.0, Mean: 44.9 | No significant difference |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | No cytotoxic effect | Non-cytotoxic to L929 cells | Complies with standard |
| Sensitization (ISO 10993-10) | Non-sensitizer effect | Non-sensitizer (Polar and Non-Polar extracts) | Complies with standard |
| Irritation (ISO 10993-10) | Meets requirements | Meets requirements (polar and non-polar extracts) | Complies with standard |
| Endotoxin Levels (USP <161>) | <20 EU/device | Below 20 EU/device (3 lots tested) | Complies with standard |
| Sterilization & Packaging | |||
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterility Assurance Level (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Shelf Life | Three years | Three years | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several non-clinical tests to demonstrate device performance and substantial equivalence.
- Mechanical Testing (Hub/Cover tensile, Needle/Hub tensile, Impedance):
- Sample Size: For Needle/Hub tensile, performance results show a "Mean (lbf)" suggesting multiple samples were tested, but the exact number is not explicitly stated. For Impedance, "All samples pass" indicates that multiple samples were tested, and "Attribute data - 100% Pass" implies a robust assessment.
- Data Provenance: The tests were conducted by Natus Manufacturing Limited as part of the 510(k) submission for a new device. This represents prospective testing of the manufactured device. The country of origin for the data is Ireland, where Natus Manufacturing Limited is located.
- Tip Geometry-Grind Measurements:
- Sample Size: Similar to tensile testing, "Mean" values for Pencil Point Height and Facet Angle suggest multiple units were measured, but the specific number is not provided.
- Data Provenance: Prospective testing conducted by Natus Manufacturing Limited (Ireland).
- Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Endotoxin):
- Sample Size: For Endotoxin levels, "three tested lots" were evaluated. For other biocompatibility tests, the sample size (number of devices or extract samples) is not explicitly stated but implied to be sufficient for standard ISO 10993 testing.
- Data Provenance: Prospective testing conducted according to ISO 10993 series standards, likely by a certified lab. The provenance is associated with the test sponsor, Natus Manufacturing Limited (Ireland).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (disposable concentric needle electrodes) does not typically involve human expert interpretation of results to establish "ground truth" in the way image analysis or diagnostic algorithms do. The performance is assessed against engineering specifications, material properties, and biological safety standards. Therefore, the concept of "experts establishing ground truth" in a clinical/interpretive sense is not applicable here.
Instead, the "ground truth" is derived from:
- Established international standards (e.g., ISO 10993 for biocompatibility, ASTM F 1980 for aging).
- Engineering specifications for mechanical and electrical properties.
- Material science principles for component selection.
- Predicate device characteristics for demonstrating substantial equivalence.
The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at Natus Manufacturing Limited, along with personnel at independent testing laboratories, who are qualified in their respective fields to design, conduct, and interpret these types of tests against the established standards and specifications.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or performance evaluations where there can be inter-reader variability in interpreting diagnostic results, often involving human readers and a gold standard. Since the tests described are primarily bench testing and biocompatibility evaluations against predefined acceptance criteria and standards, a formal adjudication method for the "test set" is not relevant. The results are quantitative measurements or qualitative compliance assessments against specified thresholds or documented standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging or similar interpretive tasks. The Dantec™ DCN Disposable Concentric Needle Electrode is a medical device for recording biopotential signals (EMG, nerve potential) and its performance is evaluated through physical, electrical, and biological safety testing, not through human interpretation of cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This also relates to AI/software as a medical device. The Dantec™ DCN is a physical needle electrode, not an algorithm. Its function is to acquire signals, not to interpret them or provide diagnostic output independently.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the Dantec™ DCN Disposable Concentric Needle Electrodes consists of:
- Engineering Specifications and Design Requirements: These are the predefined performance targets for mechanical strength, electrical impedance, and physical dimensions established during the device design phase.
- Applicable International and National Standards: Including ISO 10993 series for biocompatibility, USP <161> for endotoxin, ISO 2859-1 for sampling, and ASTM F 1980 for accelerated aging. Compliance with these standards serves as a form of ground truth for safety and performance.
- Predicate Device Characteristics: For many aspects (materials, dimensions, sterilization, intended use), the characteristics and established performance of the legally marketed predicate device (K112034 Teca™ Elite Disposable Concentric Needle Electrodes) serve as the "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
The concept of a "training set" is usually applicable to machine learning algorithms. Since the Dantec™ DCN Disposable Concentric Needle Electrodes are a physical medical device and not an AI/ML algorithm, there is no training set in this context. The manufacturing process and device design are optimized through engineering principles, quality control, and adherence to established standards, rather than through iterative training with a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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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
{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
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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. 353 091 630050 fax.
Section 5: 510(k) Summary
| Manufacturer's Name: | Natus Manufacturing LimitedIDA Business ParkGort, County GalwayIreland |
|---|---|
| Official Correspondent: | Michael GalvinManager, Quality and Regulatory AffairsNatus Manufacturing LimitedIDA Business ParkGort, County GalwayIreland |
| 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 NeedleElectrodes |
| Device Description: | The Dantec™ DCN Disposable Concentric NeedleElectrodes are designed as an electrical bipolar recordingdevice for use in electromyography.The Dantec™ DCN Disposable Concentric Needle Electrodeconsists of an insulated core wire located inside a stainlesssteel cannula. The hub has a raised bevel indicator, allowingthe user to always know the direction of the recordingsurface.A coaxial hub allows easy connection between needle andthe electrode cable. |
| Intended Use: | Dantec™ DCN Disposable Concentric Needle Electrodesare intended for use with recording, monitoring andstimulation/recording equipment for the stimulation/recordingof biopotential signals including electromyograph (EMG) andnerve potential signals. |
| TechnologicalComparison: | Dantec™ DCN Disposable Concentric Needle Electrodesemploy the same technological characteristics as thepredicate 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 havelow 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(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 Insulatingpolymer coatingbetween the core andlumen | Polyesterimide/Araldite | Polyesterimide | The Dantec™ DCN DisposableConcentric Needle Electrodes andthe predicate device Teca™ EliteDisposable Concentric Needles usethe same insulating polymerPolyesterimide. The only slightdifference is that the Dantec™ DCNuses this in conjunction with Araldite. |
| Tip geometry | Trocar Point | Trocar Point | Same |
| Recording area | Fine gauge = 0.02 mm2Medium gauge = 0.07mm2 | Fine gauge = 0.03 mm2Medium gauge = 0.07mm2 | The Dantec™ DCN DisposableConcentric Needle Electrodes finegauge needle has a slightly smallerrecording area compared to thepredicate device Teca™ EliteDisposable Concentric Needles.However, there is no significantdifference in performance as it meetsthe 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 withan orientation free needle hub. Theproximal end has a 5-pin 240° DINconnector which plugs into most EMGinstruments. | The shielded reusable needle holder(cable) is a 59 inch (1.5m) cable with anorientation free needle hub. Theproximal end has a 5-pin 240° DINconnector which plugs into most EMGinstruments. | Same |
| Wiring Method | Detachable Lead Wire | Detachable Lead Wire | Same |
| Provided to the usersterile | Yes | Yes | Same |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterility AssuranceLevel (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Commerciallyavailable, medicalgrade, packaging | Heat sealed blister pack. | Heat sealed blister pack. | Same |
| Material | Pouch: Tyvek/EVAProtective Tube: Polyethylene | Pouch: Tyvek/EVAProtective Tube: Polyethylene | Same |
| Packaging | Needles shall be individually pouchedand packaged 25 needle pouches perbox. 20 cartons per shipper box.Min 1 and Max 54 shipper boxes perpallet. 6 Shipper boxes on each level, 3by 2, can be stacked 9 levels high forthe sterilization cycle. | Needles shall be individually pouchedand packaged 25 needle pouches perbox. 20 cartons per shipper box.Min 1 and Max 54 shipper boxes perpallet. 6 Shipper boxes on each level, 3by 2, can be stacked 9 levels high forthe 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(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 & MainBevel) | Characteristic Specification Mean Pencil PointHeight (mm) LSL = 0.345USL = 0.377 0.354 Facet Angle(degrees) LSL = 40.0USL = 46.0 44.9 | Characteristic Specification Mean Pencil PointHeight (mm) LSL = 0.345USL = 0.377 0.362 Facet Angle(degrees) LSL = 40.0USL = 46.0 44.9 | No significant difference | ||||||||||||||||||
| Needle/Hub Tensile | Specification: >6 lbfResults:Mean (lbf)22.7 | Specification: >6 lbfResults:Mean (lbf)19.7 | No significant difference.Results for the DantectTM DCNshows that it meets and exceedsresults for the predicate, TecaTMElite. | ||||||||||||||||||
| Hub/Cover tensile | Specification: >1.2kgfResults:Mean (kgf)3.9 | Specification: >1.2kgfResults:Mean (kgf)3.9 | Same | ||||||||||||||||||
| Impedance | Specification: <200 K Ohms ( $KΩ$ )Results:All samples passAttribute data - 100% Pass | Specification: <200 K Ohms ( $KΩ$ )Results:All samples passAttribute 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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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.
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| No | Component | Type of contact | Material | ||
|---|---|---|---|---|---|
| Name | Skin | Blood | Tissue | ||
| 1 | Cannula | Y | Y | Y | Stainless Steel |
| 2 | CannulaCoating | Y | Y | Y | Silicone |
| 3 | ColourCover | Y | N | N | Acrylonitrile-Butadiene-Styrene (ABS) |
| 4 | Hub | N/A | N/A | N/A | Brass, copper/nickelplating |
| 5 | CoreMaterial | Y | Y | Y | Tungsten |
| 6 | Insulator | Y | Y | Y | Polyesterimide/ Araldite |
| 7 | ProtectiveTube | 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.
§ 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).