(196 days)
The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
The Allergan Botox Needle Electrode is used in EMG applications to record EMG activity while allowing injection of medication. The Allergan Botox Needle Electrode is a sterile, disposable, monopolar needle electrode with attached lead wire. The needle shaft is insulated so the needle records signals received only from the tip. The needle hub is designed to allow for precise manipulation of the electrode.
The provided text describes a 510(k) premarket notification for the "Allergan Botox Needle Electrode." This document focuses on demonstrating substantial equivalence to a predicate device (K973444 Teca Myoject Disposable Needle Electrode) through non-clinical performance data. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance tests conducted to show the device's functional equivalence and safety/effectiveness compared to its predicate.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional measurement of Needle Electrode – Needle Length | Needle length should be 37.0 ± 1.5mm. | Pass |
| Dimensional measurement of Needle Electrode - Needle Diameter with and without coating | The diameter of the Needle (without PTFE coat) Electrode should be of 27 Gauge (0.40± 0.1mm). The diameter of the Needle with PTFE coating should be between 0.420 to 0.456 mm. | Pass |
| Device Continuity measurement | The resistance between needle tip to the standard 1.5mm connector end should be less than 1.5Ω to allow the biopotential signals. | Pass |
| Biocompatibility Evaluation | Biocompatibility testing per ISO 10993-1, classifying it as an Invasive Electrode, external communicating device in limited (≤ 24 hours) contact with tissue. Tests considered: cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), and Blood Compatibility Hemolysis Test (ISO 10993-4). | Pass |
| Tensile testing | Acceptance Criteria: $>/=22N$ (Needle to Wire Crimp Pull Test). | Pass |
| Penetration testing | Comparative data (Verify that the needle consistently produces the comparative sharpness and frictional force). | Pass |
| Leak Testing | The resistance of the needle should be greater than $10MΩ$ (measured across the needle with probe on the PTFE coating). | Pass |
| Tip geometry measurements | The tip geometry of the Product should be compliant with BS EN ISO 7864:2016 standard (Verified by certificate). | Pass |
| Luer Lock Design | The Luer lock and Luer slip fit syringes should be conform to ISO 594-1 & 594-2 standard (Compliance of certificates for Luer lock and Luer slip fit syringes). | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of units tested) for each non-clinical performance test. It only states "Pass" for each test.
The data provenance is from Natus Manufacturing Limited, Ireland, the manufacturer submitting the 510(k). The tests are non-clinical performance tests, typically conducted in laboratory settings.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a non-clinical performance study of a physical device (needle electrode). The "ground truth" for these tests is established by engineering and quality control standards (e.g., precise measurements, material specifications, mechanical strength tests, and biocompatibility standards like ISO 10993). Therefore, human expert review in the sense of clinical image interpretation or diagnosis is not applicable. The expertise involved would be in manufacturing, quality assurance, materials science, and biomedical engineering.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or subjective assessment that would require adjudication. The tests are objective measurements and compliance checks against established engineering and safety standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This 510(k) submission is for a medical device (a needle electrode), not an AI-powered diagnostic or assistive tool that would involve human readers. The study performed is a non-clinical performance comparison to a predicate device, focusing on physical and functional characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards) for medical devices. For instance, needle length must fall within a specified range, resistance must be below a certain threshold, and materials must demonstrate biocompatibility through standardized tests. It's objective performance against predefined technical criteria rather than subjective clinical "ground truth."
8. The sample size for the training set
Not applicable. This is a 510(k) submission for a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 29, 2018
Natus Manufacturing Limited Martha Kennedy Senior Regulatory Affairs Specialist IDA Business Park Gort, County Galway Ireland
Re: K173815
Trade/Device Name: Allergan Botox Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: May 28, 2018 Received: May 30, 2018
Dear Martha Kennedy:
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 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For 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) K173815
Device Name Allergan Botox Needle Electrode
Indications for Use (Describe)
The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
| 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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natus.
Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode
Section 5: 510(k) Summary
| Manufacturer's Name: | Natus Manufacturing LimitedIDA Business ParkGort, County GalwayIreland |
|---|---|
| Official Correspondent: | Martha KennedySenior Regulatory Affairs SpecialistNatus Manufacturing LimitedIDA Business ParkGort, County GalwayIreland |
| Telephone Number: | +353-(0)91-647433 |
| Fax Number: | +353-(0)91-630050 |
| Summary Date: | 27 June 2018 |
| Trade Names: | Allergan Botox Needle Electrode |
| 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: | K973444 Teca Myoject Disposable Needle Electrode |
| Reference Device: | K161430, MyojectTM Luer Lock Needle Electrodes. Thisreference device has an almost identical indication for use and istechnologically very similar to that of the proposed device. Thedevice is being referenced to demonstrate that the proposed deviceis consistent with current technology. |
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natus.
| Natus Manufacturing LimitedTraditional 510(k)Allergan Botox Needle Electrode | |
|---|---|
| Device Description: | The Allergan Botox Needle Electrode is used in EMG applicationsto record EMG activity while allowing injection of medication.The Allergan Botox Needle Electrode is a sterile, disposable,monopolar needle electrode with attached lead wire. The needleshaft is insulated so the needle records signals received only fromthe tip. The needle hub is designed to allow for precisemanipulation of the electrode. |
| Indications for Use: | The Allergan Botox Needle Electrode are for SINGLE USE ONLYin electromyography (EMG) in situations wherein it is desired toinsert an electrode, in the form of a probe, into a patient to locate aparticular muscle and then inject a medication into that muscle.The hypodermic needle with an open lumen is designed for musclestimulation, motor unit action potential recording and drugdelivery. Once the physician is satisfied with the location, he/sheinjects a drug therein via the lumen of the needle. |
| Comparison: | Table 5A compares the Allergan Botox Needle Electrode to thepredicate device with respect to indications for use, principles ofoperation, technological characteristics, materials, andperformance testing. The comparison of the devices provides moredetailed information regarding the basis for the determination ofsubstantial equivalence. The subject device does not raise any newissues of safety or effectiveness based on the similarities to thepredicate device. |
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Table 5A: Substantial Equivalence Comparison Table
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
|---|---|---|---|
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Labelling | Packaging Labels | Packaging Labels | |
| Indications for Use | The Allergan Botox NeedleElectrode are for SINGLE USEONLY in electromyography (EMG)in situations wherein it is desired toinsert an electrode, in the form of a | The disposable hypodermic monopolarneedles are for SINGLE USE ONLYin electromyography (EMG) insituations wherein it is desired to insertan electrode, in the form of a probe. | Identical other than productname |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| probe, into a patient to locate aparticular muscle and then inject amedication into that muscle. Thehypodermic needle with an openlumen is designed for musclestimulation, motor unit actionpotential recording and drugdelivery. Once the physician issatisfied with the location, he/sheinjects a drug therein via the lumenof the needle. | into a patient to locate a particularmuscle and then inject a medicationinto that muscle. The hypodermicneedle with an open lumen is designedfor muscle stimulation, motor unitaction potential recording and drugdelivery. Once the physician issatisfied with the location, he/sheinjects a drug therein via the lumen ofthe needle. | ||
| PhysicalCharacteristics | Monopolar Needle | Monopolar Needle | Same |
| Connector | Single Contact Touch Proof DIN42802 | Single Contact Touch Proof DIN42802 | Same |
| Material of Needle | Stainless 304 | Stainless 304 | Same |
| Needle Size (mm) | Needle Diameter:0.41 | Needle Diameter:0.300.410.46 | The only diameter of theproposed device is identical toone of the predicate variants |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Needle Coating material | PTFE (Xylon 8820 G4075) | 0.510.71PTFE (Ultralon R-605/T-5) | Review of MSDS sheet and biocompatibility and bench tested have demonstrated the difference does not raise any new issues of safety or effectiveness. |
| Hub | Luer Lock/Slip(Replacement material used to mould the needle hub is now Polypropylene (Exxonmobil) Escorene PP9074 MED | Luer Slip(Original material used to mould the needle hub was Polypropylene (Himont - Legacy company of Lyondell Basell Industries) Pro-Fax 6329 | Review of MSDS sheet and biocompatibility and bench tested have demonstrated the difference does not raise any new issues of safety or effectiveness. |
| Hub Material | Polypropylene (Exxonmobil) Escorene PP9074 MED | Polycarbonate | Review of MSDS sheet and biocompatibility and bench tested have demonstrated the difference does not raise any new issues of safety or effectiveness. |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | new issues of safety or effectiveness. |
| Needle grind angle | 10-16 degrees conical | 10-20 degrees conical | The specification of the proposed device falls within the original specification associated with the predicate device therefore the difference does not raise any new issues of safety or effectiveness. The change does not alter the diagnostic effects of the device |
| Recording area (sqmm) | 0.33 | 0.25 | Slight difference:It is demonstrated in the proposed 510(k) that changes in recording area do not adversely affect the recording properties of the device. |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | Therefore, the physician willhave the necessaryinformation required toproperly evaluate the state ofthe muscle before and afterinjections using the AllerganBotox Needle Electrode.Therefore the difference doesnot raise any new issues ofsafety or effectiveness. |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Length (mm) | 37 | 25, 37, 50, 75, 100 | |
| Connecting lead | 655 ±13mm, Form 'ST' moulded1.5mm touch proof | 14 or 26 inches terminated in a 2mmor touchproof plug | |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | the cable are minor and do notraise new issues of safety andeffectiveness, the cable stillserves the same function asthe predicate device. Inaddition, these changes do notinterfere with the diagnosticfunctioning of the device. |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Sterilization | Supplied sterilized gamma irradiated | Supplied sterilized gamma irradiated | |
| Protective Sheath | Polypropylene Escorene PP9074MED (Exxon Mobil) | Polyethylene | Minor difference:The function of the protectivesheath is to protect the sharpneedle tip in packaging andalso provide safety to userwhen handling the devicebefore and after use. Thematerial for this device haschanged compared to thepredicate device. |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | Review of MSDS sheet andbiocompatibility and benchtested have demonstrated thedifference does not raise anynew issues of safety oreffectiveness. |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Protective Pouch | Tyvek/Mylar | Tyvek/Mylar | |
| Tip geometry | Trocar Point15 degree bevel | Lancet Point | |
| Same | |||
| Both Lancet and Trocargeometries are routinely usedby needle manufacturers inthe Medical Industry. PMSfeedback indicates that Trocarpoint is currently the preferredgeometry for this type ofneedle. | |||
| Change resulted frommodifications to the MyojectNeedle tip geometry enablingimprovements to the Myojecttip sharpness. Bench testing | |||
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| conducted has demonstratedthe difference does not raiseany new issues of safety oreffectiveness. | |||
| Sterility AssuranceLevel (SAL) | 10-6 | 10-6 | SAL remains the same. |
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natus.
27 June 2018
Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode
Nonclinical Performance Data:
| Test | Test MethodSummary | Proposed DeviceBotox needle | K973444PredicateDevice TecaMyojectDisposableNeedleElectrode | Conclusion |
|---|---|---|---|---|
| Dimensionalmeasurement ofNeedle Electrode –Needle Length | Verification ofthe Needlelength usingDigital VernierCaliper in metricunitAcceptanceCriteria:Needle lengthshould be 37.0 ±1.5mm. | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| Dimensionalmeasurement ofNeedle Electrode -Needle Diameterwith and withoutcoating | Verification ofthe Needlediameterwithout PTFEcoating usingDigitalMicrometer inmetric unit.Verify theNeedle diameterwith PTFEcoating using | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| DigitalMicrometer inmetric unit.AcceptanceCriteria:The diameter ofthe Needle(without PTFEcoat) Electrodeshould be of 27Gauge (0.40±0.1mm).The diameter ofthe Needle withPTFE coatingshould bebetween 0.420to 0.456 mm. | ||||
| Device Continuitymeasurement | Verify theresistancebetween needletip to 1.5mmtouch proofconnector endusing a DigitalMultimeter inresistance mode.Record themeasurement. | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| Acceptancecriteria:The resistancebetween needletip to thestandard 1.5mmconnector endshould be lessthan 1.5Ω toallow thebiopotentialsignals | ||||
| BiocompatibilityEvaluation | Biocompatibilitytesting per ISO10993-1. TheNeedleElectrode is anInvasiveElectrode,classified perISO 10993-1:2009 asexternalcommunicatingdevice in limited(≤ 24 hours)contact withtissue. Annex Adefines that thefollowingevaluation testsneed to beconsideredcytotoxicity(ISO 10993-5) | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| (ISO 10993-10)and irritationsensitivity (ISO10993-10) andBloodCompatibilityHemolysis Test(ISO 10993-4). | ||||
| Tensile testing | Needle to WireCrimp Pull Test.AcceptanceCriteria:$>/=22N$ | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| Penetration testing | Verify that theneedleconsistentlyproduces thecomparativesharpness andfrictional force.AcceptanceCriteria:Comparativedata | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| Leak Testing | Using theDigital Multi-meter, measurethe resistance | Pass | Pass | Conclusion: |
| across theneedle (probe onthe PTFEcoating)Acceptancecriteria:The resistanceof the needleshould begreater than$10MΩ$ . | SubstantiallyEquivalent toPredicate | |||
| Tip geometrymeasurements | Verify BS ENISO 7864certificate forthe tip geometryof the needleelectrode.AcceptanceCriteria:The tipgeometry of theProduct shouldbe compliantwith BS EN ISO7864:2016standard | Pass | Pass | Conclusion:SubstantiallyEquivalent toPredicate |
| Luer Lock Design | ISO-594-1 &594-2compliance of | Pass | Pass | Conclusion: |
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Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode
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Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode
| certificates forLuer lock andLuer slip fitsyringes forBotoxHypodermicInjection NeedleElectrode.AcceptanceCriteria:The Luer lockand Luer slip fitsyringes shouldbe conform toISO 594-1 &594-2 standard. | SubstantiallyEquivalent toPredicate | |
|---|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | --------------------------------------------- |
It has been demonstrated in this 510(k) submission that the differences between the Allergan Botox Needle Electrode and the predicate device do not raise any questions regarding its safety and effectiveness. Natus completed a number of non-clinical performance tests to demonstrate that the device is as safe and effective as the predicate device and that substantial equivalence to the predicate device that is subject to this 510(k) submission can be claimed. The Allergan Botox Needle Electrode meets all the requirements for overall design, sterilization and biocompatibility confirming that the design output meets the design inputs and specifications for the device.
The Allergan Botox Needle Electrode passed all the testing in accordance with internal requirements, national standards, and international standards shown in the table above to support substantial equivalence of the subject device.
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| Statement ofSubstantial Equivalence: | The Allergan Botox Needle Electrode is determined to besubstantially equivalent to the device cleared under K973444 as ispresented above in Table 5A Substantial Equivalence ComparisonTable. |
|---|---|
| The Allergan Botox Needle Electrode is determined to besubstantially equivalent to the predicate device as it has the sameintended use and similar technological characteristics as thepreviously cleared predicate devices. The Allergan Botox NeedleElectrode is determined to be substantially equivalent to thepredicate device. |
§ 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).